Sanofi has announced that the innovative cholesterol-lowering treatment Praluent® (alirocumab) has received Technology Appraisal Guidance (TAG) from the National Institute for Health and Care Excellence (NICE). The National Health Service (NHS) now has 90 days to ensure that alirocumab is available across England and Wales as a treatment option for people who have raised levels of 'bad' cholesterol (low-density lipoprotein cholesterol), or LDL-C, and who are at a high risk of a heart attack or stroke.1 The product was developed jointly by Sanofi and Regeneron.
Today's guidance is a major step forward for the thousands of people in the UK who are still unable to control their cholesterol levels despite taking the maximum tolerated dose of statins and other lipid-lowering therapies.
"Across the UK, someone dies from cardiovascular disease every three minutes. Raised cholesterol levels can put people at significant risk of a heart attack or stroke and, for some people, statins at the maximum tolerated dose can be insufficient to reduce this risk," said Jules Payne, Chief Executive of HEART UK - The Cholesterol Charity. "HEART UK welcomes today's publication of this NICE TAG for a PCSK9 inhibitor and is pleased that there will soon be an effective and much needed alternative treatment option for those at high risk of cardiovascular disease available on the NHS."
Alirocumab is approved in the UK for use in patients who are unable to reach their 'bad' cholesterol treatment goals, despite modifying their diet and taking a maximum tolerated dose of a statin and/or other lipid-lowering therapies.2 These patients include those with: high levels of LDL cholesterol, an inherited form of high cholesterol levels (heterozygous familial hypercholesterolaemia); and patients who are statin intolerant, or contraindicated.2 The effect of alirocumab on cardiovascular morbidity and mortality has not yet been determined.
"Sanofi is delighted that Praluent will shortly be available on the NHS for people living with the risk of raised cholesterol levels," said Dr Tunde Falode, Director of the Cardiovascular Division at Sanofi. "At Sanofi we have worked closely with NICE to address the unmet clinical needs of patients at high risk of cardiovascular disease and we are committed to ensuring that these patients have access to this innovative treatment as soon as possible."
Alirocumab is the only PCSK9 inhibitor available in two starting strengths - 75 mg and 150 mg - providing doctors with the flexibility to meet the needs of their individual patients. To further support patients, Sanofi has also launched MyPraluent Coach, a free, flexible programme, which offers one-to-one home nurse support, text message injection reminders and materials to improve patients' knowledge of their condition.