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ASCO Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options

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As reported by Schnipper et al in the Journal of Clinical Oncology, the ASCO Value in Cancer Care Task Force has released an ASCO statement detailing a conceptual framework to assess the value of cancer treatment options. The aim of ASCO in developing the framework is to encourage more patient-centered care. The Task Force was co-chaired by Lowell E. Schnipper, MD, FASCO, of Beth Israel Deaconess Medical Center, Harvard Medical School, and Nancy E. Davidson, MD, FASCO, of the University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center.

The ASCO value framework is a physician-guided tool, represented in worksheet form, to assist the physician and patient in shared decision-making. It enables comparisons of a new treatment regimen with the prevailing standard of care for specific indications using data from a prospective randomized trial.

Versions of the framework have been developed for advanced cancer and potentially curative treatment (adjuvant or neoadjuvant therapy). In both frameworks, points are awarded or subtracted in the categories of clinical benefit and toxicity; in the advanced disease framework, bonus points can be assigned if a regimen shows statistically significant improvement in palliation of symptoms or treatment-free interval. Clinical benefit and toxicity points and bonus points are combined to yield a net health benefit score, which is to be considered against the calculated direct cost of treatment displayed next to the net health benefit on the worksheet. Elements of the framework are summarized below.

Clinical Benefit

  • In the advanced disease framework, clinical benefit is assigned a categorical score of 1 to 5 based on the fractional improvement in median overall survival, median progression-free survival (if overall survival data are unavailable), or response rate (if overall and progression-free survival data are unavailable or the regimen has been evaluated in only a single-arm trial) when comparing a new regimen with a standard-of-care regimen. The categorical score for overall survival is weighted by 16 (a multiple chosen to indicate that a maximum of 80 (16×5) of 100 points can be attributed to improvement in survival), progression-free survival is weighted by 11 (because it is a less clinically meaningful endpoint and is not always a surrogate for overall survival), and response rate is weighted by 8 (because it represents a clinical benefit that might not translate to overall survival improvement).
  • For the curative framework, a categorical score of 1 to 5 is assigned based on the hazard ratio for overall survival or disease-free survival (if overall survival data are unavailable) for the new regimen vs standard of care. The categorical score is weighted by 16 for overall survival and 15 for disease-free survival.

Toxicity

  • In both the advanced disease and curative frameworks, the toxicity calculation awards or subtracts a categorical value of −20 to +20 reflecting whether the new regimen is substantially less well tolerated to substantially better tolerated when comparing the frequency of grade 3 to 5 toxicities vs the standard-of-care regimen.

 Bonus Points

  • In the advanced disease framework, a new regimen is assigned palliation bonus points if a statistically significant improvement in any cancer-related symptom is reported in a randomized trial and treatment-free interval bonus points if a statistically significant improvement in treatment-free interval is reported in a randomized trial.

Net Health Benefit

  • The clinical benefit and toxicity scores (plus bonus points in the advanced disease framework) are combined to yield the net health benefit score, with a maximum of 130 for the advanced disease framework and 100 for the curative framework.

Cost

  • Cost is represented as drug acquisition cost and patient cost. For the advanced treatment (adjuvant) framework, cost information is provided as the monthly cost of the regimen in both drug acquisition cost and patient cost. For the curative treatment (adjuvant) framework, cost information is provided as the total cost of the treatment regimen in both drug acquisition cost and patient cost for the standard duration of therapy. Costs for supportive care drugs are included in the calculations.

Summary Assessment

  • The net health benefit and cost information are provided at the end of each framework as a summary assessment. Value is inferred through the relationship between net health benefit and the cost to achieve the benefit.

Lowell E. Schnipper, MD, of Beth Israel Deaconess Medical Center, Harvard Medical School is the corresponding author for the Journal of Clinical Oncology article.

For full disclosures of the study authors, visit jco.ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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