Regeneron Pharmaceuticals and partner Sanofi have cut an unusual deal with Express Scripts, the nation’s largest drug-buying middleman. The two drug makers will cut the price of their $14,000-a-year cholesterol-lowering therapy alirocumab (Praluent). In return, Express Scripts will quickly approve treatment requests. The deal also sidelines Amgen, whose rival heart drug evolocumab (Repatha) will no longer be an option for the 25 million Americans whose health plans use Express Scripts for their prescription-drug negotiations.
The deal marks a major drug-buying decision by the nation’s largest pharmacy benefit manager (PBM), a type of middleman that wields significant influence over drug prices. Express Scripts and its peers, such as CVS Health, say they are crucial in lowering high prices, while the drug industry and other critics say the PBMs add costs to the system by taking their own cut of every transaction.
Regeneron (NASDAQ: REGN) and Sanofi (NYSE: SNY) say this morning that effective July 1, they will cut the net price of alirocumab (Praluent) in return for “straightforward, affordable access” to the drug from the pharmacy benefit manager Express Scripts (NASDAQ: ESRX), which processes prescriptions and negotiates prices with drugmakers. Without divulging the specific number, Express Scripts chief medical officer Steve Miller says the new net price will be “close to the low end” of the annual price range—$4,500 to $8,000-per year—that the nonprofit drug-price watchdog Institute for Clinical and Economic Review (ICER) recently said alirocumab was worth.
To ensure quick access, physicians will only send Express Scripts answers to answer a handful of questions about a patient who needs therapy. Miller says Express Scripts should answer within a day. Doctors typically have had to provide “books of documentation” including laboratory reports and wait a month or two before an alirocumab prescription is approved, says Sheldon Koenig, the head of Sanofi’s cardiovascular franchise.
Because of the arrangement, patients’ out-of-pocket costs will come down by “about a third,” Miller says. Depending on the health plan, a patient’s copay for an alirocumab prescription might be $100 compared to $150, for instance, Miller says. “You’ll see a pretty dramatic decrease of what comes out of your pocket,” he says.
When the deal takes effect in July, Express Scripts will remove Amgen’s (NASDAQ: AMGN) evolocumab (Repatha), the only other approved drug in alirocumab’s class—known as PCSK9 inhibitors—from its natural preferred formulary, which covers about 25 million Americans. (A formulary is a list of drugs the company’s health insurer members agree to pay for.)
Amgen’s drug is being removed for two reasons, Miller says. First is the new, lower price of alirocumab. Second are the long-term results for the two rival drugs in tens of thousands of patients. Regeneron revealed in March that alirocumab lowered the risk of heart attacks, strokes, and death for people with high cholesterol who have recently suffered heart attacks or strokes and are at risk of more cardiac events or death. In a similar study that Amgen reported last year, evolocumab lowered the risk of heart attacks and strokes, but not death.
“We’ve chosen to make what we think is the best drug exclusive,” Miller says. “And it [should] drive the price down much further because it gives [Regeneron and Sanofi] more market share.”
In an e-mailed statement to Xconomy, Amgen spokesperson Kristen Davis said the company is “disappointed” with the decision and that it impacts about 2,000 people currently on evolocumab. But she added that the change doesn’t affect many other Express Scripts patients whose health plans aren’t part of the formulary. For those patients, Amgen will continue to offer “significant discounts and rebates…in exchange for improved patient access” through Express Scripts.
Express Scripts has played hardball on drug prices in the past. It was a very vocal critic of the price Gilead Sciences (NASDAQ: GILD) slapped on its hepatitis C drugs sofosbuvir (Sovaldi) and sofosbuvir-ledipasvir (Harvoni). It eventually removed Gilead’s drugs from its formulary in December 2014 when a similar, less expensive drug from AbbVie (NYSE: ABBV), Viekira Pak, came along. (The two drugs were re-added in 2017.)
Express Scripts warned of the high costs of the PCSK9 inhibitors when they were approved in 2015 and their owners announced prices of $14,000 a year per patient. In an August 2015 blog, Miller wrote that PCSK9 blockers, which have a striking ability to lower LDL-C or “bad” cholesterol, could become “the costliest therapy class our country has ever seen.”
But it hasn’t played out that way, because payers like Express Scripts have made it very hard to get the two drugs. Their sales have been meager compared to Wall Street’s initial multi-billion dollar projections; alirocumab tallied $194 million last year worldwide, evolocumab $319 million.
Problems with patient access have been documented in numerous studies. Cardiologists interviewed by Xconomy earlier this year said the drugs are almost always rejected upon first request.
Insurers had been waiting for evidence that alirocumab and evolocumab could cut the risk of heart attacks and death. Those data have arrived the past two years, and both companies have tried to use them to spur reimbursement. However, cardiologists have questioned the magnitude of the benefit in each study.
Amgen has kept its roughly $14,000 list price in place while offering insurers refunds for patients who have heart attacks or strokes despite taking evolocumab. The FDA has since updated evolocumab’s label; it hasn’t yet done the same with alirocumab.
Regeneron was late, reporting its long-term Odyssey Outcomes data a year after Amgen. To counterpunch, it said it would cooperate with the drug-pricing watchdog ICER. Handing the Odyssey data to ICER ahead of time, it asked for a price recommendation and vowed to fall in line if insurers and other health plan providers, such as large employers, agreed.
The Express Scripts deal is the first agreement to come from the ICER plan. Mike Suesserman, the VP of Regeneron’s cardiometabolic and ophthalmology business, says the company is currently in “similar negotiations” with other national and regional payers.
Drug pricing remains a hot button topic in Washington, with President Trump repeatedly vowing to cut the cost of prescription drugs. A postponed speech on the matter is now expected on May 6. Today’s agreement marks a “continued evolution” of the national dialogue, Miller says, citing how Regeneron voluntarily worked with ICER.
“We are already in discussions with others about doing things similar to this,” Miller says. “We think this is a great model as we go forward.”