ASCO Wants Your Feedback on Plan to Define Value in Drugs

Megan Brooks

June 22, 2015

The American Society of Clinical Oncology (ASCO) today unveiled an initial conceptual framework for assessing the value of new cancer treatment options in comparison with existing standards of care, and they are seeking public comment on it.

The treatments are limited to those that have been tested head to head in randomized clinical trials.

The ASCO Value Framework defines value as a measure of clinical benefit, toxicity, and cost. It was published online today in the Journal of Clinical Oncology and at www.asco.org/value and was developed by ASCO's Value in Cancer Care Task Force, with input from oncologists, patient advocates, representatives of the pharmaceutical and insurance industries, and others.

The framework is in response to a "very clear and urgent need" with regard to cancer patients and providers who care for them, ASCO President Julie M. Vose, MD, said during a media briefing.

The cost of new cancer drugs is having a "growing impact" on patients, and there are very few tools that clinicians and patients can use to objectively assess the costs and benefits of new drugs compared with older drugs, said Dr Vose.

"Cancer care costs are growing fast and are expected to increase from $125 billion in 2010 to $158 billion in 2020, and cancer drugs are the most rapidly growing component of these costs," added ASCO chief medical officer Richard Schilsky, MD.

On average, new cancer drugs now cost about $10,000 per month for a single drug, with some exceeding $30,000 per month. "Out-of-pocket costs, which matters most to our patients, are also rising, and total out-of-pocket burden for cancer patients is greater than for other patients with chronic diseases," Dr Schilsky noted. Studies have also shown that some cancer patients take less medication than prescribed or avoid filling prescriptions altogether because of concerns about cost, which in the long run could drive up costs of care, he said.

The ASCO Value Framework proposes a methodology to compare the relative clinical benefits, side effects, and costs of treatment regimens that have been tested head to head in randomized clinical trials, as noted above. Data on the clinical benefits and toxicity of a regimen are used to calculate a combined net health benefit score, or NHB.

"The NHB represents the added benefit that patients can expect to receive from the new therapy vs the current standard of care," ASCO explains in a news release. The NHB is presented alongside the patient's expected out-of-pocket costs for the regimens being compared, as well as the overall drug acquisition cost.

Definition of Value Highly Personal

"It's critical to distinguish between value and cost," Lowell E. Schnipper, MD, chair of ASCO's Value in Cancer Care Task Force, said in the release. "Sometimes the more valuable treatment will be the more expensive one, and sometimes it won't be. Ultimately, the definition of 'value' will be highly personalized for each patient, taking into account an individual's own preferences and circumstances. For example, in the setting of advanced cancer, is length of life the most important goal, or is quality of life? Is the proposed treatment affordable? That's why we're proposing to provide information on net health benefit and cost side by side," Dr Schnipper said.

To highlight the potential utility of the framework, the ASCO Task Force applied its methodology to metastatic lung cancer, advanced multiple myeloma, metastatic prostate cancer, and adjuvant therapy for HER2-positive breast cancer.

"The results were striking: in some clinical scenarios, a newer, more expensive regimen had a much larger NHB than the previous standard. In other scenarios, the newer, more expensive regimen showed little or no net health benefit. These are sample scenarios only, and NHBs for the same regimen may vary in different types of cancer or treatment settings," ASCO notes in the release.

 
The results were striking.
 

"We envision sometime in the future to have a software that is available to utilizing this value framework or one just like it that's curated with many comparative trials such that it would be very easy for a patient to see for a given clinical indication what the treatment options are," Dr Schnipper told reporters. "The patient then might literally adjust the preference if length of life is most important to them, or quality of life/absence of toxicity is more important to them, that individualization is of critical importance in clinical oncology, particularly in the advanced disease setting, and that's where we see this heading as it matures and evolves and goes through other iterations," he added.

Dr Vose said the goal in publishing this first version of the framework is to "drive discussion and debate on this critical issue, and we are soliciting feedback over the next 60 days from all stakeholders via our website. That feedback will form the evolution of the framework, which I'm sure will change over time," she added.

ASCO is accepting comments on the framework until August 21, 2015, at www.asco.org/value.

The European Society of Clinical Oncology also recently unveiled a tool to assess the value of cancer drugs, as reported by Medscape Medical News.

Oncologists at Memorial Sloan Kettering Cancer Center, in New York City, have come up with their own interactive drug value calculator for new cancer drugs, as described in a recent article in the Wall Street Journal.

J Clin Oncol. Published online June 22, 2015. Full text

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