Value Frameworks, which attempt to quantify the value of a medicine, have been a hot topic of late, given the recent proliferation of such frameworks and the ongoing debate about the cost and value of medicines. Last month, BIO CEO Jim Greenwood wrote about the critical importance of value frameworks being patient-centric and scientifically rigorous in their methodology. Today, writing in the Oncology Business Review, five oncologists joined the discussion, proposing five principles for value framework development.
In prefacing the piece, the authors mention their recent review of a report by the Institute for Clinical and Economic Review (ICER) regarding Non-Small Cell Lung Cancer. They concluded, “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.”
The authors continue:
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 to the concerns raised by their review of ICER’s report, they propose five principles for Value Framework development. These principles include recommendations that Value Frameworks should 1) have clinical benefits and toxicities assessed by clinicians with extensive and active expertise in the disease area and treatment options being studied; 2) employ patient-centric endpoints, conclusions, and definitions of value; 3) employ rigorous methodologies reflecting evidence based medicine; 4) provide for continuous and timely review and revision, reflecting the latest scientific data, and; 5) submit their methodologies and assessments for publication in relevant peer-reviewed journals.
The concerns and recommendations identified by the authors echo many of the concerns BIO has raised with ICER’s framework. Value Frameworks should facilitate, rather than hinder, ensuring that the right medicine gets to the right patient at the right time. Unfortunately, many of the attempts to date have fallen far short of that standard. We hope that ICER and others developing Value Frameworks will take to heart the earnest feedback they have received from diverse stakeholders, including BIO, and work to ensure that their initiatives are truly patient-centric and scientifically sound.
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