PCSK9 inhibitor cholesterol drugs chosen for rapid uptake in the UK

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A class of expensive cholesterol-lowering drugs known as PCSK9 inhibitors have been chosen by the Accelerated Access Collaborative (AAC) to be fast-tracked into availability. Pharmaceutical companies Amgen and Sanofi both had their products, Repatha and Praluent, selected for rapid uptake status.
Cholesterol-lowering drugs are often prescribed to people with diabetes, prediabetes or metabolic syndrome who are considered at risk of cardiovascular events such as heart attack or stroke.
The AAC is a collaboration between NHS organisations and industry, directed by the National Institute for Health and Care Excellence (NICE). It has the purpose of speeding up access to “highly transformative technologies” for NHS patients. Chosen technologies are already available to the NHS, and have an evidence base, but have seen poor uptake.
Alongside PCSK9 inhibitors, six other potentially beneficial technologies have been chosen for rapid uptake and will share the £2 million of funding released. These other technologies include Mavenclad (a multiple sclerosis medication), a test for colorectal cancer, a test for heart attack and a test for pre-eclampsia in pregnant women.
NICE have previously recommended both Praluent and Repatha, however this recommendation alone did not ensure widespread uptake across England. NICE therefore hope that this push by the AAC will allow greater access to these costly drugs.
While PCSK9 inhibitors have been shown to significantly lower levels of LDL cholesterol, concerns have been expressed over what benefit this will actually provide to patients. A study of Repatha showed a small but statistically significant reduction in risk of cardiovascular events. However, it did nothing to prevent fatal events, and there was even a greater, albeit statistically insignificant, rate of death in the group that took the drug, compared to those that did not. The study was funded by Amgen.
Commenting on these findings, Dr Aseem Malhotra, NHS consultant cardiologist, said: “NICE needs to urgently revise its recommendations on the prescription of the drug to include information that the drug will not prevent a fatal heart attack or increase a patient’s lifespan by one day.”
Though the benefits of PCSK9 inhibitors is a point of contention between academics and healthcare professionals, it is hoped that overall, the technologies chosen for rapid uptake by the AAC will offer cost-effective benefit to NHS patients.