Miriam E. Tucker
November 13, 2013
WASHINGTON, DC — The expense of telaprevir-based triple therapy for hepatitis C — including adverse event management — is $189,000 per sustained viral response, report investigators.
"Our findings indicate that the benefit-cost ratio is lower than projected, based on results of the registration trials," lead investigator Andrea Branch, MD, from the Icahn School of Medicine at Mount Sinai in New York City.
Kian Bichoupan, MBS, who is Dr. Branch's first-year PhD clinical research student, presented the results here at The Liver Meeting 2013.
The number seemed to alarm session comoderator Sammy Saab, MD, from the David Geffen School of Medicine at UCLA, who called it "very surprising." It is "at least double what we think the cost is. I didn't know the cost of actually curing someone was so high," he said.
It is expected that 2 new direct-acting antiviral agents for the treatment of hepatitis C, simeprevir and sofosbuvir, will be approved by the US Food and Drug Administration (FDA) on December 8. Both have far better adverse-event profiles than telaprevir-based regimens, but the degree to which the cost-effectiveness calculation will change depends on their price, which hasn't yet been announced, Dr. Saab explained.
The benefit-cost ratio is lower than projected.
Before telaprevir received FDA approval in May 2011, the standard of care for genotype 1 hepatitis C was 48 weeks of pegylated interferon and ribavirin. With that regimen, the sustained viral response ranged from 40% to 50%. With the addition of telaprevir to the peginterferon and ribavirin regimen, response rates increased to 64% to 75%, but adverse events and costs also rose.
Previous studies have shown that peginterferon and ribavirin dual therapy costs $70,364 per sustained viral response in patients with genotype 1 hepatitis C. Data from phase 3 registration trials suggest that telaprevir-based triple therapy is cost-effective, but real-world data have been unavailable until now, Bichoupan said.
The researchers evaluated 147 patients who initiated telaprevir-based triple therapy at Mount Sinai. The mean age of the cohort was 56 years, and 68% of the cohort was male, 19% was black, 46% did not respond to previous hepatitis C treatment, and 35% had advanced fibrosis or cirrhosis.
They calculated the cost of the therapy itself and the management of adverse events from Medicare, the Agency for Healthcare Research and Quality, and other sources.
Sustained viral response was achieved by 44% of patients. At 48 weeks, the cost of telaprevir was $55,273, of peginterferon was $30,418, and of ribavirin for $4926. Telaprevir accounted for 61% of the $90,617 total, Bichoupan noted.
Adverse events, primarily anemia, accounted for 8% of the total cost; 48% of the patients required treatment with epoetin alpha, 9% needed blood transfusions, 8% were treated with granulocyte colony-stimulating factor (G-CSF), 13% required hospitalization, and 10% made emergency department visits.
Total costs were $664,083 for epoetin alfa, $29,007 for G-CSF, and $12,644 for transfusions.
The total cost of treating hepatitis C was higher for the 65 patients who achieved sustained viral response than for the 82 who did not ($6.33 vs $5.24 million).
The median cost per patient was $83,509. The researchers multiplied that by the reciprocal of the 44% sustained viral response (2.27), and arrived at $188,859 per response.
The cost per sustained viral response was lower for treatment-naïve than for previously treated patients ($158,403 vs $199,134). For patients with advanced liver fibrosis, the cost was $185,484. For those with less severe fibrosis, the cost jumped to $256,977, Bichoupan reported.
He pointed out that this study started when telaprevir had just reached the market, and that outcomes might improve over time with better strategies for preventing adverse events.
Dr. Branch told Medscape Medical News that these data can't determine whether nearly $200,000 per sustained viral response is cost-effective, because not enough is known about the cost savings associated with such a response.
Other investigators have compared health costs for patients who achieve a sustained viral response with costs for patients with chronic hepatitis C infection. However, "this is not the best way to do the analysis because patients who achieve a sustained viral response may be healthier than patients who do not," Dr. Branch noted.
Dr. Saab said he agrees that the cost figures are likely to improve as experience with the drugs increases. However, he noted that telaprevir will likely disappear soon after the expected FDA approval of simeprevir and sofosbuvir.
Dr. Branch echoed this opinion. Telaprevir-based regimens "are only appropriate for patients who cannot wait even a few months for newer regimens to complete the FDA review and approval process," she said.
This study was supported in part by Gilead Sciences, the National Institute of Drug Abuse, and the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Saab is a consultant to Bristol-Myers Squibb.
The Liver Meeting 2013: American Association for the Study of Liver Diseases (AASLD). Abstract 244. Presented on November 5, 2013.