How Express Scripts will manage pricey cholesterol drugs

After much criticism on the price of 2 new cholesterol-lowering drugs, Praluent and Repatha, Express Scripts said this week it will now include both drugs in its National Preferred Formulary.

Express Scripts’ formulary is the nation’s largest, covering approximately 25 million Americans. Praluent and Repatha are the first PCSK9 inhibitors to be approved by FDA.

“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,” said Steve Miller, senior vice president and chief medical officer of Express Scripts.

Recently, Express Scripts’ executives said that the PBM and insurers had rejected a high number of prescriptions for the 2 injectable drugs. “Both of these products have a list price in excess of $14,000 per year. Also, the manufacturers are still awaiting long-term clinical trials about the eventual effect of lowering LDL levels in this manner,” David Whitrap, spokesperson for Express Scripts, told FormularyWatch. “We are rejecting claims on the 2 drugs when there is insufficient evidence that a PCSK9 inhibitor is the clinically appropriate drug for that patient.”

Conversely, there is a lot of data on the long-term safety and effectiveness of statins, “which are largely generic and affordable,” Whitrap said. “For both patient safety and payer affordability, it is critical that the PCSK9 inhibitors only be provided to patients when it is clinically appropriate to do so – consistent with the FDA guidance and the protocols recommended by the manufacturers themselves.”

To that end, 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,” the PBM said in a statement.

NEXT: Express Scripts' clients may spend less on PCSK9 inhibitors

With a combination of discounts and a rigorous 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,” Miller said. “As a result, we are confident that we have received the best price possible for both products, without needing to exclude either.”

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, according to Express Scripts.