Radical or not, NICE makes evidence based recommendations

Godlee’s call for the National Institute for Health and Care Excellence to keep close to its radical roots is interesting, not least because NICE has never claimed this for itself.1 Radical or not, NICE applies thorough and robust approaches to assessing health technologies. This helps patients access innovative treatments that help them live longer, better quality lives while providing value for money.

The example chosen by Godlee is a perfect illustration of an innovative treatment with huge potential benefits. NHS England estimates that inclisiran could prevent 55 000 heart attacks and strokes, saving 30 000 lives in the next decade. Its twice yearly maintenance dosing means that inclisiran could improve health outcomes while saving the NHS valuable resources.

Using a surrogate endpoint instead of cardiovascular outcomes is normal in this area, and NICE has used this approach before. Low density lipoprotein cholesterol concentrations are a widely accepted surrogate for cardiovascular risk. The European Medicines Agency, in summarising the benefits and risks of inclisiran, noted that “recent studies with ezetimibe and PCSK9 inhibitors strengthen the value of [low density lipoprotein cholesterol] as a surrogate marker.”

Our independent appraisal committee concluded that inclisiran was clinically effective and cost effective using the best available evidence. We acknowledge that there is currently no direct comparison of inclisiran with other lipid lowering treatments and no long term evidence on cardiovascular outcomes. Clinical trials are ongoing, and we will monitor these closely.

In response to the suggestion that NICE is hiding its economic analysis, the price of inclisiran agreed with NHS England is commercial in confidence. Around 80% of our guidance contains confidential commercial arrangements between NHS England and companies.

“Rebellious” is not an epithet one would normally bestow on NICE, but if this means making evidence based recommendations for innovative treatments that sometimes divide opinion, then we’ll do our utmost to be worthy of it.