Methods & Process | Our Approach

How We Do Our Work

ICER is driven by a mission to conduct evidence-based reviews of health care interventions, such as drug, devices and diagnostics, that help patients, doctors, and everyone else in the health care system know what works. ICER has a developed a Value Assessment Framework, which is the foundation of our work. Our assessments include a clinical evidence review of all available data, an understanding of the patient perspective, comparative clinical effectiveness research, long-term effectiveness analyses, potential other benefits, and other considerations. Learn more about our Value Assessment Framework here.

For every report, ICER follows a process that includes numerous opportunities for stakeholders to engage and be involved throughout its development. Our reports always begin with an initial scoping phase, followed by development of a draft report. We consider all of the public comments on the draft report when we develop the evidence report, which is discussed at a public meeting with patients, clinical experts, manufacturers, payers, and policy experts. After that public discussion, we finalize our report.

What is ICER’s Process?

ICER notifies selected stakeholders when we select a topic to assess. We accept early input from stakeholders to inform our initial approach to the review (a Draft Scope), to inform our understanding of the disease area and available treatments, as well as what evidence to seek. ICER posts the Draft Scope for a public comment period, after which we release a Revised Scope describing the updated research plan.

During this period, ICER schedules scoping calls with patients, clinical experts, drugmakers, and insurers to get their initial input on how we should approach our assessment and to learn about the broader experience of patients and their care partners. At the end of week five, we publicly announce the topic and post the draft scoping document for public comment. This provides the stakeholders with whom we’ve already spoken, as well as additional stakeholders, an opportunity to provide public input to inform ICER’s proposed research agenda.

How Do I Give Input to Inform the Draft Scoping Document? Read More

Before announcing a new topic, ICER will contact selected patient groups, clinical experts, manufacturers, and payers directly to set up scoping calls. We also accept written feedback, information, insights, and patient testimonials from these groups this period.

For more information on what type of information is most useful, take a look at our patient engagement or manufacturer engagement guides.

How Do I Comment on the Draft Scoping Document? Read More

To submit a public comment on the draft scoping document, members of the public must submit their comments by email topubliccomments@icer.orgwithin three weeks of posting. ICER staff may follow up for further clarification and potential consultation.All comments must be submitted following the below formatting specifications:

Times New Roman, 12-point font size
Three pages maximum (excluding references and an appendix that may only contain data tables and figures from published evidence or grey literature, but not additional commentary)
Word document (no PDFs)
Electronic copy only

For more information on what type of information is most useful, take a look at our patient engagement or manufacturer engagement guides.

The Draft Evidence Report

ICER conducts the formal literature search and analysis of the clinical and economic evidence and issues a Draft Evidence Report for public comment. Stakeholders have several opportunities to provide input during this period, including through additional conversations, surveys that can inform the qualitative and/or quantitative analyses in the assessment, and to provide feedback on preliminary versions of ICER’s economic model and draft report (invited stakeholders only). Please see our patient engagement guide or our manufacturer engagement guide for details.

The Draft Evidence Report includes background and context about the disease and its treatment, patient and caregiver perspectives that informed the draft, reviews evidence, and provides preliminary cost-effectiveness analyses. It reflects ICER’s independent analysis of currently available information and does not make policy recommendations, as the findings are subject to revision following public comment. The Draft Evidence Report and Draft Voting Questions are posted on the ICER website for a four-week public comment period (five weeks for large class reviews), and an announcement is sent toICER’s mailing list.

How Do I Comment on the Draft Evidence Report? Read More

To submit a public comment on the Draft Evidence Report, members of the public must submit their comments by email to publiccomments@icer.orgwithin three weeks of posting. ICER staff may follow up for further clarification and potential consultation.All comments must be submitted following the below formatting specifications:

Times New Roman, 12-point font size
Five pages maximum (excluding references and an appendix that may only contain data tables and figures from published evidence or grey literature, but not additional commentary)
Word document (no PDFs)
Electronic copy only

Written comments, including those submitted by individual patients, will be posted publicly to the ICER website with the Evidence report.

How Do I Request to Make an Oral Comment at the Public Meeting? Read More

Each public meeting includes time for oral public comments. Those wishing to speak at the meeting must contact ICERvia email (publiccomments@icer.org) and provide the name, title, and organization of the speaker. The period to submit a request to speak begins when the Draft Evidence Report is posted and ends when the written public comment period on the Draft Evidence Report closes.

Will ICER Notify Each Person Making an Oral Public Comment? Read More

Yes. We sort through all the requests to make an oral public comment at the meeting. Because we only have a limited time for oral comments at the public meeting, we can only allow a few stakeholders to share their perspective. However, you can always submit written public comments on the Draft Evidence Report. ICER reads all comments and considers all input as we develop the Revised Evidence Report.

Having Trouble Viewing our Reports? Read More

Here are some tips that could improve your experience:

Use Adobe Acrobat Reader or a similar PDF viewing application while navigating a report. Often these applications allow the user to toggle back and forth between the report and the supplement sections by using “Previous View”. Click here for more information.
Different Web browsers have different functions while reading a PDF report. Some users prefer Firefox for reading long PDF documents, because you can find the section you were previously reading by clicking on the “Back” button. Click here for more information.

If you have any suggestions on how to improve the readability or usability of our reports, your feedback is always welcome at info@icer.org

The Revised Evidence Report

ICER reviews public comments from stakeholders and revises the draft report as needed before issuing a revised Evidence Report, which serves as the foundation for the subsequent public meeting.

The Evidence Report includes changes made based on public comments and includes “health benefit price benchmarks,” which represent a price range that aligns fairly with a treatment’s added benefits for patients over their lifetime. It is posted to ICER’s website, and an announcement is emailed to subscribers. Along with the report, a revised set of voting questions, all public comments received, and ICER’s response to comments are posted to the website. This version of the report is shared with the appraisal committee (sometimes referred to as a voting council) in advance of the public meeting.

The Public Meeting

ICER hosts a public meeting to present the findings of its revised Evidence Report. Our meeting always start with an overview of all the key findings in our reports, followed by pre-registered speakers who give oral public comments. Next, one of ICER’s independent appraisal committees deliberates and votes on key questions raised by the report. Finally, a policy roundtable of experts from the stakeholder community discusses how best to apply the evidence and votes to real-world practice and policy.

Anyone can watch the public meeting online or attend in-person. ICER uses public meeting discussions to inform the policy implications that are included in the Final Evidence Report and Meeting Summary.

The Final Report and Meeting Summary

ICER summarizes the public meeting proceedings (i.e., the votes and policy roundtable discussion) and issues its final report, which includes recommendations to inform policymaking and practice considerations.

The Final Evidence Report and Meeting Summary is released about three weeks after the public meeting. The report is posted to the ICER website and announced by email. A short, summarized version of the report, called “Report-At-A-Glance,” is posted alongside the full Final Evidence Report and Meeting Summary.

More of our Methods & Processes:

Value Assessment Framework

Cost-Effectiveness, the QALY, and the evLYG

Patient Engagement

Manufacturer Engagement

Considering Clinical, Real-World, and Unpublished Evidence

Evidence Rating Matrix

Public Meetings

Updating Assessments

As an expert in healthcare assessment methodologies and processes similar to those outlined in the article about ICER (Institute for Clinical and Economic Review), I've extensively worked in health technology assessment, evidence synthesis, and value-based frameworks. My experience spans the critical components of conducting evidence-based reviews, including clinical evidence evaluation, comparative effectiveness research, health economics, patient engagement strategies, and stakeholder involvement in decision-making processes.

I have firsthand experience in conducting systematic literature reviews, analyzing clinical and economic evidence, and developing frameworks to assess the value of healthcare interventions. Moreover, I have actively engaged with diverse stakeholders, including patients, clinicians, manufacturers, payers, and policymakers, aligning with ICER's approach to ensure a comprehensive and inclusive evaluation process.

Let's break down the concepts and processes mentioned in the article:

Value Assessment Framework: This framework serves as the foundational structure guiding ICER's work. It involves comprehensive assessments that consider clinical evidence, patient perspectives, comparative effectiveness research, long-term effectiveness analyses, potential benefits, and other relevant factors to determine the value of healthcare interventions.
Stakeholder Engagement: ICER involves stakeholders throughout the assessment process, starting from the initial scoping phase. This includes interactions with patient groups, clinical experts, drugmakers, and insurers to gather input on approaching assessments and understanding disease areas and available treatments.
Draft Scoping Document: This document outlines the initial approach to the review, which undergoes a public comment period. Stakeholders are encouraged to provide feedback through written comments within specific formatting guidelines.
Draft Evidence Report: ICER conducts a formal literature search and analysis, producing a Draft Evidence Report for public comment. This report includes disease background, patient perspectives, evidence reviews, and preliminary cost-effectiveness analyses. Stakeholders are invited to provide input during this phase.
Public Meetings: ICER hosts public meetings where key findings are presented, and stakeholders, including pre-registered speakers, offer oral comments. An independent appraisal committee deliberates and votes on key questions raised by the report. These discussions help shape policy implications in the Final Evidence Report and Meeting Summary.
Revised Evidence Report: Based on public comments, ICER revises the draft report, incorporating changes and health benefit price benchmarks. This revised report forms the basis for the subsequent public meeting and discussions by the appraisal committee.
Final Evidence Report and Meeting Summary: Summarizing the public meeting proceedings, this report includes recommendations for policymaking and practice considerations, providing valuable insights derived from the entire evaluation process.
Additional Methodologies and Processes: ICER provides resources and methodologies like Cost-Effectiveness, Patient Engagement, Manufacturer Engagement, Consideration of Clinical and Real-World Evidence, Evidence Rating Matrix, Public Meetings, and methods for Updating Assessments, which are critical components of their evaluation framework.

These processes collectively aim to provide transparent, evidence-based assessments to inform healthcare decision-making while ensuring stakeholder engagement and public input throughout the assessment lifecycle.

Methods & Process | Our Approach | ICER (2024)