CLSA Answers ICER’s Call for Improvements to its Value Assessment Framework for Evaluating New Therapies

For Immediate Release
Sept. 19, 2016
Media Contact
Will Zasadny, Associate Director, Communications
Tel: 619-961-8848

CLSA identifies several areas of concern and suggestions for improvement regarding the cost and value of new drugs and medical technologies

SAN FRANCISCO & WASHINGTON, D.C. – (Sept. 19, 2016) – California Life Sciences Association (CLSA), the nation’s largest statewide public policy and business solutions organization representing California’s leading life sciences innovators, today announced its participation in the Institute for Clinical and Economic Review’s (ICER) call for suggestions on how to improve ICER’s value assessment framework. The framework underpins ICER’s analyses and reports on the cost and value of new drugs and medical technologies, including those put before a regional “Public Deliberation Panel,” such as the California Technology Assessment Forum. ICER describes itself as a non-profit organization evaluating evidence on the value of medical tests, treatments and delivery system innovations so that others can use that evidence to improve the healthcare system.

CLSA strongly disagrees with many aspects of the overall process and methodology used by ICER to evaluate treatments. CLSA is concerned that the current framework prioritizes the speed with which an assessment can be put before a Public Deliberation Panel over taking the steps necessary to ensure that sufficient evidence and stakeholder perspectives, particularly those of patients, are incorporated into an appropriately rigorous framework. In turn, this could lead to the underutilization of or reduced access to life-saving and life-sustaining treatments, subsequently compromising long-term patient health benefits and undermining innovation and investment across the life sciences ecosystem.

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

  • Process-related Improvements: 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, particularly from patients and clinicians.
  • Methodology: CLSA urged ICER to suspend or significantly improve its methodological components related to both cost-effectiveness and budget impact analyses.
  • Impact on Innovation Ecosystem: CLSA stressed the potential impact of the current framework on patients’ access to innovative therapies and technologies, as well as the chilling effect such policies have on the research, development and investment innovation ecosystem.

“We hope that ICER makes it a priority to revise the Framework so that it is more rigorous and incorporates stakeholder perspectives, particularly those of patients. We ask that ICER move forward swiftly to incorporate all our recommendations, as well as feedback from the broader healthcare community, into its modelling and processes moving forward,” said Todd Gillenwater, Executive Vice President of Advocacy and External Relations, California Life Sciences Association (CLSA). “Through collaboration, we believe we can find sustainable solutions that support innovation and ensure patients have access to life-saving medicines. We believe in promoting a comprehensive and real-world approach that addresses patient priorities, multi-stakeholder input and the most up-to-date clinical science. California Life Sciences Association (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 healthcare system.”

To read CLSA’s comprehensive response to ICER’s value assessment framework addressing several areas of concern and suggestions for improvement, please visit this webpage.

About California Life Sciences Association (CLSA)
California Life Sciences Association (CLSA) is the leading voice driving innovation for California’s life sciences sector. CLSA works closely with industry, government, academia and other stakeholders to shape public policy, drive business solutions and grow California’s life sciences innovation ecosystem. CLSA serves biotechnology, pharmaceutical, medical device, and diagnostics companies, research universities and institutes, investors and service providers. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged to create the state’s most influential life sciences advocacy and business leadership organization. Visit CLSA at, and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.

Will Zasadny
Associate Director, Communications