Lexology September 12, 2023
The Inflation Reduction Act (IRA), signed into law on August 16, 2022, allows the federal government to negotiate prices for some high-cost drugs covered under Medicare. Under the law, many small molecule and biologic drugs that do not have approved and marketed generics or biosimilars, and that are among the 50 highest-spend Medicare covered drugs for each of Part B and D, can be eligible for negotiated prices nine years (small molecule) or 13 years (biologic) after FDA approval.[1]
There are some categories of drugs that are ineligible for negotiation, such as drugs with Medicare spending under $200 million/year, drugs with one orphan indication and no other indications, plasma-derived drugs, and some small biotech drugs (until 2029). If a biosimilar...
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