Watchdog group cites 7 best-selling drugs it says didn’t warrant price increases

Tecfidera, Biogen’s popular treatment for multiple sclerosis. NYT

Biogen’s blockbuster multiple sclerosis drug Tecfidera may have generated more than $4 billion in sales last year, but its benefit to patients didn’t warrant a nearly 10 percent price increase over two years.

That’s the conclusion of a Boston watchdog group that listed Tecfidera among the seven best-selling prescription drugs whose price increases in 2017 and 2018 had the biggest impact on the US health care system — but weren’t justified by new clinical evidence.

Tecfidera’s net price, after rebates and discounts by its Cambridge drug maker, went up about 10 percent in those two years, to $109 from $99 for a single 240-milligram pill, raising health care costs by $313 million, according to a report Tuesday by the Institute for Clinical and Economic Review. The drug ranked seventh among the seven drugs with the biggest effect on spending and was the only one made by a Massachusetts-based company.

“The norm in the United States has been for most pharmaceutical manufacturers to increase prices year after year — even accounting for the discounts they give insurers, and even for drugs that already sit at the top of the chart of spending for drugs in the US,” said Dr. David Rind, the institute’s chief medical officer.

A higher price might be justified if new evidence emerged showing that a drug was more beneficial than originally thought, Rind said. But that wasn’t true of the seven drugs in the group’s first annual “Unsupported Price Increase Report.”

Of all the drugs on the list, Humira, Illinois-based AbbVie’s blockbuster treatment for rheumatoid arthritis, had the biggest financial impact on the health care system as a result of its price increase, according to the report. The net price of a single 40-milligram injection rose 15.9 percent over two years, from $1,452 to $1,683, resulting in more than $1.8 billion in extra spending.

The makers of the seven drugs were consulted by the nonprofit when it prepared its report, as were representatives of patients and health insurers. The drug companies disputed the findings in sections of the 125-page document, and Biogen criticized the report in an e-mail to The Boston Globe.

Nina Varghese, a Biogen spokeswoman, said the institute excluded 28 published studies that Biogen submitted for the analysis and that “we don’t believe the report accurately reflects Tecfidera’s value in the health care system.”

But the institute countered that most of those studies weren’t of high quality, didn’t provide new information to justify a price increase, or were published too late to be considered.

AbbVie raised a similar objection about the group’s analysis of Humira, which approached $20 billion in sales in 2018. The firm said it provided more than 200 scientific publications demonstrating the effectiveness of Humira for rheumatoid arthritis and other autoimmune diseases. Humira was approved in 2002.

“Despite these being peer-reviewed publications — many of which have been presented at major medical congresses around the world — ICER determined that none of the evidence fully met the review process criteria,” AbbVie wrote.

The institute insisted that many of the studies provided no new evidence to justify a price increase.

After Humira, the medicines that had the biggest effect on health care spending, without new evidence to justify a price increase, the report said, were:

Rituxan, from Genentech, for cancer; Lyrica, from Pfizer, for pain; Truvada, from Gilead, for HIV; Neulasta, from Amgen, to stimulate white-blood-cell production; Cialis, from Eli Lilly, for erectile dysfunction; and Tecfidera.

The institute was founded in 2006 by Steven Pearson, a doctor with a master’s degree in health policy and management from Harvard University. The group has gained clout in the debate about dizzying drug prices.

Its researchers spend about eight months studying how well a medicine works and whether it might reduce other health care costs, then publicize their findings in the hopes of getting drug makers to set a fair price.

The group can only offer opinions and has no regulatory authority, but its views are increasingly garnering attention from insurers, drug makers, and advocates for patients.

In June, the Pioneer Institute, a libertarian-leaning think tank, said that the institute uses a “one-size-fits-all” approach to determine fair prices for prescription drugs. That mind-set, Pioneer said, was ill-suited for a growing wave of expensive medicines to treat rare diseases.

But Michael Sherman, a physician and chief medical officer for Harvard Pilgrim Health Care, the state’s second-largest private insurer, told the Globe the same month that the watchdog group is an umpire judging whether medicines are worth their prices.

“As we come to the realization that we don’t have an unlimited global budget, it becomes more important to have some objective metric that we can point to,” he said.