Aug 18, 2015
Assessing the value of new cancer therapies based on benefits, toxicities, and costs
Balancing effective cancer treatment along with rising drug costs is one of the most difficult challenges in oncology today.
On one hand, more new cancer drugs are entering the market, offering hope for improved treatment. On the other, new agents are increasingly expensive and do not always outperform what is considered the standard of care.
Understanding the value of cancer treatment is critical as drug costs increase. Cancer drugs cost, on average, more than $10,000 a month, according to ASCO Chief Medical Officer Richard L. Schilsky, MD, FACP, FASCO, who discussed the topic in a June press conference.
In addition, cancer care costs continue to grow in the United States, with an expected increase from $125 billion in 2010 to $158 billion in 2020.1
Patients want guidance from their doctor
Studies have shown that when faced with questions regarding financial information, medical effectiveness, or treatment toxicity, patients want to talk to their doctor.2-3
"The reality is that many patients don't get [cost] information from their doctors, and many doctors don't have the information they need to talk with their patients about costs," Dr. Schilsky said.
For that reason, ASCO has drafted a new system designed to assist doctors and patients in assessing the relative value of certain cancer treatment options by examining the additional effectiveness, toxicity, and cost of a given drug regimen when compared to a standard of care.
"Value and cost are some of the biggest issues in health care today," said ASCO President Julie M. Vose, MD, MBA, FASCO. "There are very few tools, unfortunately, that doctors and patients can use to objectively assess the costs and benefits. and standardized information is really largely unavailable."
The ASCO value framework, which was published in the Journal of Clinical Oncology in June, employs a unique evaluation methodology developed by ASCO's Value in Cancer Care Task Force, chaired by Lowell E. Schnipper, MD, FASCO, under the direction of the Society's Board of Directors.
The framework evaluates data from comparative clinical trials with the goal of helping patients and their doctors discuss the added clinical benefit of new cancer drugs compared to established agents, while also allowing the cost of new drugs to be considered.
"The general feeling is there is a high cost to drugs, and sometimes therapies don't necessarily provide an enormous benefit despite an enormous cost," said Dr. Schnipper, Clinical Director of the Beth Israel Deaconess Medical Center (BIDMC) Cancer Center and Division Chief of the Hematology-Oncology in the Department of Medicine at BIDMC.
Ultimately, ASCO plans to use the value framework as the basis for a user-friendly tool. presented in a visually appealing way. Physicians can then use this tool as a decision-making resource in discussions with patients in the practice setting.
How ASCO's value framework works
The ASCO value framework is not a drug-ranking system. It compares one new agent in cancer treatment to the prevailing standard of care for a specific clinical cancer indication using data from a prospective randomized trial.
The framework does not score different drugs against each other. Instead, it examines the clinical benefit and toxicity of an agent in order to generate a "net health benefit" score that is juxtaposed against the cost of treatment.
In the advanced disease framework, clinical benefit is assigned a score between 1 and 5 based on improvement in median overall survival when compared with the standard of care in a specific clinical scenario. If overall survival data are not available, progression- free survival is used.
For the curative framework, clinical benefit is assigned a score between 1 and 5 for overall survival based on the hazard ratio when compared with a standard of care. Disease-free survival data are used if overall survival is not reported.
Both versions compare toxicity of the new drug to the standard of care using randomized trial data. The advanced disease framework offers palliative bonus points for any significant improvement in cancer-related symptoms, as well as treatment-free interval bonus points if a statistically significant improvement in treatmentfree interval is reported in a randomized trial.
Clinical benefit scores are weighted, multiplied, and added to the overall toxicity score. A maximum of 180 points for clinical benefit. 20 points for toxicity, and 30 bonus points are available. Total points are then calculated to determine the net health benefit, which has a maximum of 130 points for the advanced disease framework and 100 points for the curative framework.
The value framework generates a summary assessment for the drug regimen under consideration, with the net health benefit displayed alongside cost information. Cost information is broken into two categories: the drug's acquisition cost and the patient cost, which is personalized based on a particular patient's insurance benefits.
The framework separates net health benefit and cost to highlight their importance in cancer care, Dr. Schilsky said. The result, he sa id, is not a grade for cancer drugs but rather a starting point for physicians and patients to decide which treatment makes the most sense. Importantly, the relative value of a given cancer treatment will likely change over its lifetime, thanks to rapid advances in genetic biology and more effective organization of cancer data.
"We never set out to develop a rating scale. We don't have one now, and we don't intend to have one in the future," Dr. Schilsky said. "We set out to develop a framework to facilitate a discussion between doctors and patients."
"The version of the framework that we are publishing is something we consider a good first draft," said Dr. Schnipper. "Now, actually rolling it out to a larger constituency of patients, physicians, manufacturers, payers, and others, we hope to refine it."
Although the public comment period for the value framework ended in late August, ASCO still welcomes feedback regarding the framework. Additional comments regarding the proposed value framework can be emailed to email@example.com.
For more information, visit asco.org/value.
Members of the ASCO Value in Cancer Care Task Force
Lowell E. Schnipper, MD, FASCO - Chair
Beth Israel Deaconess Medical Center, Harvard Medical School
Josephs. Bailes, MD, FASCO
Texas Oncology, P.A.
Douglas W. Blayney, MD, FASCO
Stanford University Medical Center
Diane Blum, MSW, FASCO
National Executive Service Corps
Nancy E. Davidson, MD, FASCO
University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center
Adam P. Dicker, MD, PhD
Sidney Kimmel Cancer Center. Jefferson Medical University
Patricia A. Ganz, MD, FASCO
Jonsson Comprehensive Cancer Center, University of California Los Angeles
J. Russell Hoverman, MD, PhD
Robert M. Langdon, Jr., MD, FASCO
Oncology Hematology West
Allen S. Lichter, MD, FASCO
American Society of Clinical Oncology
Gary H. Lyman, MD, MPH, FASCO, FRCP
Fred Hutchinson Cancer Research Center and University of Washington
Neal J. Meropol, MD, FASCO
University Hospitals Case Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University
Therese M. Mulvey, MD, FASCO
Southcoast Centers for Cancer Care
Lee N. Newcomer, MD
Jeffrey M. Peppercorn, MD, MPH
Massachusetts General Hospital
Blase N. Polite, MD, MPH
University of Chicago
Derek Raghavan, MD, PhD, FACP, FASCO
Levine Cancer Institute
Gregory P. Rossi, PhD
Leonard Saltz, MD
Memorial Sloan Kettering Cancer Center
Deborah Schrag, MD, MPH, FASCO
Dana-Farber Cancer Institute
Richard L. Schilsky, MD, FACP, FASCO
American Society of Clinical Oncology
Thomas J. Smith, MD, FASCO, FAAHPM
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University