The American Society of Clinical Oncology stepped up the drug-cost debate last year when it proposed a tool to help doctors and patients compare potential treatments. Now, after collecting critiques from providers, patients and the pharma industry, the influential organization has rolled out a new version of that “value framework.”
Next up: A software tool that doctors can use to help patients make decisions about treatment.
ASCO received more than 400 comments on its original proposal, with “a majority of respondents” supporting the framework’s goals—evaluating treatments for effectiveness and safety, in the context of their costs, the organization said in a Monday statement.
Drug costs are growing fast, and expensive new therapies are storming the market—some more effective and more advanced than others, the framework’s developers wrote in a Journal of Clinical Oncology article explaining the new approach.
“These treatment choices often differ by only small degrees in clinical effectiveness and toxicity. Yet, there is often a wide disparity in cost to patients and payers,” the authors wrote.
Plus, patients shoulder a big chunk of that burden, and they need a means of comparison, the article notes. “The goal of describing a relationship between the cost of an agent or regimen and the clinical benefits it delivers takes on great importance,” the article states.
Fast-growing drug costs are also the reason the latest iteration of ASCO’s method, like the former version, focuses only on cancer drugs, leaving out radiation therapy and other treatments.
“As some commenters noted, the cost of drugs is only one component of overall cancer care costs. But evidence shows that drug costs are the most rapidly rising component of cancer care and among patients’ biggest concerns--in large part because they pay a significant share of these costs through co-pays,” ASCO President Julie Vose said in the statement.
The biggest change comes in ASCO’s calculations of “Net Health Benefit” scores, which weigh a treatment’s benefits and side effects. For one thing, the group dropped comparisons of straight survival data in favor of hazard ratios, when they’re available.
The new framework also adds points for treatments that help control cancer in the long term for a “significant portion” of patients. It considers the full range of side effects linked to each treatment, rather than focusing on the most serious, as the first proposal did.
“This change reflects feedback from patients who emphasized that even mild side effects can have a major impact on quality of life,” Vose said. Improvements in quality of life deliver bonus points to a drug’s overall score.
One big limitation to the framework is that it’s restricted to drugs studied head-to-head against other treatments in randomized clinical trials. As Vose noted Monday, some commenters advocated cross-trial comparisons--which would rope in placebo-controlled trials in addition to head-to-head studies--but ASCO still believes that head-to-head trials are the “only scientifically valid way to compare two treatments,” Vose said.
The journal article sets out the details of ASCO’s comparison tool, with examples. It outlines two separate calculation methods, one for treating advanced disease, the other for cancers that are potentially curable. The software tool that’s in the works will allow users to tweak comparisons by giving different weights to clinical benefit scores versus toxicity numbers, for example.
That’s one way ASCO’s current evaluation model steers away from the pricing debate that’s put pharma companies and drug costs under a spotlight since last summer. It ultimately puts doctors and patients in charge of the comparisons--rather than offering hard numbers that politicians, for instance, could use to criticize the drug industry.
The journal article also flatly states that the framework isn’t intended to spark policy discussions about pricing--at least not now. Yes, “value assessments” could be useful for developing healthcare policy, the authors write, but that would require ASCO’s tool to be revamped.
- see the ASCO statement
- get the journal article
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