A Health Affairs Forefront article, “Blockbusters and Loopholes: Expanding Exemptions in Medicare Drug Price Negotiations,” examines how certain high-cost “blockbuster” drugs may avoid Medicare’s Drug Price Negotiation Program (DPNP) as a result of a small provision in the One Big Beautiful Bill Act (OBBBA), signed into law July 2025 by the Trump administration. The provision broadens the definition of “orphan drugs” under the DPNP, ultimately excluding them from negotiation or delaying their eligibility. The article illustrates which drugs impacted by OBBBA would have otherwise been eligible for selection in 2026 and 2027 under the DPNP.
“This research demonstrates that the provisions in the OBBBA impact the eligibility of several blockbuster drugs, such as Keytruda and Darzalex, leading to rippling effects in how much Medicare will save from the Medicare Drug Price Negotiation Program and ultimately patient access.” -Emma Cousin, PharmD, 4th Year PhD Candidate and Co-Author
This work was authored by Professor Sean D. Sullivan, BScPharm, PhD and CHOICE PhD Candidate Emma M. Cousin, PharmD, in collaboration with Kristi Martin, MA, MPA.
Read the article in Health Affairs Forefront: https://www.healthaffairs.org/content/forefront/blockbusters-and-loopholes-expanding-exemptions-medicare-drug-price-negotiations.