- The UK National Institute for Health and Care Excellence (guideline setting organisation) has approved a PCSK9 inhibitor called inclisiran, which is administered by injection twice a year.
- The list price is approximately £2,000 per injection. A commercial deal has been struck between the manufacturer (Novartis) and the UK National Health Service (NHS), which is being kept confidential from the taxpayers who fund it.
- Inclisiran was approved by the European Medicines Agency (EMA) in December 2020. It has not yet been approved by the US Food and drug administration (FDA).
- Inclisiran is a novel drug which uses RNA interference to boost the liver’s ability to remove cholesterol from the blood.
- A number of trials on inclisiran are ongoing. The drug has been shown to lower LDL-cholesterol substantially, which is not surprising when you know what it does. Trials thus far have focused on cholesterol lowering as the primary outcomes. The trial to examine things that actually matter – cardiovascular events – is not due to report back until 2026.
- Currently, therefore, there is no evidence that inclisiran reduces cardiovascular events.
- Side effects, other than injection reactions, are largely unknown – the patient leaflet is relying on the first recipients of inclisiran to document them.
- Despite the fact that there is no evidence that inclisiran reduces CVD events, the (Novartis supported) trials and researchers claim that 30,000 lives will be saved.