Anthem Won’t Cover $300K Duchenne Drug, Citing Doubts About Treatment’s Efficacy
“The clinical benefit … has not been demonstrated," Anthem said.
Stat:
Anthem Declines To Cover Sarepta Drug For Duchenne, Citing Doubts Over Data
One of the nation’s largest health insurers has decided not to cover a controversial Duchenne muscular dystrophy drug after raising doubts about clinical trial data that regulators relied on to approve the medicine last month. In a bulletin issued to clients on Friday, Anthem reviewed the results from various studies and concluded that Exondys 51, which is sold by Sarepta Therapeutics, is “not medically necessary” and that “the clinical benefit … has not been demonstrated.” Duchenne is a rare disease that confines boys to wheelchairs and condemns them to an early death. (Silverman, 10/7)
Morning Consult:
Anthem Declines To Cover New Drug For Duchenne Muscular Dystrophy
Anthem said on Friday that it has decided not to cover a new drug aimed at treating Duchenne muscular dystrophy, citing concerns about a lack of data regarding how the treatment would improve health outcomes. The insurer, one of the largest in the country, said it won’t cover Exondys 51, a drug manufactured by Sarepta Therapeutics to treat the genetic disorder, which affects about one out of every 3,600 male infants. The treatment was approved by the Food and Drug Administration last month under an accelerated approval pathway, but Sarepta must complete a clinical trial to confirm the drug’s benefits. (McIntire, 10/7)
Boston Globe:
Sarepta Stock Hit After Anthem Says It Won’t Cover Duchenne Drug
Anthem Inc. said Friday it would not cover the cost of the first drug approved to treat Duchenne muscular dystrophy, a surprising move by one the nation’s biggest insurers that pushed down the stock of Sarepta Therapeutics Inc., the Cambridge company that makes the treatment. The Indianapolis-based insurer, which has about 40 million members, questioned the effectiveness of the new medicine, citing a Food and Drug Administration statement saying that “a clinical benefit has not been established.” The FDA approved the drug, called Exondys 51, last month despite an internal dispute over its benefits. (Weisman, 10/7)
In other pharmaceutical news —
The Wall Street Journal:
Insulin Prices Soar While Drugmakers’ Share Stays Flat
Insulin prices are soaring, creating pain for patients whose lives depend on the injectable drug—yet most of the revenue from the increases isn’t going to the drug manufacturers. It is largely the middlemen that benefit. The major manufacturers of insulin— Eli Lilly & Co. of Indianapolis, Novo Nordisk A/S of Denmark and Sanofi SA of France—are collecting about the same or less than they did several years ago. (Roland and Loftus, 10/7)
Check out KHN's past coverage on the drug pricing pipeline: Tracking Who Makes Money On A Brand-Name Drug.
Stat:
The Race To Create A New Class Of Ovarian Cancer Drugs Heats Up
Ovarian cancer has historically been one of the harder cancers to treat — but a promising new class of drugs, called PARP inhibitors, is proving powerful in delaying the growth of tumors by preventing cancer cells from repairing themselves after they’ve been damaged by chemotherapy. In recent days, the researchers behind three PARP drug contenders threw down preliminary data during the European Society for Medical Oncology conference in Denmark. (Keshavan, 10/8)