May 17, 2011
On May 13, 2011, the FDA approved Merck's Victrelis (boceprevir), the first new drug for the treatment of hepatitis C virus (HCV) infection to come to market in almost ten years. 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 a very exciting development for the HCV community, the Fair Pricing Coalition (FPC) is very disappointed at the price set by Merck for Victrelis," said FPC member Lynda Dee. "The FPC is concerned that the exorbitant wholesale acquisition cost (WAC) of $1,100 per week will adversely affect the ability of people with HCV to access Victrelis and that it will also set an excessively unreasonable future price point for the many HCV drugs in the pipeline. You can bet that no future HCV drugs will be priced less than Victrelis. This is a very bad start."
Victrelis 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, but there is no reason for a drug from the protease inhibitor class to be so expensive," said Dee. Two other drugs, pegylated interferon and ribavirin must be taken with Victrelis, and the WAC price for HCV treatment with these two drugs is approximately $30,000. The FDA label recommends that Victrelis be taken with pegylated interferon and ribavirin for either 24, 32 or 48 weeks, depending on a patient's response to the regimen. The WAC price for Victrelis is $26,400 for 24 weeks, $35,200 for 32 weeks and $48,400 for 48 weeks of treatment. "These amounts added to the already high $30,000 cost of pegylated interferon and ribavirin make the cost of the new Victrelis containing regimen astronomical," said Dee. "Although the addition of Victrelis 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."
"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. If each of the new drugs costs approximately $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 Society 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 8,100 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 are very disappointed by the cost set by Merck for Victrelis and are even more concerned that Vertex's Incivek (telapravir) which will probably be approved by the FDA later this month may be even more expensive," 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," 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."