Updating Assessments

Updating Assessments

ICER recognizes that relevant new data may become available after we complete an initial evidence report. We have established the following processes to update our assessments.

12-Month Report Check-Up

Because our reports are designed to coincide with the FDA approval timeline, we recognize that available information is always changing, we offer stakeholders this opportunity to comment 12 months after public meetings so that any new information that stakeholders feel is relevant may be available for readers to reference.

One year after a public meeting, we will reach out to key stakeholders (manufacturers and clinical and patient experts who participated in the policy roundtable) to offer them the opportunity to submit comments on any evidence or coverage information that has become available since the public meeting. Their written comment will be included in an addendum to the existing report.

New Evidence Updates

ICER conducts a New Evidence Update to assess critical new information about an intervention or set of interventions that might substantially change our original conclusions regarding comparative clinical effectiveness, long-term value for money, potential budget impact, and/or value-based price benchmarks. Examples of critical new information may include the completion of a large clinical trial or the publication of more comprehensive safety data. Via press release, ICER will announce our intention to conduct an eight-week review of the new information and highlight which aspects of our original report may be affected. During this review period, we will engage with at least one affected patient group and clinical expert with knowledge of the new data, as well as with the manufacturer(s) of the affected products. ICER will release to the public a two- to three-page summary of our new analyses and conclusions. Because these interventions previously have undergone a comprehensive evidence review and deliberation by one of ICER’s public panels, New Evidence Updates are not subject to additional deliberation at a public meeting. Additionally, while stakeholders are invited to submit comment, there is no formal process for disposition of these comments or update revision.

Full Condition Updates

In addition to assessing new evidence on previously reviewed interventions, ICER’s Full Condition Updates also evaluate additional interventions that have recently received or are nearing regulatory approval. Because these additional interventions have not been subject to a previous ICER review, Full Condition Updates follow an eight-month assessment process similar to our traditional evidence reviews. We formally announce the topic on our ICER website and conduct outreach to both original and new stakeholders. We publish a draft scope that delineates any planned changes in clinical and/or economic analyses, and we revise this scope based on public comments we receive. We then produce a draft report – also subject to a public comment period – that typically highlights any major shifts in clinical practice guidelines or payer coverage policies since the publication of our initial report. ICER may publicly present the revised Full Condition Update to one of our independent deliberation panels and will convene a policy roundtable only if major potential changes in policy or practice need to be considered since the time of the initial meeting on the topic.

ICER Policy on Correcting Errors

ICER reports routinely summarize data from multiple sources, including the results of de novo meta-analyses, network meta-analyses, and cost-effectiveness analyses.

All elements of ICER reports are reviewed for accuracy through a variety of systems, including multiple reviews by internal staff and separate checks by external reviewers.  ICER also posts draft versions of its reports for feedback by all stakeholders and the public.  Prior to finalization of its reports, ICER also offers to share the cost-effectiveness model for each report with relevant manufacturers so that they can examine and test the model and help identify any errors or other concerns.

As with all such work, however, there remains the possibility of errors appearing in the Final Report.

After publication of the Final Report, if ICER becomes aware of an error, ICER takes the following steps: 

ICER corrects the error in all relevant sections of the Report.
For corrections of any key findings or facts that could be of importance to readers of the report, ICER places a box on the first page of the updated report describing the error and the correction, and lists that there is an updated version of the report on the report landing page on the ICER website.
Additionally, for any correction that substantially changes the results of a report, if the report would be considered current, ICER notifies relevant stakeholders of the correction.  In deciding whether a report is sufficiently current to warrant stakeholder notification, ICER considers factors including whether it is an older report where newer data would potentially alter results unrelated to the error and whether the overall treatment landscape has substantially changed since the report.
Additionally, for any correction that alters important conclusions of the report, ICER will issue a press release about the correction.

Anyone concerned that they may have found an error in an ICER report can notify ICER of that error by emailing info@icer.org.