Reason for request

Modification of the listing conditions

Summary of opinion

Favourable opinion for reimbursement only for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as dual therapy with metformin,
  • as triple therapy with metformin and a sulphonylurea,
  • as triple therapy with metformin and basal insulin.

No clinical added value of the new forms compared to the forms already available.


Clinical Benefit

Moderate

The clinical benefit of OZEMPIC (semaglutide) is moderate only “for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as dual therapy with metformin,
  • as triple therapy with metformin and a sulphonylurea,
  • as triple therapy with metformin and basal insulin”.
Insufficient

The clinical benefit of OZEMPIC (semaglutide) is moderate only “for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise insufficient to justify public funding in the other MA situations.


Clinical Added Value

no clinical added value

These medicinal products are range supplements that provide no clinical added value (CAV V) compared to the forms already listed.


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