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
  Welsh Government
Patient carer groups British Cardiovascular Society
  Royal College of Pathologists
  Royal College of Physicians

Commentators

Comparator companies Accord Healthcare (atorvastatin, ezetimibe, fluvastatin, pravastatin, rosuvastatin, simvastatin) (confidentiality agreement not signed, not participating)
  ADVANZ Pharma (ezetimibe) (confidentiality agreement not signed, not participating)
  Amgen (evolocumab)
  AstraZeneca (rosuvastatin)
  Aurobindo Pharma – Milpharm (atorvastatin, ezetimibe, pravastatin, rosuvastatin, simvastatin) (confidentiality agreement not signed, not participating)
  Consilient Health (atorvastatin) (confidentiality agreement not signed, not participating)
  Dexcel Pharma (atorvastatin) (confidentiality agreement not signed, not participating)
  Lupin Healthcare (simvastatin) (confidentiality agreement not signed, not participating)
  Merck Sharp & Dohme (ezetimibe, simvastatin) (confidentiality agreement not signed, not participating)
  Mylan (atorvastatin, ezetimibe, fluvastatin, pravastatin, rosuvastatin, simvastatin) (confidentiality agreement not signed, not participating)
  Novartis Pharmaceuticals (fluvastatin)
  Pfizer (atorvastatin) (confidentiality agreement not signed, not participating)
  Rosemont Pharmaceuticals (simvastatin) (confidentiality agreement not signed, not participating)
  Sandoz (ezetimibe, fluvastatin, rosuvastatin, simvastatin) (confidentiality agreement not signed, not participating)
  Sanofi (alirocumab)
  Sun Pharmaceuticals (atorvastatin, rosuvastatin) (confidentiality agreement not signed, not participating)
  Wockhardt UK (atorvastatin) (confidentiality agreement not signed, not participating)
  Zentiva (atorvastatin, ezetimibe, rosuvastatin, simvastatin) (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
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