![]() The focus seems to be on comparative effectiveness, manufacturer ROI, and potentially international price comparisons. CMS has a lot of flexibility in its approach, as the law only excludes the use of metrics that result in a different valuation for elderly versus younger populations. There is no lower limit, the process is confidential, and the penalties for not accepting CMS demands appear to be excessive. So far, it is known that the upper limit of MFP is the lower of the current negotiated price (Part D) or average sales price (ASP, Part B), and a percentage of the average manufacturer price (AMP), which ranges from 75% for small molecules between nine and 12 years after FDA approval, to 40% for all drugs beyond 16 years of approval. The main questions are how the negotiated price will be set by CMS, and how it will impact pricing and formulary access of competitor drugs.ĬMS will set a maximum fair price (MFP) for each drug molecule that is on the negotiation list. The penalties for not negotiating are also clear and extravagant. The process for identification of the “negotiated” Medicare Part D and later Part B drugs is clear. I will discuss some high-level implications. ![]() Sullivan, PhD’s overview, alongside some ZS commentary (via Howard Deutsch et al). For an update on IRA and a discussion on the elements, I am referring to Sean D. ![]() The March 15 Centers for Medicare & Medicaid Services (CMS) guidance document provided some clarity, but many questions remain. However, this edition of Value and Access will focus on the evolving Inflation Reduction Act (IRA) implementation in the US. The debate continues regarding the European Commission’s plans to shorten effective patent lives by two years unless a drug is launched in all 27 EU countries within two years of European Medicines Agency (EMA) approval. In the US and Europe, there is quite a bit of movement on the market access front. ![]()
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