A recent cost-effectiveness analysis evaluating the value of interferon-free therapies for the treatment of hepatitis C virus infection genotype 1 revealed that administering less expensive regimens to non-cirrhotic patients and expensive yet more effective regimens to cirrhotic patients resulted in optimal outcomes for patients and insurers. Meanwhile, limiting treatment only to those with more advanced disease often resulted in poor outcomes, according to researchers.
“Our analysis demonstrates that expanding treatment access, including to patients with early stage disease, will improve clinical outcomes and is cost-effective, but will have a very high cost,” Bruce R. Schackman, PhD, professor of health care policy and research at Weill Cornell Medical College, and colleagues wrote in Open Forum Infectious Diseases. “Currently, many payers restrict access to [hepatitis C virus (HCV)] therapy based on fibrosis stage, and while some have been forced to relax restrictions through litigation, these policy changes are occurring without clear evidence of the right cost control measures and without knowledge of the long-term consequences of these policies on human health and local budgets.”
Bruce R. Schackman
Schackman and colleagues used simulation models to estimate the clinical outcomes and treatment costs for hypothetical non-cirrhotic and cirrhotic patients with HCV genotypes 1a and 1b, including those with and without a history of treatment and varying levels of HCV RNA. One million patients were incorporated into each patient type and treatment strategy, which included various combinations and durations of pegylated-interferon, ribavirin, Olysio (simeprevir, Janssen Therapeutics), Sovaldi (sofosbuvir, Gilead Sciences), ledipasvir (Gilead Sciences), Daklinza (daclatasvir, Bristol-Myers Squibb), paritaprevir/ritonavir (AbbVie) and Exviera (dasabuvir, AbbVie). The estimated costs included the price of medications, clinic visits, laboratory tests and on-treatment toxicity management.
The models predicted that treating all patients yielded a non-discounted 5-year payer cost that ranged from $1.02 billion to $2.14 billion per 10,000 patients, depending on the selected regimens. In all patient types, strategies that involved treating all patients rather than only those with advanced disease had “economically attractive” incremental cost-effectiveness ratios (ICERs) based on conventional benchmarks (ICER < $100,000/quality-adjusted life year[QALY]), and many patient types had more favorable outcomes at a lower cost per QALY gained, according to the researchers. They noted that approaches limiting treatment access were almost never preferred because most patients eventually needed treatment and lost QALYs while waiting for therapy, and some patients with advanced disease were inappropriately deferred. However, Schackman and colleagues identified a threshold utility weight of 0.97 for quality of life — much higher than the 0.89 utility weight of the base case — in which limiting treatment to patients with advanced fibrosis was the optimal approach.
In probabilistic sensitivity analyses, efficacy had a large role in determining ideal treatment regimens for cirrhotic patients, with the more effective regimen being preferred more than 75% of the time. In contrast, selecting optimal regimens for non-cirrhotic patients depended on cost. Analyses demonstrated that the most inexpensive regimens were preferred when the threshold for willingness to pay for each year of healthy life was $100,000/QALY gained.
“We find that among competing regimens with efficacy >90%, cost should be the primary driver of formulary decisions,” Schackman and colleagues concluded. “Negotiating prices and limiting formulary for non-cirrhotic patients is a better approach to cost control than current disease stage treatment restrictions.” – by Stephanie Viguers
Disclosure: The researchers report no relevant financial disclosures.