Orphan Drugs Exclusion

Manufacturer List: Orphan Drug Availability Update

In July 2014, HRSA issued an interpretive rule pertaining to the statutory requirement for inclusion of drugs with orphan drug designations in the 340B drug pricing program. The interpretive rule outlines the agency’s interpretation that the 340B statute requires manufacturers to offer entities newly eligible for 340B under the Affordable Care Act 340B pricing on drugs that have received an orphan designation when those drugs are used for their non-orphan indication. After receiving multiple reports that certain manufacturers are not complying with statutory requirements, HRSA communicated with manufacturers regarding their compliance with the statute.

Based on information gathered through that inquiry, HRSA is making available a list of manufacturers that are not offering 340B pricing for their designated orphan drug products (when used for their non-orphan indications) to newly eligible covered entities. As 340B discounts are not being provided on these drugs, there is no risk of 340B duplicate discounts. Therefore, States may utilize this information to obtain Medicaid rebates for such drugs.

• AuroMedics Pharma LLC
• Bayer AG
• Eisai Co., Ltd.
• Eli Lilly and Company
• Genentech Inc.
• Ipsen
• Novartis International AG
• Pfizer, Inc.
• Roche.
• Virtus Pharmaceuticals, LLC

Program Integrity

340B Drug Pricing Program covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.

Covered entities are subject to audit by manufacturers or the federal government. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts obtained.

Learn more: Program Integrity