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The C-Suite Advisor ManagedHealthcareExecutive.com EXECUTIVE SPECIAL ONCOLOGY ISSUE CANCER MOONSHOT Better quality, lower costs by 2020 PLUS Big data boosts cancer research Oncology pipeline developments Cancer collaborative holds promise November 2016 VOL. 26 NO. 11 Your members with retinal diseases* may be facing the serious risk of vision loss without screening and doctor-recommended treatment.1-3 Vision loss may require ongoing resources.1-3 THERE’S EYLEA—a treatment option that can fit your plans for proven visual acuity outcomes EYLEA has proven outcomes as demonstrated in phase 3 clinical trials in patients with Wet AMD, Macular Edema following RVO, DME, and DR in patients with DME With monthly and every-other-month dosing,† EYLEA offers flexible dosing options to meet the needs of your providers and your members INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS • EYLEA® (aflibercept) Injection is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in Patients with DME. CONTRAINDICATIONS • EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA. WARNINGS AND PRECAUTIONS • Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA. • Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately. • There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies. ADVERSE REACTIONS • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment. • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment. *The FDA-approved indications for EYLEA are Wet AMD, Macular Edema following RVO, DME, and DR in Patients with DME. † After an initial monthly dosing period for certain indications. References: 1. American Academy of Ophthalmology. Preferred Practice Pattern®: Age-Related Macular Degeneration. http://www.aao.org/preferred-practice-pattern/age-related-maculardegeneration-ppp-2015. 2. American Academy of Ophthalmology. Preferred Practice Pattern®: Retinal Vein Occlusions. http://www.aao.org/preferred-practice-pattern/retinal-vein-occlusions-ppp-2015. 3. American Academy of Ophthalmology. Preferred Practice Pattern®: Diabetic Retinopathy. http://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp-updated-2016. Please see brief summary of full Prescribing Information on the following page. EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc. ©2016, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591 All rights reserved 08/2016 US-PMA-12565 BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION FOR COMPLETE DETAILS, SEE FULL PRESCRIBING INFORMATION. 1 INDICATIONS AND USAGE EYLEA® (aflibercept) Injection is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in Patients with DME. 2 DOSAGE AND ADMINISTRATION 2.1 Important Injection Instructions. For ophthalmic intravitreal injection. EYLEA must only be administered by a qualified physician. 2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD). The recommended dose for EYLEA is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the "%./0āĂƬ3!!'/Ĩă)+*0$/ĩċ 2.3 Macular Edema Following Retinal Vein Occlusion (RVO). The recommended dose for EYLEA is (0.05 mL or 50 microliters) administered by intravitreal injection once every 4 weeks (monthly). 2.4 Diabetic Macular Edema (DME). The recommended dose for EYLEA is (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months). 2.5 Diabetic Retinopathy (DR) in Patients with DME. The recommended dose for EYLEA is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first ĂĀƬ3!!'/ĨĆ)+*0$/ĩċ 2.6 Preparation for Administration. EYLEA should be inspected visually prior to administration. If particulates, cloudiness, or discoloration are visible, the vial must not be used. Using aseptic technique, the intravitreal injection should be performed with a 30-gauge x ½-inch injection needle. For complete preparation for administration instructions, see full prescribing information. 2.7 Injection Procedure. The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include surgical hand disinfection and the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a topical broad– spectrum microbicide should be given prior to the injection. Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, a sterile paracentesis needle should be available. Following intravitreal injection, patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye pain, redness of the eye, photophobia, blurring of vision) without delay (see Patient Counseling Information). Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before EYLEA is administered to the other eye. After injection, any unused product must be discarded. 3 DOSAGE FORMS AND STRENGTHS Single-use, glass vial designed to provide 0.05 mL of 40 mg/mL solution (2 mg) for intravitreal injection. 4 CONTRAINDICATIONS EYLEA is contraindicated in patients with • Ocular or periocular infections • Active intraocular inflammation • Known hypersensitivity to aflibercept or any of the excipients in EYLEA. Hypersensitivity reactions may manifest as severe intraocular inflammation. 5 WARNINGS AND PRECAUTIONS 5.1 Endophthalmitis and Retinal Detachments. Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments (see Adverse Reactions). Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately (see Dosage and Administration and Patient Counseling Information). 5.2 Increase in Intraocular Pressure. Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA (see Adverse Reactions). Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular edothelial growth factor (VEGF) inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately (see Dosage and Administration). 5.3 Thromboembolic Events. There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies. 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section of the labeling: • Endophthalmitis and retinal detachments • Increased intraocular pressure • Thromboembolic events 6.1 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 other clinical trials of the same or another drug and may not reflect the rates observed in practice. A total of 2711 patients treated with EYLEA constituted the safety population in seven phase 3 studies. Among those, 2110 patients were treated with the recommended dose of 2 mg. Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment. The most common adverse reactions (*5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment. Neovascular (Wet) Age-Related Macular Degeneration (AMD). The data described below reflect exposure to EYLEA in 1824 patients with wet AMD, including 1223 patients treated with the 2-mg dose, in 2 double-masked, active-controlled clinical studies (VIEW1 and VIEW2) for 12 months. Table 1: Most Common Adverse Reactions (*1%) in Wet AMD Studies Active Control EYLEA (ranibizumab) (N=1824) (N=595) Conjunctival hemorrhage 25% 28% Eye pain 9% 9% Cataract 7% 7% Vitreous detachment 6% 6% Vitreous floaters 6% 7% Intraocular pressure increased 5% 7% Ocular hyperemia 4% 8% Corneal epithelium defect 4% 5% Detachment of the retinal pigment 3% 3% epithelium Injection site pain 3% 3% Foreign body sensation in eyes 3% 4% Lacrimation increased 3% 1% Vision blurred 2% 2% Intraocular inflammation 2% 3% Retinal pigment epithelium tear 2% 1% Injection site hemorrhage 1% 2% Eyelid edema 1% 2% Corneal edema 1% 1% Less common serious adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, and endophthalmitis. Macular Edema Following Retinal Vein Occlusion (RVO). The data described below reflect 6 months exposure to EYLEA with a monthly 2 mg dose in 218 patients following CRVO in 2 clinical studies (COPERNICUS and GALILEO) and 91 patients following BRVO in one clinical study (VIBRANT). Adverse Reactions Table 2: Most Common Adverse Reactions (*1%) in RVO Studies Adverse Reactions CRVO BRVO EYLEA Control EYLEA Control (N=218) (N=142) (N=91) (N=92) Eye pain 13% 5% 4% 5% Conjunctival hemorrhage 12% 11% 20% 4% Intraocular pressure increased 8% 6% 2% 0% Corneal epithelium defect 5% 4% 2% 0% Vitreous floaters 5% 1% 1% 0% Ocular hyperemia 5% 3% 2% 2% Foreign body sensation in eyes 3% 5% 3% 0% Vitreous detachment 3% 4% 2% 0% Lacrimation increased 3% 4% 3% 0% Injection site pain 3% 1% 1% 0% Vision blurred 1% <1% 1% 1% Intraocular inflammation 1% 1% 0% 0% 0% Cataract <1% 1% 5% Eyelid edema <1% 1% 1% 0% Less common adverse reactions reported in <1% of the patients treated with EYLEA in the CRVO studies were corneal edema, retinal tear, hypersensitivity, and endophthalmitis. Diabetic Macular Edema (DME). The data described below reflect exposure to EYLEA in 578 patients with DME treated with the 2-mg dose in 2 double-masked, controlled clinical studies (VIVID and VISTA) from baseline to week 52 and from baseline to week 100. Table 3: Most Common Adverse Reactions (*1%) in DME Studies Adverse Reactions Baseline to Week 52 Baseline to Week 100 EYLEA Control EYLEA Control (N=578) (N=287) (N=578) (N=287) Conjunctival hemorrhage 28% 17% 31% 21% Eye pain 9% 6% 11% 9% Cataract 8% 9% 19% 17% Vitreous floaters 6% 3% 8% 6% Corneal epithelium defect 5% 3% 7% 5% Intraocular pressure increased 5% 3% 9% 5% Ocular hyperemia 5% 6% 5% 6% Vitreous detachment 3% 3% 8% 6% Foreign body sensation in eyes 3% 3% 3% 3% Lacrimation increased 3% 2% 4% 2% Vision blurred 2% 2% 3% 4% Intraocular inflammation 2% <1% 3% 1% Injection site pain 2% <1% 2% <1% Eyelid edema <1% 1% 2% 1% Less common adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, corneal edema, and injection site hemorrhage. 6.2 Immunogenicity. As with all therapeutic proteins, there is a potential for an immune response in patients treated with EYLEA. The immunogenicity of EYLEA was evaluated in serum samples. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to EYLEA in immunoassays. The detection of an immune response is highly dependent on the sensitivity and specificity of the assays used, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to EYLEA with the incidence of antibodies to other products may be misleading. In the wet AMD, RVO, and DME studies, the pre-treatment incidence of immunoreactivity to EYLEA was approximately 1% to 3% across treatment groups. After dosing with EYLEA for 24-100 weeks, antibodies to EYLEA were detected in a similar percentage range of patients. There were no differences in efficacy or safety between patients with or without immunoreactivity. 6.3 Postmarketing Experience. The following adverse reactions have been identified during postapproval use of EYLEA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hypersensitivity including rash, pruritus, and urticaria as well as isolated cases of severe anaphylactic/anaphylactoid reactions. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy. Pregnancy Category C. Aflibercept produced embryo-fetal toxicity when administered every three days during organogenesis to pregnant rabbits at intravenous doses *3 mg per kg, or every six days at subcutaneous doses *0.1 mg per kg. Adverse embryo-fetal effects included increased incidences of postimplantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, heart and major vessel defects, and skeletal malformations (fused vertebrae, sternebrae, and ribs; supernumerary vertebral arches and ribs; and incomplete ossification). The maternal No Observed Adverse Effect Level (NOAEL) in these studies was 3 mg per kg. Aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal NOAEL was less than 0.1 mg per kg. Administration of the lowest dose assessed in rabbits (0.1 mg per kg) resulted in systemic exposure (AUC) that was approximately 10 times the systemic exposure observed in humans after an intravitreal dose of 2 mg. There are no adequate and well-controlled studies in pregnant women. EYLEA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Females of reproductive potential should use effective contraception prior to the initial dose, during treatment, and for at least 3 months after the last intravitreal injection of EYLEA. 8.3 Nursing Mothers. It is unknown whether aflibercept is excreted in human milk. Because many drugs are excreted in human milk, a risk to the breastfed child cannot be excluded. EYLEA is not recommended during breastfeeding. A decision must be made whether to discontinue nursing or to discontinue treatment with EYLEA, taking into account the importance of the drug to the mother. 8.4 Pediatric Use. The safety and effectiveness of EYLEA in pediatric patients have not been established. 8.5 Geriatric Use. In the clinical studies, approximately 76% (2049/2701) of patients randomized to treatment with EYLEA were *65 years of age and approximately 46% (1250/2701) were *75 years of age. No significant differences in efficacy or safety were seen with increasing age in these studies. 17 PATIENT COUNSELING INFORMATION In the days following EYLEA administration, patients are at risk of developing endophthalmitis or retinal detachment. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients to seek immediate care from an ophthalmologist (see Warnings and Precautions). Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations (see Adverse Reactions). Advise patients not to drive or use machinery until visual function has recovered sufficiently. Manufactured by: Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, NY 10591-6707 EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc. © 2016, Regeneron Pharmaceuticals, Inc. All rights reserved. Issue Date: June 2016 Initial U.S. Approval: 2011 June 2016 Opinion from DANIEL J. HILFERTY Why we cover whole genome sequencing Independence’s president and CEO explains groundbreaking decision W hen it comes to covering emerging medical technologies, insurers must responsibly steward the resources of those who ultimately pay for healthcare—employers, governments, and individuals who buy health insurance. At the same time, we must embrace our role in giving patients access to lifesaving innovations as quickly as possible. Nowhere is that balance more important than cancer care. Personalized medicine is revolutionizing clinical care, including oncology, and the next great leap forward in cancer treatment may be just around the corner. New genetic tests can show which treatment regimen will be most effective in an individual, and what therapies are unlikely to work and may even cause more suffering. Among the most promising advances is whole genome sequencing, which fully sequences thousands of genes in a single test. Whole genome sequencing detects specific DNA mutations that may guide oncologists to the optimal treatment for each of their patients. cancers for which the test is most likely to help determine effective therapies: certain rare cancers, tumors in children, metastatic cancer of unknown primary, triple negative breast cancer, primary brain cancer, virally infected tumors, and metastatic cancer where conventional therapies have been exhausted and patients remain candidates for further therapy. Whole genome sequencing for cancer is an evolving area of medicine that requires ongoing research and evaluation. Our decision to make this test available for the patients who might benefit the most reflects our commitment to our members to balance innovation and cost management. Collective effort needed Doing what’s best for patients The success of personalized medicine also depends on vastly expanding the evidence base across all types of cancer and all clinical circumstances. To that end, Independence supports the Cancer MoonShot 2020 Program, which you’ll read about in this issue’s cover story. The program is a series of phase 2 trials in 20,000 patients and 20 tumor types seeking quantum advances in individualized cancer treatment by 2020. I believe insurers have a responsibility to engage with efforts like this that are bringing stakeholders together to find new solutions. Independence is proud to promote both of these objectives—testing a patient’s entire genome to find out how best to treat her or his individual cancer, and accelerating the large-scale research that will lead to new therapies. We know these are ambitious undertakings, but given the toll that cancer takes on our community, ambitious thinking is exactly what is needed. After carefully considering its promise and consulting with experts, Independence Blue Cross this year became the first major insurer to provide coverage for certain members who are seeking access to whole genome sequencing. We are beginning with patients with specific Daniel J. Hilferty is president and CEO of Independence Blue Cross. “The next great leap forward in cancer treatment may be just around the corner.” 2 MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 ABOUT THE AUTHOR ❚ ManagedHealthcareExecutive. com EXECUTIVE Editorial Advisory Board Mission Managed Healthcare Executive provides healthcare executives at health plans and provider organizations with analysis, insights, and strategies to pursue value-driven solutions. Roy Beveridge, MD, is senior vice president and chief medical officer for Humana, where he’s responsible for developing and implementing Humana’s clinical strategy with an emphasis on advancing the company’s integrated care delivery model. Don Hall, MPH, is principal of DeltaSigma LLC, a consulting practice specializing in strategic problem solving for managed care organizations. He most recently served as president and chief executive officer of a nonprofit, provider-sponsored health plan. Mark Boxer, PhD, is executive vice president and global Daniel J. Hilferty, MPA, is president and chief chief information officer for CIGNA, where he is responsible for driving the company’s worldwide technology strategy. executive officer of Independence Blue Cross, a leading health insurer in southeastern Pennsylvania with nearly 10 million members in 25 states. Joel V. Brill, MD, is the chief medical officer for Predictive Health, LLC, which partners with stakeholders to improve coverage of value-driven care that optimizes health for people. Margaret A. Murray, MPA, is the founding chief executive officer of the Association for Community Affiliated Plans, which represents 54 nonprofit safety net health plans in 26 states. David Calabrese, RPh, MHP, is vice president and chief pharmacy officer of OptumRx, a pharmacy benefits firm that manages more than 200 million prescriptions each year on behalf of 25 million members. Kevin Ronneberg, MD, is vice president and associate medical director for health initiatives at HealthPartners, an integrated, nonprofit healthcare provider and health insurance company located in Bloomington, Minnesota. Douglas L. Chaet, FACHE, is the founder and chairman Dennis Schmuland, MD, is chief health strategy officer, emeritus of the American Association of Integrated Healthcare Delivery Systems and a managed care thought leader. U.S. Health & Life Sciences division of Microsoft Corp., where he is responsible for setting the company’s strategy and overseeing solutions for the managed care industry. Perry Cohen, PharmD, is chief executive officer of The Paul J. Setlak, PharmD, MBA, is associate director, Outcomes Solutions, at Astellas Pharma, where he focuses on strategic market access, pricing and reimbursement. Pharmacy Group and the TPG family of companies, which provides services to associations, healthcare and information technology organizations, payers and pharmaceutical companies. CONTENT PUBLISHING & SALES SARA MICHAEL GEORGIANN DECENZO VP, Content & Strategy PATRICK CARMODY MAUREEN CANNON Account Manager Classified /Display Permissions Executive Vice President, Managing Director (440) 891-2621, [email protected] (440) 891-2742, [email protected] AUBREY WESTGATE SARAH CAMERON MIFSUD JOANNA SHIPPOLI Executive Editor VP, Digital Solutions (203) 523-7116, [email protected] KEN SYLVIA TRACEY L. 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Ext. 121 SUBSCRIPTION SERVICES: 888-527-7008 ManagedHealthcareExecutive. com MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 3 Volume 26 Issue 11 EXECUTIVE NOVEMBER 2016 COVE R STORY CBetter ANCER MOONSHOT quality, lower costs by 2020 10 PROGRAM OVERVIEW 12 INSURER INVOLVEMENT 11 NEW CANCER TEST 14 BROADER EFFORTS 6 BUSINESS STRATEGY Cater to consumers by Judy Packer-Tursman 8 THE LIST Effective ways to partner with your board by Aubrey Westgate 16 TECHNOLOGY Cancer initiative harnesses big data’s full potential by Donna Marbury 18 PHARMACY BEST PRACTICES Drug pricing tools that influence consumers by Mari Edlin 20 HOSPITALS AND PROVIDERS Fall prevention programs gain traction by Mari Edlin 23 DRUGS IN THE PIPELINE Four things to know about the oncology pipeline by Erin Bastick, PharmD, RPh 25 POLICY OUTLOOK Precision medicine initiative has staying power by Judy Packer-Tursman 27 HEALTH MANAGEMENT Highmark’s cancer collaborative by Rachael Zimlich, RN 31 CONFERENCE INSIDER Highlights from ASCO 2016 by Bryant Furlow COMMEN TARY 2 OPINION Why we cover whole genome sequencing by Daniel J. Hilferty 33 INDUSTRY ANALYSIS Oncology medical home model pays off by Tracey Walker DEPARTMEN TS 3 EDITORIAL ADVISORS 33 AD INDEX 29 Q&A Fertility benefit services: pros and cons by Tracey Walker 4 MANAGED HEALTHCARE EXECUTIVE ] NOVEMBER 2016 Managed Healthcare Executive. com Cover: Lightspring / Shutterstock.com (cancer); Joe Belanger / Shutterstock.com (pencil) ESSEN TIALS WHAT ARE BIOSIMILARS? Let’s Clarify Biosimilars Biosimilars are a new step in biologic medicines and are highly similar to originator (or “reference”) biological products.1 Merck can help. There is a great deal of complexity surrounding biosimilars. At Merck, we believe in providing clarity among the confusion. We want to deliver clear, concise answers and information that will help you understand biosimilars. Get answers at merckclarifiesbiosimilars.com Reference: 1. US FDA. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. www.fda.gov/downloads/ drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf. Published April 2015. Accessed June 3, 2016. Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. BIOS-1193204-0000 08/16 Business Strategy TO P-LI N E O P E R ATI O NAL TR E N D S CATER TO CONSUMERS Your customers want more, and it’s time to deliver by J U DY PACKE R-TU R S MAN B 6 y the time federal open enrollment begins November 1, Horizon Blue Cross Blue Shield of New Jersey intends to have what one executive describes as a “much simpler” consumer website so individuals know immediately where to find information. The insurer also is providing more bill payment options, and conducting major outreach to individual members. That outreach focuses on its plans’ broad value—including wellness products, telemedicine, prenatal care, and free basic preventive services. Spurred on by the Affordable Care Act’s emphasis on the individual market, Horizon is also pursuing targeted initiatives, such as the launch of a dedicated Hispanic enrollment and service center, and mall kiosks with bilingual agents and Spanish-language materials. This is part of an ongoing marketing partnership with HolaDoctor. The upshot? Nearly 400% membership growth since 2013 to 30,000-plus Hispanic members—about 15% of the previously uninsured people who joined Horizon for 2016. “We’ve had a customer-experience team since 2012 trying to understand the most important things our customers look for. … We’re looking for ‘pain points’ and where to fix them for all members,” “We’re looking for ‘pain points’ and where to fix them for all members.” - ED LARA, HORIZON BLUE CROSS BLUE SHIELD OF NEW JERSEY explains Ed Lara, Horizon’s vice president of marketing and product development. The health plan’s efforts are part of a national trend in which managed care plans are using an array of tools to improve members’ experiences, build trust, and become more accessible. Long way to go The trend isn’t surprising to consultant Ingrid Lindberg, chief experience officer at Chief Customer, a customer-experience consulting firm. Her clients include national carriers and Blues plans. Yet Lindberg, who served as chief experience officer for Cigna in 2007, says the healthcare industry still has a lot to learn. “Plans have been doing consumerism ... for years and it’s not changing consumer experience with health plans,” she says. “Some plans have lots of MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 [consumer] engagement tools and very low engagement scores.” Larry Bridge, senior vice president of strategy and corporate development for TriZetto, a business unit within Cognizant’s healthcare practice, says finding ways to better engage with consumers is critical. “I think the key shift that healthcare hasn’t made is moving from functional communication to real [member] engagement,” he says. Apart from investing in tools and technology, plans must think broadly about how to address members’ preferences (such as not focusing on mobile apps for seniors), Bridge says. It’s important to have “24-7 multi-channel engagement,” ensuring that members trust you to follow up and respect their time by not making them repeat information, he says. Here are six other strategies plans should consider: STRATEGY #1 SIMPLIFY LANGUAGE “We know understandability is one of three major drivers of the customer experience, so the first thing I tell plans to do is simplify their language,” Lindberg says. People don’t understand terms such as “coinsurance” and “provider,” and acronyms are overused. Robin Gelburd, president of FAIR Health, an independent notfor-profit organization providing access to healthcare cost and insurance information, says plans must also clearly communicate basics, such as the difference between emergency care and urgent care, and the availability of telehealth. They also must explain how consumers may face larger out-of-pocket costs depending on their choices, she says. “We see movement from trans- Managed Healthcare Executive. com Business Strategy parency—making information and data available—to clarity,” Gelburd says. Horizon’s initiatives provide a good example of how this guidance can be applied. It streamlined its welcome letter, and instead of sending the member ID card and welcome letter separately, now affixes the card to the letter, Lara says. ID cards also have a sticker with information on how to sign up for online services, and consumers can phone-scan part of the letter to reach an educational video on how products work. STRATEGY #2 SHORE UP BASIC CHANNELS Consumers want to easily access information on the plan’s website, and be able to email and call easily, Lindberg says. Ensure basic channels are functioning well so responses are timely whether they are given by phone representatives or by online chat. “If you can’t nail the basics, then you can’t open new channels,” she says. “In healthcare the costs keep going up, yet health plans aren’t showing customers the value for their dollar.” INGRID LINDBERG, CHIEF CUSTOMER right, language and access are important,” she says. “I’ve found, time and again, plans tend to push information out [to members on clinical issues, claims, benefits, etc.] ... and it’s not orchestrated,” says Lindberg. “So I say, ‘Print and put all the pieces in a room and look at what the company is distributing and pare it back.’” Also, ensure members are receiving correct information, she says. For example, a new member doesn’t want inaccurate data about which physicians are in-network or accepting new patients. procedures based on their plan design and deductible. Since its 2010 launch, the tool has gotten 6.6 million-plus hits, according to Aetna, and members using it are saving on out-of-pocket costs. Fresh, clearly presented information creates a win-win situation extending beyond members’ informed decisions and administrative savings, Gelburd says. “It’s creating a level of comfort and goodwill between the member and the plan that information is being provided in a way that brings [clinical and financial] value to consumers.” STRATEGY #5 Judy Packer-Tursman is a writer in Washington, D.C. STREAMLINE PROCESSES STRATEGY #3 OPEN NEW CHANNELS Lindberg often discusses access with clients. It’s “about being available through lots of different channels and being available on your customers’ time, not your own,” she says. Most plans don’t offer online chats or rapid responses, even though phoning a plan Monday through Friday, 8 a.m. to 5 p.m. is not convenient for many patients, she says. Find ways to be available to members 24/7. STRATEGY #4 ORCHESTRATE COMMUNICATIONS Typically, plans only have 1.4 oneon-one interactions per member per year—whether through a conversation with a case manager, an email correspondence, or an interaction at an enrollment fair, Lindberg says. “Because you only have that one moment to get it Managed Healthcare Executive.com Be proactive with new members by getting information on drugs that need prior authorization and making the process easier upfront, says Lindberg. For example, if members are transferring between plans due to the employer changing the insurer, make medication continuity a part of the transition and do outreach to members based on their claims data. Horizon BCBSNJ individual membership growth 173,933 127,940 116,407 STRATEGY #6 SHOW VALUE “In healthcare the costs keep going up, yet health plans aren’t showing customers the value for their dollar,” Lindberg says. Plans must compare and communicate— telling members, for example, whether they’re paying $100 for a medical service instead of $300 that non-members pay. Aetna, Inc.’s online “Member Payment Estimator” shows what members will pay for common 2013 2014 2015 Source: Horizon Blue Cross Blue Shield of New Jersey MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 7 The List EFFECTIVE WAYS TO PARTNER WITH YOUR BOARD INDUSTRY LEADERS SHARE THEIR GO-TO STRATEGIES BALANCE PERFORMANCE ANALYSIS AND FUTURE GOALS “On the IHI Board, we’ve been talking recently about the need to balance looking back at our performance to generate learning, and looking forward to create strategy. An effective board partnership needs that type of discourse. In many ways, it comes down to finding the right balance between assurance and strategy, between ‘holding to account’ and empowerment, and between governance of operations and tolerance of risk. As with much of what we do in healthcare, relationships are vitally important, as are finding ways to connect the board to the impact our work is having at the point of care. So the board meeting can’t just be about looking at the numbers; the board needs to hear the stories and engage with the staff who are making a difference for patients.” —Derek Feeley, president and CEO, Institute for Healthcare Improvement UNDERSTAND BOARD MEMBERS’ PRIORITIES “We clearly and regularly communicate with our board, but we don’t send trivial information they can easily get from a news source. We also regularly hold one-on-one meetings to probe where the board member is on an issue and whether their organization’s priorities have changed.” —Joel White, president, the Council for Affordable Health Coverage “Be upfront, honest, present the facts, and ask for their guidance. Your board is there to assist you. They bring expertise and have often dealt with the problems you are facing. Most importantly—if you report to the board, and you aren’t meeting the objectives of the board (which represents the shareholders), and you lose the trust of the board, well, you can figure out how that story ends.” MAKE TIME FOR ONE-ON-ONES “It’s important to meet with board members individually and build a relationship based on one-toone interaction and trust. This can help defuse many situations where board members need to support their CEO on the basis of that trust.” —Don Hall, principal, DeltaSigma LLC, Managed Healthcare Executive editorial advisor BE TRANSPARENT “I think the CEO and board partnership comes from building and maintaining trust. Trust comes from open communication and transparency—you never want your board to be surprised. It’s essential in board effectiveness. This fosters support of innovative ideas and helps to keep pace with change.” FOCUS ON THE INDIVIDUAL —AND THE GROUP “An engaged board is an effective board. I try to ensure each member has a defined role and feels an ownership for our shared vision.” —Chad Johnson, senior vice president, Phoenix Children’s Care Network —Pamela Morris, president and CEO, CareSource —Joel Brill, MD, chief medical officer, Predictive Health, LLC, Managed Healthcare Executive editorial advisor MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 dotshock / Shutterstock.com 8 ASK FOR HELP by AU B R EY WE STGATE Managed Healthcare Executive. com CANCER MOONSHOT Better quality, lower costs by 2020 By K AR E N APP OLD EXECUTIVE VIEW Efforts include: ❚ Collaborations to advance combination immunotherapy ❚ Trials to develop a vaccine-based immunotherapy 10 with a sense of uncertainty. Our goal is to develop personalized immunotherapeutic treatment options and arm oncologists with the necessary tools to combat cancer with certainty.” The Cancer MoonShot 2020 Program brings together stakeholders from pharma, community and academic oncology, as well as government and scientific communities to accelerate the potential of combination immunotherapy as the next-generation standard of care in cancer patients. The program’s goal is to initiate randomized phase 2 trials in 20,000 patients at all stages of disease in 20 tumor types before 2020, called the Quantum Integrative Lifelong Trial (QUILT). These findings will be used to develop an effective vaccinebased immunotherapy to combat cancer by 2020. Lightspring / Shutterstock.com (cancer); Joe Belanger / Shutterstock.com (pencil). ❚ A new test to identify personalized treatment IN 2016, MORE THAN 1.6 MILLION new cases of cancer will be diagnosed and cancer will kill an estimated 600,000 Americans. The Agency for Healthcare Research and Quality estimates that the total cost for cancer care in the United States in 2011 was $88.7 billion. Fifty percent of this cost was for hospital outpatient or doctor office visits, 35% was for inpatient hospital stays, and 11% was for prescription drugs. “The truth is, cancer is still a mystery; no two cancers are alike, making it nearly impossible to choose the best treatment path for each patient,” says Patrick Soon-Shiong, MD, founder and chief executive officer of NantWorks and founder of the Chan Soon-Shiong Institute of Molecular Medicine, located in Culver City, California. In January 2016, the billionaire launched the Cancer MoonShot 2020 Program in an effort to win the war on cancer. “When a patient is first diagnosed with cancer, they are overwhelmed MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 Managed Healthcare Executive. com Cancer MoonShot The approach provides researchers with necessary testing materials and patients with more opportunities to participate through local facilities and wider insurance coverage. Oncologists receive real-time clinical trial results, and patients have hope for more positive outcomes. BREAKING NEW GROUND According to Leonard Sender, MD, medical director, Hyundai Cancer Institute at Children’s Hospital Orange County, Orange, California, and codirector of the Chan Soon-Shiong Institute of Molecular Medicine, “Cancer MoonShot 2020 is the first program to test the hypothesis that the immune system has the ability to defeat cancer.” Up until recently, he says, major advances in cancer medicine involved targeted therapy, in which a particular drug targeted a change in DNA (the whole genome), and immunotherapy. These treatments were often separated in different silos. “This program will bring both concepts together; multiple partners will conduct testing in real patients, not animals, to see if the combination results in greater cures,” says Sender. “This will be done as quickly as possible by bringing in infrastructure that will allow for rapid adoption of clinical trials in light of governmental regulations.” Immunotherapy, a form of biologic therapy, is a type of cancer treatment designed to boost the body’s natural defenses to fight cancer. “We are using lower-dose chemotherapies in a way that the immune response is maintained,” says John Lee, MD, cancer center director, Chan SoonShiong Institute of Molecular Medicine, and surgical oncologist at Sanford Health in Sioux Falls, South Dakota, which is one of the first national and regional self-insured employers to cover next-generation whole genome sequencing and proteomics for various cancers. “Treatments also include immune modulators—both antibodies and small molecule therapy—as well as a natural killer cell therapy.” HOW THE PROGRAM WORKS Soon-Shiong is using NantHealth, his foundation, to help fund oncology patients on clinical trials with a new molecular cancer test called GPS Cancer. The test sequences the whole DNA of 3 billion base pairs with more than 20,000 genes, as well as RNA, to identify mutated genes which express the proteins from a patient’s cancer. Testing is performed in NantOmics’ CLIAcertified laboratories that are accredited by the College of American Pathologists. Only through this test can physicians more ManagedHealthcareExecutive. com Ultimately, the aim of the program is to win the war on cancer—to get to a point in the very near future when cancer is managed the same way as other chronic disease, such as diabetes or asthma.” —PATRICK SOON-SHIONG, MD, NANTWORKS accurately identify which molecular alterations are present in cancer cells that will translate to abnormal proteins being produced—which are the key targets for many therapeutic interventions, Soon-Shiong says. This helps oncologists develop personalized treatment strategies. The opportunity to identify through GPS assay which patients have “hot” (inflamed) or “cold” (immunosuppressed) tumors will play a critical role in treatment decisions and trial design in the MoonShot Program. “The GPS Cancer test allows clinicians to better predict whether a cancer drug will or won’t work,” says Lee, noting that it’s very similar to how physicians perform laboratory testing to determine if an antibiotic for a bacterial infection will be effective. “For the first time, we can measure proteins that denote resistance to taxanes and cisplatin ... standard chemotherapy that has been administered in an empiric fashion,” Soon-Shiong says. “Now with GPS, information regarding chemo resistance or chemo sensitivity can be identified from the patient’s tissue by GPS and a better informed decision can be made before treatment begins. The patient and doctor can now address the question: What information could be gleaned from my tissue sample that would better inform the treating physician of the probability that the treatment about to be prescribed would be effective?” The GPS test is unique in that it measures RNA transcription and affected protein pathways downstream and has the capability of profiling the inflamed status of the tumor. “In this era of immunotherapy, knowing whether the tumor is ‘hot’ or ‘cold’ has huge outcome implications,” Soon-Shiong says. EXPERTISE FROM MULTIPLE AREAS As part of the initiative, Soon-Shiong formed clin- MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 11 Cancer MoonShot ical working groups in specific cancer specialties, including the Melanoma and Sarcoma Working Group, Head and Neck Cancer Working Group, Breast Cancer Working Group, and Radiation and Immuno-Oncology Working Group. “We will collect data from scientists and clinicians in both academic and community settings,” says Sender, a founding member of Cancer MoonShot 2020’s National Pediatrics Consortium. “We want to learn about experts’ ideas for treating specific cancers and evaluate all of the science that is known about these cancers so we can start creating our first clinical protocols.” Another goal is to find treatments for solid tumor cancers that don’t fall into the top 10 types of cancers and pediatric cancers that haven’t been successfully treated before. These include uncommon cancers that don’t typically have clinical trials such as head and neck cancer along with melanoma and sarcoma, says Lee, a leader of the Head and Neck Working Group and a member of the Radiation and ImmunoOncology Working Group. Test results for certain patients will be obtainable within 21 days, and oftentimes within seven days. By using a HIPAA-compliant app, called the GPS genome browser, physicians and study investigators can access report summaries. “No one on the market today has that level of sophistication,” Sender says. 14.5 MIL L ION 69% The number of Americans with a cancer or a history of cancer who were alive January 1, 2014. The 5-year relative survival rate for all cancers diagnosed between 2005 and 2011. Death rates are declining for all four of the most common cancer types: lung, colorectal, breast, and prostate. 23% The drop in rate of cancer deaths per 100,000 persons between 1991 and 2012. Source: American Cancer Society, “Cancer Facts and Figures 2016” 12 MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 The Cancer MoonShot 2020 program can work with both academic and communitybased cancer centers, which is important given that 85% of cancer patients are treated at community cancer hospitals. BIGGEST ACCOMPLISHMENTS SO FAR To date, more than 300 individuals with cancer have had their testing completed. Fifteen QUILT clinical trials have opened as of September 2016. “Hopefully, we will have sequenced 5,000 patients by the end of this year,” Lee says. “I think we can make it if we ramp things up a bit. We’ve had more enrollment as the year progresses. Oncology patients are seeking out newer testing methods and are looking for newer therapies that use their body’s own immune responses to fight off cancer. By using less toxic treatments, patients experience less sickness and may not lose their hair.” Another achievement is the formation of The National Pediatric Consortium, formed in February 2016. The consortium is focused on offering combined immunotherapy as the next-generation standard of cancer care to children. Ten founding members spanning major cities nationwide are participating in a national data sharing infrastructure to accelerate clinical development of next-generation immunotherapy. For example, as a physician and scientist whose practice and laboratory specializes in cancer caused by human papillomavirus, Lee will facilitate a collaboration between Sanford Health and the Chan Soon-Shiong Institute of Molecular Medicine to advance cancer care and increase immunotherapy clinical trials available at Sanford. Also, the first clinical trial milestone was achieved in January when an immunotherapy trial demonstrated encouraging survival rates in patients with end-stage metastatic colorectal cancer who were not responsive to standard therapy. More than 30% of patients who failed all standard chemotherapy and antibody therapy are still alive after neo-epitope immunotherapy ensituximab. The longest current survivor was treated more than two years ago. INSURER INVOLVEMENT Health insurers can play a significant role in the MoonShot Program. “Managed care companies may find the cancer space scary because pharma prices are rising quickly and it’s difficult to determine which drugs will actually work,” says Sender. “But now, by using NantHealth’s novel GPS Cancer test, which provides a more rational, science-based approach, we will start to Managed Healthcare Executive. com Cancer MoonShot provide the types of tools that allow managed care providers to better understand what drugs should be used to treat cancer patients. This will result in less-expensive care in the long-term.” Treating cancer patients with medicines that won’t work is occurring much too frequently. For example, data has emerged showing that HER2, a new test to detect breast cancer, often has incorrect results. Consequently, patients with a false positive result have been given extremely expensive drugs and patients that were falsely negative were not given life-saving drugs, Sender says. “Although a physician wouldn’t prescribe an antibiotic to a patient with a bacterial infection if they knew it wouldn’t work, this has been done with cancer medicine,” he says. “But with the GPS Cancer test, which employs next-generation whole genome sequencing and proteomic testing, physicians can now know that a particular drug will not work, although they still may not know which drugs will work for sure. This becomes more important as expensive checkpoint inhibitors become commonplace, but is found effective in only 10% of patients. With the GPS Cancer test we may be able to predict which patient would benefit and which would not.” “We think it’s a win-win program for patients, providers, and health insurers,” Sender says. “Our goal is to cure many patients with treatments that are less toxic at reduced costs. The fact is, if we don’t proceed in this manner, the healthcare industry may become unsustainable.” INSURER PARTNERSHIPS When health insurers partner with Cancer MoonShot 2020, drugs will be provided to their members on clinical trials free of charge. “Insurers will still be responsible to pay for GPS testing, delivering the cost of care, and part of the cost of clinical trials [which are also funded by pharma companies],” Sender explains. “In the long-run, it is in a managed care company’s best interest for patients to be treated with appropriate imaging, therapies, and drugs.” Lee says his institution chose to offer GPS testing because, “We felt that the informatics and depth of coverage of DNA sequencing offered the best testing option available. In addition, our health insurer decided to cover this testing because by gleaning knowledge from the GPS test, we will be able to save a significant amount of money because some drugs cost hundreds of thousands of dollars.” “This is a value-added test from the perspec- ManagedHealthcareExecutive. com tive of cost savings,” Lee continues. “What is exciting is that more insurance companies are getting on board since the launch of this test just a few months ago.” FIRST INSURER ON DECK The National Immunotherapy Coalition—a collaboration with Independence Blue Cross, one of the nation’s largest payers, and Bank of America, one of the country’s largest self-insured companies, formed around the same time the Cancer MoonShot 2020 began. The collaboration’s singular focus is to accelerate the potential of combination immunotherapies as the next-generation standard of care in oncology patients. Independence Blue Cross became the first major insurer to offer access to GPS Cancer testing in March 2016, after entering into an agree- With this initiative we are hoping to complete what normally takes 10 years in five years.” - LEONARD SENDER, MD, HYUNDAI CANCER INSTITUTE MoonShot 2020 vs. Cancer Moonshot program Cancer MoonShot 2020 is led privately and is focused on investigating the potential of combination immunotherapy as the next standard of care by leveraging the power of genomics and proteomics. VS The National Cancer Moonshot program, which was tasked to Vice President Joe Biden by President Obama in January 2016, is aimed at pooling resources from multiple federal agencies and is focused on multiple initiatives (e.g., cancer prevention, early cancer detection, building an FDA Oncology Center of Excellence, cancer immunotherapy and combination immunotherapy, investing in high-risk/high-reward projects). In April, the National Cancer Institute appointed Soon-Shiong to the Blue Ribbon Panel, a group of scientific experts, cancer leaders, and patient advocates that will inform the scientific direction and goals of the National Cancer Moonshot program. MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 13 Cancer MoonShot SURVIVORS IN MILLIONS 20 18.9 THERE ARE 14.5 MILLION CANCER SURVIVORS IN THE U.S. BY 2024 THERE WILL BE ALMOST 19 MILLION 15 14.5 10 5 1970 3.3 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020 2025 Source: American Cancer Society, 2014 ment with NantHealth in January 2016. “Whole genome sequencing fully sequences thousands of genes in a single test, detecting DNA mutations that may serve as markers that inform decisions about optimal cancer therapy,” says Anthony V. Coletta, MD, MBA, executive vice president and president, Facilitated Health Networks, Independence Blue Cross. “The science around genomics and immunotherapy and their potential to advance cancer care is evolving. Making the GPS Cancer test available is one way that Independence is responsibly contributing to the development of the evidence base and potentially helping to advance cancer care.” The test will be covered for insured members with specific conditions including rare cancers, tumors in children, metastatic cancer of unknown primary brain cancer, triple negative breast cancer, and metastatic cancer when conventional therapies have been exhausted and patients remain candidates for further therapy, including immunotherapy. “Insurers have an obligation to engage in responsible efforts to advance cancer care and to encourage innovative approaches,” Coletta says. “Our goal is to support our members and their oncologists in accessing the best care and helping our customers continue to be able to afford coverage. By offering access to GPS Cancer, we are giving our members one more option to help inform a personalized, effective cancer treatment plan. Rapid advances in molecular biology and genetics may require healthcare executives to fundamentally rethink the way we determine whether a given service is considered effective—so we are responsibly promoting the adoption of more effective therapies.” clinical report that provides actionable patientspecific clinical information for physicians and patients at the point of care. Earlier this year NantHealth, which already offers the eviti oncology decision support software, added NaviNet Open, a payer-provider collaboration platform. The eviti clinical decision support platform facilitates determination of evidence-based protocols based on the molecular and clinical stage of a patient’s cancer. The NaviNet Open payer-provider collaboration platform enables doctors and payers to review information in real time. Together, the NantHealth operating system serves as a scalable, real-time access point and portal for providers and patients to receive scientific, clinical, and other information about novel therapies and relevant clinical trials, all based on the results from a patient’s GPS Cancer test. Support from leading insurance companies and self-insured employers is crucial in order to provide coverage for whole genome sequencing and proteomic testing, says Soon-Shiong. These payers will ensure medical policy is in place to support patients having access to leading edge science. “The launch of GPS Cancer, together with coverage by a major payer serving with their affiliates 10 million people in 34 states, combined with the introduction of a collaboration and clinical decision support portal providing access to more than 450,000 healthcare professionals for real-time communications and access to ground-breaking clinical trials, and a multi-payer portal for more than 100 million covered lives, collectively creates a healthcare collaboration network at a national scale,” he says. “We believe this platform will provide more personalized and cost-effective treatment options for patients with cancer.” BROADER EFFORTS The GPS Cancer test includes a web-based 14 MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 Karen Appold is a medical writer in Lehigh Valley, Pennsylvania. Managed Healthcare Executive. com Isn’t it time to move beyond software? Learn about how the athenahealth® network is helping to unbreak hospitals. athenahealth.com Technology TR AN S FO R M I N G CAR E TH R O U G H H EALTH IT Cancer initiative harnesses big data’s full potential New database makes research more accessible by DON NA MAR B U RY C ancer research is becoming more accessible due to a new initiative that gives researchers access to big data from thousands of patient cases. In June 2016, the Genomic Data Commons (GDC), a web portal that features information on cancer tumors from more than 30,000 patients, was revealed to the public during the American Society of Clinical Oncology’s (ASCO) annual meeting. The database is managed by the National Cancer Institute (NCI) at the University of Chicago, and it is funded by the National Cancer Institute through President Obama’s Precision Medicine Initiative for Oncology. A portion of the GDC data is open to the public, while qualified researchers can access more detailed data, says Louis M. Staudt, MD, PhD, senior investigator at NCI. “The database includes all common cancer types. There are 50 to 500 or more tumors in each type,” Staudt says. The pediatric database features 29 cancer types and more than 3,000 patient cases. What makes it unique The GDC is the first open-access cancer database that combines genetic information on cancer 16 “The Genomic Data Commons has the potential to transform the study of cancer at all scales.” —ROBERT GROSSMAN, UNIVERSITY OF CHICAGO tumors and treatment information. In total, the database features 4.1 petabytes—or about 4 million gigabytes—of information. Staudt says that depending on the type of cancer included in the database, some behavioral or environmental data is collected, such as whether patients with lung cancers are smokers. “Data sets include genomic data from tumors from patients with cancer, clinical data, treatment, and the results from treatment,” says Staudt. “There’s also genomic data mutations in DNA, RNA expressions data, which is the activity of genes in a cancer cell. It’s a multiple platform approach to looking at data.” Nearly 14,000 patient cases in the GDC came from the NCI. Foundation Medicine, a cancer genome MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 analysis company, donated 18,000 cases, Staudt says “We can easily add many more thousands of patients from other public databases,” he says. “We are measuring the success of the Genomic Data Commons attracting other public data sets.” Inspired by Facebook and Google GDC creation began in 2014 at the University of Chicago Center for Data Intensive Science. Working with the NCI, researchers from the University of Chicago created information frameworks and standards that make raw and processed data from cancer treatment more accessible and easier to understand. The architects of the GDC used Facebook and Google as inspiration—both platforms house large amounts of diverse data, but also focus on the user experience, which can vary from computer novice to expert. Though the full data is only open to qualified researchers, it is open to research teams regardless of size or budget. In 2014, Robert Grossman, GDC co-principal investigator and professor of medicine and director of the Center for Data Intensive Science at the University of Chicago, stated, “The Genomic Data Commons has the potential to transform the study of cancer at all scales. It supplies the data so that any researcher can test their ideas, from comprehensive ‘big-data’ studies to genetic comparisons of individual tumors to identify the best potential therapies for a single patient.” Staudt says that increasing the usability is a short-term goal of the project. The GDC also provides an application programming interface ManagedHealthcareExecutive. com Technology that allows developers to access specific data files. “In the near future, we hope that researchers will be able to ask questions on the site, and visualize the data,” Staudt says. “Also, the massive size of the data precludes many researchers.” Use and potential Here are four ways the GDC could advance cancer care and other treatments: Make it easier for researchers to advance care. The diversity of data available is important, because often researchers in different groups are analyzing different aspects of cancer and its treatment. The GDC uses algorithms to harmonize and standardize data to ensure that researchers across platforms can utilize it. Improve the understanding of cancer tumors. One of the goals of the GDC is to create a more diverse pool of candidates for clinical trials to get a better understanding of the differences in cancer tumors. Vice President Joe Biden, who leads President Obama’s National Cancer Moonshot initiative, announced the GDC to researchers, clinicians and patient advocates at ASCO. “Increasing the pool of researchers who can access data and decreasing the time it takes for them to review and find new patterns in that data is critical to speeding up development of lifesaving treatments for patients,” Biden said at the event. (From left to right) Grossman, Biden, Staudt touring the Genomic Data Commons Advance precision medicine. In the future, the GDC will support single-person clinical trials, which is a first step in enhancing precision medicine for cancers. Also, GDC architects are working with cloud-based technologies that will allow researchers to perform on-site experiments and remote analyses of large amounts of data. “Long term, we want to create a knowledge base for cancer and increase clinical data on drugs,” Staudt says. “This is called precision medicine in oncology. We hope to collect data from clinical trials and move forward with some more useful clinical knowledge.” Donna Marbury is a writer in Columbus, Ohio. Top 10 GDC data downloads as of September 2016 Source: University of Chicago # of requests File Size 56,713,391 114.90 TB 1,210,351 34.10 TB Lung Adenocarcinoma 383,309 43.57 TB Glioblastoma Multiforme 354,541 22.70 TB Skin Cutaneous Melanoma 344,659 17.15 TB Brain Lower Grade Glioma 285,509 21.54 TB Colon Adenocarcinoma 284,960 22.53 TB Serve as a model for future databases. The GDC could be used Bladder Urothelial Carcinoma 263,929 20.48 TB to create open-source databases for other illnesses, including diabetes, heart disease and Alzheimer’s, says Grossman. Ovarian Serous Cystadenocarcinoma 262,898 39.68 TB Kidney Renal Clear Cell Carcinoma 239,632 12.47 TB ManagedHealthcareExecutive.com Project Name Thyroid Carcinoma Breast Invasive Carcinoma Source: NCI GDC Portal https://gdc-portal.nci.nih.gov/reports/data-download-statistics MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 17 Pharmacy Best Practices I N N OVATIVE I D EAS FO R D R U G UTI LI ZATI O N AN D MANAG E M E NT Drug pricing tools that influence consumers Three tools that meet patients’ demands by MAR I E D LI N M ore companies are turning to price transparency tools to help members make the smartest decisions about their medications. “Drug pricing tools have the potential to help employees and their organizations significantly reduce their prescription drug costs, while helping those without insurance find the lowest costs between different pharmacies and to take advantage of coupons and discounts,” says Marcia Otto, vice president, pricing and transparency applications at Health Advocate, a national health advocacy, patient advocacy and assistance company. Here’s an in-depth look at three popular online price transparency tools, sponsored by pharmacy benefits managers (PBMs) and other organizations: 1 SingleCare Rick Bates, CEO/cofounder of SingleCare, an online retail marketplace that helps users compare prices for a wide range of healthcare services, including medications, says consumer-driven healthcare is the impetus behind online pricing marketplaces like his. Consumers are concerned 18 about coverage limits, costs, and access, he says. Launched in early 2016, the tool is available in Arizona, Maryland, Virginia, Washington, D.C., and Pennsylvania, totaling 750,000 users. Users can view prices for prescription offerings at major pharmacies including Walmart, CVS, Walgreens, Rite Aid and Kroger, by specific location. Bates says the site includes all drugs that can be dispensed at a regular pharmacy, excluding specialty medications. If a request is for a branded drug, the site will provide information on an equivalent generic and its price. “It’s important to publish drug prices because they might be lower outside of insurance coverage if a member has not hit a deductible yet,” he says. “This is the only way consumers can truly understand the competitive market price for a specific drug; otherwise plan members become a captive audience.” Prices found on the SingleCare site vary depending on the pharmacy and whether a transaction is cash-based or through insurance with copayments or deductibles. MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 2 Castlight Health Castlight Health introduced its prescription drug comparison tool to employer groups in 2013—not unlike SingleCare but with some bells and whistles. “Our core objective is to help employees make better decisions using information on our site or through their mobile devices,” says Will Bondurant, director of product marketing for Castlight. In addition to comparing prices, users can: ❚ Compare generics to branded counterparts; ❚ Base prices on the amount and dosage of a prescription; and ❚ Tailor prices to their pharmacy benefits packages—formularies and tiers. The tool also compares prices based on whether consumers have copayments or coinsurance, purchase at retail or through home delivery, use a discount card, or have pharmacy services that overlap with a medical benefit. Bondurant says the site also provides contextual information about each drug from Consumer Reports; and educational content from physicians and insurers including information on side effects, medication alternatives and appropriate use. Fifty-one percent of eligible members have used information from Castlight over the year, including all offerings—pharmacy, medical and dental services. Bondurant identifies two primary groups of users: ❚ Those with serious health conditions relying on long-term medication management and whose pharmacy and medical benefits might overlap; and Managed Healthcare Executive. com Pharmacy Best Practices ❚ Those with high-deductible health plans or covered by PPOs with a $300 to $500 deductible topped by coinsurance. 3 Our core objective is to help employees make better decisions using information on our site or through their mobile devices.” Express Scripts The country’s largest PBM has an online price transparency tool on its website and via mobile devices. The product provides drug prices along with retail and home delivery alternatives based on a member’s location. Unlike the other tools, members can refill prescriptions through the app. For new drugs, they only can price the medication. Then, a physician needs to submit a prescription via e-prescribing or by phone, or a member can mail the script request to a pharmacy. The PBM also offers My Rx Choices, which provides lessexpensive generic alternatives and branded drugs when a member inputs a brand name. The tool provides clinical information on each drug based on a member’s profile—side effects; drug-drug, drug-OTC and drugallergy interactions; information based on age, gender and medical conditions; administration; and dosing. Brian Cavanagh, senior director, home delivery product management for Express Scripts, says that when the PBM surveyed members about information they most desired, it was potential side effects. Users can also input how they take their medications—whether it be once a day for 90 days, a rather straightforward prescription, or two inhalers a month rather than one— so that they can see exactly how much they should expect to pay. “We believe our patients absolutely must have full transparency as to what a drug will cost them and if there are opportunities to decrease that cost,” says David Whitrap, Express Scripts spokesperson. The website and mobile app prompt members with additional Managed Healthcare Executive.com — WILL BONDURANT, CASTLIGHT HEALTH An ideal price comparison tool According to the California Health Care Foundation’s California Health Care Almanac survey, released in March 2015, 26% of consumers look for information about the cost of a test, treatment or other type of healthcare service before receiving the care. The majority of them seek information using the Internet. If you are considering a drug price comparison tool for your members, Maribeth Shannon, program director for the foundation, says to offer these key assets: ❚ ❚ ❚ ❚ SHANNON Information on drug interactions and side effects; Pricing based on formularies; Comparisons of retailers to online pricing; and Information on generic alternatives to branded drugs. Legislating drug price transparency Many states are considering legislation that would require drug manufacturers to be transparent about the high cost of their drugs by sharing research and development costs. Most of the measures have stalled this year, except in California, New Jersey and Pennsylvania, according to the National Council of State Legislatures. Although California Sen. Ed Hernandez (D-West Covina) recently pulled his sponsored legislation that required drug manufacturers to notify state agencies and health insurers when an FDA-approved new drug costs $10,000 or more per year or per course of treatment, California Proposition 61 is on the November ballot. It prohibits state agencies from paying more for any prescription drug than the lowest price paid by Veterans Affairs. savings opportunities based on their specific benefit designs, such as using a less expensive, clinically equivalent alternative or dispensing a medication at a more affordable retail pharmacy. Express Scripts’ members can take advantage of a lower cost if a pharmacy offers patients a “usual and customary” cost of a drug that might be less than the price available with a plan’s copayment and still achieve the benefit of Express Script’s clinical safety review of the medication. Mari Edlin, a frequent contributor to Managed Healthcare Executive, is based in Sonoma, California. MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 19 Hospitals & Providers C LI N I CAL C O N S I D E R ATI O N S WITH SYSTE MWI D E I M PACT Fall prevention programs gain traction Effective strategies cut costs, improve quality by MAR I E D LI N O ne out of three older adults falls each year, making falls the leading cause of injuries for adults ages 65 years and older, according to the CDC. Combine those statistics with the aging of America—the number of adults 65 and older is projected to jump to 83.7 million by 2050, almost double the estimated 43.1 million in 2012, according to the U.S. Census Bureau—and a disaster is ready to happen. As many as 2.5 million older adults end up in hospital emergency departments for treatment every year, creating a financial burden of $34 million annually in direct medical costs, with hospitals assuming two-thirds of the total, according to the CDC. In response to the frequency and potentially dangerous repercussions in older adults, hospitals and other organizations have developed a variety of programs to address fall prevention. Patient engagement makes big differences In 2011, Sharp Memorial Hospital in San Diego started its STOP program targeting falls. As Verna Sitzer, manager, nursing innova- 20 tion and performance excellence says, the hospital has been improving upon it ever since. In 2010, the hospital experienced 95 falls with injuries, dropping to 36 in 2015. As reported by the CDC, the average hospital cost for a fall injury is $35,000 (2012 dollars), translating to cost avoidance for Sharp of $2.07 million. What made the difference? Sharp formed a special team that developed patient assessments and recommendations to prevent falls, and staff training. “Outcomes related to falls are nursingsensitive indicators (depend on the quantity or quality of nursing care),” says Sitzer, “but falling is also an interdisciplinary problem so everyone needs to be trained.” Sitzer says being in a new environment such as a hospital where so much is happening at once, and taking new medications, opens the door for more risk for falls. When patients are admitted to Sharp Memorial, they have to “unlock” televisions in their rooms. Once registered, they watch a video that introduces them to the hospital and also covers safety issues, including fall prevention. Six hours after being admitted, patients take a fall risk survey and MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 if any of the questions prompt a “yes” response, staff members urge patients to watch a more comprehensive video pointing out areas for potential falls during their stay. Specific areas to watch Since toileting is one of the major activities generating falls, nurses at Sharp pay attention to what mode of toileting—bedpans, bedside commode or a bathroom—should be used based on mobility, says Sitzer. “We make it easy to do the right thing.” The hospital also conducts monthly debriefings on falls and has developed a variety of fall prevention protocols, such as lowering beds before patients try to get out of them. Sharp uses special signage outside patient rooms to indicate certain conditions to staff members (red maple leafs signify patients who are at risk for falling). Patients at risk also wear yellow armbands and red, non-skid socks. Nurses also include risk information on whiteboards in patient rooms. Further, stop signs in patient rooms remind patients to ask for help if needed, while alarms notify nurses if patients are trying to get out of bed. Sitzer says the hospital is exceeding benchmarks based on voluntary reports to organizations, such as the National Database of Nursing Quality Indicators. These organizations measure nursing quality and satisfaction, monitor relationships between quality indicators and outcomes, assess staffing levels and improve reimbursement. Adopting a broader focus While older adults tend to have higher fall risks, patients of all ages Continued on page 22 Managed Healthcare Executive. com LE AB AVAIL W O N BIOPSY BREAKTHROUGH The World’s First & Only 2D/3D™ Imaging Capable, Dedicated Prone Breast Biopsy System COMPLETE PATIENT PROCEDURES FASTER WITH THE 3D™ BREAST BIOPSY OPTION MAXIMIZE EFFICIENCY, OPTIMIZE PRODUCTIVITY SIGNIFICANTLY IMPROVE WORKFLOW* Introducing the Affirm™ Prone Breast Biopsy System. In a survey of early patients, 98% agree that the procedure was faster, more comfortable, and less painful than expected.† Is your facility ready for a better biopsy experience? Innovation is in high demand. CONTACT A HOLOGIC REPRESENTATIVE VISIT AFFIRMPRONEBIOPSY.COM *Compared to the MultiCare® Platinum system. †Based on a survey of 57 patients post procedure on the Affirm™ Prone Breast Biopsy System (8 clinicians, 2 sites). ADS-01632 © 2016 Hologic, Inc. Hologic, 3D, Affirm, MultiCare, The Science of Sure, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the US and/or other countries. Hospitals & Providers Continued from page 20 are susceptible. That’s why Holy Cross Hospital in Silver Spring, Maryland, implemented a fall prevention program that targets patients of all ages and starts with a fall assessment upon admission and upon transfer of each patient every shift. 2.8 $31 MILLION The number of elderly patients treated in emergency departments for falls each year. The direct medical costs for fall injuries, adjusted for inflation. Hospital costs account for twoBILLION ANNUALLY thirds of the total. Source: CDC “We believe that every patient that comes through our doors is at risk for falling regardless of their age,” says Kimberly Elliott, senior director, medical/surgical senior services for the hospital. Holy Cross uses signage in every patient room that states, “Call Don’t Fall,” along with a telesitter (someone who monitors patient activity remotely) to oversee patients who are at risk for falls. The hospital also uses bed and chair alarms for those at higher risk; hourly rounding; floor mats; non-skid socks; and a self-release roll belt for impulse patients. Modifying known risk factors The John A. Hartford Foundation develops models of care to improve health outcomes for older adults. One if its initiatives is funding research on fall preven- Death rate Per 100,000 U.S. individuals ages 65 and older Unintentional Fall Death Rates, Adults 65+ 58 56 54 52 50 48 46 44 42 40 2004 2005 2006 2007 2008 2009 Year Source: www.cdc.gov/injury/wisqars 22 MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 2010 2011 2012 2013 tion that supports a program developed by Mary Tinetti, MD, professor of medicine and chief of geriatrics at Yale School of Medicine. Tinetti’s research studied 301 men and women who were at least 70 years old, lived in the same community, and who had at least one of the following risk factors for falling: postural hypotension (a rapid drop in blood pressure when standing); taking four or more medications or psychoactive medications causing dizziness; or impairment in range of motion, balance or gait. The control group of 148 had usual healthcare services and social visits, while the intervention group of 153 subjects received a combination of medication adjustment, behavioral instructions and exercise programs. After a year of observation, 35% of the intervention group fell, while 47% of the control group did. Of the research participants who had a particular risk factor at baseline, a smaller percentage of those in the intervention group than in the control group still had the risk at reassessment. More recent outcomes indicate a risk reduction in falls of 25% to 35% when older adults receive a combination of similar interventions as described above. Amy Berman, a registered nurse and senior program manager with the John A. Hartford Foundation, says falls are preventable, which is why the program addresses the modification of known risk factors. She says the number one risk of falling is a previous fall. “When it happens, older adults stop becoming as active, lose their mobility and stay in bed more,” she says. Mari Edlin is a frequent contributor to Managed Healthcare Executive. She is based in Sonoma, California. Managed Healthcare Executive. com Drugs In The Pipeline Four things to know about the oncology pipeline How to recognize changes, maximize value by E R I N BASTICK, PHAR M D, R PH utilization and cost. The IMS Health Report predicts that future growth in the oncology drug market will be driven by wider utilization of new products, especially immunotherapies, and will be offset by decreased use of existing treatments. More than 70 new cancer treatments approved to treat more than 20 tumor types have been developed in the past five years. pipeline 2 The is expanding O ncology therapeutic and supportive care agents in the development pipeline promise to be more effective, more therapeutically targeted, more personalized—and far more costly, according to industry experts. “At the same time, more effective management of cancer care is increasingly facilitated by increasing penetration of electronic health records [EHRs], EHR-embedded clinical pathways, increasing share of patients treated in integrated delivery systems and larger oncology practices, transition from fee-for-service payment to risk-share payment, and the use of ‘big data’ to discover how resources can be optimally applied,” says Elan Rubinstein, PharmD, MPH, principal of EB Rubinstein Associates, a pharmaceutical man- “Medicines are personalized via use of biomarkers for whom therapy is likely to be effective.” —ELAN RUBINSTEIN, EB RUBINSTEIN ASSOCIATES Managed Healthcare Executive.com agement consulting firm. “Understanding the many changes under way in the healthcare marketplace, including oncology drugs in the pipeline, healthcare executives can coordinate the reaction of their organization to those market changes and thereby maximize value for money related to the care of cancer patients.” Here are the top four trends you should keep on your radar. trend 1 Drug is increasing The global oncology market reached $107 billion in 2015, according to the “Global Oncology Trend Report: A Review of 2015 and Outlook to 2020” released by IMS Health in June 2016. This amount represents an 11.5% increase in spend from 2014. The annual global cancer drug market is expected to grow another 7.5% to 10.5% in the next few years, to a total of approximately $150 billion in 2020, according to the report. Nadina Rosier, health and group benefits practice leader at Willis Towers Watson, says oncology drug trend will increase exponentially over the next few years because of the rich pipeline of innovative new drugs and their According to IMS Health, the pipeline for oncology drugs in clinical development has grown by more than 60% in the past decade. One possible explanation is the fact that the median time from patent filing to approval for cancer drugs The average cost of branded oncology treatments is $10,000 a month, up from $5,000 a decade ago. Source: IMS Health “Global Oncology Trend Report: A Review of 2015 and Outlook to 2020,” June 2016 in 2015 was 9.5 years, down from 10.3 years in 2013. Contributing to the reduction in approval time may be the FDA’s breakthrough therapy designation introduced in 2012. More than 500 companies are currently pursuing oncology drug development, accounting for approximately 600 new molecules through late-stage clinical development, according to IMS Health. MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 23 Drugs In The Pipeline Of these 600 new agents, most are seeking approval for non-small cell lung, breast, prostate, ovarian and colorectal cancers. Several oncology drugs are expected to be approved sometime in 2017. One is abemaciclib, an oral CDK4 and CDK6 inhibitor being developed by Eli Lilly for breast cancer treatment. Other examples include brigatinib, from Ariad Pharmaceuticals for lung cancer, and rucaparib (Clovis Oncology), for ovarian cancer. Cynthia Ambres, MD, principal at KPMG Strategy and a member of the firm’s Global Healthcare Center for Excellence, adds that biosimilar drugs could also reach the market for some of the targeted therapies that were introduced in the 2000s. According to Ambres, some of the adjuvant treatments, such as filgrastim to help restore white blood cell counts, already face competition and these could act as a constraint against rising prices. 3 Personalized medicine is growing According to PHRMA’s “Medicines in Development for Cancer” 2015 report, 73% of cancer medicines in the pipeline have the potential to be personalized medicines. “Medicines are personalized via use of biomarkers to identify patients for whom therapy is likely to be effective,” says Rubinstein. “So while healthcare executives can expect new cancer therapies to be increasingly expensive, biomarkers [i.e., personalized medicine] can support that their use is channeled in such a way to minimize waste of drugs and unnecessary risk to patients, due both to toxicity and to delay in alternative therapy that has a better chance of being effective.” Ambres agrees. “The medicines will target the cancers more effectively and have fewer side effects than the older, toxic chemotherapies and the treatments will gradually become the standard of care as treatments gain more exposure 24 Cancer drugs now make up 11.5% of the total drug costs in the United States, a value that is up from 10.5% in 2011. The U.S. now accounts for about 45% of the global market for oncology therapeutics, up from 39% in 2011. Source: IMS Health “Global Oncology Trend Report: A Review of 2015 and Outlook to 2020,” June 2016 in the market,” she says. “The treatments reaching the marketplace are targeting much more specific biomarkers, so oncology care will become more personalized.” One growing area of targeted cancer treatments is adoptive cell transfer (ACT), an approach to immunotherapy that involves engineering a patient’s immune cells to recognize and attack their tumors, according to the National Cancer Institute. In ACT, a patient’s T cells (immune cells collected from the patient’s blood), are genetically engineered to produce special receptors called chimeric antigen receptors (CARs). CARs allow the T cells to recognize a specific antigen on tumor cells. “From a medical coverage perspective, the CAR T cell therapies are of high interest as these therapies have shown very effective results, but have also been noted to be very expensive at $500,000 to $1,000,000 per course of therapy,” says April Kunze, PharmD, senior director, formulary development and trend management strategy at Prime Therapeutics. “Additionally, MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 they are used with other expensive treatment options and therefore will have a significant impact on medical drug trend. This will push payers to evaluate the best patient population to receive these therapies, with the potential for some difficult coverage decisions.” change 4 Payment is coming As more cancer therapies are developed, payers are expected to tighten their negotiation stance with manufacturers and adopt new payment models to drive greater value from their expenditures, according to IMS Health. There has also been a swing in the mix of new therapies toward oral medications, which make up nearly 40% of the targeted therapies in the U.S. and shifts drug payment to pharmacy benefits and demands greater delivery via retail channels. As for drug management strategies, Rosier says most pharmacy benefit managers (PBMs) use traditional utilization management like prior authorization, quantity limits, and step therapy for oncology drugs. Rosier has also seen some PBMs use preferred oncology “formularies” or contracting efforts to “prefer” one drug over another for specific cancer indications. “In 2017, we will see oncology exclusions for the first time in the marketplace,” says Kunze, “With more ‘me-too’ therapies, payers will be looking for additional management opportunities and preferred product designations as a way to manage trend in a class that has historically been managed by the FDA-labeled indication(s).” The IMS Health report notes that the average total treatment costs for patients in commercial insurance plans with a cancer diagnosis who are receiving active treatment reached $58,000 in 2014, up 19% from 2013. Erin Bastick, PharmD, is a graduate intern at University Hospitals Elyria Medical Center in Elyria, Ohio. Managed Healthcare Executive. com Policy Outlook LEG I S LATIVE / PO LI CY D EVE LO P M E NTS, TR E N D S AN D I M PACTS Precision Medicine Initiative has staying power Effort could better target patient care by J U DY PACKE R-TU R S MAN D espite significant challenges, President Obama’s ambitious initiative to lay the scientific foundation for precision medicine remains on track, say federal officials and outside experts. Yet, the long-term effort to accelerate research aimed at helping clinicians tailor medical treatments to individual patients must have funding to continue. Obama asked Congress for $309 million to fund the Precision Medicine Initiative (PMI) in fiscal year 2017, up about $100 million from the previous year. Some experts assert that PMI’s bipartisan support and enrollment of the first volunteers into its 1-million-person research cohort (the PMI Cohort Program) will also put pressure on Capitol Hill to keep the initiative going. PMI is “a strong effort, a great commitment from the [Obama] administration, and I believe it will continue on ... regardless of the outcome of the elections,” Daryl Pritchard, PhD, vice president of science policy for the Personalized Medicine Coalition in Washington, D.C. told Managed Healthcare Executive earlier this fall. “... It’s not a controversial program.” The coalition’s 225-plus members Managed Healthcare Executive.com include Aetna and numerous academic health centers, community hospital systems and information management firms. A complex initiative The PMI, first announced by Obama during his 2015 State of the Union Address, has many moving parts. Funding for fiscal year 2016 provided $130 million to the National Institutes of Health What is the PMI? A collaborative public and private effort that will leverage advances in genomics, emerging methods for managing and analyzing large data sets, and health information technology to accelerate biomedical discoveries. The Initiative will engage a million or more Americans to volunteer to contribute their health data to: ❚ Improve health outcomes; ❚ Fuel the development of new treatments, and ❚ Catalyze a new era of data-based and more precise medical treatment. Source: A 2015 statement from The White House Office of the Press Secretary (NIH) to create a 1-million-person research cohort (the PMI Cohort Program); $70 million to the National Cancer Institute (NCI) to ramp up efforts to identify genomic drivers in cancer; $10 million to the FDA to acquire more expertise and develop databases to support the regulatory framework for precision-medicine advances; and $5 million to the Office of the National Coordinator for Health Information Technology to develop interoperability standards and ensure privacy. Anyone in the U.S. who is willing to share their medical information, take a health survey, get a baseline medical exam, and provide a blood sample can volunteer to serve as part of the PMI Cohort Program. In February 2016, during a summit to discuss next steps, John Holdren, director of the White House Office of Science and Technology Policy, described PMI as “an all-hands-on-deck operation.” “Precision medicine holds incredible promise for the future of healthcare,” Holdren says. The initiative has brought the “relevant federal agencies to a new level of activity and collaboration in pursuit of that promise, and it’s drawing as well on the essential contributions of groups outside of government—providers, technologists, researchers, privacy and security experts, physicians, and, of course, patients.” Progress to date Infrastructure. NIH has made “significant headway” in establishing the infrastructure for the PMI Cohort Program, including a data and research support center, biobank, participant technologies MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 25 Policy Outlook Could PMI disappoint? PMI’s potential upside? “This effort, through the patient-consent policies they develop, can truly be a shared information resource,” says Pritchard. “...What you really have here is an opportunity to create this ‘learning health system’ at a scale that can make a difference...[and] you can really utilize information from the Human Genome Project in a way you couldn’t previously.” The genome project finished sequencing and mapping all human genes in 2003. The possible downside? “The main concern is [PMI] will be a lot of investment and time and won’t have as much impact as we hoped,” Pritchard says. “Going forward, I think we’ll need measurable progress,” he explains. “With the Human Genome Project there were a lot of naysayers up front, but sequencing technology accelerated well beyond what was expected. ...So, the same sort of thing can happen [with PMI] if we see incremental progress, and it catches fire and you can see its effectiveness.” center, and a network of healthcare provider organizations to help enroll and retain volunteers, collect samples and handle bio-banking, says Gwynne Jenkins, PhD, the program’s chief of staff at NIH. NIH’s network of healthcare provider organizations includes regional medical centers such as Columbia University Medical Center and the University of Chicago. Enrollment. NIH is not on track to recruit 79,000 individuals into the cohort by the end of 2016, federal officials say, but Jenkins describes that figure as an initial estimate. “We anticipate launching in phases, when systems are secure and ready to go and we can ensure a high-quality experience for our users,” says Jenkins. “When we are ready to enroll participants, we will spread the word.” Cancer research. As part of NCI’s contribution to the initiative, Jeff Abrams, MD, acting director for clinical research in NCI’s Division 26 of Cancer Treatment and Diagnosis, says his division applied funding toward expanding its portfolio of genomic-based trials, improving the understanding of resistance to targeted agents and drug combinations, and developing a mechanistic understanding of immunotherapy. The Precision Medicine Initiative in Oncology (PMI-O), which is part of the larger initiative, has also committed resources to improving pre-clinical models for evaluating targeted therapeutics, says Abrams. Finally, a major component of this overall effort was the launch of NCI’s Genomic Data Commons (GDC) in 2016. Abrams’ NCI division intends to deposit molecular data from clinical trials into the GDC to foster secondary analyses and permit data mining by a broad range of investigators. For more on the GDC, read “Cancer initiative harnesses big data’s full potential” on pg. 16. Concept to reality Pritchard says the Personalized Medicine Coalition is exploring strategies to rapidly integrate precision medicine into the delivery system, examining issues ranging from scientific discovery to regulation, reimbursement and clinical application. “I am seeing a rapid increase in the work we’re making in the clinical adoption area now,” he says. According to Pritchard, the federal PMI effort still faces “considerable challenges, and they [i.e., federal officials] are aware of them.” He cites three primary hurdles: Patient empowerment. This includes data protection, consent, and ensuring volunteers for PMI’s cohort are appropriately informed, he says. PMI than has likely been collected in any other research project, Pritchard says. “You need to collect and manage that to create a learning health system.” This means building a system that collects and stores outcomes data in a standardized way and informs participants in a timely manner, he says. Significance determination. A third challenge is how to draw results and determine clinical significance, Pritchard says. Many of the genetic alterations studied will be relatively rare, he says, “but because you have 1 million patients, you can analyze rare occurrences statistically ... and assess whether this truly makes a difference.” As for front-line challenges, Florence Comite, MD, an endocrinologist who runs a precisionmedicine clinic in New York City and writes on the topic, describes “a rift between academic institutions and the practice of medicine.” Clinicians see the promise of precision medicine, she says, but the concept “doesn’t yet have traction” as it does among academics. Comite supports PMI, but views it as “a starting point.” Collecting a wealth of genomic data is exciting, she says, but it must be translated into actionable information for clinicians who often don’t know how to make sense of Fitbit data, much less genomic information. “We’re actually taught in medical school you don’t want to go on any fishing expeditions,” she notes. “Is one going to be able to take the scale of 1 million [participants in PMI’s research cohort] and extract it down to one human being? It’s a complex universe we’ve entered into [that is] going to leave perhaps more questions than answers because of what we face in medicine.” Information management. More information is being gathered for MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 Judy Packer-Tursman is a writer in Washington, D.C. Managed Healthcare Executive. com Health Management B EST P R ACTI C ES FO R O PTI MAL O UTC O M ES Highmark’s cancer collaborative Payers, providers come together in new ways C ollaborative, coordinated care is the catchphrase of the decade in healthcare, but for cancer patients in one area of Western Pennsylvania, it has become much more. With the launch of the new Highmark Cancer Collaborative, payers and providers are working together in a new way, removing barriers that for too long have prevented true progress in affordable and accessible cancer care. David S. Parda, MD, FACP, professor and system chair of the Department of Oncology and the Cancer Institute at Allegheny Health Network (AHN), which is part of the collaborative, says he hopes the partnership will help overcome what the Institute of Medicine calls a “cancer care crisis” in the United States. In a September 2013 report, the institute noted that despite remarkable advances in cancer care over the last 50 years—leading to a nearly 70% cure rate—cancer care is still inadequate and being delivered at unsustainable costs. “We agree with this assessment and the tough solutions that are required,” says Parda. “We need to improve patient-centered, accessible, coordinated, and evidencebased treatment and care. We need to increase the focus on prevention and psychosocial wellness as some estimates indicate that 50% of cancers may be preventable.” Managed Healthcare Executive.com Program specifics The collaborative is made up of a partnership between AHN (which is based in the Pittsburgh area), Highmark Blue Cross Blue Shield, and the Johns Hopkins Sidney Kimmel Cancer Center. The premise is that Highmark is providing AHN physicians with a system for identifying evidencebased cancer care pathways based on patients’ individual information. Incentives for ineffective, or unproven treatments are removed and instead, value-based care is pursued. Highmark is also removing pre-authorizations for cancer patients, and it is streamlining the claims and payment process to help providers get paid faster. by RACHAE L Z I M LICH, R N Johns Hopkins is also collaborating on patient cases—particularly in rare or complex cases—through direct physician peer-to-peer review and other virtual methods. It also offers joint educational programs, and participation in collaborative research projects and clinical trials. Terry Langbaum, MHS, chief administrative office at Johns Hopkins Kimmel Cancer Center, says Johns Hopkins has had a partnership with AHN for the past two years, but the new collaboration expands the possibilities. “We are bringing together a lot of assets and all working together toward better outcomes for cancer patients,” Langbaum says. “Some estimates indicate that 50% of cancers may be preventable.” —DAVID S. PARDA, MD, ALLEGHENY HEALTH NETWORK AHN and Highmark will focus on bringing experts together to advance cancer care on all levels— quality of care, access, experience and value for all stakeholders, says Parda. Cancer patients can be sure that they get the most appropriate, earliest treatment by getting a second opinion or confirmation of their cancer diagnosis and staging by specialists at Johns Hopkins. Patients will not necessarily receive treatment at Johns Hopkins—which sees 8,000 new cancer patients each year—with the exception of rare or complex cancers, or patients who are eligible and elect to participate in a clinical trial. The majority of cancer care can and should be delivered at facilities within a patient’s community, like at AHN, she says. “Really the whole point of it is MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 27 Health Management to make sure each patient has the right diagnosis and right stage to drive the correct treatment plan, and that they are getting their treatment in the right place,” Langbaum says. “It’s not just about pathways ... it’s models and incentives to get people the care they need.” —VIRGINIA CALEGA, MD, HIGHMARK BLUE CROSS BLUE SHIELD Streamlining information AHN and Johns Hopkins are integrating their electronic health record (EHR)/IT platforms to help providers communicate more rapidly and efficiently. The collaborative will utilize a Web-based tool that connects to an EHR network and the physician, accessing patient information, physician, demographic, and genetic input to match it to an appropriate pathway. Physicians can even use the technology for patients not in the Highmark system. and the patient, it takes that worry away from them.” Calega says the collaboration brings providers and payers together in a new way to really focus on improving access, affordability, and appropriateness of care. For example, she points to the use of therapeutic radiation. For years, providers have used sixweek courses of radiation to treat Pharma Implications Stakeholders say the collaborative will have implications for pharmaceutical cancer care costs. These costs increase 17% each year, and the median cost of new cancer drugs coming to market is nearly $10,000 per month, according to Highmark. The partnership will allow patients and providers to review evidencedbased care paths that deliver targeted treatments, reducing the likelihood that a patient will receive a medication that is unlikely to result in improved outcomes. The system will also provide physicians with access cost information, so that they can discuss it with concerned patients. “Those kind of discussions are critically important, and patients want to have those discussions with their clinical team,” says Virginia Calega, MD, MBA, FACP, vice president of strategic clinical solutions at Highmark Blue Cross Blue Shield. “What are the options, and what are the side effects, and what is going to be their quality of life? If you can make the payment more predictable both for the doctor 28 breast cancer, but now research shows that a three-week course can be just as effective with less negative effects, says Calega. “Outcomes are equivalent with less toxicity,” she says, adding the shorter course is just as effective, easier for the patient, and more affordable. Under the collaborative, providers get paid the same for a six-week course of treatment or a threeweek course. Prior authorizations are removed, and providers get half of the payment up front and half at the end of treatment. MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 Criticisms and concerns While care pathways have received some criticisms for impinging on physicians’ autonomy, Calega says that is not the case in this collaboration. “It’s not just about pathways, but it’s models and incentives to get people the care they need,” she says. “You don’t use pathways as a prior authorization, you use them to help people get better.” Physicians are usually pleasantly surprised once they understand how the collaboration works; that they no longer need to deal with prior authorizations, and that they will be rewarded for caring for patients in accordance with National Comprehensive Cancer Network pathways, she says. Highmark also plans to sit down with physicians and look at historic data to come up with a payment rate for patients in various cancer groups. “We’re going to pull prior authorization and we’re going to sit down with [physicians] and say, ‘How are we doing?’” Calega says. “We’re really able to not just look at pathways but how we reimburse differently for pathways. That’s the piece where I think having a partnership with an insurance [company] changes the conversation in the marketplace.” Rachael Zimlich is a writer in Columbia Station, Ohio. Managed Healthcare Executive. com Q&A I N D USTRY E X P E RTS WE I G H I N Fertility benefit services: pros and cons Experts weigh in I n an effort to attract and retain top talent, employers are offering a variety of family-friendly benefits including fertility services, according to a new survey. The Employee Benefits Survey 2016, conducted by the International Foundation of Employee Benefit Plans, found that 24% of employers with 500 or more employees offer fertility services as part of their healthcare benefits. Nineteen percent cover in vitro fertilization (IVF) treatments, 12% cover fertility medications and 9% cover non-IVF fertility treatments. Smaller numbers cover visits with counselors (geneticists, surrogacy, etc.), at 6%, or egg harvesting/freezing services, at 4%. Karin Ajmani, president of by TRACEY WALKE R healthcare services at Progyny, a digital healthcare company that provides a fertility solution to employers, and Brian A. Levine, practice director at the Colorado Center for Reproductive Medicine (CCRM), New York location, recently spoke with Managed Healthcare Executive (MHE) about the details of fertility plans. Q: MHE: What is a fertility benefit plan? Ajmani: About 25% of employers offer some coverage for infertility treatments and that percentage is growing annually due to the recognition that infertility is a medical condition like any other (in 2009, the World Health Organization officially designated infertility as a disease). Typical infertility benefits are not comprehensive and only “There are about 15 states where fertility and infertility benefits are ‘mandated’ by the state legislature.” —BRIAN A. LEVINE, COLORADO CENTER FOR REPRODUCTIVE MEDICINE Managed Healthcare Executive.com cover fertility medications or a very limited amount of infertility treatments. Most infertility benefits currently offer a defined dollar maximum, and do not cover all of the costs associated with the consultation, diagnostic testing, and latest infertility treatment technologies which drive success rates. Therefore, patients suffer longer, with higher rates of infertility treatment failures, higher miscarriage rates, and much higher out-of-pocket costs (the typical retail rate for one full IVF cycle, including diagnostic testing and labs, is as high as $20,000 per cycle). Since the average fertility benefit only covers $10,000, and it takes about three IVF cycles to obtain a successful live birth, patients are forced to make difficult decisions about what treatments to pursue based on cost, not best practice. Levine: A fertility benefit plan is additional coverage for fertility and infertility benefits to an existing insurance policy. There are about 15 states where fertility and infertility benefits are “mandated” by the state legislature. With that said, the breadth and depth of coverage can vary quite a bit. Q: MHE: What is happening in healthcare that makes this benefit attractive? Ajmani: Employers are getting hit hard with medical costs related to high-risk pregnancies and NICU expenses as a result of employees seeking infertility treatments. And this trend is only going to increase, as the average age of women having children increases. MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 29 Q&A Currently, one in five couples now has their first child at 35 years of age or older, let alone their second or third child. People struggling to get pregnant don’t stop if they don’t have a fertility benefit; they simply pay out of pocket and begin with less-expensive, less-effective technologies, such as fertility medications or intrauterine insemination, lending to the high rate of twins. It is widely known that pregnancies involving twins result in much higher prenatal, maternity and neonatal intensive care unit (NICU) expenses. Any employer looking to support their employees during the stressful and expensive journey of infertility will be interested in this benefit. Employees who struggle with infertility face higher rates of depression and absenteeism in the workplace, as well as turnover. The employees who need to utilize their fertility benefit is small, less than 1% per year, but they’re disproportionately more vocal and proactive in their quest to obtain coverage through their employers. In the end, HR and benefits executives recognize that providing coverage is the right thing to do from both a cultural and cost perspective. By enrolling in this type of benefit, HR directors are able to retain and attract employees, especially millennials. Q: MHE: What are the pros and cons of adding a fertility benefit? Levine: It is important to recognize that both the cost of the plans and the scope of the plans can vary widely. Many employees might be excited at first to learn that they have fertility coverage only to later find out that they are only covered for certain treatments at certain clinics. 30 “One in five couples now has their first child at 35 years of age or older, let alone their second or third child.” —KARIN AJMANI, PROGYNY To further complicate the matter, certain insurance companies can dictate where patients can fill their fertility prescriptions since the medications typically come from a specialty pharmacy. It’s important when selecting a plan to select a plan that is broad and that also allows for fertility preservation, which includes egg freezing, something that many young female employees might be interested in doing. Q: MHE: What is the ROI of this benefit? Ajmani: The most significant ROI is related to medical cost avoidance. If someone doesn’t have coverage, or has very limited fertility coverage, an employee will still seek treatment and pay out of pocket. This leads people to choose less expensive, less effective, treatment options, such as fertility medications and artificial insemination, which have the highest chance of producing twins or multiples (the current rate of multiples through use of fertility treatments is about 27%, as compared to a natural multiples rate of about 1.5%). And if that doesn’t work IVF is often utilized, and multiple embryos are transferred per cycle to increase the chance of pregnancy, because option B is a second round of IVF at an average retail rate of $20,000. The minute a woman gets pregnant with multiples, her employer or plan is now responsible for the costs related MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 to her high-risk maternity care, as well as a likely C-section, pre-term birth and NICU expenses. These downstream expenses far outweigh having a comprehensive fertility benefits plan. But just providing a fixed dollar amount of coverage doesn’t solve the problem; Progyny has been able to decrease the rate of multiples for people needing fertility treatment to only 4% by providing patient care advocates to help our members through the opaque maze of fertility options, and by including coverage for the latest technologies. Q: MHE: What are your top recommendations for executives thinking about a fertility benefit plan? Levine: sure that the benefit 1 Make package is accepted by the providers in the area. sure that the benefit 2 Make package does not require the patient to maximize all out-ofnetwork benefits before using their fertility benefits. a plan that is flexible to 3 Select patients who may want to preserve their fertility as opposed to solely seeking fertility treatment. a plan that is open to 4 Pick single parents who desire to reproduce with donor eggs/ sperm. Tracey Walker is content manager for Managed Healthcare Executive. Managed Healthcare Executive. com Conference Insider Highlights from ASCO 2016 Biosimilar uptake may lag for cancer patients by B RYANT FU R LOW A s cancer biologics come off-patent and non-brand “biosimilars” hit the marketplace over the next few years, costs should decline. Still, oncology practices and cancer centers will confront more complex prescribing and purchasing decisions—and challenging conversations with patients, experts said at the American Society of Clinical Oncology (ASCO) Annual Meeting 2016, held in Chicago in June. As of January 2016, efforts were under way to develop and seek FDA approval for dozens of biosimilar versions of 18 reference biologics under FDA’s Biosimilar Product Development program. The larger numbers of biosimilars will have a “major impact in cancer treatment and supportive care management, with the potential to drive cost savings in healthcare,” said Francisco J. ESTEVA Esteva, MD, PhD, of the New York University Clinical Cancer Center, during a biosimilars panel at the conference. The estimated cost of developing a biosimilar is one-fourth to one-eighth the cost of developing the originator (the brand-name reference drug), Esteva noted. Based on what’s happened in Europe and Asia, he expects to see biosimilars costing 20% to 30% of brand-name biologics. Managed Healthcare Executive.com Acceptance a concern It is not yet entirely clear that patients will widely accept biosimilar cancer drugs, at least right away. Biosimilar versions of supportive-care medications like filgrastim (a bone marrow stimulant that helps cancer patients avoid infections during treatment) do seem to be acceptable to clinicians and patients, so far, Esteva noted. The FDA’s March 2015 approval of Zarxio ( filgrastim-sndz, Sandoz, a Norvartis Company), a biosimilar of Amgen’s Neupogen ( filgrastim), was the first such approval under the Biologics Price Competition and Innovation Act of 2009. It is less clear how patients will feel about the arrival of the FDAapproved biosimilar versions of brand-name cancer treatments— that actually attack tumor cells. “Biosimilar cancer therapeutics, like [biosimilars for] rituximab and trastuzumab, are likely to raise concerns,” Esteva said. “Safety and efficacy data must be communicated effectively to patients.” Post-marketing surveillance will sometimes be needed to ensure that biosimilars match originatorbiologics’ safety and efficacy, he said. He predicted that widespread adoption will take more time in the U.S. than elsewhere. Explaining the evidence base for biosimilars to patients might also prove to be challenging. Comparative clinical studies may be undertaken when there is “residual uncertainty,” but the goal of biosimilar development is not to independently re-establish the safety or efficacy of the proposed biosimilar for each potential indication, explained Steven Lemery, MD, MHS, associate director (acting) of FDA’s Division of Oncology Products, Office of Hematology and Oncology Products. Physician misgivings A “totality of the evidence” approach is used to determine biosimilarity, including lab animal and human toxicity, pharmacokinetic and pharmacodynamic data, analytical data, immunogeLEMERY nicity studies, and clinical findings, Lemery said. That may leave some clinicians with misgivings, at least initially. “How confident will clinicians be with limited data on the efficacy and safety of biosimilars compared with the original biologics?” Esteva said. The FDA’s approval of a biosimilar does not mean the product is interchangeable at the pharmacy with the brand-name reference drug. “An interchangeable product may be substituted without the intervention of a healthcare provider,” explained Lemery. “A biosimilar product must be prescribed by the healthcare provider and should not be substituted by the pharmacist without intervention by the provider.” Continued on page 32 MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 31 Conference Insider Conference Insider continued from page 31 Patient-reported outcomes poised to improve cancer care by B RYANT FU R LOW Patient-reported outcomes (PROs) are playing a growing role in cancer research and are poised to become an important part of regulatory review in drug development—and even routine clinical cancer care, according to experts at ASCO. During the session “Integrating Patient-Reported Outcomes into Cancer Clinical Trials and Regulatory Review,” experts discussed PROs, which are measures of patients’ symptoms and physical, cognitive, social and emotional functioning, and health-related quality of life, that are obtained via self-administered questionnaires or structured interview questions. In research settings, there are indications that PROs might improve early detection of side effects. “Early data suggest PRO [measures] might also enhance our ability to discriminate adverse events between study arms,” said Ethan Basch, MD, MSc, of the University of North Carolina at Chapel Hill, a leading researcher in PRO assessments of adverse events among cancer patients. In one study, the BASCH number of adverse events found to be statistically significantly different between treatments was three times larger when adverse events were measured using PROs instead of traditional cliniciandriven adverse-events reporting, Basch noted. Incorporating PROs in drug development Such findings have prompted the MORE ONLINE 32 FDA to take a serious look at how best to incorporate PRO assessments of symptomatic adverse events in drug development, said Paul Gustav Kluetz, MD, a medical oncologist at the FDA’s Office of Hematology and Oncology Products. “We are now in a different era of drug development; patient voices are more important,” Kluetz said. “Thoughtful incorporation of patients into clinical trials and drug development is becoming a priority.” Improved assessment of tolerability represents a real “PRO measurement opportunity,” Kluetz said. “Symptomatic adverse events are best assessed by patients themselves.” Drug developers and regulators have long “looked at drug KLUETZ safety through the clinician’s lens,” Kluetz said. The emphasis is on precisely-measured lab test results and radiographic or histological variables. PROs provide new insights Such measures have proven to be very valuable to researchers and clinicians alike. But adding PROs to the mix can afford new insights into how treatments really affect patients. PROs offer “different but complementary data to current clinicianreported safety data,” Kluetz explained. The US National Cancer Institute (NCI) has developed a PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™)—a “promising tool for this purpose,” Kluetz said. PRO- CTCAE data can be collected using web portals between visits in just minutes, noted Basch. Expanding adverse-events detection to include PROs is increasingly important as the durations of cancer treatments grow, and the field of drug development transitions from an era of cytotoxic chemotherapies infused intravenously at cancer centers, to more diverse treatments that are self-administered orally every day, he said. Drug efficacy and PROs There are currently significant challenges in assessing cancer drug efficacy using PRO measures, Kluetz cautioned. “Many patients enrolled on cancer trials are asymptomatic with good performance status,” he explained—making it difficult to detect potential impacts on patients in real-world clinical settings. But enrolling more symptomatic patients could allow researchers to use PROs to better measure symptom improvement and palliation. Incorporating PROs into research will help develop treatments with an eye toward patients’ expressed needs and priorities. Bringing PROs into clinical practice can also help practices and hospitals to bolster quality of care. ASCO has a PRO committee that has begun to test PRO quality-ofcare measures. The development of so-called “ePRO” apps will allow patients to routinely self-report symptoms from home. Efforts are under way to integrate ePRO approaches with electronic health record portals to allow the addition of longitudinal PRO data to patients’ medical records. To see Managed Healthcare Executive’s full conference coverage of the ASCO conference, visit bit.ly/MHE-ASCO-2016. MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 Managed Healthcare Executive. com INDUSTRY Analysis Oncology medical home model pays off New partnership between payers, providers Tracey Walker CO NTENT MANAGER A NEW value-based cancer care model is focusing on better aligning providers with health plans and employers through an independent practice association (IPA) structure that creates oncology patient-centered medical homes. The Vantage Cancer Care Network (VCCN) model, launching in Philadelphia, is already under way with the establishment of an IPA advised by John Sprandio, Sr, MD, FACP, a practicing medical oncologist and hematologist and an innovator for the Oncology Patient-Centered Medical Home. The VCCN has formed a single specialty IPA of oncologists who have contracted with a payer in the market to share savings. More than 60 oncologists in seven locations from the Philadelphia area are participating in the network, and more than 30 patients are participating. It’s anticipated that 750 patients will participate by the end of 2016. “It is a model that ensures the best outcome, minimizing side effects at a lower overall utilization of services,” says John Iacuone, MD, MBA, president and chief clinical officer, VCCN. “Typically this results in a lower overall cost to the patient and payer, while providing shared savings with the physician managing the patient.” WHY ONCOLOGY? Making critical, value-based care management decisions is the purview of the oncologist, says Iacuone. “A value-based contract allows the oncologist to manage the patient, and with different incentives for utilization of IACUONE services, the health plan is protected from potentially harmful overutilization of services.” He adds that participating oncologists are monitoring outcomes, quality of life, and access to care as part of their commitment to the payer that its patients will be receiving comparable or exceptional care—value—while Managed Healthcare Executive (ISSN 1533-9300, Digital ISSN 2150-7120) is published monthly by UBM Medica 131 W First St., Duluth MN 55802-2065. Subscription rates: 1 year $99.00, 2 years $145.00 in the United States & Possessions; 1 year $122.00, 2 years $173.25 in Canada and Mexico; 1 year $192.00, 2 years $295.00 in all other countries. For air-expedited service, include an additional $87.00 per order annually. 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EARLY RESULTS While it is too soon to report outcomes, preliminary data from the model show excellent and timely access to providers, and 100% compliance with utilization of value-based treatment guidelines based on National Comprehensive Cancer Network Guidelines, according to Iacuone. “Providers and patients are now incentivized to avoid unnecessary and costly utilization to manage their cancer that do not improve outcomes, reduce toxicity or improve quality of life for the patient,” he says. “Historically, providers have been paid when they utilize services, for example, order a test, prescribe a medicine, or perform surgery. This is bankrupting Medicare and patients due to unsustainable inflation of healthcare costs that may have unproven, or limited improvement or value. This is happening in cancer care as well, but at twice the inflation rate of all other healthcare services.” MANAGED HEALTHCARE EXECUTIVE does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. MANAGED HEALTHCARE EXECUTIVE welcomes unsolicited articles, manuscripts, photographs, illustrations and other materials but cannot be held responsible for their safekeeping or return. Library Access Libraries offer online access to current and back issues of Managed Healthcare Executive through the EBSCO host databases. To subscribe, call toll-free 888-527-7008. Outside the U.S. call 218-740-6477. ADVERTISER INDEX The following is a list of the advertisers in this issue. Although every effort is made to ensure accuracy, this publication assumes no liability for errors or omissions. Advertiser name Brand name Page No Athenahealth Great Call Hologic Merck & Co., Inc. Regeneration RXCrossroads Corporate Corporate Affirm Prone BioSimilars Eylea Corporate 15 Back Cover 21 5 Inside Front Cover - 1 9 MANAGED HEALTHCARE EXECUTIVE ❚ NOVEMBER 2016 33 Leading the way in connected health. GreatCall® is the leader in connected health technology for the active aging market, with a proven record of solutions that keep senior members independent longer. $ When you provide members with the fastest response time* from IAED-certified Agents via our 5Star® mobile emergency response service, you can help prevent adverse events from leading to emergency room care and hospital admission. All without impacting your processes or service abilities. Over 900,000 active users and caregivers have already chosen GreatCall as an essential part of their health and wellness regimen. 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