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  • Question on Document

    Has all of the relevant evidence been taken into account?

  • Question on Document

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

  • Question on Document

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

  • Question on Document

    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 race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Draft guidance consultation

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ID3941 Maralixibat Cholestatic pruritus Alagille DG v1.0 to PM for release (noCON).docx

The Department of Health and Social Care has asked the National Institute for Health and Care Excellence (NICE) to produce guidance on using maralixibat 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?

Note that this document is not NICE's final guidance on maralixibat. 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 maralixibat 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: 21 August 2024

  • Second evaluation committee meeting: TBC

  • Details of the evaluation committee are given in section 4