#SFHS2613379AEribuline Hikma Added to France’s Public-Sector Approved Medicines List
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This order adds Eribuline Hikma 0.44 mg/mL injectable solution to the list of medicines approved for use by public healthcare institutions and other public services in France. Health insurance coverage is limited to specific uses: later-line monotherapy for locally advanced or metastatic breast cancer after at least two chemotherapy regimens, and treatment of adults with unresectable liposarcoma after prior anthracycline-based chemotherapy, unless that treatment could not be given. Hospitals, public healthcare buyers, prescribers, and reimbursement teams should apply these indication limits when using or billing the product.
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Key Changes
- Adds Eribuline Hikma 0.44 mg/mL injectable solution to the approved medicines list for public institutions and services.
- Limits health insurance coverage to specified advanced breast cancer and unresectable liposarcoma indications.
- Identifies the covered product presentation and CIP code for procurement and reimbursement purposes.
Obligations
What this law requires
Use ERIBULINE HIKMA 0.44 mg/mL injectable solution only within the approved public-sector medicine listing for collective/public service use, as added to the list of pharmaceutical specialties approved for use by public healthcare institutions and other public services.
Apply health insurance reimbursement only for ERIBULINE HIKMA 0.44 mg/mL when used as third-line or later monotherapy for patients with locally advanced or metastatic breast cancer whose disease progressed after at least two chemotherapy regimens for advanced-stage disease.
For breast cancer reimbursement, verify that prior treatment included both an anthracycline and a taxane, unless the patient could not receive those treatments.
Apply health insurance reimbursement only for ERIBULINE HIKMA 0.44 mg/mL when used to treat adult patients with unresectable liposarcoma who previously received an anthracycline-containing chemotherapy regimen for advanced or metastatic disease, unless the patient could not receive anthracycline treatment.