Express Scripts sees slow 2016 sales for new cholesterol drugs

NEW YORK (Reuters) - A surge in sales of pricey new cholesterol treatments is unlikely to materialize this year, contrary to the previous expectations of Express Scripts Holding, an executive from the largest manager of U.S. drug benefits said on Friday.

Express Scripts Chief Medical Officer Steve Miller, who last year warned about the drugs’ potential cost, said his company miscalculated how many cardiologists would prescribe the potent medicines, which were approved last summer.

The new drugs, one from Amgen and another from Regeneron Pharmaceuticals in partnership with Sanofi , slash “bad” LDL cholesterol by blocking the protein PCSK9. They were approved for a small population of patients with extremely high LDL.

Express Scripts and rival CVS Health warned last year that using a wider group of patients would place too large a cost burden on the healthcare system. The drugs are priced at more than $14,000 per year, before discounts, compared with a few hundred dollars per year for statins, the standard cholesterol treatments.

Amgen did not disclose fourth-quarter Repatha sales, saying they had not been material, but said it expects growth in 2016. Regeneron earlier this week reported fourth-quarter Praluent sales of just $7 million.

“We believe that the net sales in the 4th quarter understates actual physician and patient demand,” Regeneron spokeswoman Arleen Goldenberg said in an email.

Express Scripts expects the slow take-off to continue this year, in part because doctors have not been prescribing the medicines at the rate it was expecting.

The companies have said sales were affected by issues with insurers, who were slow to cover the drugs. Meanwhile, the drugmakers have been providing free product to patients.

“Cardiologists are waiting for health outcomes data,” Miller said in an interview in New York, referring to large clinical trials to determine how much the drugs reduce the risk of heart attacks and death. Interim results are due later this year.

P.K. Shah, a cardiologist with Cedars Sinai Medical Center in Los Angeles, said many doctors are reluctant to prescribe the new drugs because of costs and lack of definitive data yet showing they prevent heart attacks

Another top cardiologist cited road blocks placed by pharmacy benefit managers and health insurers.

“The barriers the PBMs have set up to getting patients on PCSK9 inhibitors are the reason sales have been slow,” said Dr. Steven Nissen, head of cardiology at the Cleveland Clinic.

CVS Health Chief Medical Officer Troyen Brennan declined to comment on PCSK9 sales, but said its cost management in the category has been effective.

Reporting by Caroline Humer and Ransdell Pierson; editing by Bill Berkrot and Chizu Nomiyama