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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 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The content on this page is not current guidance and is only for the purposes of the consultation process.

Pitolisant hydrochloride for treating excessive daytime sleepiness caused by obstructive sleep apnoea

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ID 1065 pitolisant hydrochloride for EDS ACD to PM for consultation [noACIC].docx

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

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

The appraisal 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 race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?

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 appraisal committee will meet again to consider the evidence, this appraisal consultation document and comments from the consultees.

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

  • After considering these comments, the committee will prepare the final appraisal document.

  • Subject to any appeal by consultees, the final appraisal document may be used as the basis for NICE's guidance on using pitolisant hydrochloride in the NHS in England.

For further details, see NICE's guide to the processes of technology appraisal.

The key dates for this appraisal are:

Closing date for comments: 24 June 2021.

Second appraisal committee meeting: To be confirmed.

Details of membership of the appraisal committee are given in section 5.