Using published evidence and compendia to support expanded coverage for an off-label medication dosage
Strategies and Insights Driving Impactful Payer Decisions:
Supporting Off-Label Coverage and Reimbursement
This case study outlines how Magnolia Market Access guided a pharmaceutical company in securing payer coverage for an off-label, higher-dose use of a drug with an FDA-approved maximum dose.
Key Insights Include:
- Challenge: Achieving payer support for an off-label dosage in an orphan disease setting with limited clinical data.
- Approach: Magnolia reviewed compendia listings to identify the optimal compendium for a favorable rating, prioritizing those accepting lower levels of evidence for rare diseases. They collaborated with the client to develop a robust data packet for submission.
- Outcome: A positive compendia listing enabled the client to secure coverage for the off-label dosage with federal programs and key commercial payers, ensuring patient access to the higher-dose therapy.
Highlights:
- Payer Considerations: Federal payers rely on Medicare-accepted compendia and may accommodate off-label uses supported by peer-reviewed evidence. Commercial payer acceptance varies, though positive compendia listings can influence decisions.
- Strategic Compendium Selection: Magnolia identified a compendium favorable to rare disease settings and data from phase 2 studies, increasing the chances of a positive evaluation.
- Comprehensive Submission: The collaborative approach ensured the submission packet demonstrated clinical tolerability and efficacy at higher doses, leading to successful outcomes.
Download the full case study to learn how Magnolia’s tailored strategies enable pharmaceutical companies to overcome challenges and secure impactful payer decisions.
