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CTAF Report: Newest Treatments for Hepatitis C, Genotype 1: next public meeting of the California Technology Assessment Forum (CTAF) on Thursday, December 18, 2014 in Oakland, California.
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Download the PDF here
http://ctaf.org/reports/newest-treatments-hepatitis-c-genotype-1
This draft report examines the comparative clinical effectiveness of multiple new, all-oral direct-acting antiviral agent (DAA) regimens for the treatment of hepatitis C developed by Gilead Sciences Inc., AbbVie Inc., and Bristol-Myers Squibb Co. The report also assesses the potential financial impact on the health care system of several FDA-approved combination therapies, which can cost approximately $65,000 to $190,000 for a course of therapy. The report will be the subject of deliberation and vote at the next public meeting of the California Technology Assessment Forum (CTAF) on Thursday, December 18, 2014 in Oakland, California. CTAF's public deliberation of the evidence helps provide clarity and guidance to clinicians, insurers, and patients confronted with decisions on treatment of hepatitis C.
Summary
Our findings have important implications for patients, physicians, and payers. Specifically, model results suggest that the introduction of LDV/SOF for both treatment-naïve and treatment-experienced individuals would confer substantial clinical benefits in comparison to historical treatment standards and even in relation to other sofosbuvir-based regimens. While the use of this new regimen would increase treatment costs, such use appears to be cost-effective by conventional standards. However, the additional expenditures required to treat all patients with genotype 1 infection (even if only 50% of them are aware of their infection) are substantial; when added to the additional expenditures required for genotypes 2 and 3, this represents a per-member per-month premium increase that is five-fold higher than frequently-discussed manageable thresholds for new interventions. It is clear that patients, physicians, insurers, and health systems will have to grapple with the budget impact of new, highly effective, and expensive treatments for hepatitis C. Whether this will result in prioritization of clinical care, new contracting and financing mechanisms, evolving market dynamics, or policy actions remains to be seen.
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In the base-case analysis, we found that LDV/SOF regimens for treatment-naïve and treatment-experienced patients were very cost-effective, producing ICERs ²$20,000 per QALY gained regardless of the comparison (i.e., PR alone vs. next-least costly alternative, treat all vs. treat at F3/F4, weighted estimates for a combined treatment-naïve and treatment-experienced cohort).
Our analysis also found that, while treating patients at all fibrosis stages was more expensive in comparison to waiting to treat until patients reached F3 or F4, it was also more effective. For example, treating all naïve patients with LDV/SOF 8/12 (according to viral load and fibrosis stage) or LDV/SOF 12 (all patients get 12 weeks of therapy) or PR alone produced ICERs <$40,000 per QALY gained in comparison to treating only at F3/F4. Among treatment-experienced patients, differences in effectiveness were more pronounced, with more than two years of quality-adjusted life expectancy gained for single DAA sofosbuvir-based regimens relative to PR alone (generating ICERs of $10,000-$20,000 per QALY gained). Comparisons of the "treat all" vs. "treat at F3, F4" approaches in the treatment-experienced subgroup generated more costs (in part because single DAA sofosbuvir-based regimens are longer) but still produced estimates of cost-effectiveness of ~$50,000 per QALY gained.
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We assessed the potential budgetary impact of new hepatitis C therapy over three periods of follow-up: one, five, and 20 years after treatment initiation from a health system perspective. As with the cost-effectiveness analyses, the regimen of interest for genotype 1 was the LDV/SOF strategy (8/12 weeks for treatment-naïve, 12/24 weeks for treatment-experienced), as this represents the cost-effective strategy that is currently available and most likely to receive widespread use in this population.
Findings for the performance of LDV/SOF vs. PR are presented in Table ES3 on the next page. LDV/SOF produces incremental clinical benefits very soon after treatment initiation; for example, compared with PR alone, LDV/SOF prevents approximately six cases of cirrhosis and two HCV-related deaths per 1,000 patients treated in the first year alone. Benefits are more fully realized at later time points; at five years, LDV/SOF would avert 44 cases of cirrhosis (15 of which would be decompensated), five cases of HCC, and 17 HCV-related deaths per 1,000 treated. Cost offsets would total approximately 7% of incremental treatment costs. At 20 years, there would be a nearly six-fold reduction in the incidence of cirrhosis, HCC incidence would be reduced by more than half, and 140 HCV-related deaths would be averted per 1,000 treated. More than 25% of treatment costs would be offset by these reductions.
The availability of new HCV treatments would increase costs by approximately $1.6 billion, $545 million, and $901 million for genotypes 1, 2, and 3 respectively (see Figure ES2 on page ES8), resulting in a total increase of $3 billion, or $33 PMPM. This represents a 5% increase over the base per-member per-month (PMPM) Medi-Cal costs of $611. Cost offsets after five years would total $254 million, reducing net expenditures modestly to $2.8 billion. More substantial offsets after 20 years ($1.2 billion) would reduce net expenditures further to $1.8 billion.
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