#SFHS2612595AFrance Adds ZADENVI to the Reimbursable Medicines List for Specific Osteoporosis Treatment
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ZADENVI 60 mg, a denosumab injectable medicine, becomes reimbursable by French health insurance for a narrow osteoporosis use: post-menopausal women at high fracture risk, only as a second-line treatment after bisphosphonates. Coverage is limited to patients meeting specific fracture-risk criteria. The first prescription must come from a specialist involved in osteoporosis care, such as a rheumatologist, gynecologist, geriatrician, or internist.
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Key Changes
- Adds ZADENVI 60 mg denosumab injectable solution to the list of medicines reimbursed by French health insurance
- Limits reimbursement to post-menopausal osteoporosis patients at high fracture risk after bisphosphonate treatment
- Requires the initial prescription to be issued by a specialist involved in osteoporosis care
Obligations
What this law requires
Reimbursement of ZADENVI 60 mg must be limited to treatment of post-menopausal osteoporosis in women at high risk of fracture, and only as second-line therapy following bisphosphonate treatment.
Patients may be treated as high fracture risk for reimbursement only if they have had a fragility fracture, or if they meet the specified bone-density and additional-risk-factor criteria.
In the absence of a fragility fracture, reimbursement eligibility must be limited to women with T-score below -3, or T-score at or below -2.5 combined with other fracture risk factors such as age over 60, systemic corticosteroid therapy of at least 7.5 mg/day prednisone equivalent, BMI below 19 kg/m2, first-degree maternal history of femoral neck fracture, or menopause before age 40.
The initial prescription for reimbursable ZADENVI 60 mg must be made by a specialist involved in osteoporosis care, such as a rheumatologist, gynecologist, geriatrician, or internist.