Amgen's Repatha Gets NHS Nod, Sanofi's Praluent Misses Out
This article was originally published in Scrip
Amgen Inc. looks to be in with a chance to push back its biggest rival, partners Sanofi and Regeneron Pharmaceuticals, and strive for dominance of the PCKS9 market space in the UK for patients with high cholesterol.
NICE, the health technology appraisal body for England and Wales, has delivered draft decisions not recommending Sanofi's Praluent (alirocumab) for lipid disorders, but promoting use of Amgen's Repatha (evolocumab) instead on the National Health Service (NHS).
NICE recommended Repatha in a new draft guidance on Feb. 5 as an option for some people with primary hypercholesterolemia (heterozygous-familial and non-familial) or mixed dyslipidemia. This was a turnaround decision for Amgen's product, which NICE had said in previous guidance was too expensive for the NHS. An independent appraisal committee considered new analyses of the cost effectiveness of using Repatha on the NHS in subgroups of people with primary hypercholesterolemia, particularly those who have a high clinical unmet need, in response to consultation on the previous draft guidance. Amgen has offered a discount to NICE under a patient access scheme for Repatha – covering just these specific patient subgroups. The draft guidance now recommends Repatha 140mg every two weeks, alone or in combination with other lipid-lowering therapies.
However on Feb. 9, NICE rejected use of Sanofi's product in the same indications in a draft guidance. The HTA body said that though it had concluded Praluent is clinically effective in reducing LDL-c levels when compared with placebo, ezetimibe or statins in people with hypercholesterolemia, the data provided by Sanofi did not provide robust information on important cardiovascular outcomes.
Professor Carole Longson MBE, director of the NICE Centre for Health Technology Evaluation, said in a statement: "[The committee] concluded that, although it was reasonable to infer that alirocumab would reduce cardiovascular events, the extent of this reduction was uncertain."
Longson also noted that NICE was concerned that alirocumab had not been compared with the combination therapy of ezetimibe plus a statin, in the large population of people with non-familial hypercholesterolemia.
Furthermore, Praluent's cost-benefit ratio did not lean in Sanofi's favor. Cost analyses run for Praluent resulted in ICERs (incremental cost-effectiveness ratio) exceeding the range normally considered to be an economical use of NHS resources. However, Sanofi was keen to point out to Scrip that the list price of Praluent to the NHS (£168.00 for a 75 mg or 150 mg single-use prefilled pen: £4,383.00 per annum for 75 mg or 150 mg every two weeks) is lower than that of Repatha (£170.10 for a 140 mg prefilled pen or syringe: £4,437.79 per annum based for 140 mg every two weeks, and £6,123.60 for 420 mg monthly).
Similar to Amgen's drug though, Sanofi is now considering a patient access scheme for Praluent – details for which it would not disclose.
A spokesperson for Sanofi said, in response to NICE's concerns about the trial data provided, that ezetimibe usage in the NHS was limited and "highly varied" and therefore may not be the most relevant comparator. "Because ezetimibe usage in the NHS is highly varied we consider that alirocumab is most likely to be used as an add-on therapy to maximal tolerated dose statins (alone, not in combination with ezetimibe)," the spokesperson said.
Sanofi has until Feb. 29 to submit comments to NICE on this preliminary guidance. NICE's next draft guidance for Praluent will be published after a March 9 committee meeting.
Sanofi told Scrip the company will be providing "a comprehensive response to the draft NICE consultation document." The big pharma said at this point it would be "premature" to comment on how a final guidance rejecting Praluent could affect the company's strategy in the UK. "Sanofi and Regeneron are working with NICE to ensure obtaining a positive final appraisal determination," the company said.
Sanofi declined to comment on Amgen's apparent success in changing NICE's mind on its PCKS9 product.
Repatha and Praluent are proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.