REGULATORY UPDATE REGULATORY UPDATE US ELECTION 2016 Japan Slashes Opdivo Price 50% Payers Want Access To US FDA’s OTC Drug Industry Could Stand To Gain After Prescriptions Surge, p. 10 Pre-Submission Meetings, p. 14 With ‘Pragmatist’ In White House, p. 7 Pharma intelligence Pinkpink.pharmamedtechbi.comSheetVol. 78 / No. 47 November 21, 2016 informa “ There may be a growing number of advisors in his camp, as well as the president-elect himself, that would not want to get rid of CMMI wholesale,” ADVI’s Shutterstock: Robert Crusitu Shutterstock: Lucian Samuels suggests. Trump, Congress And The Future Of to conduct experiments in new payment models, can make participation in the models mandatory for providers and pa- Value-Based Drug Contracting tients, and can expand the experiments CATHY KELLY [email protected] if they are considered to be successful at saving money while preserving quality or he pace and trajectory of federal change. But I’m not as bullish as some enhancing quality and keeping costs level. government involvement in pro- drug [industry] colleagues that things will Because Trump and the Republican Con- T moting value-based drug contract- just disappear,” Marc Samuels, founder gress are expected to try and repeal at least ing for prescription drugs may change un- and CEO of the ADVI consulting firm, said part of the ACA, some stakeholders believe der the administration of President-elect in an interview. CMMI might also be targeted. However, Donald Trump but it probably won’t go Speculation about a new direction in Samuels sees CMMI as aligned with the away altogether. government-driven value-based purchas- drug price concerns Trump espoused on Specifically, there may be modifications ing is centering on the future of the Center the campaign trail. “He has talked about in the way the Centers for Medicare and for Medicare and Medicaid Innovation. Es- price transparency, price negotiation and Medicaid Services designs and implement tablished by the Affordable Care Act, CMMI even importation, and there may be a value-based (rather than volume-based) is the organization within CMS that is de- growing number of advisors in his camp, purchasing in Medicare through payment signing and carrying out experiments in as well as the president-elect himself, that experiments, which has been a major focus value-based payment. would not want to get rid of CMMI whole- for the Obama Administration. The innovation center and CMS have sale,” he pointed out. Samuels formerly was “I believe there are things that will the power to waive certain laws in order CONTINUED ON PAGE 4 BROUGHT TO YOU BY THE EDITORS OF SCRIP REGULATORY AFFAIRS, THE RPM REPORT, TAN SHEET, GOLD SHEET, PINK SHEET DAILY AND PINK SHEET Maximize Your Reimbursement Potential The balance of power behind the prescribing decision is changing: payers are ever more in charge. 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See the payer perspective. cover 9 13 exclusive online content inside: COVER Trump, Congress And The Future Of Value-Based Sarepta’s Aftermath: FDA Staff Still Working Together, Drug Contracting Califf Says http://bit.ly/2fm3ARw US ELECTION 2016 US FDA commissioner and others say they have put disagreements 5 Trump’s Election Could Bring ‘Best Of Times’ For Pharma from controversial decision to approve Sarepta’s Duchenne muscular dystrophy drug behind them. 7 OTC Drug Industry Could Stand To Gain With ‘Pragmatist’ In White House Value-Based Reimbursement For Antibiotics Gets Skeptical Reception REGULATORY UPDATE http://bit.ly/2f9i9ue 9 Brexit Minister Says ‘No’ To UK Staying In EU Drug Duke Margolis Center floats idea of market entry payments tied Regulatory Framework to insurance contracts, but insurers and even some sponsors raise 10 Japan Slashes Opdivo Price 50% After Prescriptions Surge concerns, highlighted by question of what constitutes value. 11 Japan Delays Keytruda Pricing Amid PD-1 Cost Concerns Medicare Part B Drug Waste From Single-Dose 13 Eisai Predicts “Mayhem” For Kisplyx After NICE Finally Vials To Be Studied By OIG Okays Halaven http://bit.ly/2fBd2DH 14 Payers Want Access To US FDA’s Pre-Submission Meetings HHS watchdog suggests savings to Medicare Part B could be generated if manufacturers sold smaller-size vials at lower prices; LEGISLATION Office of Inspector General will also consider potential savings 15 PDUFA Acronym War Begins: Could Reauthorization from establishing inflation-based rebates in Part B. Be Called Patient-UFA? Diabetes Tsunami? China Eyes More Modern BIOSIMILARS Therapies Under 2025 Plan 17 Amgen Exec Backs WHO’s ‘Biological Qualifier’, Says First http://bit.ly/2g3lqdA Ones Could Be Issued By End Of 2017 Diabetes poses a triple whammy and is likely to cripple China’s health care system in near future. To counter, the Chinese CONSUMER PRODUCTS government looks at total disease management, long-acting 19 OTC Homeopathic Labels Must Include Scientific insulins and GLP-1 products. Disclaimers – FTC NOR-SWITCH Results ‘Concerning’ In Crohn’s Disease, Says Janssen MANUFACTURING QUALITY http://bit.ly/2g0Op17 21 Focus On Equipment And Software For Validating Continuous Manufacturing Processes – FDA Janssen Biotech says that the NOR-SWITCH study on switching from Remicade to biosimilar infliximab raises “significant REIMBURSEMENT questions” over safety and efficacy in patients with Crohn’s disease, and does not support interchangeability. 23 Drug Affordability Review By National Academies Kicks Off With Lower Profile Than Expected NEW PRODUCTS Don’t have an online user account? 25 FDA’s NDA And BLA Approvals: Selzentry, Bonjesta, You can easily create one by clicking on the Vemlidy, Intraros “Create your account” link at the top of the online page. Contact [email protected] or call: ADVISORY COMMITTEES 888-670-8900 or +1-908-547-2200 for additional information. 26 Recent And Upcoming FDA Advisory Committees pink.pharmamedtechbi.com November 21, 2016 | Pink Sheet | 3 US ELECTION 2016 CONTINUED FROM COVER manufacturers and health care providers. sicians, patients and other relevant stake- an advisor to President George H. W. Bush, The Part B demo could reduce payments holders in the development of new CMMI where he actively assisted the President’s for physician-administered drugs – such models.” Council on Competitiveness, helping craft as chemotherapy and drugs for inflamma- Even if the pace of payment experi- the president’s health care plan. tory conditions – in two phases. The first ments in Medicare “slows down” under the CMMI offers opportunities for a “softer” involves changes to the Part B payment new administration, drug manufacturers approach to managing drug costs than formula and the second, implementation will continue to face pressure to establish measures like drug importation, Samuels of value-based contracting. CMS has yet to the value of their products in the private suggested. “A lot depends on who will be issue a final rule on the payment demon- sector, Samuels emphasized. at CMS and HHS but in the final analysis, I stration and there is considerable uncer- “Outside the bubble of Washington, think, given the president-elect’s focus on tainty about its future. transparency and drug pricing reform and drug pricing or transparency, that some of For the biopharma industry, concerns questions of value are going to continue. the softer tools are: 1) a good solution; and with CMMI’s authority have been galva- Payers on the commercial side are going 2) something they may go forward with.” nized by the Part B demo and Republicans to continue to use utilization management Furthermore, the fact that the Propo- in Congress have also expressed alarm tools, pathways, guideline adherence and sition 61 ballot initiative failed to pass about the broad authority given to CMMI other things to bend the cost curve. … The in California “is a good talking point his by the ACA. age of volume purchasing is over.” internal team could give him as to why The Congressional Budget Office has -es The biopharma industry has publicly wholesale drug pricing changes are not timated CMMI would save the government supported the concept of outcomes- the way to go.” Prop 61 would have re- $34bn by 2026 through its work. The size based risk sharing contracts but progress quired state agencies to pay no more of the projection complicates prospects been very slow. Companies are also work- than the US Department of Veterans Af- for an outright repeal of the organization, ing on indication-based pricing and novel fairs pays for a drug. because Congress would have to find that approaches to pricing for combination The biopharma industry has not been savings elsewhere. That suggests restric- therapies, Samuels said. directly impacted so far by most of CMMI’s tions on the center’s activities might be a However, the industry has pointed to demonstration projects, such as account- preferable route. several regulatory obstacles standing in the able care organizations and bundling pay- way of broader adoption, including FDA ment models. CMMI AUTHORITY COULD BE restrictions on communications between CURTAILED manufacturers and payers, a lack of legal ONCOLOGY CARE MODEL Restrictions on CMMI’s authority could be “safe harbors” from anti-kickback rules and WIDELY SUPPORTED BY made in standalone legislation, Samuels concerns that prices negotiated under out- PROVIDERS, PAYERS noted.