The efficacy of oral antivirals for hepatitis C infection is a moot point. The prevailing discussion now delves into the best combinations that can target different viral genotypes, access to these combination regimens, and the subsequent dent in the budget of the patient, the health plan, or the care provider-as the case may be.
The efficacy of oral antivirals for hepatitis C infection is a moot point. The prevailing discussion now delves into the best combinations that can target different viral genotypes, access to these combination regimens, and the subsequent dent in the budget of the patient, the health plan, or the care provider—as the case may be.
The session, Access, Delivery, and Cost of Care, on the afternoon of the fourth day at The Liver Meeting 2014, an annual meeting organized by the American Association for the Study of Liver Disease, held in Boston, Massachusetts, November 7 to 11, 2014, touched upon some of these issues.
Jagpreet Chhatwal, PhD, assistant professor, Department of Health Services Research, The University of Texas MD Anderson Cancer Center, told the audience during his talk, “The Economic Impact of Sofosbuvir- and Simeprevir-based HCV Treatment in the United States,” that although sofosbuvir (SOF)-, simeprevir (SMV)-, and ledipasvir (LDV)-based therapies for chronic hepatitis C virus (HCV) infection offer highly efficacious, safer but substantially more expensive options than the old standard-of-care (oSOC), the economic impact of the uptake of these new treatments and resulting downstream cost savings remain unknown. To identify whether there is a balance between uptake and downstream cost-savings, the authors estimated the resources needed to treat all eligible HCV patients with new drugs over the next 5 years.
The researchers used a previously validated Markov model that simulated the natural history of HCV. Treatment-naive as well as treatment-experienced patients were included in the analysis, and the baseline population was defined based on HCV genotype, age, and fibrosis distribution of the HCV-infected population in the United States. “Our model predicted that HCV will be a rare disease by 2036,” said Dr Chhatwal, “but what can we expect in the next 5 years?”
Along with SOF/SMV-based therapies, Dr Chhatwal presented data with the newly approved SOF/LDV combination, as well as the oSOC (protease inhibitors or peginterferon/ribavirin-based therapies). Efficacy for SOF, SMV, LDV, and the oSOC was established from published trial data, while treatment costs were estimated from published wholesale acquisition costs. Discounts rendered to private, Medicare, Medicaid, and Veterans Affairs-managed medical plans were accounted for in this model. A validated prediction model of HCV disease burden in the United States and a National Health and Nutrition Examination Survey study were the basis for estimating the number of people who will be eligible for treatment in the next 5 years and the resources needed to treat them.
The authors found that in addition to the 1.32 million treatment-naïve and 0.45 million treatment-experienced people who would be aware of their infection in 2014, 0.51 million people would be diagnosed in the next 5 years because of risk-based and birth-cohort HCV screening. The analysis determined that about 1.60 million people with insurance coverage would be eligible for treatment during the next 5 years, leading to $188 billion in drug costs for all treatment-eligible HCV patients. The average spending on HCV treatment would be $27 billion per year, which they estimated was 10% of the prescription drug spending for the year 2012. Compared to the oSOC drugs, the newer treatments, he said, would result in $65 billion in extra spending, a cost offset of $16 billion. “Our results do not support an assertion that new direct-acting antivirals (DAAs) will save money by avoiding future HCV-related complications,” Dr Chhatwal emphasized.
With respect to the specific drug combinations, the authors estimated the total drug cost of SOF/LDV for genotype 1 at $136 billion, and SOF/SMV at $188 billion. He summarized his findings by stating that while new oral DAAs will substantially reduce the disease burden associated with HCV, we’d need to spend an additional $136 billion over the next 5 years on drugs to treat all the eligible patients. He added that in addition to the huge budgetary impact on both private and government payers, lifetime savings from these new treatments would account for only 24% of the spending on drugs.
Dr Chhatwal reiterated what’s been a debate for some time now: at their current price, these path-breaking oral DAA therapies are unsustainable. “What we need is additional resources from the government, price reduction or negotiations, and value-based patient prioritization to manage HCV patients effectively.”
The subsequent talk by Zobair Younossi, MD, MPH, Chairman, Inova Fairfax Hospital, and vice president for research of Inova Health System, presented somewhat of a counter-argument to Dr Chhatwal’s data. He presented research from his group, evaluating the economic impact of oral regimens for HCV coupled with the recent CDC-recommended birth cohort screening.1
“The aim of our study was to determine the potential cost-effectiveness and population impact of different strategies to screen for HCV and to treat with the most effective all-oral regimens,” said Dr Younossi. Using a decision analytic Markov model that simulated patients until death, 5 screening strategies were utilized for chronic hepatitis C (CHC) in people born between 1945 and 1965 without known CHC, excluding 2% ineligible for oral therapy:
1. Risk-based screening with treatment based stage of liver disease (RBS)
2. Risk-based screening and treat all without staging (RBA)
3. Birth cohort screening with treatment based on the stage of liver disease (BCSS)
4. Birth cohort screening and treat all without staging (BCSA)
5. No screening and treatment.
Treatment based on staging, he said, implied treatment for fibrosis stages F2-F4 with subsequent staging every 5 years for F0-F2. Treatment in BCS was phased-in over 5 years from the initiation of the screening program. Oral therapy was assumed to have 98% SVR at a cost of $1000/day for 12 weeks, with no discontinuation of treatment. Drug costs were based on the cost of acquisition. Effectiveness was measured in quality-adjusted life years (QALYs) and disease progression.
Based on their findings, the authors predict that about 100 million people would be screened, 1.4 million with unknown CHC. BCSA was the most cost effective strategy, with an ICER of $32,263/QALY. Compared to the RBS strategy, the BCSA strategy cost an extra $123 billion and produced an additional 22.9 million QALYs.
Dr Younossi concluded that the availability of highly efficacious and well tolerated all-oral regimens for CHC patients with excellent tolerability makes BCS of the baby boomers highly cost-effective with great health and economic benefits at the population level.