Amgen to sell Repatha in Europe at steep discount to US

Amgen's cholesterol-lowering antibody Repatha is being launched in Europe at well below the new drug's cost in the US, raising the chance that American payers will seek hefty discounts on the drug.

Repatha (evolocumab) will be sold in the UK at a cost of $6,780 per year, less than half the $14,100 Amgen is charging for the drug in the US, with the price in other EU markets typically below $9,000.

The US price for Sanofi's rival PCSK9 inhibitor Praluent (alirocumab) is $14,600 a year – pricing for the European market has yet to be revealed – but analysts have suggested the class as a whole could eventually reach sales of several billion dollars a year.

The disparity between the US and European price tags is likely to spark renewed debate about fairness and the cost of new drugs, although it should be noted that the price of both drugs will probably be negotiated down by pharmacy benefit managers (PBMs) and health insurers.

Analysts had predicted that the new drug class would be priced at around $10,000 a year, so the premium being sought by Amgen and Sanofi in the US will increase calls for measures to pare down the impact of the class on healthcare spending.

Earlier this year, one of the leading US PBMs, CVS Health, said that the PCSK9 inhibitors pose an 'unprecedented challenge' to healthcare budgets because they could address a very large population and are administered chronically over many years.

Amgen maintains that more than 60 per cent of high-risk patients in Europe are still unable to adequately lower their LDL-cholesterol levels with statins or other lipid-lowering agents.

Unusually, Amgen acknowledges the quandary in its press release about the US FDA approval of Repatha, where Anthony Hooper, the company's vice president of commercial operations, says the company "is sensitive to the concerns of payers around cost, budget predictability and paying for value."

Hooper maintains that Amgen will "be working with payers and other purchasers to provide innovative pricing programmes linking the net price of Repatha to the expected LDL-cholesterol reductions and anticipated appropriate patient utilisation."

Similarly, Sanofi's approval statement has also talked about the "discounts and rebates" that will be on offer to reduce the cost from the wholesale acquisition price listed.

The two companies will still have to convince prescribers of the value of the new drugs in the millions of patients who cannot meet cholesterol targets with just statin therapy, which has a very large evidence base and is now largely off-patent and low cost.

Adding to the debate, a new non-profit group in the US called the Institute for Clinical and Economic Review (ICER) has pledged to publish a report on the cost-effectiveness of the drugs later this month.

CVS Health and other PBMs, such as Express Scripts, have already talked about placing restrictions on prescribing, for example by setting threshold cholesterol targets or requiring that patients fail intense statin therapy first.

In the UK meanwhile, even with the discounted price on offer for Repatha, there have been suggestions that the drug may see its use restricted, with the National Institute for Health and Care Excellence (NICE) due to deliver a draft verdict on cost-effectiveness next April.