(Story updated at 10:50 a.m. ET Monday, Dec. 22, 2014.)
The Food and Drug Administration on Friday approved Viekira Pak, a combination of pills that becomes the fourth treatment the agency has approved in the past year to treat hepatitis C.
Viekira Pak, produced by North Chicago-based AbbVie, includes ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets. It will compete with three other hep C drugs: Johnson & Johnson's Olysio and Gilead Sciences' Sovaldi and Harvoni.
Treatment for HCV, a liver disease that can cause cirrhosis or liver cancer, is extremely expensive. The cost of Viekira Pak was not immediately available from AbbVie. Twelve-month treatments using Olysio cost $66,000, for Solvadi, $84,000, and for Harvoni, $94,500. Harvoni became the most expensive HCV drug on the market after being approved in October.
Express Scripts Holding Co., the largest U.S. manager of prescription-drug benefits, said Monday that it will make Viekira Pak the only hepatitis C drug available to its enrollees, the Wall Street Journal reported. Due to discounts it negotiated with Abbvie, the company will no longer pay for Gilead’s hepatitis C drugs that treat the most common form of the virus, according to the Journal.
Public and private insurers have said that HCV treatments, especially Sovaldi, cost them as much as $150 million a year. Government payers, which insure the disproportionately affected elderly and low-income populations, fare worse: The rising cost of HCV drugs is expected to increase Medicare Part D spending by $2.9 billion next year, and state Medicaid programs expect to incur costs as high as $2 billion a year.
Three of the ingredients in Viekira Pak—ombitasvir, paritaprevir and dasabuvir—are new drugs. The combination was evaluated in six clinical trials of 2,308 HCV-positive patients with and without cirrhosis, the FDA said.
A class-action lawsuit filed this month accuses Gilead of illegal price-gouging in its sale of Solvadi, arguing that by charging $1,000 per pill, the company is violating antitrust statutes, engaging in unjust enrichment and discriminating against individuals who need the drug who can't afford it, among other claims.
Sales of Sovaldi made up 47% of Gilead's $6 billion in revenue during the third quarter, and generated $8.5 billion in total worldwide sales so far. Gilead CEO John Martin has said that concerns over price will diminish as more people are cured of the virus.
Follow Adam Rubenfire on Twitter: @arubenfire
