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NICE rejects Amgen’s Repatha in draft guidance

Published on 18/11/15 at 10:49am
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NICE says the uncertainty in the cost-effective of Repatha, which costs up to £79,000 per QALY, is too high

NICE has published draft guidance rejecting Amgen’s Repatha as a treatment for people with high cholesterol.   

The draft guidance does not recommend Repatha (evolocumab), alone or in combination with lipid-lowering therapies, for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia. The healthcare spending body says there is a lack of clinical trial evidence to support the drug’s effect on heart disease-related events. Repatha is approved by the EMA for the same indications.

The drug is an antibody that targets the PCSK9 protein, which reduces the number of receptors on the liver that remove LDL cholesterol (or ‘bad’ cholesterol) from the blood. By blocking PCSK9’s ability to work, more receptors are available to get rid of LDL cholesterol from the blood, which results in lower LDL cholesterol levels.

People with hypercholesterolaemia have an increased risk of cardiovascular disease because long term raised cholesterol levels accelerate the build-up of fatty deposits in the arteries. The narrowing of the arteries can eventually lead to angina, heart attacks and strokes, and accounted for approximately 150,000 deaths in 2012.

Primary non-familial hypercholesterolaemia affects an estimated 1.5 million people in England. The inherited condition, primary heterozygous familial hypercholesterolaemia, affects about 106,000 people in England. People with this condition have raised cholesterol levels from birth.

Commenting on the decision, Meindert Boysen, programme director at NICE, says: “The committee concluded that although evolocumab was effective in reducing levels of LDL cholesterol in people with primary hypercholesterolaemia, there have been no clinical trials to measure the direct effect of evolocumab on CVD events. They felt the question of whether reducing LDL cholesterol with evolocumab would reduce angina, heart attacks and strokes remains unanswered.

The Committee also considered that Amgen analyses “had several limitations which called in to question the reliability of the cost-effectiveness results.” These included overestimating the risks of cardiovascular disease in a UK population, as Amgen had not used a NICE-recommended risk assessment tool. The committee also highlighted Amgen’s ‘unrealistic’ calculations of the risk of cardiovascular disease in people with heterozygous-familial hypercholesterolaemia.

“The Committee concluded that the degree of uncertainty in the cost-effectiveness evidence was too high for it to be able to make well-founded recommendations about evolocumab.”

Prof. Peter Weissberg, Medical Director at the British Heart Foundation (BHF), said:“Evolocumab represents an entirely new approach to lowering cholesterol and this new class of drug holds great promise for the future.“However, before approving evolocumab for long term treatment of high cholesterol, NICE, quite appropriately, wants to see evidence that the treatment is safe and that it actually prevents heart attacks and strokes. And, because statins are effective, well tolerated and cheap, NICE also needs convincing that any benefit evolovumab offers justifies its substantial additional cost.“For the vast majority of people with elevated cholesterol levels, statins offer an effective solution. It is to be hoped that before long evolovumab and similar drugs in the pipeline will gain approval for treatment of those few people with extremely high cholesterol levels who, for whatever reason, have not had a satisfactory response to statins.”

Professor Peter Weissberg, medical director at the British Heart Foundation, says: “Evolocumab represents an entirely new approach to lowering cholesterol and this new class of drug holds great promise for the future.

“However, before approving evolocumab for long term treatment of high cholesterol, NICE, quite appropriately, wants to see evidence that the treatment is safe and that it actually prevents heart attacks and strokes. And, because statins are effective, well tolerated and cheap, NICE also needs convincing that any benefit evolovumab offers justifies its substantial additional cost.

“For the vast majority of people with elevated cholesterol levels, statins offer an effective solution. It is to be hoped that before long evolovumab and similar drugs in the pipeline will gain approval for treatment of those few people with extremely high cholesterol levels who, for whatever reason, have not had a satisfactory response to statins.”

Joel Levy

Counting the cost: How the price of Repatha stacks up

Non-familial hypercholesterolaemia without CVD: £74,300 per quality-adjusted life year (QALY) gained for evolocumab plus statin compared with ezetimibe plus statin (statin-tolerant), and £78,800 per QALY gained for evolocumab compared with ezetimibe (statin-intolerant).

Non-familial hypercholesterolaemia with CVD: £46,000–50,900 per QALY gained for evolocumab plus statin with or without ezetimibe compared with ezetimibe plus statin (statin-tolerant), and from £49,300–52,800 per QALY gained for evolocumab with or without ezetimibe compared with ezetimibe (statin-intolerant).

Heterozygous-familial hypercholesterolaemia: £22,900–24,800 per QALY gained for evolocumab plus statin with or without ezetimibe compared with ezetimibe plus statin (statin-tolerant), and £23,900–25,600 per QALY gained for evolocumab with or without ezetimibe compared with ezetimibe (statin-intolerant).

Source: NICE

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