Pricey hepatitis C pill approved

FDA last week approved Harvoni (ledipasvir and sofosbuvir), a daily pill to treat hepatitis C virus (HCV) that reportedly costs $1,125 per pill.

Harvoni (Gilead Sciences) is the first combination pill approved to treat chronic HCV genotype 1 infection. FDA said Harvoni is easier to administer than traditional hepatitis C treatments because it does not require administration with interferon or ribavirin. It is the third drug approved by FDA in the past year to treat chronic HCV infection.

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“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 Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and healthcare professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”

According to the FDA, in clinical trials Harvoni cured up to 99% of patients within two to three months. The World Health Organization estimates that between 130 million and 150 million people worldwide are infected with HCV, and the disease kills as many as 500,000 each year.

Harvoni contains 90 mg of ledipasvir, an HCV NS5A inhibitor, and 400 mg of sofosbuvir, a nucleotide analog inhibitor of HCV NS5B polymerase. The recommended treatment duration is 12 weeks for treatment-naïve patients with or without cirrhosis and treatment-experienced patients without cirrhosis. For those patients who have been treated previously and have cirrhosis, the recommended regimen is 24 weeks, according to the package insert.

Cost of treatment

The news agency Reutersreported that Harvoni will cost $94,500 for a 12-week course of treatment, or $1,125 per pill. "Unfortunately, we believe that the price being demanded is still inappropriately high for a product targeting such a large group of patients," David Whitrap, a spokesman for Express Scripts, told Reuters. "New innovations do not always require inappropriate, premium pricing."

Michael Weinstein, president of the AIDS Healthcare Foundation, called Harvoni’s price unsustainable. “It leads the industry-wide practice of gouging cash-strapped government programs like Medicaid, Medicare, and ADAPs [AIDS Drug Assistance Programs] as well as private insurers, as the price of Harvoni shows. There is a breaking point coming on this, and Gilead is apparently none too proud to lead the way.”

Gilead officials contend Harvoni is cost effective because it cures patients in a shorter period than traditional treatments and can prevent problems such as liver failure. "Insurers must be willing to invest in the long-term health outcomes of their patients. They can't just look at it as an immediate cost," Gregg Alton, a Gilead vice president, told the Associated Press.