GPs in England not amused: Specialist societies go against inclisiran

The medical community is concerned about its high costs, administrative burden, lack of patient monitoring resources, and the drug's long-term safety data.

Inclisiran and its use in the UK

Inclisiran - a miracle cure?

Studies have shown that inclisiran is very effective in lowering LDL cholesterol. It is therefore reasonable to conclude that the effects of the drug can significantly reduce heart attacks and strokes. The drug is thus often touted as a miracle cure. However, the reality is not (yet) quite so rosy. While the positive effects on LDL levels are undisputed, there is a lack of long-term data on the safety of the active ingredient. It is also not yet clear whether Inclisiran actually has a greater effect on preventing strokes than other (and more thoroughly studied) PCSK9 inhibitors, according to the experts.

Why has its recommendation been withdrawn?

The NHS in England has recommended the prescription of inclisiran for certain patient groups since 2021. However, an increasing number of local GPs are advising practitioners not to prescribe it. This is not a national recommendation, but merely localised.

Local representatives have various reasons for this. On the one hand, they are concerned about the reimbursement structure for the injection, and the subsequent monitoring of patients. Physicians in private practice, for example, would bear the costs of the drug. There is also a lack of funds for injections in surgeries.

In addition, the professional associations criticise the lack of long-term data on the drug's safety. Final results are not expected until 2026. Until then, the prescribing and use of inclisiran should be restricted to specialised practices, according to doctors' representatives.

Quo vadis, inclisiran?

Whilst inclisiran is very effective in lowering LDL cholesterol levels, there is a lack of long-term safety data. This and the lack of cost-effectiveness have led local medical associations in England to recommend the use of the drug only for specialised practices or hospitals. The effort involved in injecting and monitoring patients is too great. According to experts, other PCSK9 inhibitors are just as efficient. Further safety data is expected in 2026. Until then, it remains to be seen which recommendations will follow.

  1. BMJ 2023;382:p1757