#SFHS2612143AFrance Adds ELREXFIO to the List of Medicines Approved for Public Healthcare Use
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This order adds two presentations of ELREXFIO, a Pfizer injectable medicine containing elranatamab, to the list of medicines approved for use by public healthcare institutions and other public services in France. Health insurance coverage is limited to one specific use: adult patients with relapsed and refractory multiple myeloma who have already received at least three prior treatments, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and whose disease progressed during the last treatment. Hospitals and public healthcare buyers can now use the listed presentations under those reimbursement conditions.
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Key Changes
- Adds two ELREXFIO injectable presentations to the approved public-use medicines list
- Limits health insurance coverage to a specific adult relapsed and refractory multiple myeloma indication
- Identifies the covered Pfizer presentations by CIP codes and dosage volumes
Obligations
What this law requires
Public healthcare institutions and other public services may procure and use the listed ELREXFIO presentations only as medicines approved on the collectivités/public services list, as modified by the annex to this order.
Health insurance reimbursement for the listed ELREXFIO presentations is limited to monotherapy treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior treatments including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and whose disease progressed during the last treatment.
The approved listed presentations are ELREXFIO 40 mg/mL solution injectable 1.1 mL single-dose vial containing 44 mg elranatamab, CIP 34009 550 983 0 0, and ELREXFIO 40 mg/mL solution injectable 1.9 mL single-dose vial containing 76 mg elranatamab, CIP 34009 550 983 1 7.