FCS THE MAGAZINE
A S E P T E T O F PAT E L S » CA R E M A N AG E M E N T
Former patient Skipper Rodgers and family.
FCS Senior Management Team: Front Row: Stephanie Ertel, Katie Goodman, Nicole Picazio, Rich Dyson, Sarah Cevallos, Brad Prechtl, Shelly Glenn, Michael Essik, Melody Chang; Second Row: David Curry, Melisa Chandler, Christy Banach, Sam Watkins, Inga Gonzalez, Claudia French, Lynn Sawyer, Ray Bailey, Sue Kearney, Denice Veatch;Third (back) Row: Don Champlain, Mark Moch, Levester Jones, Eric Grindstaff, Jeff Rubin, Todd Schonherz
Thank you for your continued dedication! The FCS Senior Management team thanks every Thank You for Your Continued Support team member putting Your actions andfor thealways dedication you our patients show our patients makea success. firsttoand making are ourwhat practice Florida Cancer Specialists a successful Warmest wishes for the holiday season to all of organization. Thank you! you and your families!
in this issue
DEPARTMENTS 6 FCS News 26 FCS Events 30 FCS Volunteer Program 40 Get to Know Dr. Matthew Fink 46 Pink Day at FCS! 47 The Path Lab
SPOTLIGHTS 20 Administrative Spotlight: SHELLY GLENN
FEATURES 12 A Septet of Patels
Office Spotlight: GAINESVILLE
Nurse Spotlight: MELODY ANDERSON, R.N.
A Value Proposition
Doctor Spotlight: DR. LEE ZEHNGEBOT
Better speed, better accuracy
Correction – Please note in the Summer 2016 issue of FCS The Magazine, it was stated that Charles Able was the former Director of Physics. Charles Able is the (current) Director of Physics. We apologize for the inadvertent error.
FCS The Magazine
Brad Prechtl Dear Colleagues, In June of 2016, the Center for Medicare & Medicaid Innovation announced a select list of oncology practices in the country were chosen to participate in the Oncology Care Model (OCM), an innovative new care delivery model that supports and encourages higher quality, more coordinated cancer care for patients undergoing chemotherapy. Florida Cancer Specialists is proud to be among the practices chosen to pilot this new initiative. Participation in this initiative will reinforce our commitment to continually improving both the quality and value of the care we provide. With more than 1.6 million people diagnosed each year, cancer is one of the most common diseases in the United States. The majority of those diagnosed are Medicare beneficiaries. At FCS, all patients with traditional Medicare Part A and Part B undergoing active treatment for cancer will be participating in the Oncology Care Model. This initiative’s cornerstone is our Care Management Program. Associate Director Don Champlain oversees the program and ensures there is a seamless and collaborative effort between FCS physicians, physician extenders, nurses, Financial Counselors and other staff within FCS. In addition to the services the patient receives today, each OCM patient is assigned a Care Manager (nurse) and will have access to 24/7 support from the Care Management team. Over the past few months, we have hired or transferred additional personnel to the Care Management team to ensure that our patients will realize the full benefit of the OCM. FCS currently has over 40 nurses and support staff serving on the Care Management team to provide centralized care coordination and management services. Working together, we can achieve our overarching goal of improving overall quality of care by helping to manage side effects, reduce unnecessary emergency room visits and decrease hospitalizations of our patients. You may contact the Care Management team at 855-327-6112 or email at [email protected]
Participating in the Oncology Care Model requires an extra effort on everyone’s part. We understand that every patient’s case is unique and we often encounter situations that call for an innovative solution. I am confident that together, we will set a national benchmark for community oncology. Thanks to you, in advance, for helping make the Oncology Care Model a success in our practice and for our patients. Brad Prechtl CEO
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FCS THE MAGAZINE PHYSICIAN LEADERSHIP PRESIDENT
WILLIAM N. HARWIN, M.D. ASSISTANT MANAGING PARTNER, DIRECTOR, EXECUTIVE BOARD
~SAV E T H E DAT E~ FCS FOUNDATION CHAIRMAN: BRAD PRECHTL HONORARY CHAIRS: DR. SCOTT LUNIN, DR. JANICE EAKLE & DR. FADI K AYALI INVITE YOU TO
STEPHEN V. ORMAN, M.D.
DIRECTOR OF PATIENT ADVOCACY, DIRECTOR, EXECUTIVE BOARD
MICHAEL DIAZ, M.D.
SCIENTIFIC DIRECTOR OF CLINICAL RESEARCH, DIRECTOR, DRUG DEVELOPMENT PROGRAM
LOWELL L. HART, M.D.
DIRECTOR OF RESEARCH OPERATIONS
JAMES A. REEVES, JR., M.D.
EXECUTIVE MANAGEMENT CHIEF EXECUTIVE OFFICER
CHIEF OPERATING OFFICER
TODD SCHONHERZ GENERAL COUNSEL
CHIEF MARKETING & SALES OFFICER
CHIEF REVENUE CYCLE OFFICER
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news FCS Adds to its Roster of Outstanding Physicians FCS has welcomed a number of physicians to the practice in recent weeks. They include:
Outstanding Teacher Dr. David Molthrop
• Dr. Alexander Glick, a hospitalist who sees FCS patients who require hospitalization. He has privileges at three Charlotte County hospitals: Fawcett Memorial, Bayfront Port Charlotte and Bayfront Punta Gorda. • Dr. Renjitha Ignatius, who has been with FCS, is now seeing patients part-time at the hospital in Riverview and part-time in the FCS Sun City office.
Dr. Alexander Glick
Dr. Renjitha Ignatius
Dr. Jay Avashia
• Dr. Estrella Carballido, who sees patients at three FCS locations in Lee County: the Gladiolus Cancer Center, the Cape Coral Cay West office and the Colonial office. Dr. Susan Ross
Dr. Estella Carballido
Dr. Ayman Barakat
• Dr. Muhammed Imam and Dr. Yaman Suleiman, who see patients in the Orlando Orange office of FCS.
Dr. Muhammad Imam
Dr. Yaman Suleiman
Dr. Kevin Koehler
• Dr. Raymond Esper, who sees patients at two Southwest Florida locations: the Cape Coral Cay West office and the Gladiolus office.
Dr. Padmaja Sai Chosen for “Heart & Soul” Award Dr. Padmaja Sai, who practices at the FCS office in Palm Coast, received top honors in the annual Reader’s Choice Awards for the Daytona Beach News Journal.
• Dr. Hugo Davila, the first FCS Urologist, sees patients in his Sebastian and Vero Beach offices. • Dr. Craig Reynolds, who sees patients at the Ocala office of FCS.
Dr. Lalit Aneja
“We are pleased to have all of these skilled and experienced physicians join the FCS family,” said FCS CEO Brad Prechtl. “Together, they will bring added convenience to our patients throughout the state of Florida.”
FCS The Magazine
Dr. Raymond Esper
Dr. Hugo Davila
Readers nominated their favorite “Top Doctor” and Dr. Sai was among the 24 area physicians recognized. Further, she also received one of the three highest awards – The Heart & Soul Award – for her remarkable rapport with patients. Congratulations to Dr. Sai!
Left to right: Dr. Padmaja Sai, Dr. Jeffery Smith and Dr. Delicia Haynes
Tampa Patients & Children Enjoy Movies at One Buc Place Patients from Hillsborough and Pinellas counties and their children recently attended a special movie screening of “Home,” an animated tale of a lovable alien and his adventures with an earthling teenager. The families were treated to lunch at One Buc Place, the training facility of the Tampa Bay Buccaneers, before viewing the movie.
✚ Dr. Craig Reynolds
Dr. David Molthrop Named Outstanding Teacher by Residency Program The Internal Medicine Residency Program of the Central Florida Division of Florida Hospital has named Dr. David Molthrop as one of its Outstanding Teachers of the Year. Dr. Molthrop, who practices in the Orlando Orange and Winter Park locations of FCS, received the award at the 2016 Residency Graduation ceremonies, held in Orlando.
• Dr. Kevin Koehler, who sees patients at FCS’ Downtown Sarasota office. • Dr. Lalit Aneja, who will see patients at two FCS locations in Sarasota County: the Venice Healthpark office and the Englewood office.
FCS Physicians Participate in “Stand Up to Cancer” The 2016 Stand Up to Cancer television special raised over $111 million in pledged donations to help fund cancer research. The telecast, which aired simultaneously on 60 networks and streaming services in the United States and Canada, included several interviews with FCS physicians on local stations. Drs. Shachar Peles (West Palm Beach), Scott Tetreault (Tallahassee) and Sumithra Vattigunta-Gopal (West Palm Beach) were invited to appear on the telecast to inform viewers about the importance of clinical trials research across Florida.
• Dr. Jay Avashia and Dr. Susan Ross, who are enabling FCS to add three new clinical sites to its network: Davenport, Lake Wales and Poinciana.
• Dr. Ayman Barakat, who sees patients at two locations in Hernando County: the Brooksville office and the County Line Road office.
FCS Selects Pump for Use at its Infusion Centers In September, FCS selected the ZynoFlo Z-800WF infusion pumps for all of our treatment locations. FCS COO Todd Schonherz said, “We are excited to implement the most current generation of infusion technology at FCS. It represents our continued commitment to invest in the best technology tools available to serve our patients. Our decision was based on a comprehensive RFP process followed by month-long trials with the leading vendors.”
news FCS and NFL’s Tampa Bay Buccaneers Renew Partnership FCS has renewed its partnership with the Tampa Bay Buccaneers with a multi-year deal.
“The work being performed by FCS in research and treatment of cancer is making a real difference in the lives of so many here in the Bay Area and throughout our state,” said Buccaneers Chief Operating Officer Brian Ford. “The Buccaneers are proud and excited to renew our partnership with Florida Cancer Specialists as they continue in their mission to provide world-class cancer care.” FCS CEO Brad Prechtl said, “The Tampa Bay Buccaneers have been a great partner for FCS in many ways, including having players participate in our patient appreciation events. As a communitybased oncology practice, we also are grateful that the Buccaneers get so involved in recognizing and supporting our patients in local communities at special events such as the annual Breast Cancer Awareness Game. We are looking forward to continuing our partnership with this great organization.” From left to right: Joe Catti, CEO FineMark Bank; Mark Stevens, Builder; Lee Woods, Architect; Todd Schonherz, FCS COO; Randy Henderson, Mayor; William Harwin, MD, FCS Founder & President; Frank Rodriguez, MD; Brad Prechtl, FCS CEO; Syed Zafar, MD; Raymond Esper, MD; Shelly Glenn, FCS Chief Marketing & Sales Officer
FCS Celebrates Opening of Signature Center in Fort Myers FCS was proud to celebrate the opening of a new signature cancer center, located at 8260 Gladiolus Drive in Fort Myers. At 27,000 square feet, the Gladiolus Cancer Center is a multi-million-dollar, state-of-the-art facility that also is home to the first-in-the-nation Horizon True V PET/CT Scanner from Siemens, which offers next generation imaging technology. The new PET/CT scanner provides clinicians with highly advanced and detailed images, and increases patient comfort by significantly reducing scan times.
With 10 FCS physicians practicing at this location and 8 nurse practitioners and physician assistants, Founder and President Dr. William Harwin said, “We have closed two of our older offices to form this state-of-the-art facility. Among its many advantages, the new center has an expanded infusion area and more than 20 exam rooms to better serve patients with added convenience and comfort.” FCS CEO Brad Prechtl said, “This new facility is an example of our continued commitment to bringing the most advanced treatments and cutting-edge technologies to our patients within their communities, large and small, across Florida. We are particularly proud to serve the Fort Myers community, where Florida Cancer Specialists opened its first office in 1984.” Drs. Magda Meichert and Matthew Fink Chair Gala Dr. Magda Meichert and Dr. Matthew Fink served as honorary co-chairs of the FCS Foundation's annual fundraising gala in Tampa. “50 Shades of Awesome Pink” was held on Oct. 8 at the Grand Hyatt Tampa Bay and netted $60,000.
This year, the event had a 1980s theme and featured music videos, dancing, arcade games and a silent auction. All proceeds benefited the FCS Foundation, which provides financial assistance for non-medical living expenses to qualified cancer patients who are currently undergoing treatment in Florida. In addition to events such as the “50 Shades of Awesome Pink” Gala and other fundraising efforts, the FCS Foundation is actively supported by the physicians and employees of FCS.
FCS The Magazine
Dr. Magda Meichert
Dr. Matthew Fink
Former Cancer Patient Becomes Brand Consultant A successful battle against breast cancer gave Colleen Chappell, CEO & President, ChappellRoberts, a deep, personal passion for her medical team at FCS. Now, Chappell and her agency team will translate this rare, first-hand experience into a brand elevation for FCS.
“As a patient, I’ve experienced the unparalleled expertise and unwavering compassion that allowed me to win my battle against cancer,” said Chappell. “Ensuring that more patients know that leading cancer treatment is available right near their home is the most important assignment in my career.” “ChappellRoberts’ extensive branding experience with some of the most admired brands combined with Colleen’s personal experience with FCS make them uniquely qualified to bring innovative, integrated solutions,” said FCS CEO, Bradley Prechtl. “We’re excited to write the next chapter of our growth and success with them as our strategic agency partner.” ChappellRoberts was selected after a national agency search. Their award-winning healthcare strategists will help increase FCS’ consumer awareness and preference, build patient volume and create long-term consumer affinity. “Working with ChappellRoberts will help us achieve our strategic goal – raising awareness that we deliver world-class care close to home,” added Shelly Glenn, Chief Marketing & Sales Officer, FCS. “Colleen’s personal journey is going to help us tell our important story.”
Left to right: Shelly Glenn, Dr. Jorge Ayub, Dr. Mamta Choksi, Dr. David Wenk, Cabrina Adams, Margaret Galon, Joy Colwell, Cyndee Orfanides, Veronica Rios, Heather Kraengel, Joan Covell, Austin Seferian-Jenkins
Let’s Talk Prosigna
An interview with William N. Harwin, M.D.
Florida Cancer Specialists and Research Institute Founder and President With the availability of the Prosigna™ Breast Cancer Prognostic Gene Signature Assay in Florida Cancer Specialists and Research Institute’s (FCS) Fort Myers laboratories, physicians have local, fast access to advanced testing technology to assess a breast cancer patient’s risk of recurrence of disease over a 10 year period. FCS Magazine recently spoke with William N. Harwin, M.D., FCS Founder and President, about Prosigna, the patients it is intended to serve and how it can provide additional insights into the course of treatment.
FCS: What is Prosigna and what does it offer FCS physicians and patients?
Dr. Harwin: NanoString Technologies’ Prosigna is one of the most sophisticated advancements in breast cancer tests. It is an in vitro diagnostic assay that is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive hormone receptor-positive breast cancer. It is prognostic, in that it can help determine a breast cancer patient’s risk of reoccurring cancer, and it is also predictive, by informing decisions about how that risk can be reduced via chemotherapy. At FCS, we see it as a powerful tool for oncologists considering adjuvant therapy for their post-surgery patients. What’s more, because we can do the test locally at our Fort Myers lab, it has an added advantage: speed. Customized results come back in as little as five to six days. FCS is the only community network in Florida that offers Prosigna.
FCS: Before Prosigna, what tests were available?
Dr. Harwin: The National Comprehensive Care Network (NCCN) and American Society of Clinical Oncology (ASCO) guidelines include two other commonly known tests in addition to Prosigna. Prosigna can project risk of recurrence over a 10 year period and in clinical trials has provided greater insight into probability of breast cancer recurrence between years 5 and 10 after diagnosis. Prosigna is the only assay that has the convenience of local lab testing which generates results in just days versus weeks. The faster the results, the faster patients can continue their course of treatment.
FCS: We’ve talked a bit about patients best indicated for Prosigna and the benefits of the test. Can you talk about the results?
Dr. Harwin: Prosigna precisely measures breast cancer genomic signatures. It looks at the activity of 58 genes -- the PAM50 signature – and reports the Risk of Recurrence (ROR or Prosigna Score) in two ways: nodenegative (low, intermediate or high) and node-positive (low or high). Results are precise. For example, for low risk, node-negative patients, the distance recurrence-free survival is greater than 95 percent. For the moderate risk group of node-negative patients, the survival rate is 90 percent; for the high risk group it is less than 85 percent. The higher the risk, the more likely chemotherapy will be a recommended or required course of action. For early stage, HR+ invasive breast cancer
FCS: Are there barriers to using Prosigna?
Dr. Harwin: While most major health plans cover Prosigna, patients need to check with their individual insurer for specific coverage benefits. To assist patients in understanding what’s covered by their health plan, NanoString offers a robust Prosigna Patient Support Program that not only provides more in-depth information about what can be learned from the test but also assists patients in determining insurance benefits.
FCS: What’s the next step for FCS physicians in terms of Prosigna?
Provide fast and accurate risk assessment with Prosigna • The only genomic breast cancer assay run in-house by Florida Cancer Specialists • Available to order through EMR • Proceed with confidence; enroll your patients in the Prosigna Patient Support Program Prosigna® is indicated for use in postmenopausal women with HR-positive, node-negative or nodepositive (1-3 positive nodes) early stage (stages I and II) breast cancer to be treated with adjuvant therapy. The Prosigna Assay is 510(k)-cleared for in vitro diagnostic use, in conjunction with the nCounter Dx Analysis System.
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Dr. Harwin: Having this pathology offering in our in-house lab is a wonderful benefit to our patients in Florida and is further proof of our commitment to provide world-class cancer care on a local level. We recommend that our physicians see their patients promptly after definitive breast cancer surgery. Should the patient fall within the targeted patient guidelines and be considered for adjuvant treatment, they should recommend Prosigna as a key tool in determining the best course of treatment and increasing the likelihood of adjuvant success.
Prosigna in conjunction with the nCounter® Dx Analysis System is indicated for use in postmenopausal women with hormone receptor-positive, node-negative (Stage I or II), or node-positive (Stage II) breast cancer to be treated with adjuvant endocrine therapy. See Package insert for further details at www.prosigna.com © 2014-106 NanoString Technologies, Inc. All rights reserved. NanoString, the NanoString Technologies logo, nCounter, Prosigna and the Prosigna logo are trademarks and/or registered trademarks of NanoString Technologies, Inc. in various jurisdictions.
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A Septet of Patels Doctors exemplify drive for excellence BY TISHA KELLER
The fact that there are seven doctors in the FCS family with the surname Patel is not a coincidence – it’s an indication of the incredible drive for excellence that is synonymous with Asian-Indian culture in the United States. FCS counts many doctors with roots in India among its ranks, and Patel is hardly an uncommon name in the vast South Asian country. In fact, virtually all Patels originate from Gujarat, the westernmost state in the country, where roughly 20 percent of the state’s 63 million population share the name.
FCS The Magazine
In the 1960s and 1970s, Indian immigration to the U.S. was widespread, and especially from Gujarat, where the population is known for its upward mobility. So much so, that in the 2000 U.S. Census, Patel was 174th on the list of the 500 most common surnames.
These highly educated and successful Indian-Americans dominate the sciences, comprising a segment of the U.S. physician population that includes over 60,000 constituents. So, how does less than 1 percent of the U.S. population represent 12-15 percent of the physicians in America? In India, medicine and science are two of the few routes that lead to economic advancement, according to Dr. Manish Patel, a first-generation Indian-American physician at FCS Sarasota Cattlemen Drug Development Unit. These fields produce doctors, engineers and scientists who have a positive impact on the country and the rest of the world. Culturally and economically, since the time of the British Raj, the top tiers for professions have been (in order): medicine, dentistry, engineering, pharmacy and law. Prestige follows success, which in turn drives applications for careers in the country. “In India, top students always pick medical school as their top choice,” explains Dr. Hitesh Patel, oncologist with FCS Clearwater and renowned breast cancer researcher. “But the 12th grade entrance exam reserves only 800 seats for medical school, and that’s a statewide exam with two to three million applicants.” Not much has changed in Indian culture, even with children born in the U.S. The drive to excel at academics begins in kindergarten for these families. “The expectation from my family was always to become a doctor,” Dr. Vipul Patel says. He’s been with FCS Ocala for two years and was born in Chicago. His brother, Vijay, is a doctor at FCS Gainesville. “Maybe there’s even more pressure on Indian-American kids than there was for our parents. Culturally, you’re immersed in the expectation from day one. Every adult in your life — parents, relatives, friends’ parents — there’s this constant pressure to be successful in the traditional sense.” “At one point, I wanted to be a physicist, but that just wasn’t going to happen,” he says with a laugh.
Distinctly different systems For those FCS Patels who practiced — or have gone back and witnessed — medicine in India, the differences between the two systems are not subtle. As with many other countries, access to care in India is based on ability to pay. There are free clinics, but the lines are long and resources are short. Dr. Paresh Patel, FCS Tallahassee, practiced gynecological oncology in India before immigrating to the U.S. in 1994. He says that, in India, everyone pays out of pocket for everything, so doctors are trained to use their evaluation skills and fix what ails the patient, not necessarily what’s causing it. “Many physicians in India have access to all the resources that I have here at my clinic,” he says. “But because no one here
pays out of pocket, the U.S. system leads to a huge difference in care —investigating the cause of illness. Over there, relief from symptoms is a priority.” Dr. Hitesh Patel adds that, in India, most cancers are caught at a late stage because of the barriers to healthcare access. Much of what doctors in these situations provide is palliative care; they also tend to choose cheaper drug therapies because there are no subsidies or co-pays. Aside from the economics of healthcare, though, patients in India are treated in ways fundamentally different than how doctors practice in the U.S. The gold standard abroad, for instance, is the clinical exam. From his parents, U.S. native Dr. Shilen Patel learned that in India patients are evaluated based on touch and the physician-patient conversation is very important, while lab tests are usually minimal. “Being a great clinician is very prestigious in India,” he explains. “Exams are much longer there, and a diagnosis is made mainly from what the physicians feels, sees and hears from the patient.”
Maintaining ties Shilen points out that many Indian hospitals are set up by private doctors according to specialty, meaning there’s a cardiology hospital full of specialists, another for respiratory illness, and so on. While this is relatively rare in the U.S. (cancer treatment is an exception), it’s the main way specialties are nurtured abroad. Many expats, such as his parents, still send money back home to fund these hospitals and Indian doctors from around the world volunteer their time in the healthcare system when they travel back for frequent family visits. For all the FCS Patels, going back to India is a main priority for their families, whether naturalized or U.S.-born. The traditional family trip isn’t about a family reunion, as Americans might expect. Instead, it’s about reconnecting with Indian heritage, respecting the long line of people who made a successful life possible and passing the culture on to the next generation. “You need more than just two weeks for a trip,” Manish laments. “There’s a sense of pride in the Indian culture and we all enjoy going back, because family is so important.” Shilen Patel, who practices with FCS Springhill/Brooksville, is planning an extended trip with his parents and in-laws. He’s interested in seeing how India has progressed over the last 25 years since he last visited, as well as experiencing the many religious festivals, such as Holi in the spring with its manycolored powders and rich traditions. “Michelin Star chefs are coming out of India now, so I want to get into the cuisine,” he says. “But also we want an immersion in the language and to pass on the heritage to our kids.” A large part of that, for A.J. Patel at FCS Sarasota Downtown, is Winter 2016
helping the uber-successful Indian-Americans stay humble. His family hails from a tiny village about an hour outside Ahmedabad, the capital of Gujarat, where there’s access to running water only two hours per day. His parents came to the U.S. with nothing, and worked two and three jobs to work their way up. They bought a convenience store and then a doughnut shop, and were able to educate four children with their sacrifice. "Hard work is the secret - that's how many Indians become so successful," he says. It's this reminder of how far his family and others like them have come that he wants to pass along to his kids one day. Judging from the path of the Patels at FCS, the next generation will be instilled with the very same drive and ambition that propelled the generations before to succeed in medicine—or wherever their dreams may carry them.
Meet the Patels
• • • • • •
Lives and practices in Sarasota (Cattlemen) Born in Daytona Beach, raised in Pinellas County Married (wife is a pharmacist) with two children: 6, 2 Family is from Baroda, Gujarat Most of his family is in England University of Florida; University of Miami; Vanderbilt University; H. Lee Moffitt Cancer Center, University of South Florida • Hematologist/Medical Oncologist with special interest in early phase clinical trials and drug development • Enjoys outdoor activities, sporting events and spending time with family
• • • •
Lives and practices in Ocala 42 Born in Chicago, grew up in Atlanta Married (wife is a photographer) with three children: 9, 7, 7 months Family is from Moyad, Gujarat Brother, Vijay, practices with FCS Gainesville Hematologist/Medical Oncologist with special interest in lung and breast cancers Ross University School of Medicine; Medical College of Georgia, Tulane University Medical Center, Vanderbilt University Medical Center
“Now that my brother and I live about 30 miles apart, we see each other frequently and we are close. Our parents are moving down to the Ocala area to be closer to us. As expected, there is a LOT of pressure in our family for him to get married and start on grandchildren!”
FCS The Magazine
• • • • • •
Lives and practices in Sarasota 34 Born in India, emigrated at age 1 Raised in Gainesville Married (wife is an anesthesiologist), no children Family is from a small village of less than 1,000 people about one hour from Ahmedabad, Gujarat • Florida State University; Georgetown University Hospital/ Washington Hospital Center; University of Florida • Hematologist/Medical Oncologist with special interest in GI, thoracic oncology and hematology “My family’s village in India has running water for only two hours per day. My parents had a doughnut shop and a convenience store here in the U.S. so that we could go to college. Hard work is everything in terms of being successful.”
• • • •
Anjan "A. J."
• • • • • • •
Practices in the Springhill and Brooksville locations 39 From the Bronx, New York City Married (wife is a CPA) with two children: 6, 4 Family is from Ahmedabad, India Extended family across the U.S. and England St. George’s University School of Medicine; State University of New York, Stony Brook; Case Comprehensive Cancer Center • Hematologist/Medical Oncologist with special interest in GI oncology • Hasn’t been back to India in 25 years but is planning an extended trip with his parents and in-laws, and especially looking forward to using India’s renowned, extensive rail system. They want to experience a holiday festival, such as, Holi in the spring, “a sort of centuries-old Color Run."
Hitesh • • • • • • •
Lives and practices in Gainesville 39 From Atlanta Single, no children Family is from Moyad, Gujarat Brother, Vipul, practices with FCS Ocala Hematologist/Medical Oncologist with special interest in GI oncology • Ross University School of Medicine; University of Kansas Medical Center “I chose oncology because other specialties don’t change nearly as fast as oncology. The therapies are changing rapidly and the quality of patient life is better now. Many drugs are coming in pill form, and patients can do therapy at home. That’s very exciting.”
• • • • • •
Lives and practices in Clearwater 56 From Ahmedabad, India Married (wife is a neonatologist) with three adult children Teaches at University of South Florida Kasturba Medical College; Kingsbrook Jewish Medical Center; University of South Florida, Moffitt Cancer Center • Oncologist focusing on breast cancer “In India, children are allowed the freedom to move about, playing anywhere safely and coming home at dinner time. There’s no structure or compartmentalized play — such as the way we drove our kids to and from sporting clubs here in the U.S. I think that is very valuable in the Indian tradition.”
• • • • • •
Lives and practices in Tallahassee 45 Raised in Patan, Gujarat; family is from Visnagar, Gujarat Married with three children: 15, 13, 10 Hematologist/Medical Oncologist B.J. Medical College; Jersey Shore Medical Center; Virginia Commonwealth University Health System • Practiced gynecology oncology in India • Immigrated to U.S. in 1994 “In India and in Indian culture, the patient is the last to know the diagnosis. Their whole family knows, but not the patient. I firmly believe people should know so they can plan, and because it’s their right! I always try to push back against that cultural challenge, and in my experience, the patient DOES want to know their medical diagnosis 99 percent of the time.”
EXTEND EFFICACY. EXTEND THE POSSIBILITIES. The NINLARO® (ixazomib) regimen extended median PFS by ~6 months vs the placebo regimen*
Primary PFS analysis
Probability of PFS
Nonhematologic ARs occurring in ≥5% of patients with a ≥5% difference between the NINLARO regimen (n=360) and the placebo regimen (n=360) • All grades, grade 3 (respectively): upper respiratory (19%, <1% vs 14%, <1%), peripheral neuropathies† (28%, 2% vs 21%, 2%), diarrhea (42%, 6% vs 36%, 2%), constipation (34%, <1% vs 25%, <1%), nausea (26%, 2% vs 21%, 0%), vomiting (22%, 1% vs 11%, <1%), rash† (19%, 3% vs 11%, 1%), back pain (21%, <1% vs 16%, 3%), peripheral edema (25%, 2% vs 18%, 1%) • Grade 4 ARs occurring in ≥5% of patients with a ≥5% difference between the two regimens were 0%
median PFS with the NINLARO regimen (95% CI, 17.0-NE)
†Represents a pooling of preferred terms.
Pooled hematologic adverse events and laboratory data
• Incidence of thrombocytopenia in patients in the NINLARO and placebo regimens: all grades, 78% and 54%, respectively; grades 3-4, 26% vs 11%, respectively • Incidence of neutropenia: all grades, 67% vs 66%, respectively; grades 3-4, 26% vs 30%, respectively
median PFS with placebo+len+dex (95% CI, 12.9-17.6) 0.2 HR=0.74 (95% Cl, 0.587-0.939); P=0.012
Time from randomization (months) Number of patients at risk NINLARO regimen 360 Placebo+len+dex 362
TOURMALINE-MM1: a global, phase 3, randomized (1:1), double-blind, placebo-controlled study that evaluated the safety and efficacy of NINLARO (an oral PI) vs placebo, both in combination with lenalidomide and dexamethasone, until disease progression or unacceptable toxicity in 722 patients with relapsed and/or refractory MM who received at least 1 prior therapy. *NINLARO regimen: NINLARO+lenalidomide+dexamethasone; placebo regimen: placebo+lenalidomide+dexamethasone.
INDICATION: NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. WARNINGS AND PRECAUTIONS • Thrombocytopenia has been reported with NINLARO. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per standard medical guidelines. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and recovered to baseline by the start of the next cycle. • Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for severe symptoms.
• Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed. • Peripheral Edema was reported with NINLARO. Monitor for fluid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms.
The NINLARO regimen represented a sustainable treatment for patients • 80% of patients continued at the starting dose of NINLARO without dose reduction1 • Discontinuation rates of the placebo regimen and the NINLARO regimen were 11% and 13%, respectively1
For patients who need a proteasome inhibitor, consider NINLARO for sustainable therapy. WARNINGS AND PRECAUTIONS (continued) • Cutaneous Reactions: Rash, most commonly maculopapular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose modification. • Hepatotoxicity has been reported with NINLARO. Druginduced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed. • Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the final dose of NINLARO. ARs=adverse reactions; MM=multiple myeloma; NE=not evaluable; PFS=progression-free survival; PI=proteasome inhibitor.
Takeda Oncology and are registered trademarks of Takeda Pharmaceutical Company Limited. NINLARO is a registered trademark of Millennium Pharmaceuticals, Inc.
Copyright © 2016, Millennium Pharmaceuticals, Inc.
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ADVERSE REACTIONS The most common adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). SPECIAL POPULATIONS • Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment. • Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable. • Lactation: Advise women to discontinue nursing while on NINLARO. DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers. REFERENCE: 1. Data on File 117, Takeda Pharmaceuticals International Co.
Please see Brief Summary for NINLARO adjacent to this advertisement.
Brief Summary (cont’d)
BRIEF SUMMARY OF PRESCRIBING INFORMATION NINLARO (ixazomib) capsules, for oral use
Table 5: Thrombocytopenia and Neutropenia (pooled adverse event and laboratory data)
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3/25/16 3:11 PM
Placebo + Lenalidomide and Dexamethasone N=360
N (%) Any Grade
Eye Disorders Eye disorders were reported with many different preferred terms but in aggregate, the frequency was 26% in patients in the NINLARO regimen and 16% of patients in the placebo regimen. The most common adverse reactions were blurred vision (6% in the NINLARO regimen and 3% in the placebo regimen), dry eye (5% in the NINLARO regimen and 1% in the placebo regimen), and conjunctivitis (6% in the NINLARO regimen and 1% in the placebo regimen). Grade 3 adverse reactions were reported in 2% of patients in the NINLARO regimen and 1% in the placebo regimen. The following serious adverse reactions have each been reported at a frequency of < 1%: acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura. 7 DRUG INTERACTIONS 7.1 Strong CYP3A Inducers: Avoid concomitant administration of NINLARO with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John’s Wort) 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy: Women should avoid becoming pregnant while being treated with NINLARO. Risk Summary: NINLARO can cause fetal harm when administered to a pregnant woman. There are no human data available regarding the potential effect of NINLARO on pregnancy or development of the embryo or fetus. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose. Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal Data: In an embryo-fetal development study in pregnant rabbits there were increases in fetal skeletal variations/abnormalities (caudal vertebrae, number of lumbar vertebrae, and full supernumerary ribs) at doses that were also maternally toxic (≥ 0.3 mg/kg). Exposures in the rabbit at 0.3 mg/kg were 1.9 times the clinical time averaged exposures at the recommended dose of 4 mg. In a rat dose range-finding embryo-fetal development study, at doses that were maternally toxic, there were decreases in fetal weights, a trend towards decreased fetal viability, and increased post-implantation losses at 0.6 mg/kg. Exposures in rats at the dose of 0.6 mg/kg was 2.5 times the clinical time averaged exposures at the recommended dose of 4 mg. 8.2 Lactation: It is not known whether NINLARO or its metabolites are present in human milk. Many drugs are present in human milk and as a result, there could be a potential for adverse events in nursing infants. Advise women to discontinue nursing. 8.3 Females and Males of Reproductive Potential: Contraception - Male and female patients of childbearing potential must use effective contraceptive measures during and for 90 days following treatment. Infertility - Fertility studies were not conducted with NINLARO; however there were no effects on reproductive organs in either males or females in nonclinical studies in rats and dogs 8.4 Pediatric Use: Safety and effectiveness have not been established in pediatric patients. 8.5 Geriatric Use: Of the total number of subjects in clinical studies of NINLARO, 55% were 65 and over, while 17% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 8.6 Hepatic Impairment: In patients with moderate or severe hepatic impairment, the mean AUC increased by 20% when compared to patients with normal hepatic function. Reduce the starting dose of NINLARO in patients with moderate or severe hepatic impairment.
NINLARO + Lenalidomide and Dexamethasone N=360
1 INDICATION rabbits at doses resulting in exposures that were slightly higher than those NINLARO (ixazomib) is indicated in combination with lenalidomide and observed in patients receiving the recommended dose. dexamethasone for the treatment of patients with multiple myeloma who have Females of reproductive potential should be advised to avoid becoming received at least one prior therapy. pregnant while being treated with NINLARO. If NINLARO is used during pregnancy or if the patient becomes pregnant while taking NINLARO, the 5 WARNINGS AND PRECAUTIONS patient should be apprised of the potential hazard to the fetus. Advise females 5.1 Thrombocytopenia: Thrombocytopenia has been reported with NINLARO of reproductive potential that they must use effective contraception during with platelet nadirs typically occurring between Days 14-21 of each 28-day cycle treatment with NINLARO and for 90 days following the final dose. and recovery to baseline by the start of the next cycle. Three percent of patients in the NINLARO regimen and 1% of patients in the placebo regimen had a platelet 6 ADVERSE REACTIONS count ≤ 10,000/mm3 during treatment. Less than 1% of patients in both regimens The following adverse reactions are described in detail in other sections of the had a platelet count ≤ 5000/mm3 during treatment. Discontinuations due to prescribing information: thrombocytopenia were similar in both regimens (< 1% of patients in the • Thrombocytopenia [see Warnings and Precautions (5.1)] NINLARO regimen and 2% of patients in the placebo regimen discontinued one or • Gastrointestinal Toxicities [see Warnings and Precautions (5.2)] more of the three drugs). The rate of platelet transfusions was 6% in the NINLARO • Peripheral Neuropathy [see Warnings and Precautions (5.3)] regimen and 5% in the placebo regimen. Monitor platelet counts at least monthly during treatment with NINLARO. • Peripheral Edema [see Warnings and Precautions (5.4)] Consider more frequent monitoring during the first three cycles. Manage • Cutaneous Reactions [see Warnings and Precautions (5.5)] thrombocytopenia with dose modifications and platelet transfusions as per • Hepatotoxicity [see Warnings and Precautions (5.6)] standard medical guidelines. 6.1 CLINICAL TRIALS EXPERIENCE 5.2 Gastrointestinal Toxicities: Diarrhea, constipation, nausea, and vomiting, Because clinical trials are conducted under widely varying conditions, adverse have been reported with NINLARO, occasionally requiring use of antidiarrheal reaction rates observed in the clinical trials of a drug cannot be directly and antiemetic medications, and supportive care. Diarrhea was reported in compared to rates in the clinical trials of another drug and may not reflect the 42% of patients in the NINLARO regimen and 36% in the placebo regimen, rates observed in practice. constipation in 34% and 25%, respectively, nausea in 26% and 21%, respectively, and vomiting in 22% and 11%, respectively. Diarrhea resulted in The safety population from the randomized, double-blind, placebo-controlled discontinuation of one or more of the three drugs in 1% of patients in the clinical study included 720 patients with relapsed and/or refractory multiple NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing myeloma, who received NINLARO in combination with lenalidomide and dexamethasone (NINLARO regimen; N=360) or placebo in combination with for Grade 3 or 4 symptoms. lenalidomide and dexamethasone (placebo regimen; N=360). 5.3 Peripheral Neuropathy: The majority of peripheral neuropathy adverse reactions were Grade 1 (18% in the NINLARO regimen and 14% in the placebo The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen) and Grade 2 (8% in the NINLARO regimen and 5% in the placebo regimen and greater than the placebo regimen were diarrhea, constipation, regimen). Grade 3 adverse reactions of peripheral neuropathy were reported at thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. Serious adverse reactions reported in ≥ 2% of patients included 2% in both regimens; there were no Grade 4 or serious adverse reactions. thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more The most commonly reported reaction was peripheral sensory neuropathy of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen. (19% and 14% in the NINLARO and placebo regimen, respectively). Peripheral motor neuropathy was not commonly reported in either regimen (< 1%). Table 4: Non-Hematologic Adverse Reactions Occurring in ≥ 5% of Patients Peripheral neuropathy resulted in discontinuation of one or more of the three with a ≥ 5% Difference Between the NINLARO Regimen and the Placebo drugs in 1% of patients in both regimens. Patients should be monitored for Regimen (All Grades, Grade 3 and Grade 4) symptoms of neuropathy. Patients experiencing new or worsening peripheral NINLARO + Placebo + neuropathy may require dose modification. Lenalidomide and Lenalidomide and Dexamethasone Dexamethasone 5.4 Peripheral Edema: Peripheral edema was reported in 25% and 18% of N=360 N=360 patients in the NINLARO and placebo regimens, respectively. The majority of peripheral edema adverse reactions were Grade 1 (16% in the NINLARO System Organ Class / N (%) N (%) Preferred Term regimen and 13% in the placebo regimen) and Grade 2 (7% in the NINLARO regimen and 4% in the placebo regimen). Grade Grade Grade Grade All All Grade 3 peripheral edema was reported in 2% and 1% of patients in the 3 4 3 4 NINLARO and placebo regimens, respectively. There was no Grade 4 peripheral Infections and infestations edema reported. There were no discontinuations reported due to peripheral 69 (19) 1 (< 1) 0 52 (14) 2 (< 1) 0 Upper respiratory tract edema. Evaluate for underlying causes and provide supportive care, as infection necessary. Adjust dosing of dexamethasone per its prescribing information or Nervous system disorders NINLARO for Grade 3 or 4 symptoms. 100 (28) 7 (2) 0 77 (21) 7 (2) 0 Peripheral neuropathies* 5.5 Cutaneous Reactions: Rash was reported in 19% of patients in the NINLARO regimen and 11% of patients in the placebo regimen. The majority of Gastrointestinal disorders the rash adverse reactions were Grade 1 (10% in the NINLARO regimen and 8 (2) 151 (42) 22 (6) 0 130 (36) 0 Diarrhea 7% in the placebo regimen) or Grade 2 (6% in the NINLARO regimen and 3% 122 (34) 1 (< 1) 0 90 (25) 1 (< 1) 0 Constipation 92 (26) 6 (2) 0 74 (21) 0 0 Nausea in the placebo regimen). Grade 3 rash was reported in 3% of patients in the 79 (22) 4 (1) 0 38 (11) 0 Vomiting 2 (< 1) NINLARO regimen and 1% of patients in the placebo regimen. There were no Grade 4 or serious adverse reactions of rash reported. The most common type Skin and subcutaneous tissue disorders of rash reported in both regimens included maculo-papular and macular rash. 68 (19) 9 (3) 0 38 (11) 5 (1) 0 Rash* Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with dose Musculoskeletal and modification if Grade 2 or higher. connective tissue disorders 0 57 (16) 9 (3) 0 74 (21) 2 (< 1) Back pain 5.6 Hepatotoxicity: Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in General disorders and < 1% of patients treated with NINLARO. Events of liver impairment have been administration site conditions reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor 91 (25) 8 (2) 0 66 (18) 4 (1) 0 Edema peripheral hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms. 5.7 Embryo-Fetal Toxicity: NINLARO can cause fetal harm when administered Note: Adverse reactions included as preferred terms are based on MedDRA version 16.0. to a pregnant woman based on the mechanism of action and findings in *Represents a pooling of preferred terms animals. There are no adequate and well-controlled studies in pregnant women using NINLARO. Ixazomib caused embryo-fetal toxicity in pregnant rats and (Continued on next page)
8.7 Renal Impairment: In patients with severe renal impairment or ESRD requiring dialysis, the mean AUC increased by 39% when compared to patients with normal renal function. Reduce the starting dose of NINLARO in patients with severe renal impairment or ESRD requiring dialysis. NINLARO is not dialyzable and therefore can be administered without regard to the timing of dialysis. 10 OVERDOSAGE: There is no known specific antidote for NINLARO overdose. In the event of an overdose, monitor the patient for adverse reactions and provide appropriate supportive care. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosing Instructions • Instruct patients to take NINLARO exactly as prescribed. • Advise patients to take NINLARO once a week on the same day and at approximately the same time for the first three weeks of a four week cycle. • Advise patients to take NINLARO at least one hour before or at least two hours after food. • Advise patients that NINLARO and dexamethasone should not be taken at the same time, because dexamethasone should be taken with food and NINLARO should not be taken with food. • Advise patients to swallow the capsule whole with water. The capsule should not be crushed, chewed or opened. • Advise patients that direct contact with the capsule contents should be avoided. In case of capsule breakage, avoid direct contact of capsule contents with the skin or eyes. If contact occurs with the skin, wash thoroughly with soap and water. If contact occurs with the eyes, flush thoroughly with water. • If a patient misses a dose, advise them to take the missed dose as long as the next scheduled dose is ≥ 72 hours away. Advise patients not to take a missed dose if it is within 72 hours of their next scheduled dose. • If a patient vomits after taking a dose, advise them not to repeat the dose but resume dosing at the time of the next scheduled dose. • Advise patients to store capsules in original packaging, and not to remove the capsule from the packaging until just prior to taking NINLARO. Thrombocytopenia: Advise patients that they may experience low platelet counts (thrombocytopenia). Signs of thrombocytopenia may include bleeding and easy bruising. Gastrointestinal Toxicities: Advise patients they may experience diarrhea, constipation, nausea and vomiting and to contact their physician if these adverse reactions persist. Peripheral Neuropathy: Advise patients to contact their physicians if they experience new or worsening symptoms of peripheral neuropathy such as tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in the arms or legs. Peripheral Edema: Advise patients to contact their physicians if they experience unusual swelling of their extremities or weight gain due to swelling. Cutaneous Reactions: Advise patients to contact their physicians if they experience new or worsening rash. Hepatotoxicity: Advise patients to contact their physicians if they experience jaundice or right upper quadrant abdominal pain. Pregnancy: Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with NINLARO and for 90 days following the final dose. Advise patients to contact their physicians immediately if they or their female partner become pregnant during treatment or within 90 days of the final dose. Concomitant Medications: Advise patients to speak with their physicians about any other medication they are currently taking and before starting any new medications. Please see full Prescribing Information for NINLARO at NINLARO-hcp.com. NINLARO is a registered trademark of Millennium Pharmaceuticals, Inc. Millennium Pharmaceuticals, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. ©2016 Millennium Pharmaceuticals, Inc. 20160209 v2 USO/IXA/15/0123(2)
Winter 2016 3/25/16 3:11 PM
EXECUTIVE MANAGEMENT TEAM SPOTLIGHT
Aptitude, attitude, effort
For marketer Shelly Glenn, they add up to a formula for success BY STEVE BORNHOFT
helly Glenn really wishes she could read more, but creating time for recreational reading isn’t always possible for her. Priorities get in the way. As of this writing, she is reviewing a script and studying PowerPoint slides in preparation to serve as a moderator at a meeting of the Advanced Practitioner Society of Hematology and Oncology. It’s a unique role for a non-clinician. “One of the things I love about my job is that there are so many opportunities for learning and growth,” says Glenn, FCS’s Chief Marketing and Sales Officer. “The most challenging aspect of my role is to develop innovative and creative initiatives that will advance our organization as a whole, including my team members, while responding to the very diverse needs of regions, communities, our physicians and staff, as well as our patients.” It seems that Glenn has always been busy and has proven the truth of the adage, “If you want something to get done, ask a busy person.” On average, she travels more than 3,000 miles a month, visiting the various practice locations, as well as attending community events, ribbon cuttings, open houses and participating in both business and internal meetings. She was a marketing major at Lehigh University in Bethlehem, Pennsylvania, where she also minored in psychology. While in college, she was a member of the Delta Gamma sorority, a basketball cheerleader, played intercollegiate soccer and held numerous parttime jobs. Glenn’s father, an oral surgeon, fostered in her a desire to pursue a career in healthcare. But, she confesses, “I am terrified of blood. I practically pass out when they take a blood sample from me. So, it seemed to me that the sales and marketing side of the medical field was going to be the best fit for me.” She would, however, take an indirect route getting there.
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Glenn had accepted a job offer and was set to go to work selling pharmaceuticals upon graduation from Lehigh, but a hiring freeze at her intended employer derailed that plan. Instead, she took a position selling electronic communication equipment for a time, including pagers and beepers. “I had a multi-state territory and, while I landed large corporate accounts, including one with IBM in Armonk, New York, I also had some ‘all-cash’ customers whose activities seemed, let’s say, a little unsavory.” Glenn began feeling uncomfortable, so she decided to pursue other opportunities. She landed a job with Cincinnati Time, a maker of time/ attendance and workplace parking security systems, and where, as a female member of the sales force, she was an anomaly. While she succeeded there and received numerous awards and recognition, she never gave up on her dream of getting into healthcare. She finally did so by accepting a job with Sandoz Nutrition. There, she sold enteral feeding pumps and formulas to customers that unnervingly included Rikers Island and Sing Sing prisons, as well as New York hospitals and nursing homes in the Bronx and Westchester. Concerned for her safety by working in less than desirable areas, she found employment at Roche Professional Services -- the home infusion division of Roche Pharmaceuticals. In that job she called on labor unions, hospitals, insurance companies, self-insured and selfadministered companies. It was there that “for the first time,” she says, “I got a behind-the-scenes look at how healthcare really works.” Shortly thereafter, Glenn’s husband of 18 years, Jack, accepted an offer to work in Atlanta. The couple then relocated to Georgia and Shelly became the Chief Administrative Officer for Park ’N Fly offairport national parking services. “When I interviewed with Park ’N Fly, they asked me if I had any travel industry experience and I said I traveled a lot,” Glenn says. “They hired me based on my aptitude and attitude more than my experience and that is something I have kept in Winter 2016
EXECUTIVE MANAGEMENT TEAM SPOTLIGHT
mind as a hiring manager ever since. I have found that attitude, aptitude and especially effort equate to success, not just an impressive resume.” In her previous jobs, Glenn always had been out front as the face of an organization, but at Park ’N Fly, she instead worked with many internal customers. “To use a political term, I really pivoted at that time,” Glenn remembers. “I came to understand that as great as sales and marketing can be, you also need a really good team behind those efforts.” When a new CEO arrived at Park ’N Fly, he brought in his own executive team. Glenn then met with Brad Prechtl and was hired as the Vice President of Marketing & Sales at Physician Oncology Services. She worked with Prechtl until he left for FCS. Glenn continued working there until she rejoined Prechtl at FCS a few years later. At FCS, Glenn’s role encompasses what she calls the four pillars: sales, marketing/communications, physician recruitment and the FCS Foundation. The sales effort is carried out by the Physician Liaisons. Glenn manages a team of 10 liaisons who spend 80 percent of their time establishing relationships between referring physicians and FCS doctors. Their main focus is growing “same store” non-hospital referrals year over year by more than 5%. They also work with non-profits such as the American Cancer Society, Leukemia & Lymphoma Society and Susan G. Komen. In addition, the Physician Liaisons are responsible for identifying local marketing and awareness opportunities. Marketing communications, Glenn emphasizes, is aimed at “promoting or communicating the expertise of our physicians, clinicians and staff and letting people know how compassionately we care for our patients.” Under her leadership, there are two marketing/advertising agencies and an internal marketing team. The goal and focus is to build brand awareness, differentiate Florida Cancer Specialists from other oncology practices and to increase referrals. To that end, conveying information is important, but so are the numbers. “For example,” Glenn says, “of the 33 clinical oncology trials approved by the Food and Drug Administration in 2015, 23 were conducted through FCS. That hard data is valuable versus promising cures or making unsubstantiated claims. Other organizations have done themselves a disservice by overpromising.” In seeking new physicians, FCS seriously considers recommendations made by its own doctors. Additionally, FCS has a recruitment strategy that includes leveraging several social media platforms. One such platform is Doximity, where physicians throughout the U.S. have access so they can network with each other.
Also, the team advertises online and at key industry conferences to identify strong candidates to present to the physician partners, who are ultimately responsible for hiring associate doctors. Glenn has a special fondness for the FCS Foundation, which, she says, is fundamentally about “doing the right thing.” She oversees a team that consists of an Executive Director, a Volunteer Program Manager, a Development & Events Manager, a Client Services Team and numerous volunteers. The Foundation has a goal to raise more than $1 million in 2016. To help the FCS Foundation achieve this goal, more than five major fundraising events have been held this year.
"One of the things I love about my job is that there are so many opportunities for learning and growth."
Generous support was also received from the FCS physician partners, employees, patients and sponsors that graciously donated time and money. The Foundation helps cancer patients meet non-medical expenses and, in some cases, has enabled people to avoid foreclosure on their homes. Another incredible and unique feature of the Foundation is that approximately 30 percent of the patients assisted are not FCS patients. This is a great testament to how generous and caring the FCS community is in helping as many cancer patients in Florida as possible. Working at FCS, Glenn is cognizant of the fact that “our time is limited.” That reality was impressed upon her on 9/11. Glenn was working in Liberty State Park (near the Statue of Liberty and across the river from the World Trade Center) at the time. She witnessed the planes strike the Twin Towers and lost friends to the terrorist attacks. Glenn spent the entire day helping survivors who made it across the Hudson River into waiting ambulances or into vehicles to get home or to safety. Glenn also personally drove several survivors home that day. When she is not working, Glenn enjoys spending time with her family, which involves many trips a year, since they are located across the country. She also enjoys exercising at the gym, going out to dinner with friends and relaxing by the pool. Glenn plans to always be of use and to make a difference. “When I retire, I’d like to spend my time in the non-profit world,” she said. And maybe read a good book.
Thank You for Your Continued Support of the FCS Foundation! The FCS Foundation fulfills a unique purpose for cancer patients who are struggling to pay their everyday living expenses. Imagine cancer patients who can’t make car payments leaving them without transportation to their physician’s office; or patients who can’t pay mortgage or rent and are facing eviction while they are fighting for their lives. The Foundation pays for non-medical expenses such as mortgage, rent, utilities, car payments, etc., so that patients can concentrate on recovering from cancer.
What Separates the FCS Foundation from Similar Charities? What truly separates the FCS Foundation from similar charities is that Florida Cancer Specialists pays for all salaries and overhead for the Foundation, which means that 100% of all donations go directly to help cancer patients in need! The FCS Foundation provides help for the entire family, as well, by relieving some of the stress cancer patients and family members face on a daily basis.
Please call (941) 677.7181 or visit Foundation.FLCancer.com for more information or to donate.
5202 Paylor Lane, Sarasota, FL 34240
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Working Well Together
Gainesville team shares commitment to excellence BY TISHA CREWS KELLER
he sleek, glass-and-metal exterior of the FCS clinic in Gainesville is deceiving. The cool, new, modern building belies the warm, welcoming heart that beats within its walls. From her office situated in the middle of clinic operations, senior office manager Betty Ann Forsyth hears the laughter and witnesses the smiles of her staff and patients every day. "We are like family," she says. The staff, from physician to receptionist, is exceptional in how they treat each other — and Forsyth believes that carries over to the more than 200 patients per day they encounter. Even though FCS is a large, statewide organization, its "hometown feel" is widely recognized as one of its greatest assets. Executive leadership has focused on creating a family atmosphere from the top down, and every office integrates a community-based approach to treatment, innovation and care. It takes a large staff to handle the volume of patients they treat — five physicians and 10 clinical advanced practitioners — but Forsyth maintains the Gainesville office is a great example of this mission. "I have visited many other FCS offices," Forsyth continues. "I can say that FCS has a trait of wonderful staff and leadership." Forsyth joined the FCS family 13 years ago. She's worked in the medical field in many capacities, including medical assistant,
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registered nurse, RN supervisor and manager. "In all the roles I've been in, I have always had exceptional leadership," she says. "This stands true today with the physicians I work for and our senior management." Forsyth feels that this leadership — intellectual, emotional and business-wise — flows down to her and then through her management team to the staff. "I believe this is what makes our office significant," she explains. "The respect we have for one another shows through our actions and dedication to our patients." FCS Gainesville offers many of the comforts of home to patients, including a large, comfortable 65-chair infusion room for oncology and hematology patients. Onsite diagnostic imaging, laboratory services, and clinic trials through FCS/Sarah Cannon Research Institute makes sure patients don't have to travel for potentially lifesaving research and testing. For patients with doctor appointments, the facility boasts 33 exam rooms to ensure patients have the privacy of their own space while minimizing any wait time. And if they need radiation treatment, the practice partners with colleagues at The Cancer Center of North Florida Regional Healthcare, which is convenient for the practices' mutual patients. Supportive, integrative care including acupuncture, counseling and
nutrition is available for patients during treatment through collaboration with the Joseph J. Williams of Sunshine Integrative Health.
That beating heart With a smile, a bottle of water, a snack, a warm blanket or a listening ear—the FCS Foundation Volunteer Program is a big part of FCS Gainesville's heart. These caring individuals support the nonmedical needs of patients waiting to be seen by the oncology staff in an effort to provide comfort and companionship. In addition to providing valuable service to individuals battling cancer, this is a wonderful opportunity for FCS Gainesville to liaison for the FCS Foundation, fostering community relationships through the outreach efforts of its volunteers. Forsyth is proud to say that her clinic is one of the busiest in the FCS network, treating patients from up to a 100-mile radius. Excellent coordination of care with other specialties and community recognition as a premier cancer treatment center is what makes them stand out, she explains. Staff and physicians are involved in the annual “Run-a-Muck with the Duck” event, which raises much-needed funds for the patient services and clinical research projects of the Bonnie J. Addario Lung Cancer Foundation. They also support activities of the American Cancer Society and the FCS Foundation each year.
This dedication to patients and superior care makes FCS Gainesville a wonderful example of the Florida Cancer Specialists' mission, and it makes Forsyth proud. "The majority of the staff have longevity with FCS. We are like family," she beams. "Our patients often express their gratitude for feeling welcomed by our facility. We are blessed to have such an exceptional crew that works so well together."
FCS Gainesville offers a 65-chair infusion room.
1. BREAKFAST PROGRAM Dr. Maen Hussein and Senior Physician Liaison Danielle Spears participating at a local “Living With Prostate Cancer” Educational Breakfast Program. 1a. Pictured (L-R): Dr. Maen Hussein and Danielle Spears 1b. Program participants 2. PATIENT ART THERAPY PROGRAM The FCS Foundation held a successful launch and presentation of the Patient Art Therapy Program at the Wellington and Lakewood Ranch facilities. Coloring books, pencils and sharpeners were graciously donated by the Women of Hope, a woman's group, to the FCS Foundation Volunteer Program. 2a. Wellington - Pictured (L-R): John Shwiner - FCS Foundation Lead Volunteer, Donna Ott - Head Nurse, Kim Delgado - Office Manager,
Val Vance - FCS Foundation Executive Director, Lynn Rasys - FCS Foundation Volunteer Program Manager 2b. Lakewood Ranch - Pictured (L-R): Terri Prechtl - FCS Foundation Lead Volunteer, Paula B - FCS patient, Lynn Rasys - FCS Foundation Volunteer Program Manager 2c. Lakewood Ranch - Pictured (L-R): Valerie Vance - FCS Foundation Executive Director, Amy Morrow - Office Manager, Eric Grindstaff - Assistant Regional Director, Trudy Mc Donald - Head Nurse, Terri Prechtl -FCS Foundation Lead Volunteer, Lynn Rasys - FCS Foundation Volunteer Program Manager 3. CONGRATS! Congratulations to the FCS Foundation Paylor office’s volunteer, Bruce Colby, on winning #1 Overall in the National Competition in adult tap in Orlando, FL. Way to go, Bruce!
4. CRAZY HAT DAY AT VENICE ISLAND
7. WE CAN WEEKEND BOOTH
The Venice Island team often creates a festive environment for the staff and their patients. Fliers were posted, so even patients knew to come in wearing hats. The staff served patients hot dogs, chips and apple pie.
Physician Liaison Brett Hipsley and Dr. Vipul Patel at We Can in Ocala at College of Central Florida.
Pictured (L-R): Front row - Morgan Davis, Julie Weisensee, Jayanti Sooknanan,Kysa Medina; Back row - Lea Wonsey, Sheila Mattos, Jeanne Boudreau, Kim McDaniel,Lia Scheffler, Deena Lonzo, Acacia Borror, Nancy Olsen, Jacqui Bliss 5. “CANCER STAR DESTROYER” Jimmy Mabry, son of Tallahassee Offices Manager Debbie Mabry, won the box car race at the Relay for Life event at Leon High School in Tallahassee, with his “Cancer Star Destroyer.” When he was interviewed for winning, he proudly shared that his mom is the office manager at Florida Cancer Specialists!
8. APSHO CE PROGRAM IN TAMPA The APSHO (Advanced Practitioner Society Hematology and Oncology) CE Program in Tampa had over 30 FCS NP/PAs in attendance. FCS speakers included Diane Cope and Sarah Atkins, and was moderated by Shelly Glenn. Pictured (L-R): Sarah Atkins, ARNP, AOCNP; Beth Eaby-Sandy, MSN, CRNP, OCN from the University of Pennsylvania; winner of iPad drawing from Moffitt; Diane Cope, PhD, ARNP-BC, AOCNP; Shelly Glenn
6. VOLUNTEER ORIENTATION DAY AT NEW GLADIOLUS LOCATION First volunteer group pictured (L-R): Marshall Lieberman, Barbara Lieberman, Lynn Rasys (FCSF Volunteer Program Manager), Carole Carnes, Germaine Hoffman, Susan Waddle, Linda Lyon
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9. PATIENT APPRECIATION DAY AT DAYTONA CANCER CENTER Pictured (L-R): Maria Candell – PSS, Kryste Scherder – MA, Kim Heller – FC, Sabrina Maldonado – PSS, Pam Venneri – OM, young gentleman who donated the popsicles, Barb Bittner nurse breast navigator, Denise Norfold nurse lung navigator, Kristie Reiner - Director FH Cancer Center 10. FOOTBALL FRENZY BEER & WINE TASTING EVENT 10a. Pictured (L-R): David Wenk, MD; Patty Rogers, ARNP; JoLynn Wright, PL; Sunita Sudebi, ARNP; Uday Dandamudi, MD 10b. Great fun was had by all! Dr. Jonathan Nagy was the big winner of the Tampa Bay Buccaneers Tickets and Basket.
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Submit your recent event photos to FCS Marketing at [email protected]
11. FCS & LLS’S SUBARU LOVES TO CARE PROGRAM
13. ‘ASK THE EXPERTS’ DINNER
14. HALLOWEEN AT THE MEASE OFFICE
FCS works with Subaru dealerships in The Villages, Lake Mary, Winter Park, Downtown Orlando and Ocala areas.
Florida Hospital North Pinellas hosted an “Ask the Experts - Dinner with the Docs” event at the Innisbrook Golf & Spa Resort, Palm Harbor.
Pictured (L-R): Kristina Calamusa, LPN; Mary Jo Trotto, LPN; Tina Alberts, MA
11a - Pictured (L-R): Dr. Vipul Patel with patient Waltraud Purcell / volunteer at Ocala and the Ocala Subaru Rep 12. PINK DAY IN ALTAMONTE 12a. Pictured (L-R): Brittani Henley(PSS), Gretchen Johnson(FC), Tina Smith(FC), Dr. Gousse, Amy Hanners(PSS), Kristy Meeks(OM), Jennifer Wagner(PSS) 12b. Pictured (L-R): Dr. Gousse and his Nurse Practitioner Terry Boutty
13a. Pictured (L-R): Dr. Uday Dandamudi, FCS Physician - New Port Richey, JoLynn Wright, Physician Liaison Pasco & Hernando County and Sandy Brooks, Physician Liaison Pinellas County 13b. Pictured (L-R): Dr. Uday Dandamudi, FCS Physician- New Port Richey and patients at his dinner table 13c. Pictured (L-R): Anna Marie Zambito, Radiology Services Supervisor, Dr. David Wenk, FCS Physician- New Port Richey, Sandy Brooks, Physician Liaison Pinellas County and JoLynn Wright, Physician Liaison Pasco & Hernando County
FCS Volunteer Program BY KIM HARRIS THACKER
ompassionate. Positive. Dependable. Hardworking. Enthusiastic. Caring. These are just a few characteristics of a great volunteer. Add “greeting patients with a smile and warm blanket and offering companionship,” and every member of the oncology staff at a Florida Cancer Specialists clinic will know you’re describing their patient support volunteers. “They’re all very much go-getters,” says Jeanie Harris, an RN and OCN at the Gainesville clinic. “Our patients love them, and they’re a wonderful help to us. They do all of the little things we don’t have time to do, and that leaves us free to perform patient care.” Those “little things” are defined by Volunteer Program Manager Lynn Rasys as “the nonmedical needs of patients waiting to be seen by the oncology staff and in the infusion/chemo areas.” In other words, patient support volunteers greet patients and guests and ensure they settle in comfortably, prepare and distribute food items and beverages, engage patients and guests in conversation, hand out reading materials and FCS Foundation information, offer mobility assistance to patients and sanitize patient chairs and trays after a patient has left the facility. “There is always something to do,” says Aaron Sandoval, a volunteer at the Gainesville clinic who is also a freshman in the Pre-Professional Biology program at the University of Florida. “Even when I’m standing still, I’m trying to memorize faces and the areas patients have been in. The time flies when I’m here, because I’m busy. But it also flies because I really like being here. I get to interact, one-on-one, with patients from all walks of life. In school, I learn about virology and things like that, but here, I learn about people. I want to hear about their experiences and how what they’ve been through affects them.”
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Of course, Sandoval isn’t the only one to benefit from genuine conversation with patients. “Individuals battling cancer maximize their benefit from treatment when surrounded by emotional support and a caring, supportive environment,” Rasys explains. But she is also quick to point out that some volunteer work takes place “behind-the-scenes.” “Every day, new patient applications are submitted to the Florida Cancer Specialists Foundation, asking for nonmedical financial assistance,” she says. “These are individuals who are not only battling cancer, but who are also struggling to pay their daily living expenses. Client Services Assistants in the Sarasota Foundation office help process applications, determine eligibility and ensure all documentation has been submitted so an approval decision can be made as quickly as possible.” Although more than 175 volunteers contribute to the 650 total hours of work per week performed by volunteers at FCS clinics or at the Foundation office each week, more help is needed. “We don’t have volunteers here every day,” says Kalyn Davis, RN and OCN at the Gainesville clinic, “and I wish we did. They are so much help!” To become a volunteer, an individual must be at least 17 years old, possess a valid driver’s license, submit to and pass a background check and commit to working at least three hours per week. The volunteer application can be found at http://foundation.flcancer.com/volunteer. Questions can be sent to [email protected]
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Former patient Skipper Rodgers knows that little things make a big difference BY KIM HARRIS THACKER
t was October 2015 and Skipper Rodgers was tired – more tired, even, than was usual for the busy husband, father and pastor. Skipper assured his wife, Tricia, that nothing was wrong; he probably just needed to take more vitamins. Nonetheless, Tricia found a doctor and arranged for Skipper to have a physical. Neither of them expected the news they were about to receive. “I was told that my blood levels were in the critical range and my spleen was six to eight times larger than normal,” Rodgers recalls. He was diagnosed with Mantel Cell cancer, which is a terminal form of cancer, and was told that almost all of his lymph nodes were affected. “I underwent mega chemo treatments and spent many days in the hospital. Then, in December, the doctor told my wife that my body might not be able to handle additional treatments.” A bone marrow transplant was Rodgers’ last hope; but first, more tests needed to be run. “I was referred to a surgeon who decided to remove two lymph nodes that showed a high concentration of cancer. But when the nodes were tested, the results showed no cancer.” Further tests indicated that Rodgers had a cancer more readily treatable than Mantel Cell. He underwent at-home chemotherapy for 6 days, 24 hours each day. A month later (March 2016), he had more tests. “I was diagnosed as ‘cancer free’ – full remission,” Rodgers says. “Tricia and I believe that God took some really bad cancer cells and made them into better, more easily treatable cancer cells. We believe that God worked through the doctors and the incredible medical team at Florida Cancer Specialists, and I was healed.” It has been more than a year since Rodgers’ first cancer diagnosis, but he’s not one to dwell on the past. “None of us knows how many days we have on this planet,” he says. “I intend to use the ones I have left to serve others the best I can.” One way in which Rodgers serves others is by assisting with the creation of care packages for cancer patients at FCS. About two months into his treatment, Linda McCarver, a friend from Rodgers’ church, contacted him and proposed the idea of making cancer-care packages in Rodgers’ honor. McCarver coordinated the collection of various
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goodies, and the Sewing Seeds (a ministry group from First Family Church in Orange Park) created warm hats for FCS patients, many of whom had lost their hair due to chemotherapy. The care packages, which were delivered during the preview of the new cancer treatment building in Gainesville, came in the form of well-stuffed tote bags. Each tote contained: • Chapstick (“A huge need for chemo patients.” says Rodgers) • Individually wrapped candies (“You tend to get an awful taste in your moth from chemo – or you can’t taste anything at all.”) • A water bottle (“Your mouth gets dry.”) • Tissues (“For moments of joy or sorrow – emotions can swing!”) • Hand sanitizer (“A must-have for chemo patients, because the immune system can get low.”) • A foam-filled headrest (“Chemo treatments can last up to six hours.”) • And a note that contained Rodgers’ contact information, his cancer story – “I have gone from planning my own funeral to being in full remission.” – and an offer to pray for and talk with the patient, anytime. “We wanted them to know they weren’t alone, and that there was hope,” Rodgers says. “After my diagnosis, I was scared and depressed. A friend of mine, who is a cancer survivor, talked me through the process of chemo treatment. Another friend, who is also a cancer survivor and a missionary in a foreign country, called me and prayed with me. Both calls provided me with encouragement and comfort. Another friend who has been through chemo and who knows I love the Avengers movies gave me an Avengers lunch box, filled with goodies, to take to my chemo treatment sessions.” Rodgers knows, through experience, that it’s little kindnesses like these that make the biggest difference in a person’s life. For more information on how you can assist Rodgers in raising funds for the continued creation of FCS patient care packages, contact him at [email protected]
A Value Proposition
FCS helps lead the way in modeling the future of oncology care BY ZANDRA WOLFGRAM Winter 2016
ccording to the National Institute of Health, based on growth and aging of the U.S. population, medical expenditures for cancer in the year 2020 are projected to reach at least $158 billion — an increase of 27 percent over costs in 2010. An estimated 1.6 million new cases of cancer will be diagnosed this year. Most of those people will be 65 years old or older and Medicare beneficiaries. So, given our current national healthcare snapshot, how do we lower costs for a growing patient population, while increasing quality patient care? In support of the Affordable Care Act, the U.S. Department of Health & Human Services tasked The Center for Medicare & Medicaid Innovation (CMMI) to give it shot. On July 1, 2016, CMMI launched the Oncology Care Model (OCM) and Florida Cancer Specialists & Research Institute (FCS) is among a select group of about 200 physician group practices (along with 17 health insurance companies) chosen to participate in the five-year program designed to improve health outcomes and produce higher quality care at the same or lower cost to Medicare. “We welcome the opportunity to partner with CMMI through this new initiative,” says FCS CEO Brad Prechtl. “As healthcare costs continue to rise, it is incumbent upon us all to develop programs that focus on accountability and ensure clinical excellence and compassionate and cost-effective care in a community setting for our patients.” The program is one of the most comprehensive FCS has participated in and, for FCS Chief Revenue Cycle Officer Sarah Cevallos, it’s a winning proposition on many levels. “From an organizational perspective, it’s an important project, and we’re honored to be involved in such an innovative program, which is one of the first for oncology. From a business perspective, it’s great being on the cutting edge, not just in research, but also in how physicians are reimbursed and contracted. The focus has officially started to shift from a volume-based reimbursement system to value,” she explains. Providing value may seem simple, even common sense, but it is viewed as a paradigm shift for the entire medical community. Dr. William Harwin, president and founder of FCS, is satisfied that one of the largest community oncology providers is well prepared to embrace healthcare’s “new normal.” “Excellence in cancer care requires physicians to comprehensively address the extremely complex needs of our patients,” says Harwin. “The Oncology Care Model is consistent with our current approach and includes a focus on those patients who are undergoing chemotherapy, which has always been a priority for FCS, and another reason it is a good fit for us.”
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Cevallos couldn’t agree more and is particularly pleased that the program will engage FCS physicians who “are the ones with boots on the ground” and know firsthand what’s happening and therefore where and how costs can be saved without compromising care. It’s early, but the program is already fusing with FCS’s caregiving culture. “Our physicians are already starting to think about how to enhance our current processes and bring even more value to our patients,” Cevallos says. “They are considering quality of life for patients in ways they may not have in the past.”
"Simply put, patients who are well cared for do better.” DON CHAMPLAIN SENIOR MANAGER OF CARE MANAGEMENT
As part of the program, FCS provides enhanced oncology services and is reimbursed its traditional fee for service payments and an additional payment called a “MEOS” payment, which stands for “Monthly Enhanced Oncology Services.” In addition, FCS is required to save CMMI at least 4% on the total cost of care (including nonFCS provided services). In order to share in any of these savings, FCS is also required to meet a tight set of quality measures. Needless to say, performance is key to the financial success of the program. Given that, FCS COO Todd Schonherz says it’s important for everyone at FCS to realize they are integral to the success of OCM. “This is not just a corporate program, it’s definitely a program in which everyone — from the person who verifies insurance all the way to the person who provides the therapy — has some type of touchpoint,” he says. As to be expected for a company-wide program, the biggest price tag for the program is personnel overhead. Plans are already underway for FCS to invest in additional IT infrastructure and software. “We need quality reporting in order to give our physicians timely, accurate feedback on how well they are performing to be sure they are meeting the expectations of quality care,” Cevallos says. How is it going? “I lost a lot of sleep in June,” Cevallos laughs, “but it is going really well.” The first round of data comparing FCS to the 200 other practices and all other oncology providers was delivered a month into the program and Cevallos’ grin reveals the results. Both in patient hospital rates and emergency department visits, FCS was well below both comparable groups and we are pleased to see that our performance opportunities are where we expect to target in the future.
“This is our baseline, so the positive there is what we were doing before the program began shows we are already really effectively taking care of our patients,” she says. “We already knew this about FCS, but having real, objective data is validating.” Even before the OCM program launched, FCS had committed to making care management a focus. Don Champlain, associate director of care management, joined FCS in August 2015 and was challenged to leverage his two decades of experience to create a care management program for FCS. He delved into a flurry of forms, care plans, processes and procedures customized to suit FCS. The plan was vetted and tested and when FCS was tapped to take part in OCM, Champlain’s team was ready. “There is a difference between a case manager and a care manager,” Champlain notes. “From a care perspective, our entire focus is on the patient. We constantly ask ‘How can we improve the experience, the quality of care, the outcomes?’” FCS’s Care Management program is proactive, holistic and patientcentered. “We don’t wait for patients to call us with a cough or a temperature. We anticipate their side effects and call them and ask, ‘How are you?’” Champlain explains. Each patient in the OCM program is assigned a personal care manager who is engaged from beginning to end. The program is active in all 90 FCS clinics, but because most of Champlain’s 45-member team works remotely, he makes an extra effort to foster care managerpatient relationships. “We provide our patients with a bio and photo and the care managers develop a bond over time, building trust, and they often become very close,” Champlain says. “I know from years of experience what this will do. Simply put, patients who are well cared for do better.” Champlain sees FCS’s Care Management program as a team effort that provides an added service. “FCS already had incredible people who deliver amazing service. We are just an add-on to the collaborative team of physicians, nurses, care managers and support staff — it takes all of us.” For Champlain, it is especially gratifying to work for a company that is forward thinking. “FCS is really great. We have leadership that really has a vision that care management is a much-needed service that really does add value. “It is just thrilling to be a part of this model,” Champlain continued. “Care management has always been a value-added proposition. And now everyone will see it does decrease costs and increase satisfaction and quality of care.” For Champlain, who is clearly passionate about value-based care, the OCM program is just the beginning of positive possibilities. “What we learn over the next five years will certainly shape what
happens in the future. But my hope is one day all patients have access to care management … the more that get to experience care management, the better!” The Medicare arm of the Oncology Care Model (OCM) includes more than 3,200 oncologists and will cover approximately 155,000 Medicare beneficiaries nationwide. FCS estimates that about 55 percent of its patients will be affected. With continued success by all measures, Champlain will likely get his wish and programs like the OCM model will be expanded to include all FCS patients. “This will be the norm and not the exception,” Cevallos says. “It’s our new world in oncology reimbursement and it’s exciting for sure.”
OCM Encourages Patient-Centered Care Participating practices will provide treatment following nationally recognized clinical guidelines for patients undergoing chemotherapy, with an emphasis on patientcentered care. These services may include: • Coordinating appointments with providers within and outside the oncology practice to ensure timely delivery of diagnostic and treatment services • Providing 24/7 access to care • Arranging for diagnostic scans and follow up with other medical team members • Ensuring data from scans and tests is received in advance of patient appointments • Providing access to additional patient resources such as emotional support groups, pain management services and clinical trials
Better speed, better accuracy
FCS is the first in the nation to use the latest imaging technology BY ZANDRA WOLFGRAM
"I still get excited every time I see it,” says FCS vice president of radiation oncology and radiology Jeff Esham, “… the radioactivity looks like fireballs!” He is talking about the images from the new Siemens’ Biograph Horizon PET/CT Scanner, which utilizes a cutting-edge molecular imaging technology that enables faster PET/ CT scans, lower injected doses and better image quality to support the identification of extremely small lesions. The FCS Gladiolus office in Fort Myers is the first community oncology location in the United States to have the Horizon, which is one of three platforms; the others are the mCT20 and the Biograph 6. In addition to Fort Myers, FCS also has rolled out new technology in West Palm Beach, Palm Beach Gardens, Clearwater and Highland. “The Horizon’s high image quality helps our radiologists and physicians determine more accurate disease staging and an effective treatment strategy,” FCS CEO Brad Prechtl says. “Plus, with this new technology, we are now able to reduce the time it takes to do a scan, so that our patients are more comfortable.” FCS’ mCT20 units are the first on a mobile platform in the Southeast and offer several advantages for both clinicians and patients. Most notably, this scanner has a larger bore; the bore is the “doughnut” that the patient is inserted into for scanning. The larger size allows for greater patient comfort and helps to reduce claustrophobia. Plus, the 20-slice CT allows for faster speed while scanning, thus reducing motion and increasing resolution of images. Siemens’ PET/CT technology delivers excellent lesion detectability, spatial resolution and quantification accuracy. These advances in molecular imaging help FCS physicians learn critical details that result in meaningful improvements in patient outcomes. “With increased speed, comes more accuracy, and the clearer the images, the greater ease the physician has in pinpointing a care or concern,” Esham explains. Having an in-house PACS (picture archiving and communication system) capability equates to faster, more efficient patient service. Once a scan is done and uploaded, a doctor can immediately pull it up in
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an exam room, share it with a patient and discuss the outcome and results of therapy. “The technology all married together is an amazing, beautiful and wonderful patient-centered tool,” says Esham. PET/CT scanners are permanently installed in high volume locations, where they are used five — and sometimes six — days a week. The addition of new mobile PET/CT units enables FCS to provide more patients with state-of-the-art imaging at smaller centers without a huge capital outlay. Esham oversees the six- to eight-week process of instruction, installation and calibration to bring the technology online. The program was rolled out in July and the response has been positive. “We’ve had nothing but praise. The patients are excited to see brand new equipment. They love and trust their doctors knowing they have made an investment in their care and well-being,” Esham says. According to Esham, the “maestro” keeping all 23 different sites of service “humming like an orchestra” — and pumping out 65,000 PET/CT scans in one year — is FCS’s director of radiology Levester Jones, Jr., who has clocked nearly 30 years in the field. Jones says there is just one word for being able to provide high quality customer care with state-of-the-art equipment in a timely manner: “Huge!” It’s a big deal he says, because it’s directly related to what FCS is all about. “World Class Medicine with Hometown Care is not just a tagline, it’s not just what we do … it’s who we are,” he exclaims. For Esham, who jokes he is a “dinosaur,” having graduated from X-ray school 35 years ago, being in medicine today is a thrill. “Everyone wants to be on the winning team. To be a part of FCS and to be a part of this evolution of technology is fascinating, and to be fighting every day on the lines with our patients is really rewarding professionally and personally.” And, Esham adds, this dinosaur is ready and eager to evolve into the future. “We are prepared – and this is just the beginning – with our scanners in place we are ready for the new isotopes coming on line,” he says. “We are there.”
get to know your doctor
Get To Know
A Q&A Profile of Dr. Matthew Fink Who, more than anyone else, inspired you to become a physician? My parents. Neither my mother nor father were medical professionals, but as a teenager, my mother was diagnosed with breast cancer the same time my father was battling Metastatic Melanoma. The challenges they faced and the dignity my father displayed in the face of death was inspiring. If you were empowered to change one thing about yourself, what would it be? This may be getting too philosophical, but it is both the good and bad -- it makes us who we are. I would be reluctant to go back and actually change things in my life, as it could affect where I am today. I have a wonderful wife and children. I have amazing friends and coworkers. And, I have the privilege to be a physician at Florida Cancer Specialists, where I can fulfill my purpose of helping others. What was your first job and what did you learn from it? I started a lawn service in my neighborhood in Tampa as a child. It taught me the value of hard, physical work and an appreciation for everything I have today. My favorite toy as a child was … Anything having to do with Star Wars. I was lucky I didn’t get hurt the time I … Climbed a glacier in Alaska.
We Support the Health of your Practice With the Same Dedication that You Support Your Patients
My most memorable patient has to have been … All of my patients are special to me. The best advice I ever received was … It isn’t as much advice as seeing and emulating the courtesy, kindness and respect my mother displays to friends and strangers alike. Probably the greatest medical advance of the last 100 years was … Dr. Matthew Fink
Your number one priority is the health of your patients. With the changing healthcare landscape, our number one priority is the business health of your practice. Dedicated exclusively to the viability of community oncology, ION Solutions provides contracting, technology, education and advocacy support that ensures you have the tools to run your practice both efficiently and effectively. With the practice support of ION Solutions, you can navigate this changing environment and focus on providing quality care for your patients.
The discovery of DNA. When I want to treat myself to a fine meal, I order …
Your preferred musical genre: classical, blues, country, jazz, bluegrass or rock? I enjoy all types of music. In a few minutes I can switch from Beethoven to Pitbull... Aerosmith to Wynton Marsalis... Broadway to Top 40… and of course, The Beatles. If you could own a sports franchise, which one would it be? Soccer (AKA Futbol). I grew up playing.
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Sushi Samba. For sure, the most difficult college course I completed was …
To learn how ION Solutions enables community oncology practices to improve operational efficiency, financial performance and quality of care, contact your Strategic Account Manager or visit IONonline.com.
Organic Chemistry. I don’t often get nervous, but I was the time I met … Bill Harwin. :)
To experience ION Solutions advocacy support, visit ourcommunitycounts.org.
Melody Anderson, R.N. Bear on the highway proved to be a crossroads
hen Melody Anderson was a young nurse with a 6-month-old child, her mother died. That sad experience and the perspective it gave Anderson, the head nurse at the Gainesville office of Florida Cancer Specialists, seem to have perfectly prepared her for the work she does now. “Working in oncology,” she says, “has made me realize all the more how important it is to live each minute, to make memories to cherish, and to make the choice to see the world as beautiful.” Anderson was fascinated with medicine as long as she can remember. “I had cousins and aunts who were nurses and they inspired me,” says the Orlando native. But like many young people who’ve been forced to realize the existential nature of life, she was in a hurry. “I’d thought about becoming a physician,” she says with a laugh, “but I didn’t want to be in school forever.” Instead, right after graduating a year early from high school, Anderson enrolled in Valencia Community College to earn her associate’s degree in nursing. And then, before she knew it, she was out of school. And married. “There I was, married after mid-terms in my first year at VCC, and now graduated, and I was only 20.” Anderson sounds a little breathless even thinking back on that time. Not only was she a new and inexperienced nurse, but her husband, a U.S. Navy submariner, was being assigned to San Diego. Add “pack up and move” to her list of major life changes all coming at once. While she was able to pass the tough State Board exams in California, the state was at that time hiring only nurses with bachelor’s degrees. Yet, with perseverance, Anderson landed a slot at an OB/ GYN clinic. And to her surprise, it was an immediate fit. But the Navy isn’t necessarily focused on spouses’ careers, and soon the family was on the move, first to Connecticut, where Anderson worked in an OB/GYN clinic. Shortly thereafter, she transferred to Norfolk, Virginia, and joined the staff of a women’s clinic whose physicians were adjunct professors at Eastern Virginia Medical School researching high-risk pregnancies. Next up was an overseas posting in Sardinia off the coast of mainland Italy. “That was a wonderful two years. By this time, we had a daughter who was 8 years old. She learned to speak Italian and our family traveled and hiked, and truly enjoyed seeing another side of the world.” Until, that is, the Navy sent her husband back to Norfolk. By that time, she had been in nursing for 16 years. She returned to Eastern Virginia Medical School, working on a maternal/fetal unit participating in research projects that included new HIV meds to prevent transferring of the virus between mother and baby. But, she needed a change.
BY MARINA BROWN
When the call went out for a highly experienced R.N. to work on a GYN/Oncology unit, Anderson decided to take the opportunity to expand her knowledge. And she loved it. “I would have never been prepared emotionally or otherwise for that kind of work as a 20 yearold,” she concedes. By the time she left the medical school to join a private oncology practice, Anderson felt she’d truly found her niche. In the meantime, she was a having an outcome of her own, an unexpected one. “My daughter was just entering high school, I had decided to return to school with the goal of becoming a nurse-practitioner, when I discovered that at 37, I was pregnant,” Anderson recalls. And it became a scary time. “Ironically, with all of my experience as a high-risk OB/GYN nurse, I became just the kind of patient we had treated,” Anderson said. “Major complications, hemorrhage, a newborn, a high school freshman and a husband getting ready to retire from the Navy.” It was time to realign priorities. Four years later with a husband home from the sea and, by now, a high-school senior heading to college, it was time to shift gears once again. And in walked the bear. “We knew we wanted to come back to Florida, but as I drove into Gainesville for a visit with my motherin-law, I hit a bear. On the road – a bear.” Anderson laughs with the serendipity of it. “While I was stuck there waiting for the car to be repaired, I casually looked around, and found what turned out to be a wonderful opportunity, a practice that would eventually become part of Florida Cancer Specialists.” Melody Anderson started as an infusion nurse and soon became the private nurse of Dr. Andres Bhatia. With Florida Cancer Specialists, she says she immediately felt part of “a large family.” And then there are the patients. “Patients are more brave and more courageous than I could ever imagine. So much is ‘thrown at them’—surgeries, chemotherapeutic medicines, the uncertainties.” Yet Anderson sees the astonishing changes in treatments and outcomes that have occurred in just the last few years. “New medications for breast cancer and tumors elsewhere in the body, as well as work on vaccines and the use of genetics have all changed the potential for longevity and for good outcomes.” Anderson ponders for a moment when she reflects on her own life lessons from her long career in nursing, one that encompasses life’s beginnings, through its struggles, to both happy and sad outcomes. “I think I would say that the most important thing is to persevere,” she says. “My patients teach me how to live, how to appreciate life, and that no matter what, we should all keep going forward with hope. “At the risk of sounding trite,” she says, “tomorrow really is another day. There is always something to learn, to work for, to be thankful for.”
Dr. Lee Zehngebot Excellence in oncology BY ZANDRA WOLFGRAM
“There’s never enough time in the day to do everything I want to do!” That well-worn complaint has particular significance for Dr. Lee Zehngebot, who practices in the Florida Cancer Specialists’ offices in Orlando (Orange Avenue) and Winter Park. In addition to his very busy practice, Zehngebot bikes an average of 100 miles a week and has a full family life, including the recent addition of his first grandchild, a little girl named Avi, whom he describes as “delicious.”
“See Z” Part of the reason Zehngebot works so hard and stays so busy is that he has earned a three-decade long reputation for excellence in oncology; many physicians refer patients to him and his partners. Zehngebot says that, initially, there was an intellectual challenge that attracted him to fighting cancer. Then married and starting his family, Zehngebot joined the faculty of Albany Medical School; however, after three years, he says he found academia was not the place for him. “I really needed the hands-on contact with patients,” he recalls. A college friend recommended Florida and, with a new purpose, the Zehngebots relocated to Orlando to join the oncology practice of Drs. David Smith and Philip Dunn. That relationship endured and prospered for the next 30 years, even beyond Dr. Smith’s retirement. Consistently recognized as one of Orlando’s ‘Best Doctors,’ Zehngebot says he is excited by the many recent advances in cancer research and treatment. “I’ve got three patients who would be dead right now, if not for immunotherapies. I don’t even know if they truly understand how remarkable these new treatments are. It’s incredible to be able to offer this kind of renewed hope to patients.” Zehngebot is regarded as a melanoma specialist; however, he treats all types of cancer and has led numerous clinical trials as a Principal or Sub Investigator. In fact, the quality of the clinical research program at Florida Cancer Specialists is one of the reasons Zehngebot and his group joined FCS in 2015. “In so many ways, FCS is setting a national benchmark for community oncology and that is particularly true when it comes to our clinical trials program. When one considers the number of trials we can offer our patients, including Phase 1 trials, it is very impressive and unmatched in a community practice.”
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Growing the Practice Dr. Zehngebot and his five partners (Drs. Philip Dunn, David Molthrop, Stefani Capone, William Grow & Sonalee Shroff) recently added two new physicians, Drs. Muhammad Imam and Yaman Suleiman, to the practice. This was a big change, considering the last time the group brought on a new doctor was 11 years ago; however, it’s an evolution Zehngebot welcomes. “It’s wonderful to have Drs. Imam and Suleiman,” he says. “They bring fresh energy and the latest knowledge and we can infuse their knowledge and enthusiasm with our experience. It’s the best of both worlds. We interviewed many young oncologists before finding these excellent doctors, who are a great fit for our practice.
Facing the Future with Optimism Ask Dr. Zehngebot to describe his life’s work in three words and he responds “challenging… difficult… rewarding.” While he is enthusiastic about the future of cancer treatment, he acknowledges that the work is very hard and sometimes emotionally draining. However, he finds inspiration in a 1962 quote from President John Kennedy’s speech at Rice University about the space race. “We choose to go to the moon in this decade and do the other things,” Kennedy said, “not because they are easy, but because they are hard, because that goal will serve to organize and measure the best of our energies and skills, because that challenge is one that we are willing to accept, one we are unwilling to postpone, and one which we intend to win.” “I have always loved that quote,” Zehngebot concludes. “And I find it particularly inspiring today, as we in oncology strive to answer VicePresident Biden’s challenge to join the ‘Cancer Moonshot’ initiative. Our work is very hard… and very satisfying. And you can’t separate the two.”
THE PATH LAB
New test improves prognostic accuracy for breast cancer recurrence BY KATY PHELAN, PHD, FACMG, DIRECTOR, CYTOGENETICS LABORATORY CO-AUTHORED BY: RYAN OLSON, M.D., HEMATOPATHOLOGIST, PATHOLOGY LABORATORY DIRECTOR
Pink Day at FCS! The Revenue Cycle team at FCS corporate office spearheaded an innovative way to raise awareness and funds for the FCS Foundation. Corporate-based employees recently participated in “Pink Day” by wearing pink and making a donation to the Foundation, which assists cancer patients in need with non-medical living expenses. Thank you to all who participated in this great event!
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Breast cancer accounts for a significant proportion of cancer diagnosed in the U.S. today. Treatment often includes surgery followed by radiotherapy, chemotherapy and/or endocrine therapy. These treatment strategies are not equally beneficial to all patients and may not significantly alter the risk of recurrence for some women. Florida Cancer Specialists (FCS) is using a personalized approach to determine an individualized risk-of-recurrence score for women with breast cancer. The testing platform used at FCS is the Prosigna Breast Cancer Prognostic Gene Signature Assay. It is performed on RNA isolated from formalin-fixed, paraffin-embedded breast tumor tissue that has previously been diagnosed as invasive breast cancer. The Prosigna assay uses gene expression data weighted together with clinical variables to aid in the assessment of risk of recurrence (ROR) for each patient. Testing is indicated in post-menopausal women with hormone receptor-positive, node negative or node positive early stage (Stage I or II) breast cancer being considered for adjuvant endocrine therapy. Prosigna combines two powerful tools for risk assessment. First, the Prosigna Score, which utilizes the expression level of 50 genes using qRT-PCR and DNA microarrays to produce numerical value on a 1 to 100 scale. The Prosigna score correlates with the probability of distant recurrence of cancer within 10 years. Second, the Risk Group relies on the Prosigna Score and nodal status to provide a risk classification. Cutoff values derived from clinical outcomes in large patient populations are used to interpret the Prosigna score and assign the risk category. The scores are divided into low, intermediate, and high risk groups. Prosigna was validated in a large clinical study that included both node negative and node positive patients. Validation in a large study population enables the Prosigna Score and the risk group to add prognostic information beyond what other clinical variables can provide. A significant difference in distant recurrence-free survival (DRFS) rates is observed among risk groups. In node-negative patients, the 10-year DRFS rates were over 95% for the low risk group, 90.4% for the intermediate risk group and less than 85% for the high risk group. Similarly, for the node-positive patients, the 10year DRFS rates were 94.2% for the low risk group and about 76% for the high risk group. The Prosigna Assay is an FDA-cleared in-vitro diagnostic assay that delivers precise, reproducible, and reliable results. Because the test is run at the Florida Cancer Specialists Laboratory, rather than at a national reference lab, the turnaround time for getting results is only five to seven business days. Katy Phelan, PhD, FACMG Ryan Olson, M.D. HR HAPPENINGS
Testing supplies available Don’t forget that as part of your employee benefits, FCS offers FREE diabetes testing supplies to all employees and their covered dependents who have been diagnosed with diabetes. The FCS Health Plan offers the following coverage for diabetes testing supplies, which are provided as part of the Preferred Diabetes Treatment Plan. 1. Diabetes Supplies through the ActiveCare, LLC Diabetes Wellness Program will be part of the Treatment Plan for those Plan participants who are diagnosed with diabetes. 2. All diabetes supplies provided by the FCS Plan as part of the Preferred Diabetes Treatment Plan through ActiveCare Diabetes Program will be provided to covered employees and their covered dependents, at NO COST. The supplies provided at NO COST include: • One Glucose Meter • Lancing Devices • Control Solution • Diabetes Testing Strips • Lancets 3. Participation in The Preferred Diabetes Treatment Plan is voluntary. You may enroll by calling ActiveCare at 877-862-5553.
TAGRISSOTM (osimertinib) tablet, for oral use Brief Summary of Prescribing Information. For complete prescribing information consult official package insert INDICATIONS AND USAGE TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) in the full Prescribing Information]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. DOSAGE AND ADMINISTRATION Patient Selection Confirm the presence of a T790M EGFR mutation in tumor specimens prior to initiation of treatment with TAGRISSO [see Indications and Usage (1) and Clinical Studies (14) in the full Prescribing Information]. Information on FDA-approved tests for the detection of T790M mutations is available at http://www.fda.gov/companiondiagnostics. Recommended Dosage Regimen The recommended dose of TAGRISSO is 80 mg tablet once a day until disease progression or unacceptable toxicity. TAGRISSO can be taken with or without food. If a dose of TAGRISSO is missed, do not make up the missed dose and take the next dose as scheduled. Administration to Patients Who Have Difficulty Swallowing Solids Disperse tablet in 4 tablespoons (approximately 50 mL) of non-carbonated water only. Stir until tablet is completely dispersed and swallow or administer through naso-gastric tube immediately. Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 4 to 8 ounces of water and immediately drink or administer through the naso-gastric tube [see Clinical Pharmacology (12.3) in the full Prescribing Information]. Dose Modification for Adverse Reactions Table 1 Recommended Dose Modifications for TAGRISSO Target Organ Pulmonary
Adverse Reactiona Interstitial lung disease (ILD)/Pneumonitis QTc† interval greater than 500 msec on at least 2 separate ECGsb
b c †
Withhold TAGRISSO until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec, then resume at 40 mg dose. Permanently discontinue TAGRISSO.
QTc interval prolongation with signs/ symptoms of life threatening arrhythmia Asymptomatic, absolute decrease Withhold TAGRISSO for up to 4 weeks. in LVEFc of 10% from baseline and • If improved to baseline LVEF, resume. below 50% • If not improved to baseline, permanently discontinue. Symptomatic congestive heart failure Permanently discontinue TAGRISSO. Grade 3 or higher adverse reaction Withhold TAGRISSO for up to 3 weeks. If improvement to Grade 0-2 within Resume at 80 mg or 40 mg daily. 3 weeks If no improvement within 3 weeks
Dose Modification Permanently discontinue TAGRISSO.
Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0). ECGs = Electrocardiograms LVEF = Left Ventricular Ejection Fraction QTc = QT interval corrected for heart rate
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Permanently discontinue TAGRISSO.
CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Interstitial Lung Disease/Pneumonitis Across clinical trials, interstitial lung disease (ILD)/pneumonitis occurred in 3.3% (n=27) of TAGRISSO treated patients (n=813); 0.5% (n=4) were fatal. Withhold TAGRISSO and promptly investigate for ILD in any patient who presents with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed [see Dosage and Administration (2.4) and Adverse Reactions (6) in the full Prescribing Information]. QTc Interval Prolongation The heart rate-corrected QT (QTc) interval prolongation occurs in patients treated with TAGRISSO. Of the 411 patients in Study 1 and Study 2, one patient (0.2%) was found to have a QTc greater than 500 msec, and 11 patients (2.7%) had an increase from baseline QTc greater than 60 msec [see Clinical Pharmacology (12.2) in the full Prescribing Information]. In Study 1 and 2, patients with baseline QTc of 470 msec or greater were excluded. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life threatening arrhythmia [see Dosage and Administration (2.4) in the full Prescribing Information]. Cardiomyopathy Across clinical trials, cardiomyopathy (defined as cardiac failure, pulmonary edema, ejection fraction decreased or stress cardiomyopathy) occurred in 1.4% (n=11) of TAGRISSO treated patients (n=813); 0.2% (n=2) were fatal. In Study 1 and Study 2, Left Ventricular Ejection Fraction (LVEF) decline >10% and a drop to <50% occurred in 2.4% (9/375) of patients who had baseline and at least one follow up LVEF assessment.
Assess LVEF by echocardiogram or multigated acquisition (MUGA) scan before initiation of TAGRISSO and then at 3 month intervals while on treatment. Withhold treatment with TAGRISSO if ejection fraction decreases by 10% from pretreatment values and is less than 50%. For symptomatic congestive heart failure or persistent, asymptomatic LV dysfunction that does not resolve within 4 weeks, permanently discontinue TAGRISSO [see Dosage and Administration (2.4) in the full Prescribing Information]. Embryo-Fetal Toxicity Based on data from animal studies and its mechanism of action, TAGRISSO can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, osimertinib caused postimplantation fetal loss when administered during early development at a dose exposure 1.5 times the exposure at the recommended human dose. When males were treated prior to mating with untreated females, there was an increase in preimplantation embryonic loss at plasma exposures of approximately 0.5-times those observed in patients at the 80 mg dose level. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose [see Use in Specific Populations (8.1), (8.3) and Clinical Pharmacology (12.3) in the full Prescribing Information]. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) in the full Prescribing Information] QTc Interval Prolongation [see Warnings and Precautions (5.2) in the full Prescribing Information] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to TAGRISSO (80 mg daily) in 411 patients with EGFR T790M mutation-positive non-small cell lung cancer who received prior EGFR TKI therapy, in two single arm studies, Study 1 and Study 2. Patients with a past medical history of ILD or radiation pneumonitis that required steroid treatment, serious arrhythmia or baseline QTc interval greater than 470 ms were excluded from Study 1 and Study 2. Baseline patient and disease characteristics were: median age 63 years, 13% of patients were ≥75 years old, female (68%), White (36%), Asian (60%), metastatic (96%), sites of brain metastases (39%), World Health Organization (WHO) performance status of 0 (37%) or 1 (63%), 1 prior line of therapy [EGFR-TKI treatment only, second line, chemotherapy-naïve (31%)], 2 or more prior lines of therapy (69%). Of the 411 patients, 333 patients were exposed to TAGRISSO for at least 6 months; 97 patients were exposed for at least 9 months; however no patient was exposed to TAGRISSO for 12 months. In Studies 1 and 2, the most common (>20%) adverse reactions (all grades) observed in TAGRISSOtreated patients were diarrhea (42%), rash (41%), dry skin (31%), and nail toxicity (25%). Dose reductions occurred in 4.4% of patients treated with TAGRISSO. The most frequent adverse reactions that led to dose reductions or interruptions were: electrocardiogram QTc prolonged (2.2%) and neutropenia (1.9%). Serious adverse reactions reported in 2% or more patients were pneumonia and pulmonary embolus. There were 4 patients (1%) treated with TAGRISSO who developed fatal adverse reactions of ILD/pneumonitis. Other fatal adverse reactions occurring in more than 1 patient included pneumonia (4 patients) and CVA/cerebral hemorrhage (2 patients). Discontinuation of therapy due to adverse reactions occurred in 5.6% of patients treated with TAGRISSO. The most frequent adverse reactions that led to discontinuation were ILD/pneumonitis and cerebrovascular accidents/infarctions. Tables 2 and 3 summarize the common adverse reactions and laboratory abnormalities observed in TAGRISSO-treated patients. Table 2 Adverse Reactions (>10% for all NCI CTCAE* Grades or >2% for Grades 3-4) in Study 1 and Study 2 Adverse Reaction Gastrointestinal disorders Diarrhea Nausea Decreased appetite Constipation Stomatitis Skin disorders Rasha Dry skinb Nail toxicityc Pruritus Eye Disordersd Respiratory Cough General Fatigue Musculoskeletal Back pain Central Nervous System Headache Infections Pneumonia Vascular events Venous thromboembolisme
* NCI CTCAE v4.0.
All Grades %
Grade 3-4f %
42 17 16 15 12
1.0 0.5 0.7 0.2 0
41 31 25 14 18
0.5 0 0 0 0.2
TAGRISSOTM (osimertinib) tablet, for oral use a
d e f
Includes cases reported within the clustered terms for rash adverse events: Rash, rash generalized, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pustular, erythema, folliculitis, acne, dermatitis and acneform dermatitis. Includes dry skin, eczema, skin fissures, xerosis. Includes nail disorders, nail bed disorders, nail bed inflammation, nail bed tenderness, nail discoloration, nail disorder, nail dystrophy, nail infection, nail ridging, onychoclasis, onycholysis, onychomadesis, paronychia. Includes dry eye, vision blurred, keratitis, cataract, eye irritation, blepharitis, eye pain, lacrimation increased, vitreous floaters. Other ocular toxicities occurred in <1% of patients. Includes deep vein thrombosis, jugular venous thrombosis, and pulmonary embolism. No grade 4 events have been reported.
Additional clinically significant adverse reactions occurring in 2% or more of patients treated with TAGRISSO included cerebrovascular accident (2.7%). Table 3 Common Laboratory Abnormalities (>20% for all NCI CTCAE Grades) in Study 1 and Study 2 Laboratory Abnormality
Clinical Chemistry Hyponatremia Hypermagnesemia Hematologic Lymphopenia Thrombocytopenia Anemia Neutropenia
TAGRISSO N=411 Change from Baseline Change from Baseline to Grade 3 or Grade 4 (%)a All Grades (%) 26 20
63 54 44 33
3.3 1.2a 0.2 3.4
The only grade 4 laboratory abnormality was 1 patient with grade 4 thrombocytopenia.
DRUG INTERACTIONS Drug interaction studies with inhibitors, inducers or substrates of CYP enzymes and transporters have not been conducted with TAGRISSO. Effect of Other Drugs on Osimertinib Strong CYP3A Inhibitors Avoid concomitant administration of TAGRISSO with strong CYP3A inhibitors, including macrolide antibiotics (e.g., telithromycin), antifungals (e.g., itraconazole), antivirals (e.g., ritonavir), nefazodone, as concomitant use of strong CYP3A inhibitors may increase osimertinib plasma concentrations. If no other alternative exists, monitor patients more closely for adverse reactions of TAGRISSO [see Dosage and Administrations (2.4) and Clinical Pharmacology (12.3) in the full Prescribing Information]. Strong CYP3A Inducers Avoid concomitant administration of TAGRISSO with strong CYP3A inducers (e.g., phenytoin, rifampicin, carbamazepine, St. John’s Wort) as strong CYP3A inducers may decrease osimertinib plasma concentrations [see Clinical Pharmacology (12.3) in the full Prescribing Information]. Effect of Osimertinib on Other Drugs Avoid concomitant administration of TAGRISSO with drugs that are sensitive substrates of CYP3A, breast cancer resistance protein (BCRP), or CYP1A2 with narrow therapeutic indices, including but not limited to fentanyl, cyclosporine, quinidine, ergot alkaloids, phenytoin, carbamazepine, as osimertinib may increase or decrease plasma concentrations of these drugs [see Clinical Pharmacology (12.3) in the full Prescribing Information]. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary Based on data from animal studies and its mechanism of action, TAGRISSO can cause fetal harm when administered to a pregnant woman. There are no available data on TAGRISSO use in pregnant women. Administration of osimertinib to pregnant rats was associated with embryolethality and reduced fetal growth at plasma exposures 1.5 times the exposure at the recommended human dose [see Data]. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data When administered to pregnant rats prior to embryonic implantation through the end of organogenesis (gestation days 2-20) at a dose of 20 mg/kg/day, which produced plasma exposures of approximately 1.5 times the clinical exposure, osimertinib caused post-implantation loss and early embryonic death. When administered to pregnant rats from implantation through the closure of the hard palate (gestation days 6 to 16) at doses of 1 mg/kg/day and above (0.1-times the AUC observed in patients at the recommended dose of 80 mg), an equivocal increase in the rate of fetal malformations and variations was observed in treated litters relative to those of concurrent controls. When administered to pregnant dams at doses of 30 mg/kg/day during organogenesis through lactation Day 6, osimertinib caused an increase in total litter loss and postnatal death. At a dose of 20 mg/kg/day, osimertinib administration during the same period resulted in increased postnatal death as well as a slight reduction in mean pup weight at birth that increased in magnitude between lactation days 4 and 6. Lactation Risk Summary There are no data on the presence of osimertinib in human milk, the effects of osimertinib on the breastfed infant or on milk production. Administration to rats during gestation and early lactation was associated with adverse effects, including reduced growth rates and neonatal death [see Use in
Specific Populations (8.1) in the full Prescribing Information]. Because of the potential for serious adverse reactions in breastfed infants from osimertinib, advise a lactating woman not to breastfeed during treatment with TAGRISSO and for 2 weeks after the final dose. Females and Males of Reproductive Potential Contraception Females Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose [see Use in Specific Populations (8.1) in the full Prescribing Information]. Males Advise male patients with female partners of reproductive potential to use effective contraception during and for 4 months following the final dose of TAGRISSO [see Nonclinical Toxicology (13.1) in the full Prescribing Information]. Infertility Based on animal studies, TAGRISSO may impair fertility in females and males of reproductive potential. It is not known if the effects on fertility are reversible [see Nonclinical Toxicology (13.1) in the full Prescribing Information]. Pediatric Use The safety and effectiveness of TAGRISSO in pediatric patients have not been established. Geriatric Use One hundred eighty-seven (45%) of the 411 patients in clinical trials of TAGRISSO were 65 years of age and older, and 54 patients (13%) were 75 years of age and older. No overall differences in effectiveness were observed based on age. Exploratory analysis suggest a higher incidence of Grade 3 and 4 adverse reactions (32% versus 25%) and more frequent dose modifications for adverse reactions (23% versus 17%) in patients 65 years or older as compared to those younger than 65 years. Renal Impairment No dedicated clinical studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of osimertinib. Based on population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild [creatinine clearance (CLcr) 60-89 mL/min] or moderate (CLcr 30-59 mL/min) renal impairment. There is no recommended dose of TAGRISSO for patients with severe renal impairment (CLcr <30 mL/min) or end-stage-renal disease [see Clinical Pharmacology (12.3) in the full Prescribing Information]. Hepatic Impairment No dedicated clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of osimertinib. Based on population pharmacokinetic (PK) analysis, no dose adjustment is recommended in patients with mild hepatic impairment [total bilirubin
3182206 11/15 Issued 11/15
IMPORTANT SAFETY INFORMATION • There are no contraindications for TAGRISSO • Interstitial Lung Disease (ILD)/Pneumonitis occurred in 3.3% and was fatal in 0.5% of 813 TAGRISSO patients. Withhold TAGRISSO and promptly investigate for ILD in any patient presenting with worsening of respiratory symptoms indicative of ILD (e.g., dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed
BREAK THROUGH THE T790M RESISTANCE BARRIER
in patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, at progression on or after EGFR TKI therapy • Proven efficacy in two separate, global, Phase II, single-arm, open-label clinical trials in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on or after EGFR TKI therapy1 – A 59% objective response rate (95% CI: 54–64) in patients who progressed with previous EGFR TKI therapy • In a separate dose-finding part of AURA, 63 patients with centrally confirmed EGFR T790M positive NSCLC who progressed on prior systemic therapy, including an EGFR TKI, were administered TAGRISSO 80 mg1: – 51% (32/63) of patients in the 80-mg cohort had a confirmed response by BICR – The median DoR was 12.4 months
• Grade 3/4 adverse events occurred at <3.5%1 • <6% of patients in a pooled analysis (N=411) had either dose reductions or discontinuations due to adverse events1 • Interstitial Lung Disease (ILD)/Pneumonitis occurred in 3.3% and was fatal in 0.5% of 813 TAGRISSO patients. Withhold TAGRISSO and promptly investigate for ILD in any patient presenting with worsening of respiratory symptoms indicative of ILD (e.g., dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed1 • The most common adverse events in a pooled analysis of TAGRISSO patients (N=411) were diarrhea (42%), rash (41%), dry skin (31%), and nail toxicity (25%)1
• QTc interval prolongation occurred in TAGRISSO patients. Of the 411 patients in two Phase II studies, 0.2% were found to have a QTc greater than 500 msec, and 2.7% had an increase from baseline QTc greater than 60 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life threatening arrhythmia • Cardiomyopathy occurred in 1.4% and was fatal in 0.2% of 813 TAGRISSO patients. Left Ventricular Ejection Fraction (LVEF) decline >10% and a drop to <50% occurred in 2.4% of (9/375) TAGRISSO patients. Assess LVEF before initiation and then at 3 month intervals of TAGRISSO treatment. Withhold TAGRISSO if ejection fraction decreases by 10% from pretreatment values and is less than 50%. For symptomatic congestive heart failure or persistent asymptomatic LV dysfunction that does not resolve within 4 weeks, permanently discontinue TAGRISSO • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during TAGRISSO treatment and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose • The most common adverse reactions (>20%) observed in TAGRISSO patients were diarrhea (42%), rash (41%), dry skin (31%) and nail toxicity (25%)
INDICATION TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Please see Brief Summary of complete Prescribing Information. Reference: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2015.
TAGRISSO is a trademark of the AstraZeneca group of companies. ©2016 AstraZeneca. All rights reserved. 3155300 5/16
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ELEVATING PATIENT SUPPORT
YOU&iTM Instant Savings Program
1-877-877-3536 Monday – Friday, 8 AM – 8 PM ET
YOUR CONNECTION TO A WORLD OF SUPPORT YOU&i™ Support Program helps patients understand the insurance process, ﬁnd cost support options, and gather information along their treatment journey.
*For a 30-day supply of IMBRUVICA® for eligible commercial patients. Not valid for federal and state healthcare program beneﬁciaries.
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