June 18, 2018

Regeneron, Sanofi Cut Heart Drug's Price to Spur Greater Use

14 March 2018, 12:54 | Winifred Adams

Endpoints News

Endpoints News

The companies are specifically asking that insurers loosen restrictions only for patients at the highest risk of death-those who have had a heart attack or other serious coronary event in the past year, and whose cholesterol levels exceed the threshold recommended by doctors despite taking statins.

In a subgroup analysis of highest-risk patients - those with "bad" LDL cholesterol of 100 or above despite maximum statin therapy - Praluent significantly reduced all-cause death risk by 29 percent and risk of the adverse event composite by 24 percent.

Insurers have balked at paying for Praluent and a rival Amgen drug, which dramatically lower "bad" LDL cholesterol but carry list prices of more than $14,000 a year before discounts, over fear of the cost of use over many years by millions of patients. Importantly, no significant safety signals were seen across the study of nearly 19,000 patients. The drugmaker's cholesterol met phase 3 endpoints in results released this week, and CEO Tim Mayleben has previously said the company is planning to charge $9 or $10 per day, which would fall below the low end of the range ICER suggested for Sanofi's Praluent. Those patients responded best.

In that trial, Repatha reduced heart attack risks by 27%, stroke risks by 21% and coronary revascularizations by 22%, but it didn't provide a mortality benefit.

"The results were not trivial", said Fuster, from Mount Sinai Hospital in NY. The participants were on the highest statin dose they could tolerate and received either placebo or Praluent in addition to their statin therapy.

The findings may sway insurance companies and pharmacy benefit managers, which had urged the drugmakers to identify patients most likely to benefit.

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Speaking with FiercePharma, principal investigator Dr. Phillippe Gabriel Steg said the benefit in high-risk patients is particularly important, because it fits what "clinicians would want to do in real practice" and will allow the healthcare system to get the most "bang for the buck".

The results show for the first time that a PCSK9 inhibitor can reduce death, which is what everyone in the field was hoping to see, said Deepak Bhatt, executive director of interventional cardiovascular programs at Brigham & Women's Hospital in Boston and one of the trial's researchers. A price of $4,500 to $8,000 per year would be justified for patients with LDL over 100, the group said. "In terms of trying to be judicious with health care resources, it seems like this is the population to target".

Results were presented at the American College of Cardiology's 67th Annual Scientific Session in Orlando.

ICER said it plans to evaluate the impact of the drug in a later report, but that given the number of potential patients, which it estimated at 300,000 to 400,000 a year, "the budget impact may be substantial". Praluent's makers say they will aim for those price ranges for insurers that remove barriers to coverage for people at the highest risk.

In the high-risk group, Praluent would keep alive one of every three patients who otherwise would have died, said Elias Zerhouni, president of research and development at Paris-based Sanofi.

-With assistance from Kenneth Pringle and Ros Krasny.

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