Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia

Summary

The aim of this project, which was commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, was to review the evidence for the clinical and cost-effectiveness of Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia. The clinical evidence submitted by the company (Sanofi Ltd) responsible for manufacturing Alirocumab (Praluent) consisted of ten phase III RCTs comparing Alirocumab with placebo, ezetimibe or ezetimibe plus a statin. The Aberdeen HTA Group acted as the Evidence Review Group (ERG) for the project and provided an independent critique of the clinical and cost-effectiveness evidence submitted by the company.

After taking into consideration the company submission and the findings of the ERG’s critique, NICE released a technology appraisal guidance (TA393, June 2016). Alirocumab is currently recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia only if (i) low-density lipoprotein concentrations are persistently above specified thresholds despite maximal tolerated lipid-lowering therapy, and (ii) the company provides Alirocumab in line with the commercial access agreement with NHS England.

https://www.nice.org.uk/guidance/ta393

https://www.journalslibrary.nihr.ac.uk/programmes/hta/1420603/#/

https://www.nice.org.uk/guidance/TA393/chapter/1-Recommendations

Contact

Miriam Brazzelli: m.brazzelli@abdn.ac.uk

Status

Completed.

Publications

Scotland, G, Neilson, A, Javanbakht, M, Fielding, S, Cruickshank, M, Sharma, P, Fraser, C, Simpson, W, Brazzelli, M. Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia. Evidence Review Group report in support of the NICE STA Programme. University of Aberdeen: Health Services Research Unit; 2015. URL: https://www.nice.org.uk/guidance/ta393/documents/committee-papers