A Prior Auth Truce? Novartis Willing to Embrace ICER-Like Price Determinations For Increased Access
Novartis gets some praise for being willing to embrace cost-effective drug prices, but health policy analysts are skeptical the industry would truly adopt the idea for its best-selling drugs, particularly if the appropriate guardrails were put in place to ensure broader budget impact was controlled. Holes were also poked in the way Novartis determined the total cost of drug utilization management on the US health system.
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The move follows a similar price cut for Amgen's competing PCSK9 inhibitor Repatha and comes as PBMs, including UnitedHealth Group's OptumRx, are looking for ways to maintain the drug rebate status quo.
Pfizer Comes Close To Meeting FDA’s Guidance Standard For COVID Booster Dose, But It May Not Be Enough
Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear Pfizer has made the case to FDA that a booster dose is need at this time or that they provided enough safety data.
With potentially less flexibility and a simpler calculation on the benefit-risk of approving COVID vaccine boosters, FDA could punt the more challenging questions like whether boosters are needed now and for which populations, along with global equity and public health considerations to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices.