Last week, CMS released guidance on IRA price negotiation, outlining the selection process for drugs. Here are some key points:
Eligibility for Negotiation:
- Small molecules must be FDA-approved for at least 7 years and have no generic equivalent.
- Biologic molecules must be FDA-approved for at least 11 years and have no biosimilar equivalent.
Combination medications prescribed together are considered as one treatment. Ranking top 15 in Part D spending makes drugs negotiation-eligible.
Exclusions and Exceptions:
Orphan drug designation, low-spend exceptions, plasma-derived products exclusion, and small biotech qualifications are detailed by CMS.
Biosimilar Delay Determination:
CMS outlines the criteria biosimilar manufacturers must meet to request a delay in market entry to ensure a high likelihood of market competition.
