How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Draft guidance consultation

Closed for comments This consultation ended on at   Request commenting lead permission

1 Recommendations

1.1 Tirzepatide is not recommended, within its marketing authorisation, for treating type 2 diabetes alongside diet and exercise in adults when it is insufficiently controlled:

  • alone when metformin cannot be taken because of intolerance or contraindications, or

  • with other antidiabetic drugs.

1.2 This recommendation is not intended to affect treatment with tirzepatide that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Some people with type 2 diabetes have triple therapy with metformin and 2 other oral antidiabetic drugs. When this is not effective, not tolerated or contraindicated, they may switch one of the antidiabetic drugs for a glucagon‑like peptide‑1 (GLP‑1) receptor agonist (such as semaglutide), or start insulin therapy. For this evaluation, the company asked for tirzepatide to be considered only as an alternative to GLP‑1 receptor agonists. This does not include everyone who it is licensed for.

Clinical trial results suggest that tirzepatide reduces blood glucose levels (measured by HbA1c levels) and body weight compared with semaglutide, insulin therapy or placebo. There is only an indirect comparison of tirzepatide with other GLP‑1 receptor agonists, which suggests similar benefits. But the results are uncertain.

In addition to the uncertainties in the clinical evidence, there are issues with the company's economic model. These include that:

  • the external assessment group was unable to fully scrutinise it

  • it is unclear how accurately it predicts the long-term health outcomes with tirzepatide and GPL‑1 receptor agonists

  • there is no evidence showing how the model results compare with other economic models for diabetes.

So, the cost-effectiveness estimates are uncertain, and tirzepatide is not recommended for routine use in the NHS.