Appraisal consultation document
Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia
The Department of Health has asked the National Institute for Health and Care Excellence (NICE) to produce guidance on using evolocumab 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, and 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 draft recommendations made by the Committee. NICE invites comments from the consultees and commentators for this appraisal (see section 10) and the public. This document should be read along with the evidence base (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 provisional 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 determination (FAD).
• Subject to any appeal by consultees, the FAD may be used as the basis for NICE’s guidance on using evolocumab in the NHS in England.
For further details, see the Guide to the processes of technology appraisal.
The key dates for this appraisal are:
Closing date for comments: 08 December 2015
Second Appraisal Committee meeting: 13 January 2016
Details of membership of the Appraisal Committee are given in section 9, and a list of the sources of evidence used in the preparation of this document is given in section 10.
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