Harvoni was approved by the FDA Oct. 10. It costs $94,500 for a 12-week regimen. Gilead's hepatitis C drug Sovaldi costs $1,000 a pill, or $84,000, for a 12-week regimen. However, Gilead argues that Harvoni can be a bargain considering that it costs $63,000 for an eight-week regimen and as many as 45% of patients may qualify for the shorter treatment duration.
Compliance to a treatment regimen may be higher with Harvoni than it is with Sovaldi. That's because Harvoni is the first single-pill hepatitis C treatment. Sovaldi requires intravenous treatment with interferon or ribavirin, which are known to have side effects including flu-like symptoms, experts say.
In addition, clinical trials for Harvoni found that over 94% to 99% of the patients treated with the drug had no detectable virus in their blood three months after treatment was ended. This compared with 82% to 90% nondetectable rates in clinical trials of Sovaldi plus interferon and ribavirin.
Despite claims of better price, fewer side effects and higher efficacy rates, it is unlikely states will make Harvoni their preferred hepatitis C drug over Sovaldi and will likely move forward covering both drugs simultaneously, experts say. One reason is that not everyone agrees with Gilead's assertion that Harvoni is more affordable.
“The older drugs used in combination with Sovaldi are very inexpensive to the Medicaid program due to large available rebates, so the cost of the interferon and the ribavirin is negligible,” a spokeswoman from the Minnesota Department of Human Services said. As a result, “the Sovaldi combination is still less expensive than the single-pill Harvoni regimen, at least for the Medicaid program.”
Another reason is that the drugs differ in terms of effectiveness for various strains of hepatitis C. There are six different genotypes of the virus. Harvoni is shown to be best for genotype 1, believed to be the most common strain, while Sovaldi is believed to be best for genotypes 2 and 3, according to Nancy Steinfurth, executive director of Hep C Connection, an advocacy and awareness organization.
As a result, Washington state will only cover Harvoni for those with genotype 1, a spokeswoman there said. Idaho is following a similar course of action, developing prior-authorization criteria that require a beneficiary to have documented proof that clinical need is not met by Sovaldi.
Medicaid agency spokespeople from Ohio, New Mexico and Texas say their agencies have yet to make decisions on what authorization criteria they'll use. None revealed a timeline to make a decision. Texas is also believed to be only state in the U.S. to not provide coverage in any fashion for Sovaldi, having yet to craft prior-authorization criteria for its use there.
Oregon has a unique waiver that allows it to not cover drugs, even if the manufacturer has an agreement with the federal Medicaid drug rebate program. It attempted to exercise this authority earlier this summer to not cover Sovaldi, but advocates were successful in stopping the state from taking the action. Instead Oregon created a prior-authorization criteria for the drug for the 10% of Medicaid beneficiaries in the state's fee-for-service program, and left it up to coordinated-care organizations that care for the other 90% to come up with their own prior-authorization policies for the drug. A similar course of action is expected for Harvoni, an Oregon Health Authority spokeswoman said.
For the vast majority of their Medicaid populations, states such as Hawaii and Pennsylvania are following Oregon's lead, leaving prior-authorization policies for Harvoni to their managed Medicaid providers. There are 37 states that in varying degrees use managed-care organizations to provide services to beneficiaries. Of those, 28 states include pharmacy benefits in their contracts.
Spokespeople from Iowa, Florida, Georgia, Minnesota, Montana, Nebraska, Nevada, South Dakota and Virginia, said they don't expect a prior-authorization policy to be developed for Harvoni until spring 2015 when their pharmacy and therapeutics committees or drug utilization review boards again convene to look into the drug's clinical benefit. Until then, some will allow access to the drug on a case-by-case basis, depending on documented medical necessity.
Alaska, Idaho, Tennessee and Oklahoma are now covering the drug with prior authorization, though the current pre-approval criteria may be later updated as they learn more about the drug, spokespeople from those states said.
In Mississippi, if Harvoni is administered in a physician's office, prior authorization is not required, said Erin Barham, deputy administrator for communications for Medicaid.
“Although this particular drug treatment for hepatitis C can be expensive, in a majority of cases it has a high potential of curing the disease if prescribed and taken correctly, resulting in a positive impact on beneficiaries and the state budget in the long run,” Barham said.
