Abstract
The American Society of Clinical Oncology's proposed Value Framework uses data from prospective randomized trials to determine the relative benefits of newer cancer therapies versus the standard of care based on their effectiveness in extending survival and the number and severity of side effects. The goal is to develop an electronic tool that enables oncologists to easily compare the value of various treatment options and their associated costs.
The American Society of Clinical Oncology (ASCO) has proposed a tool for calculating the relative value of cancer therapies aimed at making it easier for oncologists and patients to compare the relative effectiveness of various treatment options and their associated costs.
The ASCO Value Framework, developed with input from oncologists, patient advocates, and pharmaceutical and insurance company representatives, uses data from prospective randomized trials to determine the net health benefit (NHB) of newer cancer therapies versus standard of care, based on clinical endpoints such as overall survival (OS) and toxicity. Oncologists would plug in data from randomized clinical trials to calculate the NHB scores of various treatment options that could then be presented to patients along with cost comparisons. ASCO is soliciting comments on the initial version of the framework, which appears in the Journal of Clinical Oncology.
“For some time, we've been hearing from patients and oncologists about the growing substantial financial burden of cancer care, and we've realized that the issue isn't just about cost but about what value patients are getting,” says Richard L. Schilsky, MD, ASCO's chief medical officer and senior author of the report. “This initial framework provides the guideposts for a discussion with patients about the extent to which a new treatment delivers a greater benefit than a prevailing standard, and at what cost.”
The scoring system, which would eventually be developed into user-friendly software, awards up to 80 points for clinical benefit based on fractional improvement in OS, progression-free survival (PFS), or response rate (RR) of a new drug compared with conventional therapy in a specific clinical scenario. (OS receives more weight in scoring than PFS or RR.) To calculate toxicity, up to 20 points are added or subtracted from the effectiveness score based on the frequency of adverse events. Up to 30 points can also be awarded for statistically significant improvements in other measures, such as cancer-related symptoms.
A score of zero doesn't mean that a newer therapy isn't effective, just that it offers no advantage over the standard of care when relative benefit and toxicity are considered, says Schilsky. Price is not factored into the score but is included in the report so that patients can assess clinical benefit in relation to cost.
To illustrate how the system might work in practice, the task force compared four new and established first-line treatments for metastatic non–small cell lung cancer. Bevacizumab (Avastin; Genentech) plus paclitaxel and carboplatin, for example, received an NHB score of 16 out of 130, based on data showing it extended overall survival by 2 months compared with carboplatin plus paclitaxel—the standard of care—and was better tolerated. However, the cost per month for the newer treatment was significantly higher than the standard of care: $11,907 vs. $182, based on the average sales price.
Schilsky notes that the same regimen may get a low score for one indication but a higher score in another, such as with two different types of lung cancer. Also, “the scores can change in different trials, patient populations, and lines of therapy,” says Schilsky. “The continual discovery of new biomarkers that identify patients most likely to benefit from specific therapies is really critical and will greatly impact the whole value proposition.”