Regeneron and Sanofi play follow the leader on Praluent pricing

Amgen has set the stage for low-hassle access to new cholesterol-lowering agents, leaving little choice for competitors.

Regeneron and Sanofi’s new US list price for their cholesterol-lowering injection Praluent is a curiously familiar number: $5,850, the same level Amgen set last October for its rival product, Repatha. The lower price for Praluent should allow Medicare part D plans and commercial insurers to place the drug on non-speciality formulary tiers and reduce patients’ out-of-pocket costs.

The move represents the final surrender of the makers of the potent anti-PCSK9 antibodies to the realities of the marketplace, and is also an admission of the drugs' underachievement. Amgen, Regeneron and Sanofi had bet that these agents would outperform statins by enough to justify a price more than twice as high, and now that this question has been settled all that is left is discounting.

On the other hand, the pricing developments must be taken as a positive step for patients. Regeneron and Sanofi said the new discount should get patient copays in Medicare part D plans down to between $25 and $150 a month. Assuming that Praluent was previously on a speciality tier with 33% coinsurance, lowering the price and getting it onto a “preferred” formulary tier could save patients $345 a month.

While Repatha has been a less expensive option since its price drop, physicians had wanted the option to prescribe both agents at lower prices. This is because Praluent’s Odyssey Outcomes long-term trial tested patients with acute coronary syndrome, a sicker population than the high-risk patients with elevated LDL that Repatha enrolled, and thus was seen as an important alternative (ACC – Praluent’s Odyssey ends with a whimper, March 10, 2018). The FDA is set to decide by the end of April whether to add the data from Odyssey Outcomes to Praluent's label.

What took so long?

One surprise, however, is that it took as long as it did for both drugs to reach the price they have. After all, when Odyssey Outcomes was published the cost-effectiveness body Icer determined a value-based price benchmark for Praluent of between $4,460 and $6,578 for patients with LDL levels of at least 100mg/dl.

A lower value-based benchmark calculation had been made in 2017 for Repatha – a range of $1,725 to $2,242 – that in part was the result of its less sick population. Presumably at the $5,850 price payers are not authorising coverage for all of the patients covered by Amgen’s Fourier cardiovascular outcomes trial. In that study, patients with LDL as low as 70mg/dl had been enrolled.

It is unclear whether this was a factor in Express Scripts’ decision to exclude Repatha from its formulary for 2019. If Sanofi and Regeneron set a similar price and were seen as delivering greater value, that might have been a persuasive argument.

The further question is whether price competition will continue. As long as rebates remain legal, there will probably be leeway to do so (US government formalises rebate ban proposal, but challenges await, February 1, 2019). Two competitors with the exact same price, on the other hand, might be a glimpse into a future in which the federal government succeeds in banning rebates broadly.

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