The Fair Pricing Coalition is again sounding the alarm regarding the price of newly approved treatments for hepatitis C, this time questioning the cost of Vertex’s protease inhibitor Incivek (telaprevir). The advocacy group is concerned that Incivek’s price tag of $49,200 per 12-week course will adversely affect the ability of people with HCV to access the drug, while also setting an excessively unreasonable future price point for the many hepatitis C virus (HCV) drugs in the pipeline.

“Merck’s Victrelis costs $48,400 for 48 weeks of treatment,” said FPC member Lynda Dee in a statement from the organization. “Now Vertex has set a price approximately four times greater than Victrelis for 12 weeks of Incivek treatment. While we welcome a shorter course of Incivek treatment, both price points are outrageous. What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek. What a terrible way to begin!”

According to FDA labeling for Incivek, approved May 23, the drug should be taken for 12 weeks with either 24 or 48 weeks of pegylated interferon and ribavirin, depending on a patient’s response to the regimen. The wholesale price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is about $30,000. The $49,200 WAC price for 12 weeks of Incivek, the FPC wrote, “will more than double the already exorbitant 48 week price” of hepatitis C treatment.

“Although the addition of Incivek to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current U.S. health care crisis,” Dee said.

“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner. “An encouraging number of these drugs are currently in development. It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future. Future HCV drugs will invariably be more expensive than Victrelis and Incivek.

“If each of the new drugs costs $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future. This is unsustainable and will unacceptably limit access to the regimens.”

Other costs need to be considered as well, the FPC states. According to a paper presented at the annual conference of the American Association for the Study of Liver Diseases (AASLD), the costs of treating the side effects of HCV protease inhibitors such as Victrelis are expected to be 30 percent higher than for existing treatments. And many of those with hepatitis C suffer from other illnesses. Some have diabetes or bleeding disorders; others are coinfected with HIV. All of these add completely new sets of medical expenses.

“We were very disappointed by the cost set by Merck for Victrelis earlier this month. Our fears about Vertex’s price for Incivek have now unfortunately come to pass,” Dee said. “How will this all end? We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.

“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs (PAP). Vertex’s PAP is particularly generous,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word. We have kept a tight watch on HIV drug manufacturers in this regard. We intend to do the same thing in the viral hepatitis arena.”