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IIR 12-059
Cost-effective Uses of New Hepatitis C Treatments and their VA Budgetary Impact
Douglas K. Owens MD MS
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, CA
Funding Period: June 2013 - November 2015

BACKGROUND/RATIONALE:
Chronic hepatitis C virus (HCV) is of particular concern to VHA given 165,000 veterans are infected, the condition is difficult and extremely costly to manage, and causes decompensated cirrhosis, hepatocellular carcinoma, and liver transplantation. Standard two-drug HCV treatments are effective in a limited proportion of patients and can cause substantial side effects. When added to standard treatment, directly acting antivirals improve success rates but are also expensive and increase rates of serious side effects. VA has estimated the expenditures for directly acting antivirals and associated treatments could reach one billion dollars in fiscal year 2012. In addition, recent studies provide evidence that an individual's Interleukin 28B (IL-28B) genotype predicts response to HCV therapy and may help predict response to therapy.

OBJECTIVE(S):
The objectives are to: 1) characterize the treatment costs and utilization, care patterns, and patient attributes of the VHA HCV population; 2) assess the cost-effectiveness of directly acting antivirals and IL 28B genotype testing in VHA HCV population, and to develop an analytic framework for evaluating the cost-effectiveness of additional new treatments for HCV; and 3) estimate VA budget impact and resource requirements associated with uptake of the new treatment strategies.

METHODS:
We analyzed laboratory and pharmacy data from VA Corporate Data Warehouse (CDW), VA administrative datasets, and service costs from the VA's Health Economics Resource Center to develop a VHA-specific cost-effectiveness model to evaluate how alternative HCV treatment influence long-term outcomes, including mortality, decompensated cirrhosis, hepatocellular carcinoma, and liver transplantation. We quantified differences in health improvements and changes in costs attributable to alternative treatments for subgroups of veterans in terms of age, extent of liver fibrosis, and IL-28B genotype. Finally, we conducted budget impact and resource requirement analyses using the cost-effectiveness model, and developed a spreadsheet-based tool for VA policymakers to help with roll-out and management of HCV treatments

FINDINGS/RESULTS:
Cost-effectiveness of HCV treatment.

We assessed the cost-effectiveness of direct acting antiviral protease inhibitors and an interleukin (IL)-28B genotyping assay for treating chronic hepatitis C virus with a decision-analytic Markov model. In treatment-naive patients with chronic, genotype 1 hepatitis C virus mono-infection, the strategy of direct acting antiviral triple therapy to all patients, and the strategy of selective treatment based on the results of the IL-28B genetic test, were both cost-effective. If the protease inhibitor treatment costs $1,100 per week, universal triple therapy costs $102,600 per QALY (mild fibrosis) or $51,500 per QALY (advanced fibrosis) compared with IL-28B-guided triple therapy and $70,100 per QALY (mild fibrosis) and $36,300 per QALY (advanced fibrosis) compared with standard therapy. These findings were published in the Annals of Internal Medicine.

We extended the cost-effectiveness analysis study to make them specific to Veterans with chronic genotype 1 hepatitis C. This analysis used parameters developed in our analysis of VA data on the characteristics of VA users with chronic HCV infections on the costs they incurred in the VA health care system. Adding either directly acting antivirals medication to standard two-drug therapy improved sustained viral response sufficiently to make the addition cost-effective even though it is more costly and results in more severe side-effects. IL-28B genotyping can help to identify Veterans least likely to respond to standard therapy and hence who stand to benefit the most from triple therapy and for whom, therefore, the increased risks of side-effects may be most justified. This result was published by the HSR&D Evidence Synthesis Program.

Treatment for HCV was revolutionized by the approval of highly effective anti-viral treatments that began to be used by VA in 2015. We updated our cost-effectiveness model with information on the additional cost and effective of these new drugs, and determined them to be cost-effective. The results of this analysis have been submitted for publication in the peer reviewed press.

Factors affecting the initiation of HCV treatment.

We evaluated changes in treatment of VA patients with chronic hepatitis C care by analyzing VA administrative data from October 2009 to July 2013. Uptake of the new directly acting antivirals medications was rapid. Among patients treated with directly acting antivirals, 83% received the lower-cost boceprevir and 17% received the more expensive telaprevir. Most patients completed the minimum specified treatment protocol, including 62% of patients receiving boceprevir and 69% of those receiving telaprevir. We determined that 4,090 VA patients had an IL-28B genotyping test between October 2010 and July 2012. Although test results can be used to guide HCV prescriptions, less than 16% of these tests were use in this way. These findings were published in the Journal of Viral Hepatology.

We created a cohort of patients eligible for HCV treatment in the 5 year period ending in 9/30/2014 using data from the VA Corporate Data Warehouse, to evaluate whether historically disadvantaged groups were able to new HCV treatments. We identified 229,693 unique patients with chronic HCV, 6% of whom were co-infected with HIV. By the end of the study, 18% had died. There were 31,098 HCV treatment episodes during the 5 years of the study. Preliminary multivariate analysis found that liver disease stage was an important indication for treatment initiation. Treatment was less likely to be initiated in African-American patients and those with serious mental illness. Rural patients identified as HCV infected had significantly greater chance of accessing treatment. We are completing analysis of health care cost incurred by this cohort during the same period.

Findings about factors affecting treatment initiation have been rendered obsolete by the approval of highly effective anti-viral treatments that began to be used by VA in 2015, including the drugs sofosbuvir, simeprevir, ledipsavir, obmitasvir, paritaprevir, and dasabuvir, usually in combination. These treatments are not only far more effective than directly acting antivirals drugs, they also work in patients regardless of viral genotype. We determined that more than 29,000 individuals in our cohort received an HCV medication in Federal fiscal year 2015, a number nearly equal to the treatment episodes initiated in the prior 5 years. We estimate that the direct cost of these medications exceeded $1 billion. We plan to address the question of treatment accessibility using the full 6 years of treatment data.

IMPACT:
The study found that HCV treatments, including the newest medications, are highly cost-effective. We examined the accessibility of treatments and studied the cost of HCV care. We plan to update the treatment access analysis with information from 2015 to consider if new treatments are being used by historically disadvantaged groups. VA spent more than $1 billion on HCV treatment in FY 2015, more than in the previous 5 years combined.

PUBLICATIONS:

Journal Articles

  1. Gidwani R, Barnett PG, Goldhaber-Fiebert JD, Asch SM, Lo J, Dally SK, Owens DK. Uptake and utilization of directly acting antiviral medications for hepatitis C infection in U.S. veterans. Journal of Viral Hepatitis. 2015 May 1; 22(5):489-95.
  2. Liu S, Cipriano LE, Holodniy M, Owens DK, Goldhaber-Fiebert JD. New protease inhibitors for the treatment of chronic hepatitis C: a cost-effectiveness analysis. Annals of internal medicine. 2012 Feb 21; 156(4):279-90.
Reports

  1. Goldhaber-Fiebert JD, Barnett PG, Dally S, Asch SM, Liu S, Cipriano L, Owens DK, Miake-Lye IM, Beroes JM, Shekelle PG. Assessment of Alternative Treatment Strategies for Chronic Genotype 1 Hepatitis C. Washington (DC): Department of Veterans Affairs; 2013 Mar 1. 37 p. Report No.: VA ESP Project #05-226.


DRA: Infectious Diseases
DRE: Treatment - Comparative Effectiveness
Keywords: Cost-Effectiveness, HIV/AIDS, Hepatitis C
MeSH Terms: none