CVS to Wait for 2nd Approval Before Seeking Prices on PCSK9 Inhibitors

The move comes after Sanofi and Regeneron spent $67.5 million to move ahead of the main competitor in the FDA approval process.

The nation’s second-largest pharmacy benefit manager (PBM) today said it will wait until there is competition in the US market for PCSK9 inhibitors before setting prices for the new class of cholesterol-fighting drugs, with its chief medical officer telling Reuters that “all bets are off” after the first therapy came in at a price well above expectations.

“It’s smart to wait and see what the competitor medication looks like in terms of what the FDA label is,” Troyen Brennan, MD, chief medical officer at CVS, told Reuters. The wholesale price of $40 a day, or $14,600 a year set by Sanofi and Regeneron, means that CVS is making no predictions on what type of patients will be given the drug prior to its negotiations, Brennan said.

CVS’ move comes after Sanofi and Regeneron spent $67.5 million to be first in line for FDA for alirocumab, to be marketed as Praluent, which received FDA approval on July 24, 2015. The drug’s sponsors purchased a voucher from an orphan drugmaker based on alirocumab’s indication for familial hypocholesterolemia, a relatively rare genetic condition. But the millions paid to move ahead of Amgen’s evolocumab, which has an approval deadline of August 27, 2015, was based on the potential for the drug to eventually be used to treat millions of patients who cannot tolerate statins or lower their cholesterol with other therapy.

For now, however, FDA’s label is more limited: US regulators did not go as far as those in Europe went in approving Amgen’s evolocumab, to be marketed as Repatha. In the United States, alirocumab is approved only for those limited numbers of patients with demonstrated heart disease who cannot control cholesterol through diet while at the maximum statin dose.

It is expected that all PBMs will have strict criteria for who gets access to PCSK9 inhibitors, the monoclonal antibodies that were demonstrated in clinical trials to lower cholesterol levels as much as 60%, both alone and in combination with metformin. The fear among health plan leaders and PBMs, however, is that unlike other high-priced drugs to hit the market in recent years, this new class will stand apart because they could replace a low-cost stand-by with a high-cost drug that could be used for an indefinite period of time.

Brennan told Reuters that CVS will have a management program that will examine patient history of heart disease and diabetes, cardiovascular risk factors, and the patient’s history and experience with using statins.

The interview with Reuters coincides with a commentary published today in JAMA by William Shrank, MD, MSHS, CVS chief scientific officer and a frequent contributor to The American Journal of Managed Care. Shrank said that current guidelines published by the American College of Cardiology and the American Heart Association, which were just updated in 2013, do not, “provide clarity as to how these expensive new medications could fit in the treatment paradigm, potentially resulting in some scenarios where a prescriber could consider a PCSK9 inhibitor for a low-risk patient.”

“There is a need for consensus around management strategies for patients with high cholesterol, given that the cost differential between proven older therapies and this new class of drugs is substantia,” Shrank said. “In fact, if used broadly, PCSK9 inhibitors would likely be the most costly class of medications we have seen thus far.”

The 2013 ACC/AHA guidelines update resulted in recommendations that increased the likelihood that more patients might be recommended for statins; at the time, statins were the most popular treatment option available, including high-dose options for patients at elevated risk.

After the experience with Sovaldi, the cure for hepatitis C, PBM leaders have been determined to hold firm against aggressive pricing for the PCSK9 inhibitor class. Many pushed back against the $14,600 annual price tag, since the expected annual cost was between $7000 and $12,000 a year.