Citing cost, top doctors back limits on PCSK9 cholesterol fighters

Payers unhappy with the cost of new PCSK9 drugs are getting some help from doctors. As Reuters reports, top U.S. physicians are recommending against using the drugs outside their FDA-approved scope.

The agency limited those approvals to patients with a genetic disease that causes extremely high cholesterol levels, plus those whose cholesterol can't be controlled with aggressive statin therapy. But at a Rethinking Cholesterol panel presented by Harvard T.H. Chan School of Public Health, physicians pointed out that other patients may think they're eligible.

Some who think they are statin-intolerant might be likely to seek out the drugs, Patrick O'Gara, ex-president of the American College of Cardiology, told Reuters, enlarging the patient pool considerably. Considering that the list prices of PCSK9 meds--Sanofi ($SNY) and Regeneron's ($REGN) Praluent and Amgen's ($AMGN) Repatha--run more than $14,000, that would be a costly development. Some experts have estimated that adding this group to PCSK9 therapy could cost $20 billion; others see the cost as much higher.

Patrick O'Gara

"Release of these medications in an unfiltered way to a large number of patients with statin intolerance is a very worrisome proposition at this point and time, looking ahead and thinking about cost," O'Gara said.

New products could eventually bring prices down, said Paul Ridker, a medical researcher at Brigham and Women's Hospital and professor at Harvard Medical School. "The good news is three different companies and potentially as many as 5 may have products in this arena soon, and hopefully competition will bring us there," Ridker said during the panel, as quoted by Reuters.

The physicians' views mirror those of some health insurers, the Reuters article notes, as CVS Health ($CVS) and rival PBM Express Scripts ($ESRX) look for ways to limit spending on the pricey meds. CVS recently published studies indicating an overwhelming cost burden for the drugs, saying that they could cost the U.S. as much as $150 billion per year if broadly used. CVS says it's planning to use its formulary power to force discounts.

Express Scripts is taking a similar tack. President Tim Wentworth said earlier this year that the cost of Praluent and other next-generation cholesterol meds could "wreak havoc" among the PBM's clients. Sanofi and Regeneron put a $14,600 tag on their med, and Amgen priced Repatha at $14,100 per year after snagging FDA approval for the drug in August. Express Scripts has said that it would make the products go head-to-head for exclusive formulary coverage, a move that could result in discounts.

A PCSK9 pricing battle could echo one launched a year ago for pricey next-generation hep C meds. Last year, Express Scripts cut an exclusive deal with AbbVie ($ABBV) to cover its hep C combo Viekira Pak in exchange for a discount, setting off a pricing war with Gilead Sciences ($GILD) and its rival meds Sovaldi and Harvoni.

Meanwhile, cost gatekeepers and medical experts are still weighing in on appropriate pricing for PCSK9 meds. Earlier this month, not-for-profit drug pricing watchdog the Institute for Clinical and Economic Review (ICER) said that Praluent and Repatha should be priced at $3,615 to $4,811 per year--a 67% discount off list prices. Some estimate that up to 15 million patients could be eligible for PCSK9 therapy. And costs will still add up quickly despite a 67% discount, ICER President Steven Pearson said.

"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.

- read the Reuters story

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