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A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
Treating Medicaid patients with hepatitis C: clinical and economic impact
Zobair Younossi1, Stuart C Gordon, Aijaz Ahmed
1Beatty Center for Integrated Research, 3300 Gallows Rd, Falls Church, VA 22042.
Insights
Treating all Medicaid patients with chronic hepatitis C virus (HCV) using ledipasvir/sofosbuvir significantly improves sustained virologic response rates and reduces disease progression. This comprehensive approach also yields substantial cost savings for the healthcare system.
Area of Science:
- Hepatology
- Health Economics
- Public Health Policy
Background:
- Chronic hepatitis C virus (HCV) infection poses a significant disease burden and economic challenge, particularly within the Medicaid population.
- Current treatment guidelines in some states impose restrictions on accessing direct-acting antiviral therapies like ledipasvir/sofosbuvir (LDV/SOF).
Purpose of the Study:
- To estimate the clinical and economic impact of comprehensive HCV treatment within the Medicaid population.
- To compare the outcomes of current restrictive treatment strategies versus an 'all-patient' treatment approach.
Main Methods:
- A decision-analytic Markov model was utilized to simulate patient outcomes over a lifetime horizon.
- The model assessed treatment-naïve genotype 1 chronic HCV patients from a third-party payer perspective.
- Ledipasvir/sofosbuvir (LDV/SOF) regimens were modeled with varying state-specific restrictions based on fibrosis stage.
Main Results:
- A 'treat all' strategy demonstrated a higher sustained virologic response (SVR) rate (95.9%) compared to restricted strategies (75.2%).
- Comprehensive treatment is projected to significantly reduce cirrhosis, liver transplants, hepatocellular carcinoma, and HCV-related deaths.
- An 'all-patient' approach is estimated to result in substantial cost savings of 39.4% ($3.8 billion) and improve life-years and quality-adjusted life-years per patient.
Conclusions:
- Implementing a 'treat all' strategy for chronic HCV in Medicaid populations leads to superior SVR rates and reduces adverse clinical outcomes.
- This approach offers considerable cost savings, challenging current restrictive state policies on HCV treatment access.
- Reassessment of state-specific HCV treatment restrictions is warranted based on the demonstrated clinical and economic benefits.
Objectives:
To estimate change in chronic hepatitis C virus (HCV) disease and the economic burden associated with comprehensive treatment of the chronic HCV-infected Medicaid population.
Study Design:
Decision-analytic Markov model.
Methods:
Treatment-naïve patients with genotype 1 chronic HCV were followed over a lifetime horizon from the third-party payer perspective. Patients entered the model insured under Medicaid and were treated under state-specific restrictions by Metavir fibrosis stage (base case) or all treated (all-patient strategy) with an approved all-oral regimen (ledipasvir/sofosbuvir [LDV/SOF] for 8 weeks or 12 weeks, depending on cirrhosis status, viral load, and state-specific LDV/SOF restrictions). Untreated patients were assumed to age into Medicare at 65 years, where they were treated with LDV/SOF without restriction by fibrotic stage.
Results:
The sustained virologic response (SVR) rate of the current Medicaid LDV/SOF restriction strategy was 75.2% versus 95.9% if all LDV/SOF-eligible patients were treated under Medicaid. Treating all eligible Medicaid patients with LDV/SOF, regardless of fibrotic stage, was projected to result in 36,752 fewer cases of cirrhosis; 1739 fewer liver transplants; 8169 fewer cases of hepatocellular carcinoma; 16,173 fewer HCV-related deaths; 0.84 additional life-years per patient; and 1.03 additional quality-adjusted life-years per patient. Treating all Medicaid patients with chronic HCV using LDV/SOF resulted in a 39.4% ($3.8 billion) savings and decreased the proportion of total costs attributable to downstream costs of care to 18.3%.
Conclusions:
A "treat all" strategy in a Medicaid population resulted in superior SVRs, substantial reductions in downstream negative clinical outcomes, and considerable cost savings. Current restrictive state policies regarding HCV treatment in Medicaid populations must be reassessed in light of these data.
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