Suggested remit - To appraise the clinical and cost effectiveness of galcanezumab within its marketing authorisation for preventing migraine.
Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
 
Status Schedule affected by COVID-19
Process STA 2018
ID number 1372

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 England
  Welsh Government
Patient carer groups Migraine Trust
  National Migraine Centre
Professional groups Association of British Neurologists
  British Association for the Study of Headache
  Royal College of Physicians
  UK Clinical Pharmacy Association

Commentators

Comparator companies Accord (amitriptyline, propranolol, topiramate) (confidentiality agreement not signed, not participating)
  Allergan (botulinum toxin type A)
  Aurobindo Pharma-Milpharm (topiramate) (confidentiality agreement not signed, not participating)
  Brown & Burk UK (amitriptyline) (confidentiality agreement not signed, not participating)
  Glenmark Pharmaceuticals (topiramate) (confidentiality agreement not signed, not participating)
  Janssen-Cilag (topiramate)
  Novartis (erenumab)
  Rosemont Pharmaceuticals (amitriptyline, propranolol, topiramate) (confidentiality agreement not signed, not participating)
  Sandoz (propranolol) (confidentiality agreement not signed, not participating)
  Teva (fremanezumab)
  Thame Laboratories (amitriptyline, propranolol) (confidentiality agreement not signed, not participating)
  Wockhardt (amitriptyline) (confidentiality agreement not signed, not participating)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
05 May 2020 Schedule affected by COVID-19, Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
03 April 2020 Topic update: this appraisal has not been defined as therapeutically critical (please follow the link titled rapid guidelines and evidence summaries within the yellow banner at the top of the page for information on recent changes to the way we work). The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide updates as and when this information becomes clear.
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