Cost-Effectiveness of GemCis with or without Durvalumab in Patients with Advanced Cholangiocarcinoma

April 2023, Vol 14, No 2

First-line standard of care for patients with advanced cholangiocarcinoma (CCA) has evolved from a chemotherapy-only regimen with gemcitabine/cisplatin (GemCis) to include the immune checkpoint inhibitor durvalumab (Imfinzi) based on results from TOPAZ-1 showing that the addition of durvalumab improved progression-free survival (PFS) and overall survival (OS) compared with GemCis alone. Although clinical benefit with the addition of durvalumab to GemCis has been proved, affordability of the regimen is still a concern. At the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, J. Alberto Maldonado, MD, Predoctoral Fellow, Medical Research Scholars Program, The National Institutes of Health, Bethesda, MD, presented results from a cost analysis of this treatment regimen.

Unit prices of durvalumab and GemCis were calculated using the LexiComp, and the drug cost per cycle was calculated for each drug assuming an average patient surface area of 1.9 m2 for men and 1.6 m2 for women. Excluded costs included cost of administration, adverse events, and follow-up. Similar to the TOPAZ-1 study design, the first 8 cycles included either durvalumab (day 1) plus GemCis (days 1 and 8) or placebo (day 1) plus GemCis (days 1 and 8) every 3 weeks, followed by durvalumab or placebo alone every 4 weeks until disease progression. The sum of all treatment cycles was included as the total treatment cost, and cost per life-year gained was calculated using a combination of total cost per year and treatment duration.

The drug cost per cycle was $13,797 for durvalumab, $282 for gemcitabine, and $87 for cisplatin. The total monthly cost for GemCis alone was $246 compared with $17,492 with the addition of durvalumab, a difference of $17,246. The median PFS in TOPAZ-1 was 7.2 months in the durvalumab group versus 5.7 months in the placebo group, a difference of 1.5 months. The difference in cost between GemCis alone and GemCis plus durvalumab, $17,246, multiplied by PFS months gained, 1.5 months, with the addition of durvalumab resulted in an estimated cost of $25,869 to gain 1.5 months of PFS. Total yearly cost by treatment arm was also higher for the durvalumab plus GemCis group ($209,899 vs $2949).

Although the results from TOPAZ-1 sparked excitement with promising PFS and OS benefit, cost-effectiveness evaluation is important to address financial toxicity for patients with CCA and suggests a need for additional research to explore cost-effective solutions.

Source: Maldonado JA, Greten TF, Monge C. Cost-effectiveness of gemcitabine plus cisplatin with and without durvalumab in patients with advanced cholangiocarcinoma. J Clin Oncol. 2023;41(4 suppl):498. Epub ahead of print.

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