Intended for healthcare professionals


NICE guidance on inclisiran should be reconsidered

BMJ 2021; 375 doi: (Published 12 October 2021) Cite this as: BMJ 2021;375:n2462
  1. Paula Byrne, research fellow1,
  2. Maryanne Demasi, investigative reporter2,
  3. Susan M Smith, professor of primary care medicine1
  1. 1HRB Centre for Primary Care Research, RCSI University of Medical and Health Sciences, Ireland
  2. 2Institute for Scientific Freedom, Copenhagen, Denmark
  1. Correspondence to: P Byrne pbyrne.research{at}

Recommendation is premature without data on cardiovascular outcomes

The National Institute for Health and Care Excellence (NICE) recently published draft guidance recommending inclisiran, a new cholesterol lowering drug, for selected patient groups.1 The director of the Centre for Health Technology Evaluation at NICE, Meindert Boysen, stated: “Inclisiran represents a potential game-changer in preventing thousands of people from dying prematurely from heart attacks and strokes.”2

The new guidance attracted media attention345 and will be of interest to clinicians, patients, and the wider public. Inclisiran has been found to lower low density lipoprotein (LDL) cholesterol by about 50% in people not responding to other lipid lowering treatments.6 This injectable drug requires biannual administration, which may improve adherence.

The pharmaceutical industry is another interested party. All statins are now off patent, so drug companies could benefit from alternatives that are patented. Lipid regulating drugs account for substantial drug expenditure worldwide; global sales of statins alone were estimated to approach $1tn by 2020.7 Statins were the most frequently …

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