The Department of Health and Social Care has asked the National Institute for Health and Care Excellence (NICE) to produce guidance on using metreleptin in the context of national commissioning by the NHS in England.  The highly specialised technologies evaluation 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 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 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 evaluation committee will meet again to consider the evidence, this evaluation 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 evaluation determination.
  • Subject to any appeal by consultees, the final evaluation determination may be used as the basis for NICE’s guidance on using metreleptin in the NHS in England.

For further details, see NICE’s guide to the processes of technology evaluation.

The key dates for this evaluation are:

Closing date for comments: 13 August 2018

Second evaluation committee meeting: 24 October 2018

Details of membership of the evaluation committee are given in section 6.

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