ALEXANDRIA, VA. – The American Society of Clinical Oncology has initiated an ambitious campaign designed to wring order out of the current chaos surrounding the efficacy, toxicities, and costs of emerging therapies for cancer.
ASCO is inviting clinicians and other stakeholders to comment on the initial version of its Value Framework, published June 22, 2015 in the Journal of Clinical Oncology.
Dr. Richard L. Schilsky
“We developed the framework because costs are increasing, and our patients are clearly feeling the impact, and we’ve heard about that directly from patients and their doctors,” said ASCO Chief Medical Officer Richard L. Schilsky at a media briefing announcing publication of the first version of the framework.
The costs of cancer care are growing rapidly, and are expected to increase from approximately $125 billion annually in 2010 to $158 billion by 2020. Cancer drugs are the fastest-growing components of that cost. New cancer drugs on average cost about $10,000 per month, compared with half that amount just 10 years ago, Dr. Schilsky said.
“Some new drugs now exceed $30,000 per month, and as we look to the future of using these new drugs in combination the costs will be even greater,” he said
Out-of-pocket costs for patients are also on the rise. The total out-of-pocket burden is greater for patients with cancer than with other chronic diseases, regardless of the type of insurance the patient has.
“Many cancer patients are facing severe financial strain, even bankruptcy in some cases. In fact, people with cancer are about 2½ times more likely to face bankruptcy than those without cancer,” Dr. Schilsky noted.
He pointed to a 2013 study of financial toxicity among cancer patients, which found that among patients surveyed, 20% took less than the prescribed amount of medication, 19% partially filled prescriptions, and 24% avoided filling prescriptions altogether in order to save on the costs of their care.
How it works
The Value Framework is intended to serve as a standardized system of information on the relative benefits, toxicities, and costs of new therapies as compared with existing therapies in randomized clinical trials.
The framework is specifically built around the comparative trial, with different methodologies to evaluate therapies for advanced/metastatic disease and treatments used with curative intent in the adjuvant setting.
Dr. Lowell E. Schnipper
“This is not meant to be a ranking or a calculator for individual drugs. It’s a way to provide information in a standardized and objective way to both physicians and patients about the value of new treatment options that emerge from clinical trials comparing a standard of care to a new treatment option,” said Dr. Lowell E. Schnipper, chair of ASCO’s Value in Cancer Care Task Force.
“I want to be clear: this is not a way of ranking drugs; this is simply a way of understanding the outcome of a clinical trial,” he said at the briefing.
The frameworks use a scoring system to award or subtract points to a specific therapy based on clinical benefit and toxicity, with the two scores combined to generate a Net Health Benefit score that will then be compared with the direct cost of the treatment.
Clinical benefit
For the adjuvant framework, a score of 1-5 for overall survival (OS) will be assigned based on the hazard ratio when the treatment is compared to the standard of care. If the trial does not report OS data, the hazard ratio for disease-free survival (DFS) will be used instead. The categorical score is multiplied, or weighted, by a factor of 16 for OS and 15 for DFS. In this and in the advanced disease framework, the maximum weight of the benefit on survival will be 80 points (16 x 5).
In the advanced/metastatic framework, clinical benefit will be scored based on fractional improvement in median OS over the standard of a care for a specific clinical scenario. As with the adjuvant framework, OS is considered first, DFS if OS is not available, and if neither is available (for example, in a single-arm trial), response rate will be used. In this framework, OS is weighted by a factor of 16, PFS by 11 “because it is a less clinically meaningful end point and is not always a surrogate for OS,” the framework creators note. Response rate will be weighted by 8, an acknowledgment that clinical responses do not always translate into improvements in OS.
In both frameworks, toxicities will be determined relative to the comparator regimen or drug, with a categorical value ranging from –20 (for substantially less well tolerated) to +20 (substantially better).