On June 22nd, the American Society of Clinical Oncology (ASCO) published a conceptual framework for assessing the value of new cancer treatment options based on clinical benefit, toxicities/side effects, and cost. The document is incredibly significant for patients in that the framework allows for a person-centered patient-provider discussion on cancer care and looks beyond what is typically considered in a clinical outcomes discussion: cost and quality of life.
Ideally the framework will facilitate patient-provider conversations around the relative value of the newer (and often more costly) cancer therapies compared with established treatments. The document may also help guide patient-provider conversations about cancer treatment options and choices, and support shared decision making by considering personalized patient values and goals.
In this new age of personalized medicine, the framework has the potential to add the person back into personalized. In describing the framework, ASCO states:
Because patient perception of value is so individualized, it is crucial that discussions with patients include an assessment of which treatments are most likely to support their needs, goals, and preferences….
However, quality of life measures and patient-reported outcomes are not a part of the actual framework because they are difficult to measure quantitatively.
Within the value framework, ASCO defines value as a combination of three factors:
- Clinical benefit (efficacy of a treatment in either eradicating or slowing cancer progression)
- Toxicity (a treatment’s documented side effects)
- Cost (individual patient costs based on insurance as well as the total cost of the drug when purchased from the manufacturer)
To calculate value across these three factors, the framework introduces the idea of a “Net Health Benefit” score, or NHB. The NHB is derived using the published clinical outcomes (overall improvement or progression-free survival) data as well as the side effects & toxicity data to give a more accurate picture of true treatment benefit.
The value framework allows for this NHB score to be represented side by side with projected costs of treatment, allowing the patient to visualize the course of treatment across several factors and determine value based on their personal preferences and circumstances.
Further acknowledging the nuances of cancer treatment and individualized care, ASCO has created two flavors of the value framework:
- One for patients with early-stage cancer when the goal of treatment is to eliminate the cancer.
- The other for patients with advanced cancer, where the goals of treatment are to “control the growth of the cancer, maintain good health as long as possible, lessen the symptoms of the cancer, and provide the best quality of life.” 1
ASCO emphasizes that the proposed framework is intended to empower patients with clear information, and should not be used to limit patient choice. “This framework is about weighing the options, not limiting them,” said Dr. Vose. “It should not be used to replace physician judgment or patient preference.”
“Value and cost are among the biggest issues in healthcare today, but there are few tools to help doctors and patients objectively assess benefits, side effects and costs,” said ASCO President Julie M. Vose, MD, MBA, FASCO. “Our goal is to help oncologists and their patients weigh potential treatment options based on high-quality scientific evidence and a thoughtful assessment of each patient’s needs and goals. In publishing this initial version of the framework, just the beginning of the process, we hope to drive discussion and debate about a critically important issue.” 2
Perhaps one of the most exciting elements about the value framework publication is the open request for public comment. ASCO will be accepting feedback on the framework through August 21st. You may peruse the Conceptual Framework to Assess the Value of Cancer Treatment Options here: http://jco.ascopubs.org/content/early/2015/06/16/JCO.2015.61.6706 and you may download a copy of the Patient and Caregivers: Understanding ASCO’s Conceptual Framework for Assessing the Benefits, Side Effects, and Costs of Treatments for People Living with Cancer document here http://www.asco.org/sites/www.asco.org/files/patient_and_survivor_value_framework_companion_guide.pdf
Comments are being collected through August 21st at: http://www.surveymonkey.com/s/Valueframework
Our #hcldr chat on Tuesday, August 18, 2015, at 8:30 PM ET (for your local time click here), will discuss the following aspects of the ASCO Framework:
- T1: How should we define VALUE in cancer care? Are ASCO’s suggested measures (clinical outcomes, toxicity, cost) the best approach?
- T2: How might patient’s individual treatment goals and quality of life measures be drawn into patient-provider discussions of value?
- T3: How might decision frameworks like ASCO’s for cancer care, be used to impact other aspects of care (ie: cost of drugs)?
- T4: Please share any additional feedback on the ASCO Conceptual Framework to Assess Value in Cancer Treatment?
According to ASCO:
Comments will inform the evolution of the value framework, which will be modified in response to feedback and updated as new data are developed about the utility and impact of new treatments in different clinical scenarios. Ultimately, ASCO plans to use the framework as the basis of physician-guided tools for day-to-day use in clinical settings. ASCO will move quickly to address input received, although the specific timeline for future steps is not yet determined.”
Balancing Act – Colin Harris ADE https://flic.kr/p/8PW6dT