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Despite Latest Report, ICER Still Limits Patient Input and Maintains Strong Ties To Insurers

August 11, 2016
After months of criticism, including some from BIO, the Institute for Clinical and Economic Review (ICER) released a document that tries to address many of the legitimate and persistent concerns that have been raised.

We appreciate that ICER is taking such criticism more seriously, and recently opened up its methodology to more public comment.  However, after reviewing the document, it remains clear to us that ICER still doesn’t quite get why so many organizations, including patient groups, are uncomfortable with its operations and methodology – in particular, ICER’s strong ties to the insurance industry and the fact that its reports have been increasingly used to justify insurers’ choices of which drugs to cover or not cover.

To be clear, and contrary to the suggestion by ICER that its critics do not support value-based pricing, value assessments of drugs are not a bad thing.  BIO even issued a set of principles in support of value-based approaches—representing the first-ever systemic, industry-endorsed set of commitments to support comprehensive and sustainable solutions to improve patient access to and affordability of innovative medicines.  What’s bad is when the methods behind those assessments do not adequately consider the viewpoints of patients and doctors, but nonetheless have the potential to influence patient access to needed care.

That’s where I and many others have a problem with ICER. And that’s why I’ve been critical.

I’ve consistently said that ICER’s flawed methodology could lead to rationed care.  Whether intended by ICER or not, the simple fact is that ICER’s flawed processes and methodology can impact patients in ways that could cost patients not only more money through higher cost-sharing requirements, but also could literally cost patients their lives through delayed or denied access.

And I am far from the only critic.  While ICER in its new document tries to paint concerns that it ignores the patient perspective as a “myth,” many patient advocates remain very concerned.

For example, Donna Cryor, J.D., President & CEO of the Global Liver Institute, and a patient who suffers from an autoimmune liver disease herself, said: “[I]ts methodology consistently misrepresents and excludes patient-centered evidence, patient-reported outcomes, and cost-offsets, perpetuating the myth of the average patient or standardized over personalized care.”

A similarly strong concern comes from Bob Goldberg, vice president and co-founder for The Center for Medicine in the Public Interest (CMPI). He recently authored an analysis and found that, based on the methodology of ICER’s review of multiple myeloma therapies, “44,000 fewer patients with the cancer multiple myeloma will be alive within the next five years than if access to new medicines continues to grow at historical levels.”

That potential impact cannot be ignored.

ICER also tries to address concerns about the influence of insurance companies in its funding and operations, but provides this information only at a high level, rather than by program or by project. Yet some facts are clear:

The Blue Shield of California Foundation provided $250,000 to help establish ICER back in 2012. It’s hard to know how much more they received from insurers since then, because updated details have not been made available since this 2014 filing. ICER states it only received 9% of its funding in 2016 from insurance companies, but it doesn’t say how much of the 70% of its budget that comes from foundations have ties to the insurance industry, like the Blue Shield of California Foundation that helped create ICER in the first place.

Moreover, these questions about what perspective ICER really represents stem from real concerns with how its Value Framework is applied to specific therapeutic areas, including: the continued lack of clarity around how ICER chooses the topics it studies; why more diverse viewpoints—including from patients and patient advocates—aren’t sufficiently included among the voting panels responsible for drug assessments; and why ICER insists on a siloed study of the cost of healthcare—focusing only on a single type of intervention (drugs)—when we know that the system must be viewed in aggregate to understand how to incentivize high quality, efficient care for all patients.

As Ms. Cryor has pointedly noted, “ICER has involvement from a consumer organization and limited opportunities in its process for patient comment, but is overwhelmed by payer participation in the composition of its governing board, topic selection process and curation of evidence.”

Even some groups identified by ICER as funders have made public their concerns about ICER’s use of their name to imply balanced support for ICER’s methodology or approach to value assessment.  Following ICER’s release of the “myth/fact” document, the National Pharmaceutical Council (NPC) immediately put out a statement clarifying its current role and distancing itself from the group’s methodology, noting that: “[t]o be clear, NPC’s engagement with ICER is not an endorsement of that organization nor its value assessment framework.”

BIO believes we must all work together to ensure patients have access to the medicines they need and to reform a broken healthcare system. ICER, along with other value assessment initiatives, could play a useful role in this effort, but only if ICER makes major changes to the transparency of its operations, limits the influence of the payer perspective, broadens the incorporation of input from patients and other stakeholders, and improves its flawed methodology to fully account for the patient perspective and the need for individualized patient care.