On July 24th, the FDA approved Praluent™ (alirocumab) for certain patients with high cholesterol. This is the first of the so-called PCSK9 inhibitors to reach the U.S. market.
Praluent has performed very well in its initial clinical trials, and it promises to significantly lower LDL cholesterol levels for patients with heterozygous familial hypercholesterolemia (HeFH) or with clinical atherosclerotic cardiovascular disease (ASCVD).
Estimating Patient Population and Total Costs
Sanofi and Regeneron, the makers of Praluent, have announced a list price of $14,600 per patient per year – which is more than 50 times higher than the annual price of the generic statins that are currently being used to treat the majority of these patients.
It is estimated that between 5 to 10 million Americans currently live with HeFH or clinical ASCVD. While it is not reasonable that all of the patients will seek treatment in the next one or two years, the total annual cost burden of this therapy for U.S. payers and patients could eventually grow to more than $100 billion each year, if not managed properly. At those numbers, PCSK9 inhibitors would represent a potential 30% increase to the $374 billion the U.S. spent on all prescription drugs last year.
Additional clinical trials are underway for PCSK9 inhibitors that ultimately may expand the target patient population in 2017, further increasing this potential cost burden. 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.
The announced price for Praluent is on the high end of what we were expecting. We will work hard over the next month – at which time a competitive PCSK9 inhibitor, Amgen’s Repatha™ (evolocumab), is expected to be approved by the FDA – to achieve the best possible price for the patients and payers that we represent.
Managing Utilization Responsibly
In the immediate term, we will cover Praluent for those patients for whom the drug is clinically appropriate. Later this year, once our national Pharmacy & Therapeutics (P&T) Committee has had an opportunity to thoroughly review both Praluent and Repatha, we may make additional formulary updates.
Although the clinical trials for Praluent have been successful, it should be noted that these trials have been short-term, and little has been proven about the long-term effect of lowering LDL in this manner. For both patient safety and payer affordability, it will be important that the healthcare industry ensure that this class of drugs is managed appropriately.
Express Scripts recently launched to our clients our Cholesterol Care Value ProgramSM (CCV), which uses a rigorous clinical documentation process to preserve access to the right patients, while minimizing unnecessary risks and wasteful spending. Through this program, we anticipate that we will be able to prevent up to 90% of potential cost increases among cholesterol medications for participating plan sponsors.
Ensuring the Best Possible Care
PCSK9 inhibitors rely on a mechanism of action and administration that will likely be unfamiliar to these patients who are used to taking a once-a-day pill to manage their cholesterol levels. Since Praluent is a biologic drug that will need to be self-injected once every two weeks, it is critical that all patients who are prescribed this medication receive proper training, close monitoring and ongoing support.
Praluent will be available to patients through Express Scripts’ Accredo Specialty Pharmacy, where we will surround these patients with PCSK9 specialist pharmacists and nurses who will help them use these injectable drugs properly, remain adherent to the therapy, and achieve optimal health outcomes.
As always, our intention is to provide the right patients access to the right medication at the best possible price and with the greatest level of care.
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