ST. LOUIS, Oct. 6, 2015 /PRNewswire/ -- To ensure clinically appropriate, cost-effective use of two new cholesterol-lowering drugs, Express Scripts (NASDAQ: ESRX) today announced it will include both Praluent™ and Repatha™ on its National Preferred Formulary, the nation's largest formulary covering approximately 25 million Americans.
"As always, we make sure our patients access the right medications at the best possible price with the greatest level of care," said Dr. Steve Miller, Senior Vice President and Chief Medical Officer of Express Scripts. "Since these new medications were approved a few months ago, our pharmacy experts have worked with medical professionals and our plan sponsors to ensure these drugs are used specifically by patients who will benefit the most. We are pleased to include both drugs on our National Preferred Formulary, and to put innovative medicines within reach of patients who truly need them."
Praluent and Repatha are the first PCSK9 inhibitors to be approved by the Food and Drug Administration. Both products performed well in their initial clinical trials, and hold the promise to significantly lower LDL cholesterol levels for patients with clinical atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia. Repatha has also been approved for the rarer homozygous familial hypercholesterolemia.
Managing Utilization Appropriately
Although the clinical trials for Praluent and Repatha have been successful, little has been proven about the long-term effect of lowering LDL in this manner. For both patient safety and payer affordability, it is important to ensure this class of drugs is appropriately managed.
Prior to the launch of the first PCSK9 inhibitor, Express Scripts implemented its Cholesterol Care Value (CCV) Program, which uses rigorous clinical documentation to ensure access to the right patients, while minimizing unnecessary risks and wasteful spending. For the large majority of the more than 70 million people with high cholesterol, statins are the clinically appropriate, tried-and-true therapy.
Protecting Patients and Payers from Future Cost Increases
With a combination of discounts and a rigorous utilization management program for both Praluent and Repatha, Express Scripts' National Preferred Formulary clients collectively will spend approximately $750 million on PCSK9 inhibitors in 2016, far lower than industry forecasts. Express Scripts intends to provide additional long-term protection for its payers and patients by capping the entire plan cost in 2016 for PCSK9 inhibitors for clients enrolled in the CCV program.
"Aligned with our clients, we have achieved a more balanced marketplace, which has led to more collaborative discussions with manufacturers like Amgen, Regeneron and Sanofi, who share our interest in delivering innovative treatments to patients when clinically appropriate," said Dr. Miller. "As a result, we are confident that we have received the best price possible for both products, without needing to exclude either."
Express Scripts retains the ability to make future updates to the formulary status of the PCSK9 inhibitors based on new clinical data, additional drugs approved in this class, and the demonstrated preferences of physicians and patients.
Delivering Superior Patient 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 drugs are biologics that require self-injection once every two weeks, or monthly, it is critical that all patients who are prescribed these medications receive proper training, close monitoring and ongoing support.
Praluent and Repatha will be available to patients through the Accredo Specialty Pharmacy, where patients will have 24/7 access to PCSK9 specialist pharmacists and nurses who will help them use these injectable drugs properly, remain adherent to the therapy, and achieve optimal health outcomes.
"Our CCV Program has helped focus the use of these new drugs to those patients who benefit the most, and in the process, has already saved our clients hundreds of millions of dollars," said Dr. Miller. "By providing specialized patient care to improve adherence, predicting which patients will best respond by using the industry's most robust set of pharmacy data, and leveraging our focused scale to drive affordability, Express Scripts uniquely creates the most value for patients and plan sponsors."
About Express Scripts
Express Scripts puts medicine within reach of tens of millions of people by aligning with plan sponsors, taking bold action and delivering patient-centered care to make better health more affordable and accessible.
Headquartered in St. Louis, Express Scripts provides integrated pharmacy benefit management services, including network-pharmacy claims processing, home delivery pharmacy care, specialty pharmacy care, specialty benefit management, benefit-design consultation, drug utilization review, formulary management, and medical and drug data analysis services. Express Scripts also distributes a full range of biopharmaceutical products and provides extensive cost-management and patient-care services.