Update, October 10, 2014: On October 10, 2014, the US Food and Drug Administration (FDA) approved Harvoni™, a combination of ledipasvir, an NS5A inhibitor, and sofosbuvir, a polymerase inhibitor, to treat patients with chronic hepatitis C virus (HCV) infection, genotype 1. The drug, manufactured by Gilead, is the first combination pill to treat HCV. It is also the first to do so without the use of interferon or ribavirin, previously considered the gold standard for treatment. Treatment-experienced patients, those who have been on previous HCV drug regimens, are expected to take the pill for 12 or 24 weeks, achieving sustained virological response (SVR), an indication that they have been cured.
Cost: According to Gilead, the cost of Harvoni is $1,125 per pill, or approximately $94,500 for a 12-week supply. Most insurers require prior authorization before covering it. Further, some state Medicaid programs are restricting its use to patients with advanced liver disease.
Update, September 2014: Vertex Pharmaceuticals, Inc., announced in a letter to providers that it would discontinue the sale and distribution of Incivek® in the US in mid-October 2014. “This decision has been taken in view of available alternative treatments and the diminishing demand for Incivek,” wrote Charles Johnson, vice president of global medical affairs at Vertex, in the letter. Patients will be allowed to complete their treatments. They should consult with their physicians regarding next steps.
Original article: The bleeding disorders community welcomed the news in May that the US Food and Drug Administration (FDA) had approved two new drugs to treat hepatitis C. Boceprevir (Victrelis™) and telaprevir (Incivek™) are protease inhibitors used with pegylated interferon and ribavirin to help patients with hepatitis C clear the virus.
As these drugs come to market, the community will begin to learn how people with hemophilia and hepatitis C—some of whom also have HIV—will respond to them. Whether either of the drugs is a treatment option for a particular patient should be considered in consultation with a liver specialist and a hematologist.
One issue potential candidates will need to consider is the drugs’ price, which will be added to the already steep cost of interferon and ribavirin.
The Victrelis regimen involves taking four tablets three times a day for either 24 or 48 weeks, depending on a person’s response. The treatment begins with pegylated interferon and ribavirin for the first four weeks, then Victrelis is added. The weekly cost of Victrelis is $1,100, according to Specialty Pharmacy News, meaning a 24-week treatment would cost approximately $22,000; a 48-week treatment would cost $48,400.
The Incivek regimen involves taking two tablets three times a day for 12 weeks at a cost of $49,200. After 12 weeks, patients stop taking Incivek and continue the regimen with pegylated interferon and ribavirin. Depending on the response to the drug, the treatment regimen is either 24 or 48 weeks.
The high cost of interferon and ribavirin treatment—approximately $30,000 for 48 weeks—would need to be added to either treatment. (Ribavirin is a pill available under various brand names. Pegylated interferon is sold under several brand names and is injected, typically by the patient.) Future hepatitis C drugs are expected to be even more expensive.
The increased costs of treating side effects of the new drugs must also be considered. The most common side effects of Victrelis are fatigue, low red blood cell count, nausea and headache. The most common side effects of Incivek are rash, low red blood cell count, nausea, fatigue, pain, headache, diarrhea, itching (pruritus), and anal or rectal irritation. The rash can sometimes be so severe that patients must stop treatment.
Most insurance plans will provide coverage for any of the four drugs used in hepatitis C treatment. Coverage will vary.
Insurance plans will typically require preauthorization for coverage of any of the four drugs as part of an overall treatment plan. They may also have monitoring and adherence requirements.
If your medical team agrees Victrelis or Incivek may be an option for you, be sure you know what your costs could be. Verify the details of your insurance coverage and out-of-pocket costs, as well as any preauthorization or monitoring and adherence requirements.
It is hoped that these new drugs will usher in a new era of more successful hepatitis C treatment.