FDA on Thursday approved AbbVie's combination drug Mavyret to treat certain adults with hepatitis C virus (HCV).
According to the Associated Press, Mavyret is the second drug FDA approved to treat all HCV genotypes, following Gilead Sciences' Epclusa. However, FDA said it is the first eight-week therapy approved to treat all six HCV genotypes in adults without cirrhosis of the liver who have not received a previous treatment. FDA said, in the past, standard treatments for HCV had to be taken for at least 12 weeks.
Approximately 2.7 million to 3.9 million U.S. residents have HCV, according to CDC.
Mavyret is a combination of the direct antiviral agents glecaprevir and pibresentasvir. Patients take the drug as three separate pills once per day. FDA said the drug's most common side effects include fatigue and headache. According to the AP, the drug also can commonly cause itchy skin and nausea.
FDA approved the combination drug based on several clinical trials that involved about 2,300 adults with HCV who had either mild or no cirrhosis. According to FDA, between 92 and 100 percent of patients who received Mavyret for eight, 12, or 16 weeks had no signs of the virus in their blood 12 weeks after completing the treatment—which indicates the patients had been cured of HCV.
FDA approved the treatment for:
- Adults with HCV genotype 1 who previously received a treatment regimen that included either an NS5A inhibitor or an NS3/4A protease inhibitor, but not both; and
- Adults with HCV genotypes 1 through 6 who have mild or no cirrhosis and have not received treatment for the virus.
According to FDA, the duration of treatment will differ for each patient, depending on their cirrhosis status, viral genotype, and treatment history. FDA recommended that patients who are taking the drugs atazanavir and rifampin and those with moderate or severe cirrhosis should not take Mavyret.
FDA also warned that Mavyret potentially could reactivate the hepatitis B virus (HBV) in patients who are co-infected with HBV and HCV. The agency recommended that all patients be screened for HBV before using Mavyret.
According AP, Abbvie said Mavyret's list price will be:
- $52,800 for a 16-week course of treatment;
- $39,600 for a 12-week treatment course; and
- $26,400 for an eight-week treatment course.
According to AP, the drug's list price is "well below" the price of other approved HCV therapies, and the price does not account for the drug's costs with insurance. For example, Epclusa in 2016 was listed at $74,760 per 12-week treatment course before discounts.
Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said Mavyret's "approval provides a shorter treatment duration for many patients, and … a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past."
According to the AP, Mavyret's addition to the HCV drug market will provide insurers, physicians, and patients with another treatment option, and therefore additional leverage to negotiate lower drug prices. Government health programs and insurance plans have had difficulty covering the high cost of breakthrough HCV drugs, some of which cost as much as $94,500 for a single course of treatment.
AbbVie spokesperson Morry Smulevitz said the company plans to initially focus on ensuring Medicare, Medicaid, and Veterans Affairs will cover the drug (Grover, Reuters, 8/3; Johnson, AP/Sacramento Bee, 8/3; Gever, MedPage Today, 8/3; FDA release, 8/3).
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