In the war for affordably treating the hepatis C liver virus, pharmacy benefits managers are fighting back now that alternatives are becoming available.
Express Scripts is updating its national preferred formulary to use AbbVie's new breakthrough hepatitis treatment Viekira Pak as the "exclusive" option for hepatitis C patients with genotype 1, the most common variety of the virus representing about 75 percent of cases.
It's an "unprecedented solution to an unprecedented healthcare challenge," Express Scripts said. Beginning in January 2015, the company's preferred formulary will exclude Gilead Sciences' sofosbuvir treatment, Sovaldi, along with its oral version, Harvoni, and Olysio, Johnson & Johnson's drug for combination with sofosbuvir or other treatments.
Those three drugs will remain available for hepatitis C patients covered by Express Scripts who have begun treatment, as well as those with other virus genotypes in advanced stages of disease. But for the majority of patients served through Express Scripts' drug plan, the primary option will be AbbVie's newly-approved Viekira Pak, a combination of ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir.
The deal comes less than a week after the Food & Drug Administration approved Viekira Pak as the 11th new drug product under a "breakthrough" therapy designation.
AbbVie has set a list price of $83,319 for the typical 12-week course, which isn't much less than Gilead's $84,000 U.S. list price for Sovaldi. Doubtless, though, Express Scripts and other PBMs are inking discounts. Express Scripts said patients will have access to the Viekira Pak "regardless of symptoms or disease progression," suggesting the drug won't be subject to the default rationing that has been used to wait out Sovaldi's high price.
"For the first time, a pharmaceutical manufacturer and a pharmacy benefit manager have created an agreement to deliver on the promise of a curative therapy for hepatitis C patients," said Steve Miller, MD, senior vice president and chief medical officer at St. Louis-based Express Scripts.
"Pharmaceutical innovation must be rewarded based on the value it brings to patients and payers," Miller continued. "This agreement marks a fundamental change in how sustainable access and affordability will be delivered to hepatitis C patients."
After winning the FDA's approval, Richard Gonzalez, AbbVie's CEO, said "appropriate patients, regardless of their fibrosis stage, should have broad market access to Viekira Pak, and we are committed to supporting access to this therapy."
Viekira Pak's efficacy was evaluated based on six clinical trials of 2,308 participants with chronic HCV infection. Across different populations, including those with cirrhosis, at least 91 percent of participants who received Viekira Pak were free of the infection in their bloodstream at the end of the 12-week course. The FDA said recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily.
The new deal with Express Scripts is representative of pharmaceutical benefits generally, with volatile pricing and scrums for payers discounts, and specialty drugs specifically, given their high costs and increasing availability for complex, chronic conditions like arthritis and cancer.
"If the specialty drug trend continues to increase by double digit percentages, payers will be forced to implement even more narrow management tools, thus limiting the number of patients who can afford to receive the drug therapy," said Paula Jakub, CEO of the American Foreign Service Protective Association, whose health plan uses Express Scripts as a drug manager. "It only makes sense for manufacturers to work with payers on pricing decisions."