Sanofi and Regeneron Pharmaceuticals Inc. won U.S. approval for a powerful cholesterol-lowering drug that will sell for almost $15,000 a year, likely escalating a nationwide debate over the cost of medicine.
The drug will be sold using the name Praluent. It’s approved for people with a genetic disease causing ultra-high levels of bad cholesterol, and for those with atherosclerotic cardiovascular disease such as heart attacks or strokes, the Food and Drug Administration said in a statement Friday.
Sanofi and Regeneron had sought to sell the drug to people whose ultra-high cholesterol levels aren’t inherited. Along with Amgen Inc. -- whose competing drug could be approved next month -- they’re studying whether the medicine can prevent heart attacks, stroke and death, which could help eventually expand their use.
When Amgen’s drug comes to market, pharmacy benefit managers may pit the companies against one another, much like they recently did with hepatitis C treatments. How successful they’ll be depends on how similar the cholesterol drugs are.
“Our greatest preference, to be very clear, is to be where we are now in hepatitis, to have multiple drugs out there at affordable prices,” Express Scripts Holding Co. Chief Medical Officer Steve Miller said in a telephone interview.
The makers of the cholesterol drugs have taken a different approach than Gilead Sciences Inc., which didn’t discuss pricing before its hepatitis C drugs hit the market.
“The companies have had discussions with us about what is sustainable and what isn’t,” Miller said. Express Scripts is the biggest U.S. pharmacy benefit manager, and has been at the forefront of the pricing discussions.
America’s Health Insurance Plans, the lobby group for insurers, criticized Praluent’s cost. “The exorbitant price raises concerns as to whether consumers and the health system can sustain the long-term cost,” said Dan Durham, the group’s interim chief executive officer.
CVS Health Corp. is the second-biggest pharmacy manager, and Chief Medical Officer Troy Brennan said the pharmacy benefit manager would ensure patients have tried other drug first. Statins, like Pfizer Inc.’s Lipitor and AstraZeneca Plc’s Crestor, are the current standard treatment.
“It’s going to be very much an emphasis on evidence-based guidelines -- getting people on and keeping people on statins for people that are going to benefit and preserving PCSK9s for the rare patient that can’t use them and those that have a genetic disease,” Brennan said.
Amgen’s drug, called Repatha, is scheduled to get an FDA decision by Aug. 27. The European Union approved it Tuesday with a broader label that includes all patients with high cholesterol who aren’t able to get it under control with statins, and those who can’t tolerate statins.
Praluent and Repatha are part of a category of drugs known as PCSK9 inhibitors, designed to help patients who can’t get very high levels of bad cholesterol under control. According to the FDA, Praluent is supposed to be used along with “maximally tolerated statin therapy” and a better diet. The wording may leave room for interpretation and lead to debate between insurers and doctors.
About 6 million people in the U.S. who either can’t take or can’t adequately control their cholesterol with a statin may be eligible for Praluent, said Elias Zerhouni, Sanofi’s head of research and development.
“We’re not talking about a huge population,” Zerhouni said by telephone. “Our commercial folks have had extensive preliminary discussion with payers, trying to really understand where would be the sweet spot of maximum value, maximum access and optimal cost.”
Praluent is given in either a 75 milligram injection or 150 milligram injection. Being able to offer patients two doses will give Sanofi an edge over Amgen, which will only offer a 140 milligram dose, Zerhouni said. About 75 percent of patients reach their cholesterol targets with the lower dose, he said.
Sanofi’s American depositary receipts gained less than 1 percent to $53.54 at the close in New York. Regeneron fell 2.7 percent to $541.85. Amgen dropped 3.4 percent to $158.59, and Esperion Therapeutics Inc., which has another type of cholesterol treatment in development, plunged 21 percent to $75.91.
Praluent is expected to generate $1.1 billion in sales for Sanofi in 2018, according to analysts estimates. Repatha may bring in $1.36 billion in sales the same year.