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What is ICER & How Does it Impact the Pharmaceutical Industry?

The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization. ICER’s mission is to conduct evidence-based reviews of healthcare interventions that help guide patients, doctors, and payers to high-value, cost-effective treatments using rigorous, transparent methods.

ICER was founded in 2006 by Steve Pearson, a former fellow at the Americas Health Insurance Plans (AHIP); the organization began publishing “cost-effectiveness analyses” or “value assessments” for drug treatments in 2014. ICER is funded by various sources, including health insurance companies, philanthropic organizations, and government grants; their largest investor is Arnold Ventures.

ICER follows a standardized approach to evaluate treatments and drugs, incorporating input from various stakeholders, including patient advocacy groups, clinicians, and manufacturers.
The general overview of the assessment process is as follows,

  • Scoping: ICER identifies the patient population who will be affected by the treatment or drug and the clinical and economic questions that need to be addressed.
  • Evidence Review: ICER systematically reviews the available clinical evidence on the treatment or drug, including clinical trial data and other relevant studies.
  • Economic Analysis: ICER uses various economic models to estimate the treatments or drug’s cost-effectiveness, comparing it to existing treatments or standard of care.
  • Stakeholder Engagement: ICER engages with patients, clinicians, manufacturers, payers, and other stakeholders to obtain feedback on preliminary findings.
  • Draft Report: ICER develops a draft report summarizing the evidence and analysis, including the treatment’s estimated cost-effectiveness.
  • Public Comment: The draft report is available for public comment, and ICER solicits stakeholder feedback.
  • Final Report: ICER revises and finalizes the report based on the feedback received during the public comment period.

ICER reports have grown in popularity over the years, becoming more relevant among payers when making coverage decisions. For example, a 2021 study conducted by XCENDA found that of 160 active payers surveyed, 62% indicated that ICER assessments influenced at least some coverage decisions. In recent years, ICER has gained more attention due to its evaluations of high-cost drugs for rare diseases, also known as orphan drugs. ICER’s assessment of these drugs has been controversial as orphan drugs often have high prices but need more evidence of their clinical effectiveness. In addition, ICER’s evaluations have led to debates over balancing the need to incentivize developing treatments for rare diseases with the need to control healthcare costs.

Criticism of ICER’s approach

While ICER’s assessments are intended to help identify cost-effective treatments that provide high value to patients, they can also negatively impact patient access to medicines. For example, an ICER assessment deeming a drug as a low value can affect stakeholder groups in different ways, such as:

  • Payers: can apply pressure on pharmaceutical companies for lower prices and decide not to cover the drug or require higher co-pay or out-of-pocket costs
  • Pharmaceutical companies: may see a negative impact on revenue and profitability of drugs they produce, which can also result in decreased interest to invest in developing similar medications identified as low value by ICER.
  • Patients: as a result, may see diminished access to treatments, which is especially likely for those with rare diseases 

Patient advocacy groups have criticized recent ICER assessments for treatments for Amyotrophic Lateral Sclerosis (ALS) and Sickle Cell Disease (SCD) for the implications of ICER’s evidence ratings on patient access to treatment. In the ALS case, ICER found that treatment was sufficient only for patients meeting the narrowly defined clinical trial criteria but insufficient for patients outside these criteria. Thus, that assessment may support payers in limiting oral Edaravone (Radicava) to just the clinical trial population, which would be narrower than the label indication.

In the SCD treatments assessment, ICER used their value assessment framework to determine that the impact of the therapies studied still needed to be demonstrated in the clinical trial. However, that assessment received fierce pushback from patient advocacy groups, SICK Cells and Innovation and Value Initiative (IVI), as ICER conducted the report without including representative data for the population most affected by SCD, leading to limited access to therapy.

ICER’s most significant criticism is its use of the quality-adjusted life year (QALY), which measures health effects in quantity and quality of life. Organizations such as the IVI, SICK Cells, and the National Council on Disability (NCD) have argued against using the QALY in ICER’s decision-making framework. For example, the NCD states that “The QALY works by weighting the lives of people with disabilities: If we were to assign autism a disability weight of 0.2, that [number] would mean that a year in the life of an autistic person would be worth 80 percent of a nondisabled person’s life.”

United States lawmakers have also made statements against using the QALY, with Republican lawmakers being the most vocal and introducing the “Protecting Health Care for All Patients Act” to ban using the QALY and expanding access to life-saving cures and preventing discrimination against Americans with disabilities. However, the US federal government does not have a comprehensive policy against using QALYs.

ICER’s response

In response to the criticism, ICER president Steve Pearson announced their equity project “to identify best practices where possible to guide health technology assessments in the US and create the conditions for accelerating the use of HTA [health technology assessment] to support society’s goal of improving health equity.”

In March 2023, ICER released its long-awaited white paper addressing steps they will take to support enhanced health equity in their assessments. ICER focused on seven elements of HTA “in light of the goals of this paper and limitations in the scale of what was feasible for us to accomplish within a reasonable time frame”:

  • Selecting health care interventions for the assessment
  • Engaging patients and patient groups in the HTA process
  • Evaluating the diversity of participants in clinical trials
  • Analyzing results by subpopulations
  • Measuring the opportunity to reduce health disparities.
  • Promoting health equity through quantitative methods of cost-effectiveness analysis
  • Promoting health equity through deliberative methods of appraisal

Under each “element of HTA,” ICER presents 3 to 4 recommendations (a total of 25) that are described as “potential new methods that may help improve the ability of HTA to advance health equity.”​

Under the “evaluating the diversity of participants in clinical trials” element, ICER proposes developing and publishing an equity diversity rating for each trial used in its technology evaluations. ​They’ve initiated this by employing their modified trial criteria to evaluate diversity in the minimum participation-to-disease prevalence representation ratio (PDRR). A PDRR of .8 means that the population is adequately represented; the PDRR is used to find a corresponding representation score to rate the clinical trial.

Under the “measuring the opportunity to reduce health disparities” element, ICER proposes presenting to decision-makers a relative prevalence metric (e.g., HIDI – Health Improvement Distribution Index). The HIDI is calculated as the disease prevalence in a subpopulation of interest divided by the disease prevalence in the overall population. A HIDI above 1 suggests more health benefits may be gained on the relative scale in the subpopulation of interest compared to the entire population.

Public response to ICER’s equity proposal

IVI released a statement to its members in response to the ICER white paper emphasizing the need for greater patient participation throughout the process and the use of mixed methods, including quantitative and qualitative analyses.

On the issue of the QALY, organizations such as CMS (Centers for Medicare & Medicaid Services) have proposed a qualitative approach to replace it. For example, CMS issued a memorandum to provide initial guidance on sections of the Inflation Reduction Act (IRA) as a part of the “Medicare drug negotiation program,” which includes a specific comment on QALYs stating that “CMS is required not to use evidence from comparative clinical effectiveness research in a manner that treats extending the life of an individual who is elderly, disabled, or terminally ill as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.”

In a recent webinar hosted by ICER discussing their HTA white paper, Steve Pearson said that ICER may employ severity-adjusted QALYs, where the qualities of life for gravely ill patients are weighed against less ill patients, which would follow the lead set by The National Institute for Health and Care Excellence (NICE).

In the coming months, the true impact of ICER’s HTA revisions will be seen for patients and the pharmaceutical industry.

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To learn more about ICER and their Unsupported Price Increase Report, please read this white paper.

About the author

Alexandra Olivier
By: Alexandra Olivier

Alexandra Olivier is a Senior Analyst, US Access Strategy, within Certara’s Evidence and Access Group.

Prior to joining Certara, Alexandra worked as a Clinical Trial Associate at Meditrial, where she supported the clinical trial management in high prevalence therapeutic areas such as respiratory, CV, oncology, and infectious diseases. She oversaw the FDA and EU regulatory body submissions for medical devices and therapeutics.

Alexandra holds a Doctorate in Pharmacy and an MBA in Complex Health Systems from Nova Southeastern University.