Alexandra Chambers

Do the American Society of Clinical Oncology Value Framework and the European Society of Medical Oncology Magnitude of Clinical Benefit Scale Measure the Same Construct of Clinical Benefit

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.

Multiple Dimensions of Value: Evaluative Frameworks for New Cancer Therapies

TO THE EDITOR: The increasing burden of costs associated with novel cancer therapies has become untenable. In the United States, the annual cost of a new cancer therapy routinely exceeds

Comparing assessment frameworks for cancer drugs between Canada and Europe: What can we learn from the differences?

100,000; such costs may prevent patients from receiving effective options or only enable access under risk of significant financial duress or bankruptcy. In this context, we applaud the recent development of the ASCO Value Framework, a tool that enables physicians and patients to discuss the relative value of a new cancer therapy compared with the standard of care. The framework assesses benefit and toxicity of a cancer therapy through a net health benefit score while highlighting the direct drug costs borne by patients. A core tenet in ASCO’s process was to ensure that the framework development was transparent and malleable. Some criticisms already have targeted the arbitrariness of net health benefit scoring and limited perspective on costs as well as the inability of the framework to evaluate the methodological strength of evidence, consider noncomparative studies despite the increasing propensity for regulatory drug approvals based on earlier-phase trials, and evaluate scenarios in which multiple comparators represent current standards or for which nontrial (real-world) data are available. Over time, these limitations in the initial process may be addressed or proven of minimal consequence; certainly, we now have a much-needed starting point for a dialogue with patients on relative clinical benefit and costs. We highlight that additional dimensions may also warrant consideration to create the most fulsome assessment of value. In particular, such factors as patient preferences, burden of illness, feasibility of adoption, and formal cost-effectiveness analysis (CEA) may broaden the perspective of value from the individual level to society at large. Since 2007, the provinces and territories of Canada (with the exception of Quebec) have participated in the pan-Canadian Oncology Drug Review (pCODR). pCODR provides evidencebased cancer drug funding recommendations and evolved from iterative processes for formal evaluation of cancer therapies at a national level that have spanned more than a decade. The Canadian experience suggests that although clinical and economic evidence are fundamental building blocks for evaluation, additional factors often come into play when funding decisions are implemented. As such, pCODR follows an established deliberative framework (Table 1) in making recommendations by systematically assessing clinical and economic evidence in addition to patient perspectives and the feasibility of drug adoptionwithin the provincial context and budget. The framework aspires to ensure that no single element overrides another and that no single threshold must be met for any element in the review. Can these additional elements enhance our understanding of value beyond the traditional pillars of benefit and drug costs already considered by ASCO? In its consideration of benefit, pCODR expands its scope beyond efficacy and safety to consider quality of life, burden of illness on society, and availability of

The impact of cancer drug wastage on economic evaluations

The increasing burden of costs associated with novel cancer therapies is becoming untenable. In Europe and Canada, assessment frameworks have been developed to attribute value to novel therapies and ultimately facilitate access to cancer drug funding. A review of the two frameworks has not previously been undertaken. This review provides insight into the relative strengths and benefits of each approach, the various perspectives of value (patient, physician and societal) and how the frameworks relate to their unique context and core principles. Both frameworks assess the clinical benefit of a new cancer therapy. The European framework considers effectiveness, quality of life, and toxicity in its determination of benefit and has the advantage of providing a simple summary score to facilitate priority setting. The Canadian framework considers other elements including cost-effectiveness, patient preferences and adoption feasibility; its deliberative framework precludes a simple summative presentation of value but can address complex and nuanced drug funding considerations with flexibility. Both frameworks have evolved to meet the needs unique to their jurisdictions and offer potentially complementary tools in the assessment of new cancer drugs. Lessons learnt in both systems can be applied to future iterations of the frameworks, which remain works in progress.

Engaging specialist oncologists in the assessment of oncology drugs in Canada

The objective of this study was to determine the impact of modeling cancer drug wastage in economic evaluations because wastage can result from single‐dose vials on account of body surface area– or weight‐based dosing.

A descriptive analysis of clinician input and feedback into the CADTH pan-Canadian Oncology Drug Review process.

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