Increasing cancer drug prices present global challenges to treatment access and cancer outcomes. Substantial variability exists in drug pricing across countries. In countries without universal health care, patients are responsible for treatment costs. Low- or middle-income countries are heavily impacted, with limited patient access to novel cancer treatments. Financial toxicity is seen across cancer types, countries, and health care systems. Those at highest risk include younger patients, new immigrants, visible minority groups, and those without private health coverage. Currently, cancer drug pricing does not correlate with value or clinical benefit. Value-based pricing of oncology drugs may incentivize development of higher-value medicines and eliminate excess spending on drugs that yield little benefit. Generics and biosimilars in oncology can also improve affordability and patient access, offering dramatic reductions in drug spending while maintaining patient benefit. Oncologists can promote value-based care by following evidence-based clinical guidelines that avoid low-value treatments. Researchers can also engage in value-based research that critically explores optimal cancer drug dosing, schedules, and treatment duration and defines patient populations most likely to benefit (e.g., through biomarker selection). Cancer Groundshot proposes that we improve outcomes for today's patients with cancer, including broader global access for high-value treatments, promotion of affordable cancer control strategies, and reduction of cancer morbidity and mortality through low-cost prevention and screening initiatives. Moving forward, major oncology societies recommend promoting uniform global access to essential cancer medicines and avoiding financial harm for patients as key principles in addressing the affordability of cancer drugs.
Purpose Whether the ASCO Value Framework and the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS) measure similar constructs of clinical benefit is unclear. It is also unclear how they relate to quality-adjusted life-years (QALYs) and funding recommendations in the United Kingdom and Canada. Methods Randomized clinical trials of oncology drug approvals by the US Food and Drug Administration, European Medicines Agency, and Health Canada between 2006 and August 2015 were identified and scored using the ASCO version 1 (v1) framework, ASCO version 2 (v2) framework, and ESMO-MCBS by at least two independent reviewers. Spearman correlation coefficients were calculated to assess construct (between frameworks) and criterion validity (against QALYs from the National Institute for Health and Care Excellence [NICE] and the pan-Canadian Oncology Drug Review [pCODR]). Associations between scores and NICE/pCODR recommendations were examined. Inter-rater reliability was assessed using intraclass correlation coefficients. Results From 109 included randomized clinical trials, 108 ASCOv1, 111 ASCOv2, and 83 ESMO scores were determined. Correlation coefficients for ASCOv1 versus ESMO, ASCOv2 versus ESMO, and ASCOv1 versus ASCOv2 were 0.36 (95% CI, 0.15 to 0.54), 0.17 (95% CI, -0.06 to 0.37), and 0.50 (95% CI, 0.35 to 0.63), respectively. Compared with NICE QALYs, correlation coefficients were 0.45 (ASCOv1), 0.53 (ASCOv2), and 0.46 (ESMO); with pCODR QALYs, coefficients were 0.19 (ASCOv1), 0.20 (ASCOv2), and 0.36 (ESMO). None of the frameworks were significantly associated with NICE/pCODR recommendations. Inter-rater reliability was good for all frameworks. Conclusion The weak-to-moderate correlations of the ASCO frameworks with the ESMO-MCBS, as well as their correlations with QALYs and with NICE/pCODR funding recommendations, suggest different constructs of clinical benefit measured. Construct convergent validity with the ESMO-MCBS did not increase with the updated ASCO framework.
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