PI3K Inhibitors: Multiple Myeloma: PARP Inhibitors in Ovarian Opioid Use Disorder: Magellan Rx Report Fall 2018 Pipeline and Future Directions in Cancer: Management Managed Care Therapeutic Advances Treatment Considerations Implications Magellan Rx Report MEDICAL AND PHARMACY BENEFIT MANAGEMENT Fall 2018 Multiple Sclerosis: Current and Pipeline Treatments and Their Impact magellanrx.com Welcome to the Features Magellan Rx Report 2-3 Published By Newsstand Magellan Rx Management 15950 North 76th Street Scottsdale, AZ 85260 9-14 Tel: 401-344-1000 Opioid Use Disorder: Fax: 401-619-5215 Managed Care [email protected] Implications magellanrx.com Publishing Staff 16-18 PARP Inibitors in Themmi Evangelatos, PharmD, MSBA Lindsay C. Speicher, JD Ovarian Cancer: Management Advertising and Sales Considerations Servi Barrientos 401-344-1020 [email protected] 22-27 The content of Magellan Rx Report — including text, graphics, images, and information obtained from third parties, licensors, and other material (“content”) — is for informational purposes only. Multiple Myeloma: The content is not intended to be a substitute for professional medical advice, diagnosis, or Future Directions in treatment. Magellan Rx Report 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 Treatment other damages incurred by readers in reliance on such content. Developed by D Custom. 29-33 Multiple Sclerosis: Editorial Advisory Board Current and Pipeline Mona M. Chitre, PharmD, CGP Steven L. D’Amato, BS Pharm Treatments and Their Chief Pharmacy Officer and VP Executive Director, New England Cancer Impact Clinical Analytics, Strategy, & Specialists Innovation, Excellus BlueCross BlueShield Joseph Mikhael, MD, MEd, FRCPC, FACP 36-39 Dennis Bourdette, MD, FAAN, FANA Chief Medical Officer, Chair and Roy and Eulalia Swank International Myeloma Foundation Payer Perspectives Family Research Professor, on Botulinum Toxin Department of Neurology, Oregon Natalie Tate, PharmD, MBA, BCPS Management for Health & Science University Vice President, Pharmacy, BlueCross BlueShield of Tennessee Therapeutic Use Yousaf Ali, MD, FACR Chief, Division of Rheumatology, Mount Sinai West Associate Steve Marciniak, RPh Director II, Specialty Pharmacy, Professor of Medicine, Icahn 47-49 Pharmacy Services, School of Medicine at Mount Sinai PI3K Inhibitors: Blue Cross Blue Shield of Michigan Pipeline and Saira A. Jan, MS, PharmD Therapeutic Advances Director of Pharmacy Strategy and Clinical Integration, Horizon Blue Cross Blue Shield of New Jersey 50-51 ISSN:2159-5372 10444M Pipeline Drug List Magellan Rx Report | Fall 2018 Dear Managed Care Colleagues, Welcome to our fall issue of findings from a payer panel discussion regarding toxin man- the Magellan Rx™ Report! It’s agement for therapeutic use. been another exciting year for No issue of the Report would be complete without a phar- managed care pharmacy, with maceutical pipeline review to help you track promising new several new drug approvals agents that may receive FDA approval in the near future. To Mostafa Kamal since the summer issue. Once learn more about Magellan Rx Management and our support Chief Executive Officer Magellan Rx Management again, Magellan Rx Management of payer initiatives of the future, please feel free to contact was poised to prepare payers us at [email protected]. As always, for these approvals with the quarterly MRx Pipeline, which I value any feedback that you may have, and thanks for offers clinical insights and marketplace intelligence on reading! anticipated specialty and traditional drugs in the pipeline. In this issue of the Magellan Rx™ Report, the multiple sclerosis cover story reviews the current treatment land- Sincerely, scape and highlights the numerous pipeline agents in development. A second article of focus explores the current treatment landscape for multiple myeloma, discussing future direc- tions for treatment with the use of novel immunother- Mostafa Kamal apeutic approaches, including use of novel monoclonal Chief Executive Officer antibodies, vaccines, adoptive T-cell therapies, and chimeric Magellan Rx Management antigen receptor therapies, and the impact on managed care. Another article of interest discusses opioid use disor- der and the various treatment options available, with an emphasis on treating the symptoms associated with opioid withdrawal and information regarding an investigational therapy in development. Other notable topics featured in this issue include a budget impact model for PARP inhibition; advancements in the treatment of cancer through PI3K inhibition; and key Magellan Rx Report Fall 2018 Fall Report Rx Magellan PI3K Inhibitors: Pipeline and Therapeutic Advances Multiple Myeloma: Future Directions in PARP Inhibitors in Ovarian Treatment Cancer: Management Opioid Use Disorder: Considerations Managed Care Magellan Rx ReportImplications MEDICAL AND PHARMACY BENEFIT MANAGEMENT Fall 2018 SUBSCRIBE TODAY! Get more insight on the industry’s most innovative and groundbreaking managed care solutions for some of the most complex areas of healthcare. Email us at Multiple [email protected] to receive the latest issue, delivered right Sclerosis Current and Pipeline: to your inbox. Treatments and Their Impact magellanrx.com Managed Care Newsstand FDA Revises poses measuring effectiveness using a encourage more widespread innovation Clinical Endpoints patient-reported outcome survey, with and development of MAT drugs,” though for Demonstrating such primary endpoints as “change in it is unclear if the proposal will encour- drug use patterns” and such secondary age new MAT therapies more effective Effectiveness of New MAT endpoints as “intensity of the urge” or than current therapies. Drugs improvements in sleep or mood. 1 FDA. Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment. Claire Wulf Winiarek FDA Commissioner Scott Gottlieb August 2018. On August 6, the U.S. Food and Drug tweeted the draft guidance is a step “to Administration (FDA) released draft industry guidance revising clinical end- points for drugmakers to demonstrate the effectiveness of new medication-as- “Traditionally, MAT drugs’ effectiveness or sisted treatment (MAT) therapies for opi- oid use disorder (OUD).1 Traditionally, success has been measured based on whether a MAT drugs’ effectiveness or success patient in recovery stopped using opioids. The has been measured based on whether a patient in recovery stopped using new guidance proposes giving greater weight opioids. The new guidance proposes giving greater weight to reductions in to reductions in relapse overdoses, infectious relapse overdoses, infectious disease disease transmission, and ‘adverse outcomes of transmission, and “adverse outcomes of OUD” (e.g., mortality). It also pro- OUD’ (e.g., mortality).” CMS Announces MA Plans released a Health Plan Management hibited the use of step therapy. May Use Step Therapy for System memo to Medicare Advantage The memo laid out several limitations, (MA) organizations allowing MA plans qualifiers, and related requirements for Part B Drugs in 2019 to use step therapy edits for Medicare care coordination activities, including Reflecting concepts included in Part B drugs as part of their drug man- that patients currently in therapy are the Trump Administration’s May 2018 agement care coordination services grandfathered in and step therapy Blueprint to Lower Drugs Prices and beginning January 1, 2019. The August should not increase beneficiary costs. Reduce Out-of-Pocket Costs, the Centers 7 memo also rescinded the agency’s for Medicare & Medicaid Services (CMS) September 17, 2012, memo, which pro- CMS Issues Medicare Part B use of step therapy for Medicare Part B While CMS believes it has answered Step Therapy FAQs drugs in the coming benefit year (2019). all step-therapy related questions, Of note, CMS states Part B step therapy Government Affairs and its industry trade Claire Wulf Winiarek limits need not be reported to CMS (Page group, PCMA, have identified instances of On August 29, CMS posted on its web- 3) and plans are permitted to make mid- partial answers and will be following up site a document providing answers to year changes to step therapy if consistent with CMS to better address these. several questions posed by stakehold- with the plan’s Annual Notice of Change ers, including Magellan Health, on the and Evidence of Coverage (Page 4). 2 | Magellan Rx Report | Fall 2018 Indication-Based Pricing and Billing Challenges MRx Trend Alert | August 2018 | Volume 5, Issue 3 “If a health plan is only accepting the The FDA approved two chimeric anti- assigned temporary Q-code, the claim could gen receptor (CAR-T) cell therapies in 2017. Tisagenlecleucel (Kymriah) be reimbursed at the wrong rate, causing a was approved on August 30, 2017, for potential over- or underpayment. Most health the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia plans are currently adjudicating CAR-T medical in patients up to 25 years. On May 1 of this year, the FDA approved Kymriah for a claims on a case-by-case basis due to the high second indication of relapsed/refractory cost, so chances of the wrong payment being diffuse large B-cell lymphoma (DLBCL) in adult patients. Meanwhile, Gilead’s reimbursed are lessened.“ axicabtagene ciloleucel (Yescarta) was approved for DLBCL on