A watchdog advisory panel, meeting at Harvard Medical School, concluded Tuesday that a new class of powerful cholesterol-lowering drugs did not offer reasonable value to most patients given their high price tags.
The panel, called the Comparative Effectiveness Public Advisory Council, also accepted the findings of a report by a nonprofit group that focuses on health costs. The report warned that two newly launcheddrugs, known as PCKS9 inhibitors, have the potential to cost the US health care system about $20 billion a year if only a quarter of the 10 million eligible patients take them.
Approved by US regulators over the summer, the injectable drugs — Repatha from Amgen Inc. and Praluent from Sanofi SA and Regeneron Pharmaceuticals Inc. — carry an average price of $14,350 annually, compared with $812 for more traditional cholesterol drugs, known as statins. The report said the price of the new drugs would have to drop by 84.9 percent to meet acceptable cost thresholds.
Council member Dr. Jason Wasfy, a cardiologist at Massachusetts General Hospital, said he is sympathetic toward the need for new cholesterol-lowering drugs because he treats heart patients, and has a history of heart attacks in his own family.
But, he said, “I just don’t know how we’re going to figure this out. . . We just have to acknowledge that the costs of these therapies are toxic to our system.”
Tuesday’s votes by the council, a group of independent medical and health authorities assembled by the watchdog Institute for Clinical and Economic Review, are not binding for the commercial and government health insurers that will be asked to pay for the new drugs. But they are likely to increase pressure on drug makers amid rising concern about the cost of prescription therapies.
“The potential use of these drugs, given the size of the eligible patient population, poses a real threat to the ability of the system to afford them,” said Dr. Steven D. Pearson, president of the Boston-based watchdog group known as ICER. The group, which convened Tuesday’s council meeting, is seeking to determine “value-based” prices for new specialized drugs.
An executive from Amgen, the Thousand Oaks, Calif., biotechnology company that markets Repatha, took issue with the ICER staff report embraced by the advisory panel that questioned the price and value of the PCKS9 inhibitors, saying there was not enough evidence to support its findings.
“Amgen welcomes a balanced discussion about value,” said Dr. Martin J. Zagari, the company’s vice president for global health economics, who contended that the report underestimated the number of heart attacks and strokes suffered by patients at risk. “We disagree with the assumptions, methodology, and conclusions of the ICER report as far as it relates to value. . . These are decisions that affect people’s lives.”
The council majority found that the new cholesterol drugs represent a reasonable value for one patient segment, those with a genetic disorder called familial hypercholesterolemia, a type of extremely high cholesterol, but not for other eligible patients who can’t tolerate statins or for whom statins don’t bring down cholesterol sufficiently.
Addressing the advisory council’s members during the public portion of Tuesday’s meeting, Cat Davis Ahmed, a South Pasadena, Calif., patient with familial hypercholesterolemia, said she feared that ICER’s focus on costs would “negatively impact patients’ access to care. . . This is a report on an economic model, not a scientific report.”
Dr. Kirsten Bibbins-Domingo, a professor at the University of California San Francisco who presented the ICER staff findings, defended the group’s analysis of the clinical and cost data, while acknowledging there were still uncertainties about the safety and effectiveness of the new drugs.
Some health insurers observing Tuesday’s discussion asked how their systems could afford the prices being charged for the new pharmaceuticals.
“The cost is astronomical,” said Rob Zavoski, medical director of the Connecticut Department of Social Services. “The question for me is, if I’m going to cover these [cholesterol drugs] for Connecticut Medicaid, what am I not going to cover?”
Dolores Mitchell, executive director of the Massachusetts Group Insurance Commission, which provides health coverage to state employees, had some pointed words for drug makers at a round-table discussion following the vote.
“As members of a society, we have obligations to one another,” Mitchell said. “Knowing there’s human beings out there who need your products, I think it’s immoral to be charging the kind of prices you’re charging.”