California Life Sciences Association Answers ICER’s Call for Improvements to its Value Assessment Framework for Evaluating New Therapies

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

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

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

“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

About California Life Sciences Association (CLSA)
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,
and YouTube.


California Life Sciences Association
Will Zasadny
Director, Communications