Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia

4.1 Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within a specified period. For the purpose of this appraisal, the time period is 30 days after the date of publication, as agreed with NHS England.

4.2 NHS England & NHS Improvement will make interim funding for inclisiran available from release of positive draft guidance or from launch in the UK, whichever is later. Further information about funding arrangements will be provided by NHS England. Queries should be directed to england.lipidsphm@nhs.net.

4.3 The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final appraisal document. Queries should be directed to Pharmacyand.PrescribingBranch@gov.wales.

4.4 When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and a history of cardiovascular disease with persistent LDL-C levels of at least 2.6 mmol/l despite having the maximum tolerated lipid-lowering therapy and the doctor responsible for their care thinks that inclisiran is the right treatment, it should be available for use, in line with NICE's recommendations.