Hepatitis C Treatment Guidelines and Cost Concerns of New Drugs

The 26th Academy of Managed Care Pharmacy annual meeting (April 1-4, 2014, Tampa, FL) brought together more than 4,000 healthcare professionals who manage and evaluate drug therapies and work to improve the care of individuals in managed care programs. 

Since the FDA approved sofosbuvir and simeprevir late last year to treat patients with genotype 1 hepatitis C, the drugs have received national attention for changing the treatment regimen for the disease—and for their high costs. In the next few years, new hepatitis C medications are expected to be introduced that could lead to better cure rates and place even more of a financial burden on payers, according to a panel of experts.

In January, the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) released a hepatitis C guidance report titled, "Recommendations for Testing, Managing, and Treating Hepatitis C." The report noted that the FDA first approved direct-acting oral agents (boceprevir and telaprevir) in 2011. Both drugs are used in combination with pegylated interferon and ribavirin, but many providers are now switching patients to oral sofosbuvir or simeprevir.

For treatment-naïve patients with genotype 1 or 4 hepatitis C, the AASLD/IDSA recommends sofosbuvir, pegylated interferon, and ribavirin for 12 weeks. For genotype 2 hepatitis C, they suggest sofosbuvir and ribavirin for 12 weeks, while they recommend sofosbuvir and ribavirin for 24 weeks for genotype 3 hepatitis C.

Steven Avey, RPh, vice president of specialty pharmacy at MedImpact Healthcare Systems, Inc., said the committee only considered clinical evidence and did not evaluate the costs or the economic value of the drugs. Within the next 6 months, the AASLD and IDSA will amend the guidelines and include costs and economic value of the medications.

John Watkins, PharmD, pharmacy manager/formulary development at Premera Blue Cross, noted that there are potential drawbacks of the new agents. For instance, the impressive sustained virologic response (SVR) rates found in clinical trials may be lower in the real world, which would increase the cost effectiveness ratios that the pharmaceutical manufacturers are touting. In addition, the SVR rates were tested over a 12-week period, but they may not last longer and may not cure the disease. The studies also did not determine relapse rates, which are expensive.

The FDA is expected to approve other treatments, including the single-pill, all-oral combination of sofosbuvir and ledipasvir, within the next year. Gilead, the drug’s manufacturer, submitted a new drug application to the FDA in February for its approval.

Of the 2.7 million people with hepatitis C, only 13% to 18% have been treated because most people are unaware they have the disease or they are waiting for new regimens, according to Avey. Treatment is recommended for individuals with existing liver disease or fibrosis, but treatment could be delayed for patients with less severe disease. 

Among MedImpact’s clients, 95% of people who are taking simeprevir take the drug without pegylated interferon, which the FDA has not approved. However, the AASLD/IDSA guidelines recommend pegylated interferon-free, sofosbuvir-based regimens. Further, Avey said more patients than expected are deemed ineligible for pegylated interferon, which leads to higher costs. He added that treating genotype 1 hepatitis C patients with an interferon-free regimen costs between $58,426 and $80,491 more per patient and has a decreased efficacy compared with regimens that include interferon.

The older hepatitis C drugs may also be problematic. MedImpact found that boceprevir and telaprevir improved SVR rates by 25% to 30%, but patients did not always adhere to the drugs. It is imperative that providers and payers emphasize the importance of adhering to the medications so that patients are treated and do not have relapses.

An independent group of clinicians, methodologists, and public representatives met at the California Technology Assessment Forum (CTAF) found that for genotype 1 hepatitis C, simeprevir and sofosbuvir are better than previous medications because they have improved SVR rates and fewer side effects. They also mentioned that the evidence is inadequate to distinguish if simeprevir or sofosbuvir is superior.

For interferon-ineligible patients with genotype 1 hepatitis C, sofosbuvir plus ribavirin is superior to no treatment, but the evidence is insufficient on whether simeprevir plus sofosbuvir is adequate for treatment-naïve patients. However, for genotype 2 and 3 hepatitis C, there is adequate evidence that sofosbuvir plus ribavirin is better than pegylated interferon plus ribavirin or no treatment, according to the CTAF group.

The panel at the CTAF meeting also analyzed the economic value of hepatitis C drugs. According to a budget impact analysis on clinical outcomes and costs at 1-year, 2-year, and 5-year time horizons, treating 50% of infected patients in California with new regimens would cost more than $20 billion. The group voted that from the perspective of a Medicaid program, the new therapies represent a “low” value for the healthcare system.

The CTAF group recommended using prior authorization before treating patients, only using specialty physicians, prioritizing patients with moderate liver fibrosis, and requiring patients demonstrate a commitment to medication adherence. The panelists also said there was a high usage of simeprevir and sofosbuvir considering the limited safety and efficacy data, their high costs, and the expected FDA approval of other interferon-free regimens in the next couple of years.  ■