FDA Sued by Health Advocates Over High Cost of Harvoni

Hartford, CTIt is difficult to know what is really motivating two public health groups bent on finding out why Harvoni, the blockbuster Hep C drug, is so darned expensive. But one can assume, given a rise in denied claims and corresponding Harvoni Denied Insurance Claim Lawsuits, that Treatment Action Group (TAG) and the Global Health Justice Partnership (GHJP) can envision on the horizon a pattern of denied claims as insurance providers balk at the expense inherent to Harvoni.

The efficacy and effectiveness of Harvoni in the treatment of hepatitis C is not at issue. But its cost is: a single treatment regimen, which involves taking one Harvoni pill per day, costs $94,000. While insurance companies generally are not allowed to deny a claimant due medication as prescribed, they can seek less expensive alternatives. The problem is there is no real alternative to Harvoni other than its close cousin, Sovaldi, which is almost as expensive. That said, it leaves insurance companies with little choice but to fund the expensive medication or find creative ways to deny a legitimate claim.

Hence, the uptick in Harvoni Lawsuits. The Gilead Hep C Denied Insurance Claim Lawsuit filed by the two health advocacy groups is not tied to any specific denied claim but rather tackles the very issue as to why many such claims are denied: the exorbitant cost of Harvoni, which the plaintiffs in the lawsuit describe as “unprecedented.”

TAG and GHJP - the latter backed by the Yale School of Law - initially attempted to get to the bottom of the exorbitant price charged for Harvoni through a request for data from Gilead in November. Other pharmaceutical companies have apparently stepped to the plate, but there was no data forthcoming from Gilead.

Undaunted, the two advocacy groups next filed a request under the Freedom of Information Act with the US Food and Drug Administration (FDA) in December. TAG and GHJP would like the FDA to comment on why the costs for Harvoni and Gilead’s Sovaldi are so prohibitively high.

However, it has been reported that the FDA has yet to respond to the request, leaving TAG and GHJP little recourse but to sue. Which they have done, launching a lawsuit against the federal regulator.

“This delay will leave doctors and patients in the dark for too long,” Amy Kapczynski, a Yale Law School professor and director of GHJP, said in a statement. “Prompt disclosure of this information, which the FDA already collects, will allow doctors and policymakers to make more-informed treatment choices with real and immediate consequences for public health and spending.”

The plaintiffs claim that communication from the FDA suggested it could take up to two years to process and respond to their Freedom of Information application, without any guarantee of approval. In the meantime, patients in need of the benefits afforded by Harvoni remain at risk of having their insurance claims denied, due to the prohibitive cost.

There is also concern over the clinical data the FDA used to approve both Sovaldi and Harvoni, given the two drugs were fast-tracked to market. “Public access to the raw clinical trial data is necessary so that doctors and patients can make informed treatment decisions and cost-benefit determinations,” the complaint says. “As it stands now, doctors and patients lack the benefit of any independent assessment of the data that led to the approval of Sovaldi and Harvoni.”

The Gilead Hep C Denied Insurance Claim Lawsuit brought by the two health groups over the high cost associated with Harvoni is Treatment Action Group et al. v. Food and Drug Administration et al., Case No. 3:15-cv-00976, in the US District Court for the District of Connecticut.