COMMENTARY

A Future Without Hepatitis C?

The Liver Meeting 2014: American Association for the Study of Liver Diseases (AASLD)

William F. Balistreri, MD

Disclosures

December 16, 2014

In This Article

The Economic Impact of Treatment

SOF/SMV-based therapies for chronic HCV infection offer highly efficacious and safer, but substantially more expensive, options than the old standard of care. The population-level economic impact of the uptake of new treatments and resulting downstream cost-savings remain unknown.

Chhatwal and colleagues[35] estimated the resources needed to treat all eligible HCV-patients with new drugs in the next 5 years and resulting cost-savings. They developed a Markov model that simulated the natural history of HCV and compared simulated SOF/SMV-based therapies, as recommended by the AASLD-IDSA guidelines, with the old standard of care (first-generation protease inhibitors or Peg-IFN/RBV-based therapies).

They estimated that in 2014, 1.32 million treatment-naive and 0.45 million treatment-experienced people would be aware of their HCV disease. Another 0.51 million people would be diagnosed in the next 5 years because of risk-based and birth-cohort HCV screening. They further estimated that a total of 1.6 million people with insurance coverage would be eligible for treatment during the next 5 years, during which payers would need $188 billion to cover drug costs of all treatment-eligible HCV patients. The resources needed by the type of insurance coverage would be $104 billion by private payers, $54 billion by Medicare/Medicaid, and $30 billion by military/state/government. Compared with the previous standard of care, new drugs would cost an additional $113 billion; the lifetime economic savings because of the use of SOF/SMV would be $21 billion.

These estimates are highly dependent on drug price. At the current price of SOF/SMV-based therapies, resources needed to treat a large number of eligible HCV patients would be immense and likely unsustainable. Value-based patient prioritization is needed to manage HCV patients effectively.

The Clinical Burden of HCV in Medicare

More than a million Americans with HCV will age into Medicare by 2024. Rein and colleagues[36] used primary data to estimate the clinical burden of HCV in Medicare in 2009 and forecasted this burden until 2024. Medicare administrative claims data contained 122,417 patient-years of diagnosed HCV across the years 2002-2009. Treatment with IFN-free, all-oral regimens could substantially reduce morbidity and mortality from HCV within Medicare; the highly effective regimens could save more than 33,000 lives. The annual cost of treatment (based on 2009 estimates) would be $2.7 billion. Because of the large proportion of Medicare patients who enter the program in advanced stages of disease, treatment before Medicare entry is likely to be more effective in mitigating the health consequences of HCV.

Cost-effectiveness of HCV Drug Regimens in US Veterans

Chidi and colleagues[37] used a Markov model with 1-year cycle length to compare various treatment regimens for a cohort of 50-year old veterans with HCV genotype 1, 2, or 3. For treatment-experienced US veterans, current SOF-based regimens cost less and are more effective than waiting to treat with future all-oral therapies, regardless of genotype or METAVIR fibrosis score.

Minimum Target Prices for Developing Countries

A major limitation is accessibility to these new agents; the huge price tag will make treatment out of reach for people in the developed and developing worlds. Therefore, mass treatment programs to cure HCV in developing countries are only feasible if the costs of treatment and monitoring are low.

Hill and colleagues[38] estimated that the minimum costs of treatment and diagnostics to cure HCV were $171-$360 per person without genotyping or $261-$450 per person with genotyping. Treatments with proven pangenotypic activity will be required to avoid expensive pretreatment genotyping. Further reductions in price could be achieved through shorter durations of treatment, if efficacy is shown in future trials.

A Two-Pronged Attack on HCV

Research presented at this year's meeting offered further guidance for clinicians to wisely, effectively, and safely treat patients with HCV. The recommended screening for HCV is a major advance in public health—discovering hundreds of thousands of infected individuals, individuals who are also highly likely to benefit from the new agents to treat HCV infection.

Future studies will hopefully address the somewhat refractory genotype 3 infection, clarify the best practices and duration of treatment for the previously "hard to treat" patient, and confirm minimal drug-drug interactions with the use of these new regimens.

In a report published the day before the meeting, an experimental protective vaccine against HCV demonstrated promise in preliminary human safety trials, and a larger phase 2 trial will be performed to further determine the efficacy of the vaccine.[39]

Thus, this two-pronged attack on HCV—a variety of new drugs and the possibility of a vaccine—suggests the global eradication of HCV.

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