FDA clears shorter treatment regimen for AbbVie's hep C treatment, Mavyret. Will patients benefit?
AbbVie $ABBV has obtained FDA approval to administer its Mavyret hepatitis C pill as a two-month regimen, versus the 12-week course it was originally cleared for — a move that may help expand options for the margin of covered patients who need a shorter regimen.
“While over 100,000 patients have been prescribed Mavyret for chronic HCV in the US, there are still a significant number of patients that need options,” Janet Hammond, AbbVie’s vice president of general medicine and virology therapeutic area, said in a statement.
Vincent Lo Re, a University of Pennsylvania School of Medicine professor specializing in hepatitis, told Endpoints News that the raft of treatments approved since 2014 have been quite effective in curing the disease in most patients. Those who continue to suffer do so for a variety of reasons: alcoholism, drug abuse, mental health problems or a combination of these, making it an uphill task to complete the 12-week regimen.
This category of patient, therefore, could benefit from the shorter 8-week treatment period, he said.
“The reality is that we’ve treated many patients who have been waiting for hepatitis C therapy,” he said. “The patients that are now often presenting for evaluation and consideration for treatment often have many other co-morbidities, social challenges that make even once-daily therapy difficult to adhere to.”
Mavyret debuted in August 2017 as the cheaper alternative to Gilead’s $GILD blockbuster-yet-wallet-busting Sovaldi, which came in at $84,000 for a three-month regimen. Still, AbbVie’s option costs $13,200 per 4-weeks or $26,400 for 8-weeks and so on (at the time some forms of the virus were cured within that timeframe, others after 12 or 16 weeks).
Many insurers were willing to pay the price of these treatments, as it saved money in the long run, but some plans such as Medicaid were unable to provide it to their patients due to financial constraints. The disease has now become a lightning rod in the ever-heating debate around innovation and access — both an example of the kind of curative therapies the current R&D system can produce and the high costs that tend to deny access to those most in need.
“I would never have thought, ever, in the ’90s, that if somebody came up with a cure for hepatitis C, that people wouldn’t be able to be treated. That was inconceivable,” CDER chief Janet Woodcock told the Breakthroughs in Medicine Conference this month. “But fast-forward to now, and that’s the reality we’re seeing.”
But others have pointed to the hep C cure as an example of the American system at work, with Gilead actually offering the drug for less than they and independent researchers said would maximize their profit.
Following models first introduced abroad, drug companies have recently turned toward innovative methods of making their products available while maintaining profit margins. Gilead and AbbVie have each signed “Netflix” style agreements with Louisiana and Washington, respectively, to deliver essentially unlimited quantities of the drug to prison and Medicaid patients for a flat rate from the state. These models may not lead to lower prices for the state government but do provide cost certainty. Other states may follow suit.
Exact statistics are hard to come by and the field is changing with each drug and pricing development, but a 2018 Open Forum Infectious Disease study found 35% of 9,025 tracked patients were prescribed an HCV cure but then denied coverage. Those with private insurance were the most likely to be denied.
“Unfortunately for many patients,” wrote another group of researchers this year in the American Journal of Medicine, citing the OFID study among others, “their state of residence is the decisive factor for whether they will receive lifesaving treatment.”
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