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Opinions on drugs - Posted on Sep 21 2011

Reason for request

Renewal of inclusion on the list of medicines refundable by National Health Insurance.


Clinical Benefit


In view of its concerns related to the risk of onset of DRESS and venous thromboembolism, the Transparency Committee considers that the actual benefit of PROTELOS is moderate in a population restricted to :
- patients with a contraindication to or adverse effects with bisphosphonates,
- patients with no risk factors for venous thromboembolism, including a history of venous thromboembolism, aged over 80 years, prolonged immobilisation, etc

Clinical Added Value

no clinical added value

Like the bisphosphonates (alendronate, risedronate, zoledronate), PROTELOS has demonstrated its efficacy in preventing vertebral and nonvertebral fractures, including femoral neck fractures. However, the tolerance data show a risk of venous thromboembolism and a risk of serious hypersensitivity syndrome (DRESS), the onset of which is unpredictable. In view of these factors and in view of the alternative forms of treatment available, it seems inappropriate to maintain an improvement in actual benefit for this medicine. Consequently, the Transparency Committee considers that PROTELOS does not provide any improvement in actual benefit (V) to the treatment strategy for postmenopausal osteoporosis.

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