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”
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
Moderate
The Committee deems that the clinical benefit of MOUNJARO 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg (tirzepatide) is:
moderate only in the indication “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 Committee deems that the clinical benefit of MOUNJARO 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg (tirzepatide) is insufficient to justify public funding cover in view of the available alternatives in the other MA situations.
Clinical Added Value
no clinical added value
Considering,
the demonstrated efficacy of tirzepatide versus active comparators (semaglutide, insulin glargine, insulin degludec, insulin lispro) on an intermediate biological endpoint of HbA1c variation and on a ranked secondary endpoint of weight loss, only in combination with metformin, with metformin and a sulphonylurea, with metformin and basal insulin,
the absence of evidence of a benefit of tirzepatide on clinically relevant morbidity and mortality endpoints, in particular cardiovascular (reduction of the 3P-MACE composite endpoint including cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) or renal endpoints,
the safety profile of tirzepatide, which appears to be favourable with limited follow-up in clinical trials, characterised by gastrointestinal events, like GLP-1 analogues,
but uncertainties regarding the long-term safety of tirzepatide, particularly related to its GIP receptor agonist component,
the Committee deems thatMOUNJARO (tirzepatide) provides no clinical added value (CAV V) in the current care pathway, which includes GLP-1 analogues, in adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, only as dual therapy in combination with metformin, as triple therapy with metformin and a sulphonylurea, and as triple therapy with metformin and basal insulin.
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