Suggested Remit: To appraise the clinical and cost effectiveness of tafamidis within its marketing authorisation for treating transthyretin amyloid cardiomyopathy for national commissioning by NHS England.
 
Status In progress
Process STA 2018
ID number 1531

Project Team

Project lead Gemma Barnacle

Email enquiries

Evidence Review Group / Assessment Group School of Health and Related Research (ScHARR), University of Sheffield

Consultees

Companies sponsors Pfizer (tafamidis)
Others Department of Health & Social Care
  NHS England
  Welsh Government
Patient carer groups Cardiomyopathy UK
  UK ATTR Amyloidosis Patients' Association
Professional groups British Cardiovascular Society
  British Society for Heart Failure
  Royal College of Physicians

Commentators

Comparator companies Accord Healthcare (furosemide) (confidentiality agreement not signed, not participating)
  Advanz Pharma (furosemide) (confidentiality agreement not signed, not participating)
  Akcea Therapeutics UK (inotersen)
  Alnylam Pharmaceuticals (patisiran)
  Aurobindo Pharma (furosemide) (confidentiality agreement not signed, not participating)
  Generics UK (bumetanide) (confidentiality agreement not signed, not participating)
  Hameln Pharmaceuticals (furosemide) (confidentiality agreement not signed, not participating)
  M & A Pharmachem (furosemide) (confidentiality agreement not signed, not participating)
  Orion Pharma (furosemide) (confidentiality agreement not signed, not participating)
  Pinewood Healthcare (furosemide) (confidentiality agreement not signed, not participating)
  Rosemont Pharmaceuticals (furosemide) (confidentiality agreement not signed, not participating)
  Sanofi (furosemide) (confidentiality agreement not signed, not participating)
  Thame Laboratories (furosemide) (confidentiality agreement not signed, not participating)
  Wockhardt UK (furosemide) (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
Relevant research groups National Amyloidosis Centre, at UCL

Timeline

Key events during the development of the guidance:

Date Update
11 June 2020 - 02 July 2020 Appraisal consultation
07 May 2020 Committee meeting
18 February 2020 The company has requested a delay in the process to enable further discussions with NHS England around a commercial arrangement. Therefore, the appraisal committee meeting for this topic is being rescheduled. The new committee date will be 7 May 2020
15 July 2019 Invitation to participate
15 July 2019 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of tafamidis for treating transthyretin amyloid cardiomyopathy. Consultees and commentators will be provided with details of the timelines when the appraisal starts in mid-July. The timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust evidence submission. As a result, NICE cannot deliver on its commitment to publish guidance within 3 months of marketing authorisation for a product that was subject to the Early Access to Medicines Scheme (EAMS).
15 July 2019 In progress. Invitation to participate
12 March 2019 (14:00) Scoping workshop (London)
23 January 2019 - 20 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