ICER Watch: Doctors, patients expose more flaws in ICER frameworks

ICER Watch: Reject any coverage or recommendations based on ICER’s report

Doctors and patients are exposing more ICER flaws in its reports.

Dr. Rafael Fonseca, the Getz family professor of cancer, chair of the department of medicine and distinguished Mayo investigator at Mayo Clinic in Phoenix, Arizona, decimates the Institute for Clinical and Economic Review’s value assessment of various treatment options for relapsed multiple myeloma.

“Physicians, patients, patient advocates and patient support organizations should reflectively reject any coverage or treatment recommendations that are associated with this report,” Dr. Fonseca writes at “The mere thought of calling a peer-to-peer appeal with an insurance company and having the insurance employee cite ICER will only be tolerated by a hefty dose of omeprazole and lorazepam!”

Among the numerous ICER flaws: ICER’s failure to use real-world cost figures. The non-profit, which receives funding and support from insurance companies, omits rebates and discounts.

“To presuppose that a patient or a payer pays the wholesale acquisition price for a drug is not descriptive of reality,” Dr. Fonseca explains. “Omission of rebates and discounts limits the accuracy of the conclusions of the “care value” votes.

Another problem with ICER’s review of multiple myeloma is the failure to include experts in the field. As a result, the most promising treatments were considered “over-valued” while the least effective treatments were given high ratings.

He says, “Of all therapies approved, most myeloma experts would agree panobinostat is probably the one that is least likely to have a long-term impact on patients’ survival or long-term outcomes, and yet it consistently appeared as the favorite of the council.”

ICER’s Problematic Framework is Wrong Turn for US Health Care

Dr. Darius Lakdawalla of the USC Schaeffer Center for Health Policy & Economics and Dr. Peter Neumann of Tufts Medical Center, explain why budget criteria and drug value assessments are “a case of apples and oranges. Writing at, the pair take identify major problems with the Institute for Clinical and Economic Review’s value frameworks.

“Using narrowly construed budgetary criteria as part of the frameworks, however, is problematic,” Dr. Lakdawalla and Dr. Neumann, who also work at Precision Health Economics, a health care consultancy to the life sciences industry. “It harkens back to an earlier era in which cost and utilization considerations reigned supreme, while value and health were sidelined.”

ICER’s flawed value framework errs by punishing technological innovation and mislabeling health care as an expense.

  • Penalizing New Widely Applicable High-Value Technologies: Because everyone agrees on the importance of excluding low-value technologies, and because ICER already imposes a cost-effectiveness constraint, adding budgetary criteria serve to penalize a subset of high-value technologies — indeed, high-value technologies that affect the most people are penalized the most.
  • Treating Health Care As An Expense Rather Than An Investment: Statins provide another example of the sort of high-cost/high-value therapies that budgetary criteria aim to scrutinize. To be sure, statins rank as one of the single most expensive drug classes ever launched, racking up over $300 billion in costs over their first 20 years of use. Yet, over the same period, statins returned over $1.2 trillion in value to society.

The pair conclude, “Nearly everyone now agrees that value-based health care is the right destination for the US health care system, but there remains a long road to travel. Hitching myopic budget criteria to worthy value assessments represents a wrong turn.”

Upcoming Patients Rising Events:

This week, we’re on the road headed to events in Boston and Philadelphia. At both events, we’ll be updating patients on how ICER’s value frameworks affect our ability to access life-saving treatments and guarantee ongoing investments in medical innovation.

The War on Cancer Health Care Reform | Presented by: The Economist
September 28, 2016 | Boston, MA | #WarOnCancer

ICLIO Stakeholder Summit | Presented by: ACCC
September 29, 2016 | Philadelphia, PA

Check out all our upcoming events at the Patients Rising event page.

California Life Sciences Association: ICER Values Speed over Stakeholder Perspectives

California’s leading organization representing life sciences innovators has submitted its feedback on how to improve ICER’s value assessment framework.

The California Life Sciences Association, known simply as CLSA, says that the Institute for Clinical and Economic Review prioritizes speed over genuine stakeholder engagement.

“CLSA strongly disagrees with many aspects of the overall process and methodology used by ICER to evaluate treatments,” the organization stated in a recent press release. 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.”

  • 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.

Graphic: Patients missing from ICER’s Decision-Making

Just 3 patients have seats on the Institute for Clinical and Economic Review’s governance board and advisory boards.

In total, patient voices represent just 5 percent of ICER’s leadership. See for yourself (H/T The Catalyst).

ICER excludes patients

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