ASCO’s Value Framework: Is It All About the Drugs?
The American Society of Clinical Oncology (ASCO) recently issued its framework to assess the value of cancer treatment options in response to the major challenge of escalating healthcare costs in the United States.1 Healthcare costs in the United States are unsustainable, with cancer care costs, in particular, soaring as a result of many factors, including high drug costs, advances in technology, and an aging population. In fact, “the top 20 oncology drugs represent about 70% of the overall market spending on drugs in the United States.”2 Yet, health outcomes have not kept pace with the escalating costs.
ASCO’s framework compares the clinical benefit, toxicities, and costs of various regimens to guide oncologists, patients, payers, and manufacturers as care decisions are considered. Although it is a good step in the right direction, the current proposed method of calculating value is insufficient in this framework. ASCO’s invitation to provide feedback should help refine this important initiative.
The framework could be significantly strengthened in the areas of patient-centeredness, literacy level, and cost calculations. Provider usability, the inclusion of multidisciplinary perspectives, and integration with other systems should be considered.
An explanation of the populations studied in the data presented would be helpful as patients assess the relevance of the data to their individual medical and personal situations. Also, although Schnipper and colleagues note that “patient centeredness, timeliness of therapy, and equity in access to cancer care are essential elements of quality care,”1 these components of care were not included in the value calculation, because of the difficulty in measuring these constructs.
However, these components represent critically important constructs in the lives of patients, as well as true costs for a variety of stakeholders, including personnel time and investments in technology. It is critical that these components be incorporated into the value framework and integrated into technology for routine reporting to result in rapid learning and quality improvement.
Literacy and Health Literacy
Schnipper and colleagues note that “patients need a clear understanding of the possible clinical benefits and harms of treatment options available to them.”1 However, if the information presented is highly complex for healthcare professionals to process, it will be extremely difficult for the average patient to understand. For example, it is important that patients recognize that the framework compares a new treatment to the current standard of care and cannot be used to compare 2 new treatments.
Furthermore, the meaning of different net health benefit scores compared with the standard of treatment is important for patients to understand: low scores do not simply indicate low efficacy of the particular treatment in general. For this framework to be meaningful to providers and patients, there must be an investment of time on behalf of the care team and a commitment to helping patients understand this information; however, this time may not be available in clinical practice.
The value framework also presents the possibility for choice paralysis for patients who may not be able to make decisions based on receiving complicated information at a time of emotional distress. The tool should be used to facilitate conversations. However, it is vital that providers understand the level of literacy and health literacy of their patients and tailor conversations to their patients’ level of understanding and ability to absorb complex medical information at a challenging time in their lives.
Asking patients if they would like a loved one, a caregiver, or a patient navigator or advocate in the room when these discussions are taking place could aid in comprehension and informed decision-making for the patient.
Cancer Care CostsASCO rightly uses the net health benefits calculation rather than quality-adjusted life-years, which are subject to individual bias. However, in its value framework, costs are measured solely by the drug acquisition cost and the patient cost, ignoring critical cost information that are components of value, such as the expected costs of hospital admissions or inpatient stays based on specific courses of treatment, as well as the expected costs of managing toxicity and side effects.
Conversely, certain cost-savings could be calculated based on treatments that help patients avoid hospitalizations and other medical care. These costs should be triangulated, because there can be “spillover effects” or cost offsets associated with expensive drugs if they help patients avoid hospitalizations.
A complicating factor is oral therapeutics to which patients may not adhere for cost reasons, potentially leading to follow-up medical interventions that are more costly than would be required if the drug were not taken at all.2
In short, other medical utilization savings to patients, insurers, and the healthcare system as a whole should be taken into account to ensure that the cost of interventions are neither overstated nor understated. Methodologically, the averted costs can be subtracted from the numerator or can be added to the denominator in the cost-effectiveness ratio.
Recognizing that ASCO’s value framework is a first step, and that some of these recommendations are alluded to by Schnipper and colleagues, the following comments are our recommendations for revising the usefulness and accuracy of this tool:
- Revise the way that treatments are compared. The current approach allocates “points” that are weighted based on overall survival, progression-free survival, or response rate and degree of toxicity, with bonus points for palliation and treatment-free intervals. The current points system fails to reflect the gravity of the information being captured, and it undercuts the significance of the tool. In addition, a means of comparing various treatment options rather than comparing a treatment only to standard of care would be helpful
- Incorporate other costs of care, including the costs of expected hospital admission, averted costs, and personnel and technology costs to provide quality cancer care for various regimens
- Incorporate other therapeutic modalities. To be useful to patients in decision-making, an assessment of how different combinations of therapeutic modalities compare with other combinations and for what populations is critical. Patients cannot make informed treatment decisions for modalities in isolation
- Incorporate the perspective and role of multidisciplinary team members, such as nurses, social workers, genetic counselors, rehabilitation specialists, financial counselors, patient navigators, and support staff to ensure the true costs of quality and the essential measures of value are included in the framework for each regimen
- Refine the tool to make it more accessible to providers and patients, and/or consider a provider guide and patient guide to accompany the framework in accessible language
- Adapt the framework in a user-friendly way that fits with a provider’s busy clinical practice (eg, create a smartphone app or integrate comparative regimens within the electronic health record)
- Integrate the value framework with other recommendations from the Institute of Medicine, the National Comprehensive Cancer Network, and the National Patient Advocate Foundation regarding quality healthcare delivery
- Prioritize and capture clinical impact, toxicity, cost elements, and patient-reported outcomes data to inform a continuous improvement process for the tool and to reveal insights into patient–provider conversations and relationships and, ultimately, patient treatment decision processes (eg, such as through ASCO’s CancerLinQ)
- Issue a clear position statement on the utility of cost-effectiveness research
- Issue a position statement regarding the ability of physicians and health systems to deliver cost-effective, high-quality care given the changing healthcare financing environment. Specifically, how can we ensure that practices are adequately compensated to provide the kind of patient-centered care ASCO supports while keeping rising costs down?
Overall, ASCO should be commended for leading a critical conversation on value in cancer care. In its current iteration, the ASCO value framework appears insufficient, because it limits value metrics to drug acquisition cost and patient out-of-pocket expenses, and it is overly complex in how the information is conveyed.
For a more accurate and usable tool, the costs and benefits associated with quality, patient-centered care, and the multimodality of cancer treatments must be incorporated into these regimen comparisons, and information must be conveyed in a more accessible manner to providers and patients to aid in shared decision-making.
- Schnipper LE, Davidson NE, Wollins DS, et al. American Society of Clinical Oncology statement: a conceptual framework to assess the value of cancer treatment options. J Clin Oncol. 2015;33:2563-2577.
- Kuznar W. Cancer drugs continue to drive pharmaceutical spending trends. Value-Based Cancer Care. 2015;6:1.