Our Patient Engagement Program

In the United States, consequential decisions around prescription drug pricing and patient access are generally made based on limited evidence and without patients in the room. At ICER, our goal is to bring these pricing and coverage decisions more into the open, where we all can wrestle with how to understand the benefits drugs and other health care services bring to patients and their families, and how we should try to align our spending to make sure we get the most health we can out of the dollars available.

We are deeply committed to working with the patient community – who know the condition, know the diversity of patient experience, and who can bring a truly comprehensive view to the table on what matters most to them. Only when patient community input is made central to any assessment of value can we usefully judge the evidence on how well drugs improve the quality and length of patients’ lives.

ICER’s Patient Engagement team welcomes the opportunity to engage with patient and consumer advocacy organizations to help people understand ICER and its role in the U.S. healthcare system as well as provide practical information on how to participate in an ICER assessment for a specific healthcare innovation. We are committed to helping patient communities have a positive experience working with ICER on individual assessments as well as on longer-term partnerships to advance fair pricing, fair access, and future innovation.

For more information, please email Yvette Venable, ICER’s Vice President of Patient Engagement, at yvenable@icer.org.

cheerful creative patients sitting in a circle laughing

 

Submit information on your experience to our        Patient Input Questionnaire.

Download our Patient Engagement Guide.

Submit a public comment

Impact of Patient Community Participation in ICER Reviews

We are proud of the numerous examples of how patient engagement within an ICER review has made our work better and helped facilitate patient access. Importantly, we do not know of any ICER review that has had a direct negative impact on patient access to a new treatment.

Some examples of how we’ve incorporated patient perspectives include:

Sickle Cell Disease, 2020

The sickle cell patient community contributed extensive information and results from a patient survey to highlight what patients need in treatments as well as the significant challenges people living with sickle cell disease face due to discrimination. Highlighting these concerns in the ICER Report gave insurers a much better understanding of the lived experience and lead to the creation of exceptions to reduce barriers for opioid pain management for people with sickle cell disease. The report also called for further investment into innovative therapies for a condition that had been underserved for far too long.

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Multiple Sclerosis: RRMS and PPMS, 2017

When ICER started its evaluation of drugs for multiple sclerosis, we noted that the FDA approvals were based on reductions in relapses of the condition. But patients told us that relapses were not the most important thing to them – it was the accumulating longer-term functional disabilities. So when we built our cost-effectiveness model to help judge what a fair price would be, we used functional outcomes rather than relapses, which helped change the ranking of which drugs work best for certain patients.

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Inherited Retinal Blindness, 2018

A new treatment for blindness failed to achieve traditional measures of cost-effectiveness in the health system, but patients and their families shared with us and at the public meeting how extensive the benefits of better sight were for the entire family through improvements in school, work, and social functioning. ICER developed an alternative economic model incorporating these benefits, and at our public meeting our independent appraisal committee voted that the therapy represented reasonable long-term value despite its high price.

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Psoriasis, 2018

With input from patient groups on how to interpret the clinical results from key studies, ICER concluded that most advanced treatments for severe psoriasis were fairly priced. But after hearing from patient groups about how insurers had placed many barriers to access for these drugs, ICER’s final recommendations called for insurers to lower these barriers in recognition that fair prices should merit broad access to treatment options

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How ICER Engages with Patients

Give Input on a New Topic (Weeks 1-5)

As part of ICER’s Patient Engagement Program, ICER provides early notifications to patient groups from therapeutic areas when it has high certainty that it will pursue an assessment pertaining to their focus. Topics are chosen based on several factors, including input from the public.  Learn more about how we choose topics, or submit a suggestion for a future review.  In this initial outreach, we provide an overview of ICER procedures, answer your questions about ICER, and, if needed, can facilitate connections with other patient leaders who have participated in an ICER review.  For major therapeutic classes (i.e., immunomodulators for which ICER has performed a class review, treatments for multiple sclerosis, etc.), ICER may schedule an annual conference call or meeting to discuss the emerging pipeline of new treatments, seek input on key priorities, and explore opportunities to gather new data on outcomes of care that are important to patients and families.  This early outreach is intended to give patient organizations a chance to familiarize themselves with ICER and our processes ahead of ICER’s final selection of a topic.

Once ICER has selected a new topic for review, we spend five weeks engaging with targeted stakeholders from that therapeutic area prior to announcing our review to the public.  During this five-week period, ICER schedules scoping calls with patient groups to get their initial input on how we should approach our review and to learn about the lived experiences of the patient community. 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.

What Happens During This Step? Read More
  • After topic selection, ICER spends five weeks reaching out to targeted stakeholder groups, including patient organizations, to discuss their perspectives on the disease and treatments.
  • While ICER is speaking with patient groups and other stakeholders, ICER begins to develop a Draft Scoping Document. The Draft Scope describes what evidence ICER will look for during the review and how it plans to analyze the evidence.
  • ICER posts the draft scoping document for a three-week public comment period, which provides all stakeholder an opportunity to provide feedback on our proposed research approach.
What Information is Most Helpful? Read More

At this stage, any information is helpful.  We want to learn as much as possible from all stakeholders about the topic.  Some examples include:

  • Clinical benefits that matter most to patients
  • Other non-clinical benefits or disadvantages of new and existing treatment options
  • Contextual considerations surrounding the disease and its treatment (i.e., high lifetime burden of illness, uncertainty about long-term risks of treatment, etc.)
  • Research publications or patient-generated data to supplement clinical trial data
How Do I Give Input? Read More

ICER will contact selected patient groups directly to set up scoping calls, and we also accept written feedback, information, insights, and patient testimonials from these groups during the first three weeks of this period.

How Does ICER Use My Input? Read More
  • ICER uses the information to help guide the scoping process and inform our initial research plan. More specifically, much of the input we receive is ultimately translated into what we call “PICOTS.”  PICOTS stands for Populations (people), Interventions (treatments of interest), Comparators (other available treatments), Outcomes (benefits and harms), Timing (length of study), and Settings (where care is given).  For example, if we hear from patients with rheumatoid arthritis that the treatment under review provides relief of morning joint stiffness, we will then look for specific data that reflects this “outcome,” or clinical benefit.
  • In addition, patient input may also provide information about aspects of treatment or the disease that may not be described or captured in available clinical or economic data.
  • All submissions are considered throughout the scoping process and are incorporated into the Draft or Revised Scoping Document, depending on when the input was received. Information received towards the end of the Draft Scope Period may not be considered for the Draft Scoping Document, but will be taken into account in the revised version.
  • Information submitted during this period provides useful background throughout the report development process.

ICER does not publicly name individual patients who speak with us on these or other calls.  Additional details can be found in the disclaimer language below.

You acknowledge that you are not required to provide information to ICER and that you are doing so voluntarily.  Please see our Terms of Use and Conditions and our Privacy Policy to review how we use and disclose information submitted to us.  While we do not plan to publish information that identifies a particular individual, we intend to use the information submitted as part of our drug reviews.  We recognize that submissions sometimes contain specific medical information that might raise concerns about appropriateness of treatment, physical or mental health, and safety.  The use of this site, and information submitted to ICER, should not take the place of professional medical care.  ICER does not diagnose health problems or provide treatment advice.  The completion of this questionnaire does not trigger any patient-provider relationship.  Any information found on this site, or inferred from this survey, should in no way be considered medical advice or a plan for health management.  Anyone seeking or needing immediate medical treatment is advised to contact their health care provider or visit an emergency room.

 

 

Comment on the Draft Scoping Document (Weeks 6-8)

ICER publicly announces the topic at the beginning of this phase and posts a Draft Scoping Document for public comment.  The Draft Scoping Document outlines the plan of research, drugs or treatments to review, patient populations to include, and other related information.  The document is informed by our own independent research and conversations with clinical experts, manufacturers, policy makers, insurers, and patient groups.  Input from patient organizations and individual patients help inform specific components of the Draft Scoping Document, including our PICOTS framework.  As we note in the section above, we encourage input on the specifics included in the Draft Scoping Document.

When ICER publicly announces a review, we send an email to major patient groups and all ICER mailing lists to make sure that stakeholders are aware of our review. At this time ICER also publicly posts the timeline for the project on the ICER website.  This timeline provides dates for key milestones in the process.

What Happens During This Step? Read More
  • The Draft Scoping Document is posted to the website and announced by email.
  • The document is open to a three-week public comment period.
What Information is Most Helpful? Read More
  • Patient Input Questionnaire During this stage, we’re largely looking for feedback directly related to the content of our Draft Scoping Document, as patient input will help us revise and clarify before we release our Revised Scoping Document. This could mean input on what is included or left out of the Draft Scoping Document that is most important to patients (e.g., patient subgroups, treatments, or additional benefits to examine).
  • ICER will also accept responses to the Patient Input Questionnaire. These responses can be sent to ICER any time before the public comment period on the Draft Report ends (see the next chapter for more details).
  • Any additional patient-related resources
  • Which clinical trial data are most related to patient-centered outcomes
How Do I Give Input? Read More

Submit public comments on the Draft Scoping Document

    • ICER accepts comments on the Draft Scoping Document for three weeks
    • The deadline is listed in the posting announcement and on the website.
    • Email comments to publiccomments@icer.org.
    • Emailed public comments on the draft scope must be in the following format:
      • Submit as an attached Word document
      • Three page maximum (not including references or appendices)
      • 12-point Times New Roman font

 

Submit a response to our Patient Input Questionnaire

      • Individual patients or patient groups are encouraged to submit a response through the Patient Input Questionnaire during the public comment period on the draft scope. Please note that this is not a validated survey tool and we do not aggregate responses into data points. ICER reviews questionnaire responses throughout the assessment to reflect on what patients have told us.  As a result, patients may submit responses anytime during the process, though having this information early in our process helps us incorporate patient perspectives into our early thinking.

 

If formatting requirements present a burden to any patient, accommodations can be made on a case-by-case basis. Please email publiccomments@icer.org or call (617) 528-4013 for more information. 

How Does ICER Use My Input? Read More
  • ICER reviews all comments received and considers what changes need to be made to the scope before work on the report begins. For example, ICER might include an additional patient subgroup, comparator, or outcome measure.  We refer to components like these as PICOTS in our scoping documents (please see the previous chapter for further information on PICOTS).
  • Input received during the scoping phase informs ICER’s selection of outcomes measures to include and prioritize in our clinical and economic assessments. Further, public comments and conversations with patient groups inform the second section of our reports, “Patient Perspectives,” which precedes the sections describing the clinical and economic evidence.
  • Written comments, including those submitted by individual patients, will be posted publicly to the ICER website with the Evidence Report.
Revised Scoping Document Read More

After public comments close, ICER updates the scoping document based on comments and releases a Revised Scoping Document.  This document also includes a brief summary of additional information learned through stakeholder outreach and public comment as well as ICER’s rationale behind which major suggestions we did and did not incorporate.  The document is posted to the ICER website, along with comments received on the draft version.

Comment on the Draft Evidence Report and Voting Questions (Weeks 24-27)

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 only ICER’s independent analysis of currently available information and does not discuss policy considerations or make policy recommendations.  The Draft Evidence Report and Draft Voting Questions are posted on the ICER website, and an announcement is sent to ICER’s mailing list.

What Happens During This Step? Read More
  • Based on the topic, ICER and patient groups may partner to conduct a formal survey to gather patient preferences for treatment. The results of these surveys may inform our economic model, especially when important information is missing from the clinical evidence, and/or the discussion of patient perspectives.
  • Before we publish the Draft Evidence Report, we send it to external reviewers to make sure that the document is accurate and thorough. We typically invite several clinicians to review the clinical and economic evidence, and ask a representative from a patient organization to review the sections describing the patient experience.
  • The Draft Evidence Report is posted on the website and announced by email.
  • Stakeholders review and provide comment over a four-week period (five weeks for large reviews of entire treatment classes).

This is also the time to request to make an oral comment at the public meeting.

What Information is Most Helpful? Read More
  • Suggestions for additional data, including real world evidence
  • Added details for context
  • More explanation of additional benefits or disadvantages of a treatment
  • Anything else that, from a patient perspective, the report misses. We encourage patients to comment on Section 2, “Patient Perspectives,” as well as Section 6, “Potential Other Benefits or Disadvantages and Contextual Considerations.”
How Do I Give Input? Read More
  • The specific deadline is in the announcement and is posted on ICER’s website.
  • Email comments to publiccomments@icer.org. We will confirm receipt.
  • Comments must be in the following format:
    • Submit as an attached Word document
    • Five page maximum (not including references or appendices)

12-point Times New Roman font

If formatting requirements present a burden to any patient, accommodations can be made on a case-by-case basis. Please email publiccomments@icer.org or call (617) 528-4013 for more information. 

How Does ICER Use My Input? Read More
  • ICER carefully considers all comments relevant to every section of the report.
  • Based on specific feedback we receive on the patient-centered sections, Sections 2 and 6, we may revise to include additional factors or considerations important to patients (i.e., caregiver impact, comorbidities, etc.). In addition, comments related to the financial burden of a disease or treatment may also be helpful, such as specific information about out-of-pocket costs or other medical expenses.
  • We also welcome patient input on other sections of the report, including the clinical end economic analyses. We encourage patients to provide as much or as little feedback as they wish.  ICER considers all patient input important, no matter how much is provided.
  • All changes are reflected in an updated Evidence Report that is published before the public meeting takes place.
  • Written comments, including those submitted by individual patients, will be posted publicly to the ICER website with the Evidence Report and will be distributed to members of the relevant voting body prior to the public meeting.
  • A document with ICER’s response to specific suggestions will also be posted.
Register for Oral Comment at the Public Meeting Read More

This is also the period to request to speak at the public meeting.  Patient comments provide additional important context and help inform discussion during the panel vote and policy roundtable.  Each meeting includes up to 45 minutes for oral comment before the voting panel takes its votes.  Individual comments are limited to five minutes.  To request to speak, please follow the below steps:

  • Send request to ICER via email publiccomments@icer.orgincluding the name, title, and organization (if applicable) of the proposed speaker.
  • ICER staff will confirm receipt of the request, and reply with a link to an online conflict of interest form that must be filled out accurately to complete registration.
  • Any reported conflicts of interest will be disclosed at the meeting but will not prevent participation.

Since there may be more requests than can be accommodated during the meeting, and to help provide the opportunity for a broad range of perspectives to be heard, public comment slots will only be confirmed after the deadline for requests has passed.  Priority for public comment slots will be given to patients with the condition under study and subject-matter experts from the patient advocacy, clinical, and research communities.

Public commenters may not use a slide presentation or distribute materials to the panel or audience members prior to, or during, the public meeting.

Evidence Report (Weeks 28-31)

The Evidence Report includes changes made based on public comments and includes health benefit price benchmarks.  This is the price for a treatment that matches with the benefits to patients that have been shown in the evidence.  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 voting panel in advance of the public meeting.

Attend a Public Meeting (Week 32)

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.

What Happens During This Step? Read More
  • Report authors give an overview of report findings.
  • Pre-registered speakers give oral public comments.
  • The evidence review group votes on the strength of evidence for the topic under review. Report authors, clinical experts, and patient representatives are available to answer questions.
  • A policy roundtable, composed of patients, doctors, insurers, and drugmakers convenes to discuss how to apply the evidence to real-world policy and practice.
How Can I Participate? Read More
  • Attend:Meetings are free and open to the public.  We recommend registering in advance to ensure your spot.  Registration typically opens when the Draft Evidence Report is posted.
  • Comment:Register to give an oral public comment using the instructions above.
  • Watch:A live webcast is offered for all meetings.  ICER also posts a recording of the webcast on their website within a week after the meeting.
  • Be a member of the policy roundtable: One to two patient representatives are invited to participate in the policy roundtable, typically alongside one or two each of clinical experts, payers, and drug manufacturers.
How Does ICER Use My Input? Read More
  • ICER uses public meeting discussions to inform the policy implications that are included in the Final Evidence Report and Meeting Summary.
  • Public commenters are invited to submit a 750-word summary of their oral comment to be included in the Final Evidence Report and Meeting Summary.
Final Evidence Report and Meeting Summary (Week 35)

The Final Evidence Report and Meeting Summary includes a summary of discussions, public comments, voting results, and policy statements from the roundtable discussion during the meeting.  It takes about one to two weeks to publish the Final Evidence Report and Meeting Summary.  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.

Additional Information

We hope this guide gave you a good overview of our process and how you can get involved.  Of course, there is more to our mission than just what’s here. Still have questions, or suggestions for improvements to this guide?  Contact us at info@icer.org.  We look forward to hearing from you!

How do I submit a public comment?

  • Email comments to publiccomments@icer.org.
  • Emailed public comments on the ICER document must be in the following format:
    • Submit as an attached Word document
    • Draft Scoping Document: Three page maximum (not including references or appendices)
    • Draft Evidence Report: Five page maximum (not including references or appendices)
    • 12-point Times New Roman font