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Successfully prescribing the PCSK9 inhibitor alirocumab (Praluent) could get much easier for millions of patients, as Sanofi and Regeneron announced a deal with the nation's largest pharmacy benefits manager, Express Scripts.
Effective July 1, 2018, the companies will lower the net price (wholesale minus discounts) for Express Scripts' to within the price point set by the Institute for Clinical and Economic Review for cost effectiveness -- $4,500 to $8,000 per year for higher-risk patients with LDL ≥100 mg/dL despite intensive statin therapy.
In exchange, Express Scripts will make alirocumab the exclusive PCSK9 inhibitor for about 20 million commercially-insured people under its National Preferred Formulary. And, the benefits manager will replace the current burdensome prior authorization process with a simpler "attestation" by the physician that the prescription is appropriate based on the FDA-approved indication and patient history. Submitting laboratory results and detailed patient history will no longer be required.
The simplification isn't just for patients with LDL cholesterol >100 mg/dL at baseline, noted Sheldon Koenig, senior vice president and global head of of Sanofi's CV Franchise.
Rebates and discounts among pharmaceutical companies, pharmacy benefits managers, and insurers are nothing new. But "this is the most public we've ever been with a process like this," Sheldon told 鶹ý. He called it "significant progress" on a real challenge for physicians and patients.
Beyond just getting the prescription approved, many physicians have seen the PCSK9 prescription abandoned once patients found out the copay. The copay can range from $50 to 20% or 30% of the drug price.
The deal struck with Express Scripts will also add rebates to patients, starting July 1 as well.
"For the first time, patients will receive drug-specific rebate savings at point of sale," a spokesperson for Express Scripts said. "For example, if someone has an average monthly copay of $150, they would save about $50."
A spokesperson for Amgen, maker of evolocumab (Repatha), the other approved PCSK9 inhibitor, said in a statement that it was disappointed in the decision that will affect about 2,000 Express Scripts patients currently on evolocumab.
However, the decision applies to only about one-third of Express Scripts business segments, the statement noted. "Amgen can still compete for the other two-thirds where we are continuing to offer significant discounts and rebates on Repatha in exchange for improved patient access."
Amgen has been "aggressively" negotiating similar deals with several other payers, it added. "We are offering significant discounts that are in line with our competitors and have multiple offers pending."