UPDATED: On to the next one: FDA approves new Gilead hep C combo pill Harvoni
UPDATE: As expected, payers and providers are already balking at the $94,500 price tag for a 12-week course of treatment. Patient advocacy groups such as the National Coalition on Health Care have already sent letters to Congress arguing that Harvoni's cost "threatens to impose staggering costs on our healthcare system" and that the cost of hep C meds on insurance plans could spike even more than they already have this year.
But Gilead got some good news from Tufts researchers over the weekend, who published an extensive meta-analysis in Health Affairs finding that high-cost specialty meds (like Sovaldi and Harvoni) offer such significant health gains and increased quality-adjusted life years (QALYs) that they may provide similar, if not better, value than cheaper traditional drugs.
- On Friday, the FDA approved Gilead's new combo hep C pill, Harvoni (sofosbuvir/ledipasvir).
- Harvoni is a dual therapy that supplements the active ingredient in Sovaldi (sofosbuvir) with the new compound ledipasvir, and thus eliminates the need to concurrently treat patients using Sovaldi with interferon and ribavarin. It is a once-daily, single oral pill.
- Gilead spokespeople said that a 12-week treatment regimen of Harvoni will cost $94,500, but that many patients would only require an 8-week regimen, which will cost $63,000. It's important to note that Sovaldi will still be an essential treatment option since Harvoni may only be used on HCV genotype 1 patients.
There was widespread anticipation that Harvoni would be approved in early October, and the FDA did not disappoint. As the agency noted in its press release, this is the third major HCV drug to be approved in the U.S. since the fall of 2013—a stunning amount of progress for a disease that previously needed constant treatment and often led to kidney failure.
“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.
“Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”
Cost concerns over Sovaldi and Harvoni are likely to persist. This week, documents from government officials in the UK indicated that NHS executives believe the price of Sovaldi to be prohibitively high. But some advocates have suggested that the pricey pill is worth the cost considering its stunning 90% cure rate.