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Novartis Strikes “World First” Deal With UK NHS Following Leqvio NICE Recommendation

Date: September 1, 2021 | Country: UNITED KINGDOM | Region: EUROPE
Keywords: #discount #hypercholesterolaemia #mixeddyslipidaemia 
#nhs #nice #novartis #orion

PRICENTRIC BRIEF:

  • The National Institute for Health and Care Excellence (NICE) has issued draft final guidance recommending Novartis’ Leqvio (inclisiran) for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia in patients who have already had a cardiovascular event such as a heart attack or stroke
  • According to NICE, the positive recommendation was based on Novartis’ ORION clinical research program, including Phase III trials ORION-9, ORION-10 and ORION-11, which involved over 3,600 patients and assessed the safety, efficacy and tolerability of inclisiran in lowering LDL-Cholesterol levels
  • Following the recommendation, NHS England, NHS Improvement and Novartis have agreed on a “world first” population-level commercial deal to make Leqvio available with a discount to its list price

THE DETAILS

LONDON, United Kingdom— The National Institute for Health and Care Excellence (NICE) has issued draft final guidance recommending Novartis’ Leqvio (inclisiran) for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia in patients who have already had a cardiovascular event such as a heart attack or stroke.

According to NICE, the positive recommendation was based on Novartis’ ORION clinical research program, including Phase III trials ORION-9, ORION-10 and ORION-11, which involved over 3,600 patients and assessed the safety, efficacy and tolerability of inclisiran in lowering LDL-Cholesterol levels.

Following the recommendation, NHS England, NHS Improvement and Novartis have agreed on a “world first” population-level commercial deal to make Leqvio available with a discount to its list price.

The anti-cholesterol drug will be provided for wide access to patients at risk of heart disease and for whom conventional treatment has not worked, in particular those who also have persistently elevated LDL-C levels (2.6 mmol/l or more despite maximum tolerated statins with or without ezetimibe).

The new approach is “potentially game-changing,” according to Prof Kausik Ray, MD, Professor of Public Health at Imperial College London and Honorary Consultant Cardiologist at the Imperial College NHS Trust.

Ray added, “This represents a significant advance in patient care through effective lipid management. As a clinician, I see many patients where their cholesterol levels are insufficiently controlled for their level of risk, often despite optimal use of available therapies, putting them at increased risk of a heart attack or stroke.

“Having faster and broader access to a medicine like inclisiran, which offers the combination of a convenient twice-a-year maintenance dosing schedule, as well as the ability to be used in primary care – where most patients are cared for – and provide sustained reductions in LDL-C is a hugely positive milestone in patient care.”

In patients who have never had a cardiovascular event, the cost-effectiveness estimates were very uncertain and likely to be above what NICE considers an acceptable use of NHS resources. However, a clinical trial is planned that will look at whether Leqvio reduces cardiovascular events in this population. So in this particular indication, Leqvio is recommended for use in research trials.

Meindert Boysen, NICE deputy chief executive and director of the Centre for Health Technology Evaluation, added: “Inclisiran represents a potential game-changer in preventing thousands of people from dying prematurely from heart attacks and strokes. We’re therefore pleased to be able to recommend it as a cost-effective option on the NHS supported by the ground-breaking deal between NHS England and NHS Improvement and Novartis – a deal that could see as many as 300,000 people with high cholesterol or mixed dyslipidaemia who have already had a previous cardiovascular event receive the drug over the next 3 years.”

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