From the “Tell me something I don’t already know department”!

Coverage denials by payors are the main factor in a dramatic rise in failure to start hepatitis C drug treatment over the past three years, according to new data released March 8 by Trio Health, which has collected real-world evidence on 15,000 HCV patients since the launch of the direct-acting antiviral agents (DAAs) in 2014.

As of 2016, more than one-third of patients prescribed DAA treatment for hepatitis C did not receive therapy, according to the report.

Trio Health, a care-quality improvement company, estimated that in 2014, about 154,000 patients started DAA therapy for HCV, while another 12,281 were prescribed the treatment but did not initiate it, for a nonstart rate of 7%. In 2015, there were 256,000 starts and 55,492 nonstarts, for an 18% nonstart rate. By 2016, starts had dropped to 211,000 while nonstarts had climbed again, to 125,008—resulting in a nonstart rate of 37%.

Increasing nonstart rates were observed regardless of disease severity, Trio found. Between October 2015 and September 2017, nonstart rates for patients with no to moderate liver disease (F0-F2) climbed from 27% to 37%, whereas nonstart rates for those with severe to cirrhotic disease (F3-F4) increased from 15% to 24%.

As for the link between those nonstarts and coverage determinations, the Trio report noted that beginning in April of 2014, state Medicaid plans began to implement restrictions on DAA coverage based on factors such as liver fibrosis scores. Almost immediately, the non-start rate increased, jumping from 8% for Medicaid patients in March of 2014 to 46% in April and 56% in May. The move, the authors noted, was likely triggered by the market entry of the first DAA, sofosbuvir (Sovaldi, Gilead), in December 2013.

“There are no other disease states that I’m aware of where curative therapies are increasingly withheld from patients who are covered by commercial insurance plans, Medicaid or Medicare,” said Nezam Afdhal, MD, a professor of medicine at Harvard Medical School, in Boston, and the chairman of Trio Health’s Scientific Steering Committee, in a statement. “What is most surprising is that this trend is growing even though treatment cure rates are now above 90%, duration of therapy has been reduced to as little as eight weeks for the majority of patients, and real treatment costs are one-third lower than just a few years ago.”

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