CER Daily Newsfeed

Managed Care Reflections: A Q&A With John Michael O'Brien, PharmD, MPH

(5/5, John Michael O'Brien, PharmD, MPH, Christina Mattina, The American Journal of Managed Care) reports “...[John Michael O'Brien, PharmD, MPH:] We can’t pay for today’s treatments and tomorrow’s cures with the same reimbursement system that we used to pay for blood pressure medicines and cholesterol drugs decades ago. We need as much innovation in managed care reimbursement as we have in scientific innovation in the pharmaceutical labs. So here at NPC, we want to have an honest, evidence-driven conversation that helps decision makers, wherever they are, understand the value of scientific advancement, so that everyone understands how private-sector or government policies affect patient access to today’s treatments and tomorrow’s cures.” Full

Rare Disease Industry Awaits FDA Chief’s New Drug Pathway Plan

(5/6, Nyah Phengsitthy, Bloomberg Law) reports “...Makary outlined on the Megyn Kelly Show in April a plan to approve drugs for rare conditions based on a ‘plausible mechanism,’ allowing medicines to be approved without data from a randomized controlled clinical trial. A drug could be eligible for the pathway if it ‘makes sense physiologically,’ and ‘the mechanism is scientifically plausible,’ he said...The proposed pathway is likely to increase rare disease drugs on the market, but attorneys are eyeing how medicines will ultimately reach patients.” Full

Prior Authorization Bills Flounder Despite Bipartisan Support

(5/6, Michael McAuliff, Modern Healthcare) reports “...Sources familiar with the issue, who spoke on background to discuss ongoing talks, said congressional leaders are looking at moving legislation. There has been some talk of attaching it to the tax-and-spending cuts bill the GOP is assembling, they said. More likely, they said, prior authorizations will have to wait until that contentious process concludes, which House Speaker Mike Johnson (R-La.) wants to happen this month.” Subscription Required

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

(5/6, Francesca Bruce, Pink Sheet) reports “...Further EU cooperation on health technology appraisals could lead to joint reimbursement recommendations for very rare disease treatments and a more pragmatic approach to the joint clinical assessment (JCA). This was the conclusion of speakers at the Alliance For Regenerative Medicine’s Cell & Gene Meeting.” Subscription Required