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.
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.