1. Simulation studies for the new hepatitis C virus (HCV) treatments sofosbuviir and ledispavir show gains in cost-effectiveness, but may be associated with an increased total cost over the next five years.
Evidence Rating Level: 2 (Good)
Study Rundown: The FDA recently approved 3 new drugs for the treatment of HCV, including the first combination RNA polymerase and protease inhibitor sofosbuvir-ledipasvir. These drugs have many benefits, including avoiding interferon-associated toxicity, a superior sustained virologic response, shorter treatment duration, and fewer adverse effects. However, sofosbuvir-ledipasvir is expensive, about $1125/day. To determine its cost-effectiveness, this study utilized a microsimulation model for HCV to estimate costs for these new treatment regimens compared to old standards. From this, treating 10 000 patients with new therapies was predicted to prevent 600 cases of decompensated cirrhosis, 310 cases of hepatocellular carcinoma (HCC), 60 liver transplants, and 550 liver related deaths. The cost of treatment with sofosbuvir-ledipasvir ranged from $66 000-$154 000, compared to $15 000-$71 600 for old standards, leading to an estimated additional cost of $65 billion over the next five years for third party payers. However, this study was limited by the uncertainty in the evidence for treatment used by the model, as some studies included for analysis were not randomized, did not directly compare new drugs, or were internationally based. Analysis was also limited in that changes in health care insurance resulting from the Patient Protection and Affordable Care Act were not considered. Overall, at current pricing, this analysis suggests that new therapies may increase the cost of HCV.
In-Depth [simulation study]: A Markov-based state transition model was used to simulate the course of 120 patient profiles receiving each of old standard therapies and sofosbuvir-ledipasvir. Treatment outcomes were based on recent clinical trials, and treatment windows were between 8 and 48 weeks. Weekly costs of sofosbuvir and ledipasvir were $7000 and $875 respectively. Pegylated interferon, ribavirin, boceprevir, and telaprevir were priced at $587, $309, $1100, and $4100 per week, respectively. Sofosbuvir-ledipasvir demonstrated an average 0.56 increment in per-person quality-adjusted life-year (QALY), from 10.07 old standards to 10.63. At a $50 000 willingness-to-pay threshold, sofosbuvir-ledipasvir was predicted to be cost effective in 82% of treatment-naïve patients and 60% of treatment-experienced patients, and rose to 83% and 81%, respectively, at $100 000. The incremental cost-effectiveness ratio for sofosbuvir-ledipasvir was $54 000 per additional QALY gained in comparison with old standards of care. The authors estimated that 1.6 million persons in the US would be eligible for treatment in the next 5 years, requiring payers to cover $136 billion in costs ($61 billion by the government), with new drugs costing an additional $65 billion.
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