Suggested remit - To appraise the clinical and cost effectiveness of galcanezumab within its marketing authorisation for preventing migraine.
 
Status In progress
Process STA 2018
ID number 1372

Provisional Schedule

Expected publication 14 October 2020

Project Team

Project lead Gemma Barnacle

Email enquiries

Evidence Review Group / Assessment Group Centre for Reviews and Dissemination and Centre for Health Economics, University of York

Consultees

Companies sponsors Eli Lilly (galcanezumab)
Others Department of Health and Social Care
  NHS Central Manchester CCG
  NHS England
  NHS Wakefield CCG
  Welsh Government
Patient carer groups Action on Pain
  Brain and Spine Foundation
  Migraine Trust
  Muslim Council of Britain
  National Migraine Centre
  Neurological Alliance
  OUCH UK
  Pain Concern
  Pain Relief Foundation
  Pain UK
  South Asian Health Foundation
  Specialised Healthcare Alliance
  The Brain Charity
Professional groups Association of British Neurologists
  British Association for the Study of Headache
  British Geriatrics Society
  British Neuropathological Society
  British Pain Society
  Institute of Neurology
  Migraine in Primary Care Advisors
  Neuromodulation Society of UK and Ireland
  Physiotherapy Pain Association
  Primary Care and Community Neurology Society
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  UK Clinical Pharmacy Association

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord (amitriptyline, propranolol, topiramate)
  Allergan (botulinum toxin type A)
  Aurobindo Pharma-Milpharm (topiramate)
  Brown & Burk UK (amitriptyline)
  Glenmark Pharmaceuticals (topiramate)
  Janssen-Cilag (topiramate)
  Novartis (erenumab)
  Rosemont Pharmaceuticals (amitriptyline, propranolol, topiramate)
  Sandoz (propranolol)
  Teva (fremanezumab)
  Thame Laboratories (amitriptyline, propranolol)
  Wockhardt (amitriptyline)
General commentators All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  Neurological Alliance of Scotland
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Wales Neurological Alliance
  Welsh Health Specialised Services Committee
Relevant research groups Brain Research Trust
  British Neurological Research Trust
  Cochrane Pain, Palliative Care and Supportive Care Group
  Genomics England
  MRC Clinical Trials Unit
  National Hospital for Neurology and Neurosurgery
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
22 November 2019 Invitation to participate
22 November 2019 In progress, Referred 2 August 2019.
10 September 2019 The Department for Health and Social Care has asked us to carry out a Single Technology Appraisal of galcanezumab for preventing migraine. The appraisal is expected to start in approximately late November 2019 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early February 2020. These timings are based on a request from the company to reschedule the initial date set by NICE until after the anticipated marketing authorisation has been received, in order to facilitate a suitably comprehensive and robust evidence submission.
28 January 2019 - 25 February 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance