No Big Blockbuster Bailouts Act

This bill changes how certain drugs for rare diseases are treated under the Medicare Drug Price Negotiation Program. It modifies the definition of an 'orphan drug' that is excluded from negotiation, and raises the spending threshold for such drugs to be considered for negotiation.

Sec. 2, Treatment of orphan drugs under the Medicare Drug Price Negotiation Program: The bill amends the Social Security Act to remove the current exclusion for orphan drugs that have at least one approved indication for a rare disease. Instead, it creates a new rule: a drug designated for one or more rare diseases, where the only approved indications are for those rare diseases, will be treated as an orphan drug only if its spending exceeds $400,000,000 (instead of the current $200,000,000) in the relevant year. This change applies to initial price applicability years starting on or after January 1, 2028.