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They do not have biosimilar or generic competition available in the market. Additionally, highly competitive classes, such as rapid-acting insulin and immunologics are included on the selected drug list. After this period, CMS will begin to include physician-administered drugs covered under Part B in the program.
These high prices are the result of multiple factors: theyre derived from living organisms making them sensitive and complex for both manufacturers and patients, research requires advanced technology to test for safety and effectiveness, and theyre in high demand without much competition. Starting in 2019, the US market was valued at $4.5
The dearth of cancer drugs (only blood cancer drug Imbruvica made this first list) stems from CMS only pursuing negotiations for Part D drugs in 2026 and 2027, then expanding to Part B drugs in 2028. exclusions exist for orphan drug designation and biosimilar competition ).
In our September 2023 report on the electrophysiology market, Clarivate projected that by 2028, PFA would represent 50% of the U.S. Increased appeal for dual-energy systems: Sometimes a situation calls for RF, but physicians like the ease and efficiency of PFA. ablation market and would have a total global market value of $3 billion.
In 2026, CMS will select up to 15 additional Part B or Part D drugs for negotiations that take effect in 2028, and up to 20 additional drugs every year thereafter (Part B covers physician-administered drugs, including infusions of complex biologics).
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