Cost watchdog says PCSK9 meds should cost 85% less. Realistic or not?

Payers ready to balk at the cost of new cholesterol-fighting PCSK9 drugs could have some new backing. A not-for-profit drug pricing watchdog, which analyzed data on the drugs, says they should cost only about one-third of their list price at most--and even less to avoid an undue burden on the healthcare system.

According to the Institute for Clinical and Economic Review, Sanofi ($SNY) and Regeneron's ($REGN) Praluent and Amgen's ($AMGN) Repatha offer enough benefits to justify a price of $3,615 to $4,811 per year. That's about a 67% discount off list prices of $14,100 (Repatha) and $14,600 (Praluent).

ICER sifted the available data on the two meds, and apart from concluding that they're essentially equivalent in most patient groups, the group noted a few things pharma-watchers already know--that they can cut cholesterol levels by 55% to 60% in patients already on statins or intolerant to the standard drugs. The institute pointed out a reservation discussed by FDA advisers and doctors--that outcomes data on the PCSK9 meds won't be available for a couple of years, so it's as yet unclear whether the big cholesterol reductions these drugs deliver will translate into fewer heart attacks and strokes.

Still, the drugs' impressive ability to lower cholesterol "provides moderate certainty that PCSK9 inhibitor therapy improves patient outcomes given remaining uncertainty about whether markedly lower LDL-cholesterol levels will translate into lower rates of heart attack and stroke," the institute said in a statement about its report.

That's the basis for ICER's cost-benefit figure of $3,615 to $4,811. But the group goes farther, adding actual real-world usage into the mix. Millions of patients would be eligible for PCSK9 therapy--up to 15 million by some broad estimates. And even at the 67% discount, the costs would add up quickly, said ICER President Steven Pearson.

"Even if these drugs were used in just over 25% of eligible patients, then employers, insurers, and patients would need to spend on average more than $20 billion a year for these drugs, a cost that would continue on into the future," Pearson said.

To get costs down to a level where doctors and payers wouldn't have to try to limit patients' access to the drugs, ICER says, the prices for these meds should be $2,177 or less. Any higher than that, says Pearson, and "drug companies, doctors, insurers, and other parties may need to work together to determine ways to limit the use of these drugs, find savings in other parts of the healthcare system, or adopt other measures to help make these drugs more affordable."

The PCSK9 report is the first in a series planned by ICER, funded by a $5.2 million grant from the Laura and John Arnold Foundation. Next up is an analysis of Novartis' new heart failure drug Entresto, priced at $4,500 per year. The drug made its debut with outcomes data already in hand, showing that Entresto patients were less likely to die or be hospitalized than those taking a standard beta-blocker therapy for the condition.

- see the ICER release

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