While precise pricing information was not released, net pricing will be within the cost-effective ranges set by the Institute for Clinical and Economic Review.
Alirocumab, marketed as Praluent by Sanofi and Regeneron, will soon cost much less for patients who buy the cholesterol-fighting drug through Express Scripts, under a deal that will end paperwork delays and presumably boost access to the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. Tuesday’s agreement, which takes effect July 1, 2018, will make alirocumab the exclusive PCSK9 inhibitor on Express Scripts’ National Preferred Formulary.
Amgen’s evolocumab (Repatha), the other FDA-approved PCSK9 inhibitor, has suffered similar access problems, according to leading cardiologists and studies presented since the 2 injectable drugs were approved a month apart in 2015. Both drugs lowered low-density lipoprotein (LDL) cholesterol up to 60% in clinical trials, but neither experienced anticipated sales after being priced above $14,000, once payers and pharmacy benefit managers made it clear they would set strict criteria for who would get them.
For alirocumab users, this should change with today’s agreement. Physicians who prescribe alirocumab through Express Scripts need only sign an attestation that patients meet FDA-approved criteria—either a history of clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (FH)—and that they cannot achieve safe levels of LDL cholesterol even while taking maximally tolerated statins.
The drug makers and Express Scripts also announced that a portion of the manufacturer’s rebate will be passed directly to the consumer to lower out-of-pocket costs, in what drug company officials agree is a sign of the times. Earlier this year, Optum Rx, which is owned by UnitedHealth, announced a similar move to pass rebates directly back to consumers, which was immediately praised by FDA Commissioner Scott Gottlieb, MD, as a way to lower prescription drug prices.
The agreement comes less than 2 months after the drug makers presented data at the American College of Cardiology (ACC)’s 67th Annual Scientific Session & Expo that showed cardiovascular (CV) benefits for patients taking alirocumab, particularly those who started the drug with LDL cholesterol levels above 100 mg/dL.
When the ODYSSEY Outcomes showed an overall CV benefit of 15% for major adverse cardiac events, Sanofi and Regeneron simultaneously unveiled an updated analysis by the Institute for Clinical and Economic Review (ICER) that set value-based benchmarks at which the net price of the drug could be cost-effective. For patients who had already suffered an acute coronary event and met clinical trial criteria, ICER suggested a range of $2300 to $3400 a year; for other higher-risk patients with LDL cholesterol levels above 100 mg/dL with statin therapy, the suggested range was $4500 to $8000.
“This paradigm-shifting agreement is designed to break the gridlock so that Praluent is finally able to reach patients most in need,” said Leonard S. Schleifer, MD, PhD, president and chief executive officer of Regeneron, in a statement emailed to The American Journal of Managed Care® (AJMC®). “US cardiologists have experienced unprecedented challenges in securing access for Praluent for patients who were clearly appropriate, but were denied coverage. This agreement sets a new standard in industry and payer collaboration that we hope will serve as a model for how to make innovative medicines more accessible and affordable.”
In an interview with AJMC®, Sheldon Keonig, senior vice president, Global Head of CV Franchise for Sanofi, declined to give precise pricing information but said they will be within the ranges set by ICER. He said while the attestation requirement is open to all physicians, it is expected that most prescriptions will be written by cardiologists because of the patient population involved.
According to information from the drug makers, while the LDL cholesterol criteria for each payer are different, Express Scripts’ criteria for ASCVD will be >70 mg/dL or >100 mg/dL for heterozygous FH.
Mike Susserman, vice president for the Cardiometabolic and Ophthalmology Business Unit at Regeneron, said in the interview that the new strategy addresses the chief complaint among cardiologists, which has come up in meetings with the professional societies. Over the past 2 years, leaders in the field have spoken bitterly during presentations of studies on PCKS9 inhibitors of being unable to get these drugs for their patients—not even those with FH—despite spending weeks sending reports and following up.
Studies presented at ACC and the American Heart Association Scientific Sessions 2017 bore out their complaints and found that, in fact, cardiologists as a group had more success than endocrinologists or primary care physicians. At the most recent ACC meeting in March, Valetin Fuster, MD, of Mount Sinai, the longtime editor in chief of the Journal of the American College of Cardiology, said there was no justification for the problems he and his colleagues were experiencing. Of the payers, he said, “They try to make the patient ineligible.”
Susserman said that more payers are talking about directing manufacturers' rebates toward the consumers who are paying for the drugs, instead of spreading the rebates across the premium base.
“It seems like it’s a real trend,” he said. “We’re very much in support of that.”