Reason for request
Reevaluation
Key points
Unfavourable opinion for reimbursement in the MA indications; i.e.:
- prevention of acute bone loss associated with sudden immobilisation, particularly for subjects with recent osteoporotic fractures;
- treatment of Paget’s disease, only in patients for whom alternative treatments have been ineffective or cannot be used, for example patients with severe kidney disease and
- the treatment of malignant hypercalcaemia.
The clinical benefit is now insufficient (previously it was low) in the indications: Paget’s disease and malignant hypercalcaemia.
The clinical benefit remains insufficient in the indication: prevention of bone loss.
What therapeutic improvement?
Not applicable.
Role in the care pathway?
The proprietary medicinal product MIACALCIC (salmon calcitonin) no longer has a role in the care pathway in view of the available alternatives.
Clinical Benefit
Insufficient |
The clinical benefit of MIACALCIC (salmon calcitonin) is insufficient to justify its public funding cover in view of the alternatives available in the MA indication and dosages. |
Clinical Added Value
Not applicable |
Documents
English version
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Évaluation des médicaments