And just like that ...one day after it released its excoriating report, the FTC apparently plans to file a lawsuit against the 3 big PBMs for their rebate practices linked to insulin and other medicines according to The Wall Street Journal.
read full article ›The title of the FTC’s interim report on PBM practices, “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies,” says it all: these organizations are once again on the hot seat.
read full article ›On the last news day before the 4th of July holiday break in the US, Lilly's donanemab (brand name Kisunla) gets a positive nod from FDA. Pricing for one year of therapy is estimated to be $32K, but patients can stop therapy early if imaging shows significant removal of amyloid plaques.
read full article ›There’s no question that compliance is crucial when considering additional financial assistance for patients. Any doubts, look no further than the recent notice from Teva regarding its ongoing US Department of Justice lawsuit, which alleges that the pharma company directed patients to specific charitable foundations that helped cover Medicare patients’ out-of-pocket drug costs to drive prescriptions of Copaxone, its multiple sclerosis drug.
read full article ›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 ›