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.
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