Cost Effectiveness of Direct-Acting Antiviral Therapy for Treatment-Naive Patients With Chronic HCV Genotype 1 Infection in the Veterans Health Administration

doi:10.1016/j.cgh.2013.05.014

Clinical Gastroenterology and Hepatology

Volume 11, Issue 11, November 2013, Pages 1503-1510

https://doi.org/10.1016/j.cgh.2013.05.014 Get rights and content

Background & Aims

The Veterans Health Administration (VHA) is the largest single provider of care for hepatitis C virus (HCV) infection in the United States. We analyzed the cost effectiveness of treatment with the HCV protease inhibitors boceprevir and telaprevir in a defined managed care population of 102,851 patients with untreated chronic genotype 1 infection.

Methods

We used a decision-analytic Markov model to examine 4 strategies: standard dual-therapy with pegylated interferon-alfa and ribavirin (PR), the combination of boceprevir and PR triple therapy, the combination of telaprevir and PR, or no antiviral treatment. A sensitivity analysis was performed. Sources of data included published rates of disease progression, the census bureau, and VHA pharmacy and hospitalization cost databases.

Results

The estimated costs for treating each patient were $8000 for PR, $31,300 for boceprevir and PR, and $41,700 for telaprevir and PR. Assuming VHA treatment rates of 22% and optimal rates of sustained virologic response, PR, boceprevir and PR, and telaprevir and PR would reduce relative liver-related deaths by 5.2%, 10.9%, and 11.5%, respectively. Increasing treatment rates to 50% would reduce liver-related deaths by 12%, 24.7%, and 26.1%, respectively. The incremental cost-effectiveness ratios were $29,184/quality-adjusted life-years for boceprevir and PR and $44,247/quality-adjusted life-years for telaprevir and PR vs only PR. With the current 22% treatment rate, total system-wide costs to adopt boceprevir and PR or telaprevir and PR would range from $708 to $943 million.

Conclusions

Despite substantial up-front costs of treating HCV-infected patients in the VHA with PR, or telaprevir and PR, each regimen improves quality of life and extends life expectancy by reducing liver-related morbidity and mortality, and should be cost effective. Further efforts to expand access to direct-acting antiviral therapy are warranted.

Section snippets

Strategies in a Decision-Analytic Model

A decision-analytic Markov model was constructed to evaluate the disease and antiviral costs associated with different drug therapy strategies to the VHA health care system (Figure 1), using transition probabilities from published literature as described later. We compared the cost and the effectiveness of no antiviral HCV treatment vs 3 current treatment strategies approved by the Food and Drug Administration, with availability in VHA medical centers: (1) PR (2) boc and PR triple therapy, and

Baseline Treatment Results

The target population included 102,851 patients with HCV genotype 1 infection in the VHA as of 2010 who were not treated previously, with an average age of approximately 58 years (97% male). Estimates of baseline fibrosis in VHA patients were made from prior published case series, and initial probabilities for fibrosis were estimated to be 4.2% (F0), 18% (F1), 22.2% (F2), 27.6% (F3), and 28% (F4) (Supplementary Appendix and Supplementary Table 1). Under the 4 different strategies, we calculated

Discussion

Our model projects a cost-effectiveness analysis of the new DAA therapies in the veteran population. Our simulated cohort of 102,851 treatment-naive US veteran patients with HCV genotype 1 infection had more than a 2-fold reduction in liver-related death when they were treated with either bocPR or telPR strategies compared with treatment with PR alone. When we used VHA contract Federal Schedule Supply pricing, the ICER of bocPR and telPR compared with PR were $29,184/QALY gained and

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Because of the lack of evidence regarding long-term effectiveness and cost-effectiveness of first-generation direct-acting antivirals for chronic hepatitis C (CHC) treatment in Brazil, we performed a cost-utility analysis comparing standard dual therapy (peginterferon plus ribavirin [pegIFN/RBV]), boceprevir, and telaprevir for CHC patients.
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For short- and long-term scenarios, therapy with boceprevir was dominated by telaprevir, which was more effective than standard dual therapy (75.0% vs 40.4% SVR rate, 13.47 vs 12.59 LYs, and 9.74 vs 8.49 QALYs, respectively) and was also more expensive ($15 742 vs $5413). The corresponding ICERs were $29 854/SVR, $11 803/LY, and $8277/QALY. Based on our model, triple therapy with telaprevir was the most cost-effective treatment for the Brazilian health system. Despite a lack of data regarding the Brazilian population, we incorporated as many applicable parameters as possible.
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DAA regimens have greater efficacy, lower toxicity, and shorter treatment duration than the previous standard of care and reduce liver-related and extrahepatic morbidity and mortality, thus improving quality of life and life expectancy.3,40 Moreover, DAAs have been deemed cost-effective in the United Kingdom and globally.13,40–49 In addition to cost effectiveness, other aspects of DAAs have been studied.
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We adapted a double-queuing model of organ allocation to estimate the effects of CHC infection cures on liver, lung, heart, and kidney transplants in the United Kingdom. We assumed that cured individuals would donate organs at similar rates as the general population and no longer require liver transplants because of CHC infection. We estimated how curing CHC infection influences waitlist lengths for each organ and the annual net present value to society on the basis of quality-adjusted life-years gained through additional transplants under opt-in and opt-out organ donation policies.
Curing CHC generates the most value for patients on the liver waitlist, because it increases the number of transplantable livers and reduces the need for transplants. Under the current opt-in policy, liver waitlist length falls by 24%, generating £34.3 million of annual net present value. Growth in the number of uninfected lungs, hearts, and kidneys generates an additional £19.2 million annually, with £18.7 million from kidneys. Implementing the opt-out policy, liver waitlist length would decrease by 75%, implying that treating CHC eliminates one-third of the excess liver waitlist due to an opt-in policy.
Treating CHC has large positive spillovers to uninfected individuals by reducing the need for liver transplants and allowing cured individuals to donate organs. These spillovers have not been included in traditional value assessments of CHC treatment.
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3) Expansion of HCV therapy services from specialized centers to general practice and other healthcare workers as is the case for HIV presently. ( 4) Ensuring affordability of treatment.5,11,22,33 This data was obtained by reviewing patient's files and registers which are susceptible to missing data and misclassification errors.
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The mean age of the 669 anti-HCV antibody positive individuals was 57 (sd: ±13) years. Females were 52.8% of the study population. 410 (61.3%) were tested for HCV RNA. Three hundred and sixty-six (54.7%) were confirmed to have viral replication (HCV RNA positive). One hundred and eighty (26.9%) did a complete pre-therapeutic evaluation (both HCV genotyping and liver fibrosis assessment included). Eighty-one (12.1%) initiated treatment with pegylated interferon/ribavirin. Seventy-two (10.8%) completed treatment and 44 (6.6%) had SVR. Sociodemographic characteristics including age, gender, marital status, having medical insurance, and profession were associated with attaining later steps in the care cascade.
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We performed a prospective randomized trial at 3 medical centers in the United States. Participants (n = 363 patients attending HCV clinics) had been screened and tested positive for depression, post-traumatic stress disorder, and/or substance use; they were assigned randomly to groups that received IC or usual care (controls) from March 2009 through February 2011. A midlevel mental health practitioner was placed at each HCV clinic to provide IC with brief mental health interventions and case management, according to formal protocol. The primary end point was SVR.
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: Conflicts of interest This author discloses the following: Samuel Ho has received research and grant support from Genetech, Inc, Vital Therapies, Inc, and Aspire Bariatrics, Inc; and has received expert panel fees from Roche Pharmaceuticals, Inc. The remaining authors disclose no conflicts.

: Funding Supported by the Department of Veterans Affairs Health Services Research and Development Quality Enhancement Research Initiative (RRP 10-228).

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Original articlePancreas, biliary tract, and liverCost Effectiveness of Direct-Acting Antiviral Therapy for Treatment-Naive Patients With Chronic HCV Genotype 1 Infection in the Veterans Health Administration

Background & Aims

Methods

Results

Conclusions

Section snippets

Strategies in a Decision-Analytic Model

Baseline Treatment Results

Discussion

Lancet

Am J Gastroenterol

Am J Gastroenterol

J Hepatol

Am J Transplant

J Hepatol

J Hepatol

Am J Transplant

Management of chronic hepatitis C in veterans: the potential of integrated care models

Am J Gastroenterol

Predictors of response of US veterans to treatment for the hepatitis C virus

Hepatology

Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression

Gastroenterology

Sustained virological response to interferon-alpha is associated with improved outcome in HCV-related cirrhosis: a retrospective study

Hepatology

Histologic improvement of fibrosis in patients with hepatitis C who have sustained response to interferon therapy

Ann Intern Med

Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis

Ann Intern Med

Outcome of sustained virological responders with histologically advanced chronic hepatitis C

Hepatology

Effects of interferon treatment on development and progression of hepatocellular carcinoma in patients with chronic virus infection: a meta-analysis of randomized controlled trials

Int J Cancer

Side effects of therapy of hepatitis C and their management

Hepatology

Boceprevir for untreated chronic HCV genotype 1 infection

N Engl J Med

Telaprevir for previously untreated chronic hepatitis C virus infection

N Engl J Med

Boceprevir for previously treated chronic HCV genotype 1 infection

N Engl J Med

Telaprevir for previously treated chronic HCV infection

N Engl J Med

Original article
Pancreas, biliary tract, and liver
Cost Effectiveness of Direct-Acting Antiviral Therapy for Treatment-Naive Patients With Chronic HCV Genotype 1 Infection in the Veterans Health Administration