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

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Évaluation des médicaments