With its FDA approval this afternoon, Repatha™ (evolocumab) joins Praluent™ (alirocumab) as the first two PCSK9 inhibitors to reach the U.S. market. Both products have performed very well in their initial clinical trials, and they promise to significantly lower LDL cholesterol levels for patients with clinical atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH). Repatha has also been approved for the rarer homozygous familial hypercholesterolemia (HoFH).
It is estimated that between 5 and 10 million Americans currently live with these forms of high cholesterol. Even with their limited initial indications, PCSK9 inhibitors have the potential to grow over the next several years to become the costliest therapy class our country has seen.
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.
Lessons in Leverage Learned from Hepatitis C
Flashback to December of 2013, when the FDA approved the breakthrough Hepatitis C drug Sovaldi® (sofosbuvir), a curative but unsustainably priced therapy. We immediately announced our intention that, once a competitive product joined the market, we would leverage that competition to drive down the cost of these medications for the clients and patients we represent. Unfortunately, payers largely had to accept the list price for Sovaldi while it remained the clearly superior therapy option for the next twelve months. However, the moment that the clinically equivalent Viekira Pak™ (ombitasvir/paritaprevir/ritonavir; dasabuvir) was approved by the FDA, we fulfilled our promise by negotiating a significant discount that saved our clients more than $1 billion in 2015 and initiated an unprecedented price war in the therapy class.
Contrast that situation to what we now have with PCSK9 inhibitors, when the competitive products are receiving FDA approval one month apart from each other. While Sovaldi had a one-year head start on Viekira Pak, the back-to-back approvals for Praluent and Repatha should allow natural market competition to influence the immediate cost for the PCSK9 inhibitors. And we plan to leverage this competition to achieve the greatest possible discounts for our clients and patients.
In September, our external Pharmacy & Therapeutics (P&T) Committee is planning to review the clinical profiles of both PCSK9 inhibitors. Any formulary announcements we may make – whether to cover one or both of these products – would come after this review.
While a drug exclusion in this class remains a possibility, our preference would be that both manufacturers provide our clients favorable pricing so that it would make sense for our national formulary to cover both products. We would only exclude one of these products if our P&T Committee determines that the product we cover is at least clinically equivalent to the one we exclude. And only then would we exclude one of these products if that exclusion would deliver significant savings for our clients and patients.
Until we make a formulary decision next month, Praluent and Repatha will be available to our patients through a medical exception process, ensuring that their use is restricted only to those for whom the products are clinically appropriate and in line with the FDA recommendations.
Managing Utilization Responsibly
Although the clinical trials for both Praluent and Repatha 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.
Prior to the launch of the first PCSK9 inhibitor, Express Scripts launched 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. For the large majority of patients with high cholesterol, statins are the clinically appropriate, tried-and-true therapy, which has been used successfully by tens of millions of Americans over the past twenty years.
Through the CCV 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 both of these products are biologic drugs that will need to be self-injected once every two weeks, it is critical that all patients who are prescribed these medications receive proper training, close monitoring and ongoing support.
Both Praluent and Repatha 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.
A Value-Based Price Benchmark
The Institute for Clinical and Economic Review (ICER) has announced that, through a public and transparent review process, it will establish a value-based price benchmark for the PCSK9 inhibitors later this year. We plan to reference the findings from this independent, trusted organization in our subsequent negotiations with manufacturers to ensure that patients get to access this innovative class of drugs at a price the healthcare system can afford.
By delivering affordability, appropriate access, and specialized pharmacy care, Express Scripts puts medicine within reach for the 85 million Americans we represent.
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