Recently approved delays and exemptions to the CMS drug price negotiation program are projected to cost $8.8 billion over 10 years, according to a Congressional Budget Office report published Oct. 20.
CMS expanded orphan drug exclusions to its drug price negotiation program Sept. 30, allowing more medications to avoid negotiations. The agency said the exemption will incentivize drugmakers to develop treatments for rare conditions. CBO initially estimated this move would cost Medicare $4.9 billion through 2034.
In an updated analysis, CBO predicts an $8.8 billion expense, due to the broader orphan drug exclusion.
The original CBO estimate did not include several medications that are now exempt from future negotiation cycles beginning in 2028, including Darzalex, a multiple myeloma treatment; Keytruda, an immunotherapy approved to treat 13 cancers; and Opdivo, a non-small cell lung cancer drug.
The CBO report does not account for all changes implemented Sept. 30, including CMS’ plan to calculate Medicare Advantage spending of Part B drug expenditures to rank drugs for negotiation.
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