ICER has come under scrutiny for its methodology and calculations that impact patient access to approved therapies.
WASHINGTON – The nonprofit Institute for Patient Access (IfPA) released a new paper, “The ICER Myth,” which explores how reports from the Institute for Clinical and Economic Review on the cost of new, groundbreaking therapies impact patients’ ability to access the approved therapies that their physician prescribe.
The Boston-based ICER has made a reputation for itself by claiming to determine the price at which drugs provide value. But as “The ICER Myth” describes, that may not be a good thing for patients.
Paper author Wayne Winegarden, PhD, argues that “ICER’s ‘value-based price’ is a fallacy, and a dangerous one.” The paper notes that ICER’s prices can become negotiation tools for health plans, leading to restrictive policies that put new drugs out of patients’ reach. IfPA also released a case study detailing how ICER’s shortcomings impact its assessment of new migraine drugs.
Given ICER’s influence on patient access, “The ICER Myth” examines four limitations of the group’s analyses. Those include:
1) One-size-fits-all Approach. ICER asserts a finding, such as a cost-effective price, that cannot be applied to individual patients because of patient diversity, comorbidities, and severity of the illness or medical condition.
Example: In ICER’s evaluation of treatments for rheumatoid arthritis, researchers note that their model uses a homogenous patient cohort even though it does not reflect the diverse, real-world patient population.
Impact on patients: “The fallacy of a single, cost-effective price…encourages disingenuous negotiating among manufacturers and health plans that can undermine patients’ access to innovative medicine.”
2) Insufficient data. ICER is evaluating many new drugs too early when available data may be incomplete.
Example: With treatments for atopic dermatitis, ICER analyzed cost effectiveness even before the drug, or its price, were publicly available.
Impact on Patients: ICER’s timing denies patients, health care providers and health insurers a comprehensive understanding of a medicine’s potential benefits and risks.
3) Inability to Replicate. IfPA argues that ICER does not limit itself to objective measures that meet the standards of academic research.
Example: In ICER’s evaluation of abuse-deterrent opioids, researchers assign the drug a “C+” rating based on their “judgement.” “These are qualitative opinions offered by ICER-selected ‘experts’ evaluating the data selected by ICER employees…other experts could evaluate the same evidence but reach a different conclusion.”
Impact on Patients: Patients’ health plan coverage for innovative medicines may be influenced by ICER’s reports, even though the findings lack a hallmark of academic legitimacy.
4) Inadequate Metrics. ICER places too much emphasis on metrics that have significant shortcomings.
Example: The paper notes that concerns about the quality-adjusted life year, or QALY, have led Medicare, Congress and the U.S. Department of Health and Human Services to restrict its use. Nevertheless, ICER relies heavily on the metric to evaluate treatments for inherently qualitative diseases such as migraine, tardive dyskinesia and rheumatoid arthritis.
Impact on Patients: Because ICER analyses rely on QALYs, they significantly undervalue many potential benefits of innovative medicines.
The paper notes that ICER’s work could serve a variety of important purposes, including offering medical professionals context about the potential benefit of new medicines relative to current options, or exploring the weight of such benefits given the cost and impact of a disease.
But establishing a price that accurately reflects the personal, individualized value of medicine to a vast range of patients? That, the Institute for Patient Access concludes, is an ICER myth.
The Institute for Patient Access (IfPA) is a physician-led policy research organization dedicated to maintaining the primacy of the physician-patient relationship in the provision of quality health care.