Six Ways ICER Changes Benefit the Payer, Not the Patient

NPC Chief Science Officer Robert W. Dubois, MD, PhD

[This post originally appeared on NPC Chief Science Officer Dr. Robert Dubois’ LinkedIn page on Oct. 2 and previewed the comments that NPC submitted today to the Institute for Clinical and Economic Review on its 2020 Value Assessment Framework.]

The Institute for Clinical and Economic Review is among several organizations in the United States that conducts value assessments of (mostly) medicines. These organizations are performing an important task by examining the financial tradeoffs from medical interventions through the lens of a “value assessment framework.”

ICER recently released a new version of its framework for public comment and there are many reasons for concern, particularly for patients.

ICER states up front that its framework is intended for “broad guidelines on appropriate care, pricing, insurance coverage determinations, and payment mechanisms,” explicitly excluding any use for “individual patients and their clinicians.”

While that’s ICER’s prerogative, serving insurance companies rather than patients is a choice, not an inevitability. Perhaps through the input of public comments, ICER will take steps to better balance the needs of all of the parties it purports to serve. It could do so by addressing six specific areas of its framework that work to the detriment of patients and their care:

Patient Engagement. The revised framework includes more opportunities for ICER to meet with patients – which is positive – but stays silent on where or how patient opinions might change the way that ICER does its math, draws its conclusions, or how those conclusions may be used. Given that patients have the most at stake and can face life or death access decisions, the lack of a formal way for patients to impact conclusions is disappointing.

Societal Perspectives. ICER declined to consistently include a second base case that incorporates a broad array of benefits that are important to patients and society as part of its assessment process. ICER’s standard framework only uses the payer perspective as a base case, but an additional base case assessment is needed to understand the societal impact of a treatment, including such factors as productivity and caregiver burden. ICER’s rationale for highlighting only the payer perspective includes the comment, “Decision-makers in the U.S. health care system are not responsible for making trade-off decisions that involve broader societal resources.” Tell that to states, employers and other payers who face those “broader societal” decisions every day.

Transparency. ICER declined to commit to full transparency by making its model publicly available. While ICER explained that it makes the model available to manufacturers, it does so for a fee, with some of the information in the model often locked or redacted. And while the model might not be useful for individual patients, patient organizations are very interested in examining the models and understanding the rationale behind the choices made in ICER’s assessments. Many organizations could then share this information in a more accessible and understandable way with their constituencies.

Lower QALYs. Determining a cost-effectiveness threshold for one year of healthy life (known as a Quality-Adjusted Life Year, or QALY), is not without controversy but is central to how ICER decides what is good value, which can impact patient access to needed treatments. Until now, ICER has been using a value-priced benchmark from $100,000 to $150,000 per QALY. Although ICER is still using both benchmarks for now, ICER describes in great detail why a lower threshold -- $100,000 per QALY – would be a better benchmark. Changing how society values life in a way that would impact patients’ access to medicines is no small matter, and we owe it to patients to have that debate – loud and fractious though it may be – in public, not under the umbrella of any single organization.

Thresholds for Rare Disease Treatments. Similarly, it appears that ICER may no longer examine orphan drugs using a significantly higher cost-effectiveness threshold ($500,000 per QALY), and that it will lower the threshold range for orphan drugs to $50,000 to $200,000 per QALY, potentially harming the incentives for development of the next generation of rare-disease cures. Is the intention to make it easier for insurers to deny treatments for rare diseases by lowering the threshold at which these treatments are considered valuable?

Additional Elements of Value. ICER should quantitatively include the benefits of regimens that are easier for the patient or provide more options for treatment-resistant patients, even if those elements don’t have a traditional economic value. And while ICER discusses such factors, it does not include them in its calculation of a value-based price. That is a critical omission. There are methods to incorporate these important elements quantitatively, albeit early in their development. ICER should, at a minimum, pilot one of these methods.

And these changes are just a start on the improvements ICER needs to make.

In just a few months, ICER will be releasing the next iteration of its framework that it will use for 2020 treatment reviews. ICER has some work to do before it can truly say that it has incorporated patient concerns into the data it uses, assumptions it makes and the calculations it performs to determine value.