Amgen steals a march on Sanofi with Repatha NICE approval

Amgen has secured a recommendation for its new cholesterol drug Repatha (evolocumab) from NICE, giving it a major advantage on Sanofi/Regeneron's rival Praluent (alirocumab).

NICE rejected any use of Repatha on the NHS in November, but has changed its mind after the company submitted a re-analysis of the data. England's cost-effectiveness watchdog says the drug can now be used in patients with the most hard-to-treat high cholesterol, as long as it provides the agreed Patient Access Scheme price discount.

The decision puts Repatha ahead of Praluent, which NICE rejected yesterday in separate draft guidance.

However use of the drug has been restricted, with only a fortnightly dosing, rather than the monthly version recommended, and only those patients who do not respond or cannot take statins offered the injection.

Tony Patrikios, Executive Medical Director, Amgen UK & Ireland, welcomed the about-turn on Repatha, but said: "Beyond these draft recommendations, another priority will be patients with existing cardiovascular disease who fail to reduce their LDL-C to a satisfactory level, despite the use of statins and who remain at high risk. For them, access to new treatment options is critically important to help avoid a heart attack or stroke," he stressed.

NICE said Repatha can be used alone or in combination with other lipid-lowering therapies against primary non-familial hypercholesterolaemia, primary heterozygous-familial hypercholesterolaemia and mixed dyslipidemia.

Sanofi and Regeneron have not yet offered a Patient Access Scheme for Praluent, but they almost certainly have to do so now, given that its rival PCSK9 inhibitor has been given the green light.

While both drugs have been shown to be very effective in reducing cholesterol levels, neither has yet proven that this, in turn, lowers a patient's chances of a heart attack or stroke.

Praluent and Repatha have very similar list prices, Sanofi/Regeneron's drug costing £168 for a 75 mg or 150 mg single-use prefilled pen (excluding VAT), while Amgen's costs £170.10 for its equivalent 140 mg prefilled pen or syringe.

Repatha's annual cost of treatment per patient is around £4,448.60 for 140mg every 2 weeks, with Praluent expected to have similar yearly costs. Repatha is also available as a monthly dose, costing £6,123.60 for a year's treatment.

These figures are around 50-60% lower than the US list price, and news of this price difference in September further stoked controversy around US drug costs.

Both companies are pursuing long-term, large-scale trials to see if the drugs can cut the number of CVD events. One such trial is Sanofi/Regeneron's ODYSSEY OUTCOMES. This is an 18,000-patient study looking at Praluent's benefits in patients who have already suffered an acute coronary syndrome (ACS), such as a heart attack or angina. However this trial won't be completed until 2017.

A consultation on the Praluent decision will now run until 29 February to comment on the preliminary guidance, with NICE's committee then reviewing these submissions on 9 March.

Read NICE's draft guidance on Praluent here.