Status In progress
Process STA 2018
ID number 1515

Project Team

Project lead Gemma Barnacle

Email enquiries

Evidence Review Group / Assessment Group BMJ Technology Assessment Group (BMJ-TAG), BMJ

Consultees

Companies sponsors Daiichi Sankyo UK (bempedoic acid)
Others Department of Health and Social Care
  NHS England
  NHS Lancashire North CCG
  NHS Wandsworth CCG
  Welsh Government
Patient carer groups British Association for Nursing in Cardiovascular Care
  British Cardiovascular Intervention Society
  British Cardiovascular Society
  British Dietetic Association
  British Geriatrics Society
  British Heart Foundation
  British Inherited Metabolic Disease Group
  British Nuclear Cardiology Society
  British Society for Genetic Medicine
  British Society of Cardiovascular Imaging
  Primary Care Cardiovascular 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
  Society for Cardiological Science & Technology
  Society for Endocrinology
  Society for Vascular Technology
  Society of Vascular Nurses
  UK Clinical Pharmacy Association
  UK Health Forum
  Vascular Society of Great Britain & Ireland
Professional groups Black Health Agency
  Cardiovascular Care Partnership
  Circulation Foundation
  HEART UK
  Muslim Council of Britain
  Network of Sikh Organisations
  South Asian Health Foundation
  Specialised Healthcare Alliance

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord Healthcare (atorvastatin, ezetimibe, fluvastatin, pravastatin, rosuvastatin, simvastatin)
  ADVANZ Pharma (ezetimibe)
  Amgen (evolocumab)
  AstraZeneca (rosuvastatin)
  Aurobindo Pharma – Milpharm (atorvastatin, ezetimibe, pravastatin, rosuvastatin, simvastatin)
  Consilient Health (atorvastatin)
  Dexcel Pharma (atorvastatin)
  Lupin Healthcare (simvastatin)
  Merck Sharp & Dohme (ezetimibe, simvastatin)
  Mylan (atorvastatin, ezetimibe, fluvastatin, pravastatin, rosuvastatin, simvastatin)
  Novartis Pharmaceuticals (fluvastatin)
  Pfizer (atorvastatin)
  Rosemont Pharmaceuticals (simvastatin)
  Sandoz (ezetimibe, fluvastatin, rosuvastatin, simvastatin)
  Sanofi (alirocumab)
  Sun Pharmaceuticals (atorvastatin, rosuvastatin)
  Wockhardt UK (atorvastatin)
  Zentiva (atorvastatin, ezetimibe, rosuvastatin, simvastatin)
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
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups British Society for Cardiovascular Research
  Central Cardiac Audit Database
  Cochrane Heart Group
  Cochrane Metabolic & Endocrine Disorders Group
  Genomics England
  Heart Research UK
  MRC Clinical Trials Unit
  National Institute for Cardiovascular Preventions and Outcomes
  National Institute for Health Research
  Wellcome Trust

Timeline

Key events during the development of the guidance:

Date Update
26 September 2019 Invitation to participate
10 September 2019 In progress, Referred July 2019
10 September 2019 The Department for Health and Social Care has asked us to carry out a Single Technology Appraisal of bempedoic acid for treating primary hypercholesterolaemia or mixed dyslipidaemia. The appraisal is expected to start in approximately late September 2019 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early December 2019. 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.

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