Comparing the Current Value Frameworks in Oncology
Value frameworks in oncology are relatively early in development, and their ultimate impact remains unknown, but at a minimum, providers should be aware of the current value frameworks and how each value framework measures value, as well as their implications for clinical trial development, said Kasia Shields, PharmD, MBA, BCOP, BCPS, Director, Medical Communications, Xcenda/AmerisourceBergen, at the 2016 Hematology/Oncology Pharmacy Association Oncology Pharmacy Practice Management Program.
Value is a heavily debated topic in oncology, but it can be simply defined as benefit that exceeds cost, said Dr Shields. “We want to make sure that patients have better access to therapies, and don’t have a penalty based on the cost of the drugs. When we have better alternatives and outcomes, hopefully we will spark innovation,” she said.
Escalating drug prices have put value frameworks in the spotlight, and the identification of the key questions and the audience addressed in each value framework is vital to understanding the value landscape, said Dr Shields. “That gives you a perspective on the domain of value they choose to focus on,” she added.
Dr Shields provided a summary of the 5 current value frameworks in oncology.
Oncology Value Frameworks
The American Society of Clinical Oncology (ASCO) value framework focuses on clinical benefit in relation to cost. The ASCO value framework version 1.0 was developed as a physician-guided tool to assist providers and patients in shared decision-making regarding cancer treatments and calculated a net health benefit score, but ASCO modified the net health benefit score in version 2.0 to better reflect the true differences between cancer treatments.
ASCO’s value framework now considers all side effects in the net health benefit score, not just the most severe, high-grade toxicities. This value framework evaluates only treatments that were studied head-to-head in prospective, randomized clinical trials, and focuses only on cancer drugs and not on other treatment interventions.
The European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale focuses on clinical value but avoids cost because of the significant heterogeneity in drug prices in European countries. This value framework is intended to be used only for solid tumors, and can be applied for early (curative) or for advanced (noncurative) cancers. Drugs or treatment interventions that obtain the highest scores on the Magnitude of Clinical Benefit Scale are highlighted in ESMO’s clinical guidelines.
The National Comprehensive Cancer Network (NCCN) Evidence Blocks address how expert clinicians rate a treatment’s value, and measure various components of value on a scale from 1 to 5, with 1 being the least favorable. Value measures include efficacy and safety, which are rated using the panel members’ knowledge of the published data, in addition to their own clinical experience; quality and consistency, which are rated using the evidence cited in the NCCN clinical guidelines and the panel members’ knowledge of data supporting the treatment; and affordability, which is rated using the panel members’ knowledge of the overall cost of the treatment regimen.
Memorial Sloan Kettering Cancer Center’s DrugAbacus focuses on the fair price of a cancer drug, and uses an interactive calculator that compares the costs of more than 50 different cancer drugs. The DrugAbacus defines value based on a drug’s delivered innovation and the value that the drug brings to patients and addresses an unmet need. The DrugAbacus is considered the most personalized tool for measuring drug value, said Dr Shields.
The Institute for Clinical and Economic Review (ICER)’s drug assessment program focuses on societal value and looks at the “bigger picture,” said Dr Shields. Among other facets, the ICER Value Assessment Framework measures clinical effectiveness, incremental cost per clinical outcomes achieved (long-term), potential health system budget impact (short-term), and “care value,” which is discussed and voted on during public meetings comprising patient advocates, clinical societies, life sciences companies, pharmaceutical benefit managers, and health insurers.
Areas of Concern
“Not every area of oncology has standard of care. Things are moving really fast, and we’re left comparing apples to oranges, removing the value from the equation,” said Dr Shields. “But I think it’s better to have 5 groups trying to arrive at a definition of value than having the government telling us how we should go about it, so having this discussion is beneficial,” she added.
Dr Shields warned that because these new methodologies have not been fully tested or validated, the value frameworks lack uniformity, and it is still unclear how these findings will be used in treatment and reimbursement decisions. Some methods lack transparency, none of the methods focus on every component of healthcare and disease management, and all of the value frameworks may undergo considerable revision from their first published versions.
The current value frameworks require work before they can be considered as effective tools for shared decision-making, because they must fit into the workflow of a busy clinical practice, said Dr Shields. These value frameworks may be less pertinent to patients and physicians and more applicable to policymakers. Overall, more work is needed to determine how best to consider factors, other than cost, that matter to patients (eg, adverse events, ancillary benefits).
“This is the era of value frameworks in oncology, and I don’t think it’s going anywhere. But the bottom line is, these frameworks are early in development, so awareness is half the battle,” said Dr Shields.