Controlling HCV: ‘The time for political action is here’
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In 2015, WHO initiated a campaign to eliminate hepatitis B and C worldwide.
Why did WHO target these infections? Viral hepatitis and its consequences represent the 7th leading cause of global deaths — more than 1.5 million in 2015 — with 95% due to hepatitis B and C. This exceeds deaths from malaria, HIV and tuberculosis and is the only one in which the death rate is increasing.
In the absence of additional efforts, WHO estimated an additional 19 million hepatitis-related deaths between 2015 and 2030 and further noted that treatment can prevent deaths in the short- and medium-term.
Cost Estimates
WHO estimates the cost for elimination in low- and middle-income countries will begin at $1 billion per year, peak at over $ 5 billion in 2024 and then gradually decline, but still cost $3.5 billion annually in 2030.
Critically important to cost estimates were assumptions about cost of treatment, pegged at $60 per year for hepatitis B and $500 for a treatment course for hepatitis C.
Lowering Expectations: Control, Not Elimination
The use of the term “elimination” may create confusion. Disease control terminology recognizes four general categories: Control refers to reduction to a locally acceptable level of disease incidence, prevalence, morbidity or mortality. Elimination refers to reduction to zero in defined geographical areas. Eradication means permanent reduction to zero worldwide, as is the case with smallpox. Extinction, for which there are no examples, means the organism no longer exists in the wild or in the laboratory.
The body of the WHO manifesto recognizes this distinction and provides guidance for acceptable levels, which means control of hepatitis B and C. Countries with the most hepatitis C viremic individuals are China, Pakistan, India, Egypt, Russia and the U.S., where there are 2.7 million cases.
Treatment Efficacy
Effectiveness of antiviral therapy in curing hepatitis C approaches 100%, and the drugs most used are devoid of serious side effects. Treatment is so effective that we now use HCV-infected organs for liver, kidney, heart and lung transplants. In more than 400 cases, we have yet to encounter a failure to eradicate HCV. In the more customary context of community-acquired hepatitis C, treatment failures, including the occasional need for salvage therapy with sofosbuvir/velpatasvir/voxilaprevir, are rare.
A well-functioning system to eradicate hepatitis C requires a low coefficient of friction at all interfaces. Touchpoints of friction include incomplete awareness by the public and health care providers of the need for screening in all and special needs for individuals unable or unwilling to engage with the U.S. health care “system.”
Additional friction occurs because most screening for hepatitis C does not create reflex viremia testing for those with positive hepatitis C antibody. Varying payer demands for prior authorization, genotype testing, negative drug screens and measurement of hepatic fibrosis all create more friction, add cost and delay timely treatment.
The Largest Friction Point: Cost of Treatment
There would be little reason for payers to create barriers other than cost of HCV drugs. The cover story acknowledges high medication cost, but notes costs have dropped “dramatically,” eliminating the rationale for payers to impose restrictions.
This shift of responsibility from pharmaceutical providers to insurers remains problematic. The current costs ($24,000-$74,640, depending on drug and duration) of the three most used drugs are 48 to 148 times higher than WHO modeling cost of $500. Even with heavy discounting, cost of treatment likely represents the single largest barrier to more effective control of HCV in the U.S.
Finally, as the author noted, to achieve control of HCV in the U.S. by 2030 the time for political action is here — at local, state and federal levels. At the state level, some of the most vulnerable with HCV rely on Medicaid to cover treatment costs. A state-by-state report card of Medicaid Access is available at stateofhepc.org and indicates wide disparity in efforts to lower the barrier for treatment. Political pressure in each state to reduce or eliminate specific barriers may be successful.
At the federal level, lobbying for assistance in developing model programs will be welcome. In addition, urging Medicare drug price negotiations with pharma to bring prices to an affordable level could be a goal. Since lower negotiated prices under the 2023 Inflation Reduction Act will not go into effect until 2026 at the very earliest, this may have limited impact.
With each passing year, unnecessary deaths and higher overall system-wide costs are inevitable unless we control HCV and its sequelae.
- References:
- Hepatitis C: State of Medicaid access. Report cards. https://stateofhepc.org/report-cards/. Accessed: Feb. 28, 2023.
- Very Well Health. Hepatitis C treatment costs: What to expect. www.verywellhealth.com/hep-c-treatment-cost-5271425. Published May 24, 2022. Accessed Feb. 28, 2023.
- World Health Organization. Combating hepatitis B and C to reach elimination by 2030: May 2016 advocacy brief. https://apps.who.int/iris/bitstream/handle/10665/206453/WHO_HIV_2016.04_eng.pdf. Accessed: Feb. 28, 2023.
- For more information:
- William Carey, MD, is acting hepatology section head in the department of gastroenterology, hepatology and nutrition at Cleveland Clinic.
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