New Cholesterol Drug, Alirocumab's (Praluent), High Price May Not Be Worth It: Study

Despite being slashed by half in recent months, the price tag for advanced cholesterol-fighting drugs is still too high to make them cost-effective, a new analysis has concluded.

In March, the manufacturer of alirocumab (Praluent) announced that it would cut the cost of the medication from $14,000 a year to $7,000.

But the price would have to fall even more, to around $900 to $2,000 a year, to make it as cost-effective as cholesterol-lowering drugs that have been around far longer, researchers reported.

"We do think these drugs are useful to patients, and cost is a major barrier to access at this point," said lead researcher Dr. Dhruv Kazi. He is associate director of the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center in Boston.

"Perhaps the right thing here is to acknowledge the efforts the manufacturers have made to respond to these pricing pressures," Kazi said. "But I don't think we're there yet."

The pricing dilemma stems from the fact that there already are very cheap and very effective cholesterol-lowering drugs on the market, Kazi said. Statins and ezetimibe both are available in generic form, and have years of safety and effectiveness data behind them.

"Your additional drugs have to work harder to be cost-effective," Kazi said.

Praluent belongs to a new class of drugs called PCSK9 inhibitors. They work by boosting the liver's ability to remove cholesterol from the bloodstream. The U.S. Food and Drug Administration approved Praluent in July 2015; a second drug in this class, evolocumab (Repatha), received approval in December 2017.

Regeneron Pharmaceuticals, maker of Praluent, said in a statement that it disagrees with the new cost analysis.

The company argues that researchers did not take into account clinical trial results showing the drug's ability to ward off deaths and reduce cholesterol levels in hard-to-treat heart patients.

The American Heart Association acknowledged the usefulness of PCSK9 inhibitors in new cholesterol guidelines it released in November. The new guidelines recommend that the drugs be used alongside statins for certain high-risk heart patients who are having trouble lowering their levels.

But doctors and patients are still struggling to access these new drugs, and cost is the barrier, said Dr. Suzanne Steinbaum, director of Women's Cardiovascular Prevention, Health and Wellness at Mount Sinai Hospital in New York City.

"I can't get these medications covered by insurance. There are these amazing tools out there to help us, but unless we figure out insurance coverage and cost, it's irrelevant," Steinbaum said.

Kazi's team did a cost-effectiveness analysis on Praluent based on results from the latest clinical trial of the drug, known as the ODYSSEY Outcomes trial.

The researchers said that its price would have to be reduced by 86 percent to be considered cost-effective for treating "bad" LDL cholesterol.

That amounts to an annual price tag of $874 to $2,311, depending on the drug regimen against which Praluent is being compared, the study authors concluded.

Such a cost cut would be "unprecedented" for biologic therapies in the U.S. market, they noted.

Results of this analysis were announced in March with release of the ODYSSEY trial results, prompting the subsequent price cut by Regeneron.

"We're excited that having done this analysis in a timely manner might have contributed to this price reduction," Kazi said.

Regeneron said its own analysis concluded that Praluent is cost-effective at a yearly price range of $6,319 to $9,346 for people with serious heart problems, and at $13,357 to $19,805 a year for heart patients whose cholesterol resists treatment by other medications.

"These results are well within the current price range paid for Praluent in the U.S., and aligned to our March announcement to lower the Praluent U.S. net price to between $4,500 and $8,000 to payers who would allow for more straightforward, affordable patient access," the company's statement said.

Ultimately, the market will decide whether the price is low enough, Kazi said.

"It's important to measure how patients and doctors respond to these pricing changes," Kazi added. "Are patients actually able to get the drug? Are they able to take the drug in the long run? Because it's not helpful if people start the drug and then stop it because it's expensive or out-of-pocket costs are too high."

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