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Pricey new cholesterol Rx covered by big drug plan, but...

The nation's largest pharmacy benefits manager announced late Tuesday that it will include two new, very expensive cholesterol drugs on its list of covered drugs next year — but also has a plan to prevent the medications from busting budgets.

Express Scripts headquarters in St. Louis.
Whitney Curtis | Bloomberg | Getty Images
Express Scripts headquarters in St. Louis.

Express Scripts said it will control costs from the medications through a combination of discounts from their makers, and restrictions on who can use them. Also, it will cap the amount per member that a pharmacy plan sponsor will spend on the injectable, cholesterol-lowering drugs, called Praluent and Repatha, in 2016.

Praluent has a wholesale price of $14,600 per year. Repatha's wholesale price is $14,100 per year.

The company did not reveal at what amount it would cap spending on the medications by plan sponsors, but said Express Scripts would cover the cost of the drugs for plan sponsors beyond that threshold.

"We aren't going to allow it to bust their budget," said Dr. Steve Miller, senior vice president and chief medical officer of Express Scripts, who noted that plan sponsors had told his company "they were extremely concerned" about the potential cost impact from the drugs.

Miller said Express Scripts is also putting limits on how much the companies can increase the price of the drugs and expect to get reimbursed.

The pharmacy benefits manager is pursuing a similar strategy for other drugs it covers, and is getting to a point where "a high percentage of our total spend is covered by inflation protection," Miller said.

Express Scripts said that clients of its National Preferred Formulary will collectively spend next year about $750 million on the two drugs, known as PCSK9 inhibitors. That amount is "far lower than industry forecasts," according to the company Express Scripts' National Preferred Formulary covers about 25 million people.

The company did not disclose the discounts it obtained for Praluent, which was developed by Regeneron Pharmaceuticals and Sanofi, or for Repatha, which is made by Amgen.

But Miller said Express Scripts held "collaborative discussions with" the manufacturers, "who share our interest in delivering innovative treatments to patients when clinically appropriate."

"We've negotiated for what we think is a favorable price," Miller said. "We are confident that we have received the best price possible for both products, without needing to exclude either."

In a recent report, the Institute for Clinical and Economic Review (ICER) said that an analysis of the drugs' benefits "indicate that the price that best represents the overall benefits these drugs may bring to patients would be between $3,615 and $4,811," which would represent up to a 75 percent discount off the list price of Praulent.

Asked about that analysis, Miller said: "We used the ICER report in our negotiations. Did we receive the ICER price? The answer is no, we didn't."

Still, "we believe that for at least 2016 that we have a very good idea that this should be well-absorbed in the budgets of our plan members," he said.

Even before both drugs were approved by the Food and Drug Administration and their wholesale prices were announced, analysts had warned that the PCSK9 inhibitors could lead to significantly higher spending by insurance plans because of their potential use by millions of patients with high cholesterol levels. Express Scripts itself has voiced fears that annual U.S. spending on the new types of drugs could top $100 billion annually.

"Even if physicians adopt this new therapy slower than anticipated, it is clear that PCSK9 inhibitors are on a path to become the costliest therapy class this country has ever seen," Miller wrote in a blog post at the time.

The FDA approved the drugs for heart disease patients who cannot tolerate more levels of statins, the traditional cholesterol-lowering medications, as well as for people with a condition known as heterozygous familial hypercholesterolemia. Since then, pharmacy benefit managers have tried to control costs of the new drugs by limiting use to the approved patient population, which Miller had said two months ago would be in the range of 8 million to 10 million people nationally.

Express Scripts has started a "Cholesterol Care Value Program," which the company said uses "rigorous clinical documentation to ensure" the "right patients" get access to the drugs, "while minimizing unnecessary risks and spending."

The company also said that for a large majority of the more than 70 million people with high cholesterol, the traditional treatment of statins is "the clinically appropriate, tried-and-true therapy."

Last week, Express Scripts Vice President Everett Neville told Reuters that his company and insurers "had rejected a surprisingly high number of prescriptions for the two injectable drugs" because patients either didn't qualify or failed to produce required documentation. He also said the PCSK9 inhibitors would not be "budget-busters," Reuters reported.

Anthony Hooper, executive vice president of global commercial operations at Amgen, said, "Ensuring access to Repatha for appropriate patients is among Amgen's highest priorities."

"We are delighted that Express Scripts has chosen to preserve physician and patient treatment choice for patients who need intensive and predictable LDL lowering. This is an important milestone for patients. We will continue to engage constructively with other payers to enable patients to have access to Repatha," Hooper said.

In joint statement, Sanofi and Regeneron said they "are confident in the value that Praluent ... injection provides to appropriate patients and the overall health-care system, and are pleased that patients in the U.S. now have increased access to Praluent."

"We are committed to ensuring appropriate patients can access medicines that improve their health, and we are dedicated to establishing agreements with insurers to help achieve that goal," Sanofi and Regeneron said.