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PROTELOS (strontium ranelate), anti-osteoporosis agent
RHEUMATOLOGY - Clarification
Opinions on drugs -
Posted on
Jan 22 2015
Reason for request
Re-assessment of the actual benefit at the request of the DGS [Directorate-General for Health], in accordance with article R 163-19 of the French Social Security Code.
The Committee does not recommend reimbursement due to the insufficient clinical benefit in severe osteoporosis.
- PROTELOS now has Marketing Authorisation only in patients at high risk of fracture, for whom treatment with other medicinal products approved for osteoporosis is not possible due to, for example, contraindications or intolerance.
- Recent new data has shown an increase in the arterial cardiovascular risk. This new risk is in addition to the known life-threatening venous thromboembolic risks and serious hypersensitivity syndromes (Drug Rash with Eosinophilia and Systemic Symptoms or DRESS).
- Some doubt remains concerning its efficacy in the rare patients that might use it.
Clinical Benefit
| Insufficient |
The actual benefit of PROTELOS in the new indication of the Marketing Authorisation is insufficient to justify reimbursement by National Health Insurance. |
