Brilinta Value-Based Contract With UPMC Incorporates Two-Sided Risk
(1/31, Jessica Merrill, Pink Sheet) reports “...‘AstraZeneca pays significantly more rebate to UPMC if the drug doesn't work, as outlined by criteria within the contract. On the flip side, if the drug works better than expected we are expecting this time not to have to pay as much rebate to the health plan,’ AstraZeneca Senior VP-US Market Access Rick Suarez said in an interview. ‘This changes the conversation from being very one-sided.’” Paid Subscription Required
Framework for FDA's Real-World Evidence Program
(1/31, Beth Schurman, PharmExec) reports “...Pharma will have to consider the most efficient way to approach RWE generation for regulatory submission, given the case-by-case approach from the FDA. Additionally, companies will need to address the FDA's stated concern that real world results would be cherry picked for positive and beneficial data.” Full
Should Physicians Recommend Replacing Opioids With Cannabis?
(2/1, Keith Humphreys, PhD and Richard Saitz, MD, MPH, JAMA) comments “Recent state regulations (eg, in New York, Illinois) allow medical cannabis as a substitute for opioids for chronic pain and for addiction. Yet the evidence regarding safety, efficacy, and comparative effectiveness is at best equivocal for the former recommendation and strongly suggests the latter—substituting cannabis for opioid addiction treatments is potentially harmful. Neither recommendation meets the standards of rigor desirable for medical treatment decisions.” Full
Trump Targets Drug Middlemen With `Devastating' Rebate Plan
(1/31, Anna Edney and Robert Langreth, Bloomberg) reports “...The proposal, a long-awaited part of the administration's plan to target high list prices of drugs, would ban rebates paid by drugmakers to pharmacy benefit managers, or PBMs, in government programs like Medicare...The changes are ‘potentially devastating to the current pharma ecosystem,’ said Eric Coldwell, an analyst with Baird Equity Research. ‘The U.S. health-care system is a sandcastle and the tide is coming in.’” Full
New Center for Enhanced Value Assessment (CEVA) Established at Tufts Medical Center
(2/1, Center for the Evaluation of Value and Risk in Health Press Release) “Tufts Medical Center announced today that it will develop a new program this year aimed at better understanding cost-effectiveness and value in the delivery of health care. The new Center for Enhanced Value Assessment, funded by a three year, $500,000 grant from the PhRMA Foundation, will be led by principal investigator Peter J. Neumann, ScD, Director of the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, and will be headquartered within CEVR.” Full
NICE Recommends Another Revolutionary CAR T-Cell Therapy for Adults with Lymphoma
(2/1, NICE Press Release) “Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will be able to access another revolutionary chimeric antigen receptor T-Cell (CAR T-cell) therapy through the Cancer Drugs Fund. Tisagenlecleucel, also known as Kymriah and made by Novartis, is recommended for adults with relapsed or refractory DLBCL. It will be offered to people whose disease has not responded or those whose disease has relapsed after treatment with two or more courses of chemotherapy.” Full
Extended-Release Naltrexone Versus Standard Oral Naltrexone Versus Placebo for Opioid Use Disorder: The NEAT Three-Arm RCT
Strang J, et al.
January 2019, Health Technology Assessment