Obicetrapib and obicetrapib–ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia [ID6519]

Suggested remit: To appraise the clinical and cost effectiveness of obicetrapib monotherapy within its marketing authorisation for treating primary hypercholesterolaemia or mixed dyslipidaemia. To appraise the clinical and cost effectiveness of obicetrapib–ezetimibe (fixed dose combination) within its marketing authorisation for treating primary hypercholesterolaemia or mixed dyslipidaemia.

Status:

In progress

Technology type:

Medicine

Decision:

Selected

Reason for decision:

Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources

Process:

STA Standard

ID number:

6519

Provisional Schedule

Committee meeting: 1:

04 August 2026

Expected publication:

14 October 2026

Project Team

Project lead

Leena Issa

Email enquiries

If you have any queries please email TACommC@nice.org.uk

External Assessment Group:

BMJ Technology Assessment Group (BMJ-TAG), BMJ

Stakeholders

Companies sponsors

A. Menarini Farmaceutica Internazionale (obicetrapib, obicetrapib–ezetimibe)

Others

Department of Health and Social Care

 

NHS England

Patient carer groups

Metabolic Support UK

Professional groups

British and Irish Association of Stroke Physicians

 

British Cardiovascular Society

 

Primary Care Cardiovascular Society

 

Royal College of Physicians

Associated public health groups

None

Comparator companies

Daiichi Sankyo (bempedoic acid) (confidentiality agreement signed, participating)

 

Novartis pharmaceuticals (inclisiran) (confidentiality agreement signed, participating)

 

Amarox (atorvastatin, rosuvastatin) (confidentiality agreement not signed, not participating)

 

Amgen (evolocumab) (confidentiality agreement not signed, not participating)

 

Aspire Pharma (fluvastatin) (confidentiality agreement not signed, not participating)

 

AstraZeneca (rosuvastatin) (confidentiality agreement not signed, not participating)

 

Aurobindo Pharma - Milpharm (atorvastatin, ezetimibe, pravastatin, rosuvastatin, simvastatin) (confidentiality agreement not signed, not participating)

 

Biocon Pharma (rosuvastatin) (confidentiality agreement not signed, not participating)

 

Brown & Burk (atorvastatin, rosuvastatin, simvastatin) (confidentiality agreement not signed, not participating)

 

Dr. Reddy's Laboratories (atorvastatin) (confidentiality agreement not signed, not participating)

 

Flamingo Pharma (atorvastatin) (confidentiality agreement not signed, not participating)

 

Glenmark Pharmaceuticals Europe (ezetimibe, rosuvastatin) (confidentiality agreement not signed, not participating)

 

Krka (atorvastatin, ezetimibe, rosuvastatin) (confidentiality agreement not signed, not participating)

 

MSN Laboratories Europe (atorvastatin, rosuvastatin) (confidentiality agreement not signed, not participating)

 

Mylan (atorvastatin) (confidentiality agreement not signed, not participating)

 

Novumgen (rosuvastatin) (confidentiality agreement not signed, not participating)

 

Organon Pharma (ezetimibe, simvastatin) (confidentiality agreement not signed, not participating)

 

Rivopharm (ezetimibe) (confidentiality agreement not signed, not participating)

 

Rosemont Pharmaceuticals (atorvastatin, simvastatin) (confidentiality agreement not signed, not participating)

 

Sandoz (atorvastatin, ezetimibe, fluvastatin, rosuvastatin, simvastatin) (confidentiality agreement not signed, not participating)

 

Sanofi (alirocumab) (confidentiality agreement not signed, not participating)

 

Sun Pharmaceuticals (atorvastatin, rosuvastatin, simvastatin) (confidentiality agreement not signed, not participating)

 

Thame Laboratories (rosuvastatin) (confidentiality agreement not signed, not participating)

 

Zentiva (atorvastatin, ezetimibe, rosuvastatin) (confidentiality agreement not signed, not participating)

General commentators

All Wales Therapeutics and Toxicology Centre

 

British National Formulary

 

Department of Health - Northern Ireland

 

Healthcare Improvement Scotland

 

Medicines and Healthcare products Regulatory Agency

 

NHS Wales Joint Commissioning Committee

 

Scottish Medicines Consortium

 

Welsh Government

Relevant research groups

None

Related links

• NIHRIO briefing

Timeline

Key events during the development of the guidance:

For further information on our processes and methods, please see our CHTE processes and methods manual