CLSA Submits Comments to the Institute for Clinical and Economic Review (ICER), Calls for Proposed Improvements to its Value Assessment Framework

Sept. 13, 2016

This summer, the Institute for Clinical and Economic Review (ICER) released a national call for stakeholder feedback on improvements to their “Value Assessment Framework” (Framework), which underpins the analyses and reports they (including their core California Technology Assessment Forum program) issue on the cost and value of new drugs and medical technologies.

CLSA and others have long criticized and questioned ICER’s current Framework, arguing that it is fundamentally prejudiced against innovative therapies and technologies and could lead to the underutilization of or access to life-saving and life-sustaining treatments, therefore compromising long-term patient health benefits and undermining innovation and investment across the life sciences ecosystem.

In response to ICER’s call for feedback,  CLSA developed and submitted a detailed comment letter addressing several areas of concern and suggestions for improvement in the Framework. Our comment letter to ICER is available here.

Specifically, CLSA outlined three overarching areas in need of revision and consideration for ICER to develop a more equitable and accurate value assessment framework.

First, CLSA believes that process-related improvements – or how the reports are developed – are at the core of revising the Framework. Recommendations for improving the process include increased communication and information exchange with stakeholders, and in particular, input from patients and clinicians. Secondly, CLSA addressed the need to suspend or significantly improve the methodology used in the formulation of cost-effectiveness analysis and budget impact conclusions. Lastly, CLSA’s comment letter stressed the impact of the current Framework on patient access to innovative therapies and technologies and the chilling effect such policies have on the research, development and investment innovation ecosystem.

CLSA will continue to engage with ICER and other stakeholders to improve the Framework so that it more accurately reflects the value of innovative medicines and technologies in the health care system. Questions? Please contact Meghan Drenan, CLSA’s Associate Director, Federal Government Relations (