Alirocumab for hypercholesterolaemia and dyslipidaemia

Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia (Single Technology Assessment for NICE)

Primary hypercholesterolaemia is a form of dyslipidaemia characterised by abnormalities of lipoprotein transport, associated with high concentrations of cholesterol in the blood. Mixed dyslipidaemia is defined as elevations in LDL cholesterol and triglyceride (TG) levels that are often accompanied by low levels of HDL cholesterol. People with hypercholesterolaemia and mixed dyslipidaemia are at increased risk of cardiovascular disease (CVD) due to the fact that long-term high concentrations of cholesterol are known to accelerate atherosclerosis, the build-up of fatty deposits in the arteries.

This project was carried out as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal Process. The company responsible for alirocumab (Sanofi Ltd) submitted an evidence review and an economic model assessing the cost-effectiveness of alircoumab, alone or in combination with statin +/- ezetimibe, against no treatment or statin alone or in combination with ezetimibe, for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia. The Aberdeen HTA group were commissioned to act as the Evidence Review Group (ERG) for the project, and to provide an independent report reviewing the company’s evidence submission.

Outcome and Translation

Following consideration of the company submission and the ERG reports, the NICE appraisal committee recommended alirocumab as a treatment option for certain subgroups of people with heterozygous-familial and non-familial hypercholesterolaemia and dyslipidemia:

https://www.nice.org.uk/guidance/ta393/chapter/1-Recommendations.

National Institute for Health and Care Excellence (2016) Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia, Technology Appraisal Guidance [TA393], London: NICE.  

Publications

Scotland, G., Neilson, A. R., Javanbakht, M., Fielding, S., Cruickshank, M., Sharma, P., Fraser, C., Simpson, W. and Brazzelli, M. (2015) Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia. Report from Aberdeen Health Technology Assessment Group to NICE Single Technology Appraisal Programme.

Presentations

Scotland, G., Javanbakht, M. and Brazzelli, M. (2016) 'Report of the Evidence Review Group on Technology Appraisal TA393: alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia', NICE Appraisal Committee Meeting, Manchester, 13 January 2016.

Scotland, G., Javanbakht, M. and Brazzelli, M. (2016) 'Report of the Evidence Review Group on Technology Appraisal TA393: alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia', NICE Appraisal Committee Meeting, Manchester, 9 March 2016.