A topic near and dear to our hearts. Success for biopharmas will increasingly depend on a deep understanding of pricing strategy and market access and an ability to clearly and simply communicate product value. Elevating this issue to the C-suite - and the board - is a must.
read full article ›FDA has given Sarepta's Elevidys the green light in a broader patient population, expanding the original conditional approval to a full approval in ambulatory patients. This expansion is likely to cause sturm and drang with payers. Remember that Elevidys' clinical trial results have been decidedly mixed and that the drug is one of the most expensive on the market.
read full article ›Today's NYT piece on PBMs has us thinking about whether PBMs are now "too big to unwind" given the vertical integration of healthcare since 2018. Despite multiple investigations by FTC, PBM reform on the Hill has stalled. And, the evidence from groups tracking employer trends (think PSG or the Business Group on Health) suggests that most employers are happy enough with the status quo that they are not willing to make a change.
read full article ›The pace of scientific innovation continues to accelerate. According to the Pink Sheet’s US FDA Performance Tracker, June is set to be one of the busiest yet for approvals, with potential nods for nine novel agents and 13 potential new indications. Potential new approvals in oncology, gene therapy, and COPD are just some of the areas we are watching closely.
read full article ›In an op-ed published in BioCentury Inc. May 14, Gigi Hirsch of NEWDIGS Initiative at Tufts Medical Center and Jane F. Barlow, MD, MPH, MBA of Real Endpoints make the case that the only way to have our cake (medical innovation) and to be able to eat it (afford the innovation) is to increase health efficiency – that is, capturing the full value of medical products.
read full article ›IQVIA's annual report on US drug usage and spending trends dropped this week and boy, is it a doozy. Not surprisingly, obesity drugs figure prominently, thanks to growth in the use of GLP-1s. (And, this is before new data on the broader health value of the class emerged.) Also to be expected, growth in list prices outpaced net prices, as manufacturers paid more to ensure drugs – especially in competitive classes like immunology – made it onto payers’ formularies.
read full article ›Important milestone for sickle cell gene therapies, patients, and the two manufacturers (bluebird bio and Vertex Pharmaceuticals) developing these innovative therapies.
read full article ›https://www.linkedin.com/posts/real-endpoints_from-price-controls-to-robust-public-conversation-activity-7192243813153701890-NdPi?utm_source=share&utm_medium=member_desktop
read full article ›In case you missed it, a team from Institute for Clinical and Economic Review (ICER), Program on Regulation, Therapeutics, and Law (PORTAL), and Tufts University's Center for the Evaluation of Value and Risk in Health has an important point of view in Health Affairs on how to create an hashtag#IRA price negotiation process that is credible, transparent, and inclusive of relevant stakeholders.
read full article ›