On May 23, 2011, the FDA approved Vertex’s Incivek (telaprevir), the second new drug for the treatment of hepatitis C virus (HCV) infection to come to market in almost ten years. Merck’s Victrelis (boceprevir) was approved by the FDA on May 13, 2011. The United States Department of Health and Human Services estimates that there are between 2.7 to 3.9 million people in the United States living with HCV and that approximately 20,000 people are newly infected with HCV every year.
“While this new drug approval is another very exciting development for the HCV community, the Fair Pricing Coalition (FPC) is appalled at the price set by Vertex for Incivek,” said FPC member Lynda Dee. “The FPC is concerned that the exorbitant wholesale acquisition cost (WAC) of $49,200 per 12 week course of Incivek treatment will adversely affect the ability of people with HCV to access this new drug and that it will also set an excessively unreasonable future price point for the many HCV drugs in the pipeline.
“Merck’s Victrelis costs $48,400 for 48 weeks of treatment. Now Vertex has set a price approximately four times greater than Victrelis for twelve 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!”
Like Victrelis, Incivek is a drug from the protease inhibitor family that is relatively easy and uncomplicated to make. “We understand that drug development costs a lot of money, and we commend Vertex for their excellent Incivek drug development program, but there is no reason for a drug from the protease inhibitor class to be so expensive,” said Dee.
The FDA label recommends that 12 weeks of Incivek be taken with pegylated interferon and ribavirin for either 24 or 48 weeks, depending on a patient’s response to the regimen. The WAC price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is approximately $30,000. The $49,200 WAC price for 12 weeks of Incivek will more than double the already exorbitant 48 week price of pegylated interferon and ribavirin.
“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 US healthcare crisis,” said Dee.
“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.”
A recent paper presented at the American Association for the Study of Liver Diseases conference indicates that there will be a 30% increase in the cost of treating side effects caused by use of the new HCV protease inhibitor drugs. “These increased costs must also be considered in the equation,” said Penner.
“Many people with HIV are also co-infected with HCV,” said Bill Arnold of the FPC. “The cost of HIV drugs which must be taken over the entire course of a patient’s life, plus a course of this new HCV treatment is unreasonably excessive. At this time, there are over 8,300 people on waiting lists for federally funded AIDS Drug Assistance Programs (ADAPs). I am very concerned that these people will never gain access to promising new HCV therapies. Many may die as a result.”
Many individuals with HCV also have other medical conditions such as diabetes and bleeding disorders, and people with bleeding disorders pay as much as $150,000 each year for their clotting factor drugs alone. While many do have private insurance, the cost of co-pays and caps on insurance coverage may make these promising new therapies unaffordable for many people with private insurance, resulting in the inability of even people with insurance to access promising new HCV therapies.
“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,” said Dee. “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.”