#SFHS2609499AFrance Adds Apixaban Biogaran Medicines to the Reimbursable Drug List
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The order adds several Apixaban Biogaran 2.5 mg film-coated tablet presentations to France’s list of medicines reimbursed by social health insurance. Reimbursement is limited to specific approved uses, including stroke and systemic embolism prevention in certain adults with non-valvular atrial fibrillation, prevention of venous thromboembolism after planned hip or knee replacement surgery, and treatment or prevention of recurrence of deep vein thrombosis and pulmonary embolism. It also covers treatment and recurrence prevention of venous thromboembolic events in pediatric patients from 28 days to under 18 years, with extra conditions for children under 12: the first prescription must be issued in a hospital and supported by specific therapeutic education from a multidisciplinary team. Pharmacies, prescribers, hospitals, insurers, and patients should check that reimbursement claims match the listed indications and conditions.
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Key Changes
- Adds Apixaban Biogaran 2.5 mg tablet presentations to France’s reimbursable medicines list
- Limits reimbursement to specified cardiovascular and thromboembolic indications
- Sets hospital initial prescription and therapeutic education requirements for pediatric patients under 12
Obligations
What this law requires
Social health insurance reimbursement for APIXABAN BIOGARAN 2.5 mg film-coated tablets must be limited to the therapeutic indications expressly listed in the annex, including eligible adult and pediatric thromboembolic indications.
For adult patients with non-valvular atrial fibrillation, reimbursement is allowed only for prevention of stroke and systemic embolism where the patient has at least one listed risk factor, such as prior stroke or transient ischemic attack, age 75 or over, hypertension, diabetes, or symptomatic heart failure NYHA class II or higher.
Reimbursement for primary prevention of venous thromboembolic events is limited to adult patients who have undergone planned total hip or knee replacement surgery.
Reimbursement for treatment of deep vein thrombosis or pulmonary embolism, and prevention of recurrence of deep vein thrombosis or pulmonary embolism, is limited to adult patients.
Reimbursement for treatment of venous thromboembolic events and prevention of recurrence in pediatric patients is limited to patients aged from 28 days to under 18 years.