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  • 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?
  • Question on Consultation

    There is a requirement for relevant health bodies to comply with the recommendations in this evaluation within 3 months of the date final guidance is published by NICE (see section 4.1). We are aware there may be system challenges that mean an extension to this normal period may be appropriate because tirzepatide cannot be appropriately administered until:
    • training is in place
    • certain health service infrastructure requirements including goods, materials or other facilities are in place
    • other appropriate health services resources, including staff, are in place. These challenges may include:
    • commissioning arrangements for weight management services
    • how tirzepatide will fit into the current treatment pathway for weight management
    • the provision of counselling, psychological support and concomitant behavioural, dietary and physical activity advice
    • titration of tirzepatide and how a stopping rule based on treatment response at 6 months would be implemented
    • capacity in the system.
  • Question on Consultation

    Please specify any potential challenges with implementing these recommendations and the associated reasons.
  • Question on Consultation

    Please also provide any ways to overcome these potential challenges, any estimate of the time period within which the recommendation can be complied with, and any approaches to phase in funding to manage access to tirzepatide during any potential extended funding variation period.
The content on this page is not current guidance and is only for the purposes of the consultation process.

Draft Guidance Document.docx

The Department of Health and Social Care has asked the National Institute for Health and Care Excellence (NICE) to produce guidance on using tirzepatide in the NHS in England. The evaluation committee has considered the evidence submitted by the company and the views of non-company stakeholders, clinical experts and patient experts.

This document has been prepared for consultation with the stakeholders. It summarises the evidence and views that have been considered, and sets out the recommendations made by the committee. NICE invites comments from the stakeholders for this evaluation and the public. This document should be read along with the evidence (see the committee papers).

The evaluation committee is interested in receiving comments on the following:

  • Has all of the relevant evidence been taken into account?

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

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

  • 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?

  • There is a requirement for relevant health bodies to comply with the recommendations in this evaluation within 3 months of the date final guidance is published by NICE (see section 4.1). We are aware there may be system challenges that mean an extension to this normal period may be appropriate because tirzepatide cannot be appropriately administered until:

    • training is in place

    • certain health service infrastructure requirements including goods, materials or other facilities are in place

    • other appropriate health services resources, including staff, are in place.

These challenges may include:

  • commissioning arrangements for weight management services

  • how tirzepatide will fit into the current treatment pathway for weight management

  • the provision of counselling, psychological support and concomitant behavioural, dietary and physical activity advice

  • titration of tirzepatide and how a stopping rule based on treatment response at 6 months would be implemented

  • capacity in the system.

  • Please specify any potential challenges with implementing these recommendations and the associated reasons.

  • Please also provide any ways to overcome these potential challenges, any estimate of the time period within which the recommendation can be complied with, and any approaches to phase in funding to manage access to tirzepatide during any potential extended funding variation period.

Note that this document is not NICE's final guidance on this technology. The recommendations in section 1 may change after consultation.

After consultation:

  • The evaluation committee will meet again to consider the evidence, this evaluation consultation document and comments from the stakeholders.

  • At that meeting, the committee will also consider comments made by people who are not stakeholders.

  • After considering these comments, the committee will prepare the final draft guidance.

  • Subject to any appeal by stakeholders, the final draft guidance may be used as the basis for NICE's guidance on using tirzepatide in the NHS in England.

For further details, see NICE's manual on health technology evaluation.

The key dates for this evaluation are:

  • Closing date for comments: 25 June 2024

  • Third evaluation committee meeting: 13 August 2024

  • Details of membership of the evaluation committee are given in section 5