Our View on Value Frameworks in Oncology: Proposing Principles for Value Framework Development

By Lee Schwartzberg, MD, David Ettinger, MD, Mohammad Jahanzeb, MD, Gregory Otterson, MD and David Waterhouse, MD

 

In the past year, Value Frameworks have been introduced as potential tools for policy-setting and decision-making in oncology by organizations including ASCO, NCCN, and ICER. We recently reviewed a report issued by ICER, the Institute for Clinical and Economic Review, regarding Non-Small Cell Lung Cancer (NSCLC). This report is the basis for a meeting and voting by ICER’s committee that will take place on Thursday, October 20, 2016, in St. Louis, MO.

For us as practicing oncologists and lung cancer researchers, this report has raised serious concerns regarding ICER’s ability to interpret clinical evidence and reach conclusions on drug value that are scientific, comprehensive, and unbiased.

Based upon our reviews of this report, ICER appears to represent a perspective that is less oriented towards patient benefit than towards motivations that would limit patient access to new therapeutic options. ICER’s clinico-economic methods include approaches and metrics that, due to their singular focus on population-level health, would likely fail patients on an individual, clinical needs basis. ICER’s philosophy appears to be similar to that of NICE in the UK, whose limitations placed on drug access have been correlated with lower cancer survival rates in the UK compared to the rest of Western Europe.

In response, we propose the following principles as the start of a discussion on standards and best practices for Value Framework development, particularly as these frameworks have the potential to impact clinical practice and the patients we serve.

Principle 1: Disease Experts as Evaluators and Authors

In any Value Framework, clinical benefits and toxicities should be assessed by clinicians who have extensive and active expertise, in research and in practice, of the disease area and treatment options being evaluated. For example, a report on lung cancer should have practicing physicians who are treating patients with the drugs in question as primary evaluators of such drug technologies and authors of any publications.

Principle 2: Patient-Centered Endpoints, Conclusions, and Definitions of Value

Patients must come first. The methods, processes, value definitions, and conclusions of any Value Framework should be patient-oriented so that the policies and decisions it informs serve patients’ best interests. Likewise, primary evaluative endpoints such as Overall Survival (OS) or Progression Free Survival (PFS) for any analysis should be scientifically and clinically selected to reflect the clinical benefit of primary importance to patients. The selection of trials, datasets, and studies for inclusion in any analysis should permit a full assessment of outcomes achieved and not exclude valid studies that could contribute to accurate evaluations. Metrics selected to define value should also be validated to ensure they reflect current and relevant patient definitions of value.

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