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Anticancer Drugs in the Adjuvant Setting Have Considerable Costs Per Event Averted, Raising Questions of Sustainability

Adjuvant therapies are often approved based on composite, surrogate endpoints with high costs per event averted
20 Jul 2022
Anticancer agents & Biologic therapy;  Bioethics, legal and economic issues

A cross-sectional analysis of all approved anticancer drugs by the US Food and Drug Administration (FDA) from January 2018 through March 2022 identified 11 randomised studies in solid tumours in the adjuvant setting. The study team found the median monthly cost was 16 000 USD, and the median cost to avert 1 event as defined by the primary endpoint of the study was 1 610 000 USD, ranging from 820 000 USD to 2 640 000 USD. All approvals were based on composite, surrogate endpoints of disease-, progression-, or relapse-free survival, and no agent had yet demonstrated an overall survival benefit at the date of analysis. The findings are published by Dr. Vinay Prasad of the Department of Epidemiology and Biostatistics, University of California in San Francisco, CA, US and colleagues on 10 June 2022 in the JAMA Network Open. The authors underlined that these drugs may not achieve wide or global use unless their efficacy improves, or their prices decrease.

The authors wrote in the background that globally, the price of anticancer drugs is on an upward trajectory, with forecasts of global oncology therapeutic sales reaching 250 billion USD by 2024. It is estimated that in the US, spending on healthcare will increase from 3.6 trillion USD in 2018 to approximately 6 trillion USD in 2027, approaching 20% of the gross domestic product, with the costs of anticancer drugs playing a substantial role. The financial burden of these increasing costs falls upon patients and societies. Recent analyses call into question whether increased costs translate directly into improved survival or improved quality of life for patients with cancer.

In contrast with the metastatic setting, where all patients have disease, drugs given in the adjuvant setting benefit only a fraction of treated patients, as some are already cured, and some will relapse despite treatment. As more patients are potentially eligible for adjuvant treatment than patients eligible for metastatic treatment, the budgetary impact of adjuvant therapy may profoundly impact global markets.

An important estimate in adjuvant therapies is the cost per event averted. For this reason, the study team sought to assess the cost per event averted of different agents approved by FDA; they specifically aimed to characterise the monthly costs, the total cost for 1 patient’s treatment, and costs required to avert 1 negative outcome defined by each study primary clinical endpoint.

All approvals were reviewed from the FDA website. Approvals selected for the analysis needed to be drawn from randomised studies involving anticancer drugs studied in the adjuvant treatment of solid tumours. Treatments of nonsolid tumours, non-randomised, non-controlled studies; and unpublished studies were excluded. Approvals between January 2018 and March 2022 were included with 11 studies that met inclusion criteria. The monthly costs of each drug were abstracted from the Micromedex RED BOOK database. All variables included in calculations were derived from the original study publication. Information abstracted for each approval included the name of the drug approved, name of the study, primary endpoint, dosing regimen in the study, median duration of treatment, tumour type, monthly costs per drug, and the number needed to treat for the primary endpoint.

Main outcomes and measures were the cost per event averted for each agent studied in each clinical study, the monthly cost of each drug, the cost per patient for each drug, the primary clinical endpoint studied in each study, the study’s design and setting.

A total of 11 approvals were included in the analysis. During analyzed period, all approvals were based on a surrogate endpoint with no studies demonstrating, to date, an overall survival benefit. The median cost per event averted of drugs in the adjuvant setting was 1 610 000 USD (range, 820 000 USD to 2 640 000 USD). The median cost of a complete adjuvant treatment was 158 000 USD per patient.

The authors commented that regulatory agencies and payers should ideally ensure that approved drugs provide clinically meaningful benefits with proportional and sustainable costs. Their study confirms the substantial monthly costs of newly approved therapies. This analysis suggests that the current trajectory is unsustainable.

This project was funded by Arnold Ventures, LLC, through a grant paid to the University of California, San Francisco.

Reference

Mousavi I, Olivier T, Prasad V. Cost per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022. JAMA Netw Open 2022;5(6):e2216058.

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