Institute for Clinical and Economic Review (ICER): Review of RA Drugs
What is ICER?
ICER is a Boston-based non-profit organization that reviews the effectiveness of medications and their costs. ICER has been developing drug evaluations for almost a decade. They accelerated their work significantly in 2015, launching a framework to develop price suggestions based on their evaluation of a drug's value (effectiveness). Their recommendations are often controversial with stakeholders questioning their assumptions and modeling.
How Does ICER Affect Patients?
The recommendations ICER puts forth on a drugs value, may affect coverage options for patients. Insurers review ICER’s report to determine what drugs they will cover in an insurance plan and at what level of coinsurance.
Why is an ICER Review Important?
As the tension around the escalating prices of prescription drugs has grown, ICER’s profile has risen. At the same time, ICER has come under increasing criticism due to the methods used to determine the “value” of new medicines, and the fear that their recommendations will limit the insurance coverage of drugs patients and clinicians need.
Currently, ICER is reviewing rheumatoid arthritis (RA) therapies and will develop a report assessing the clinical effectiveness of these drugs and their value.
The RA category review will include the following:
- TNF inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab)
- CD20-directed cytolytic antibody (rituximab)
- T-cell receptor signaling inhibitor (abatacept)
- IL-6 inhibitors (tocilizumab, sarilumab [investigational])
- JAK inhibitors (tofacitinib, baricitinib [investigational])
Arthritis Foundation Involvement
The Arthritis Foundation has been reviewing ICER's work, engaged in meetings with the staff and submitted written comments throughout the review process. The Arthritis Foundation has urged ICER to recognize that treating people with RA is very nuanced and individual specific. We have asked ICER to consider the unique perspectives of individual patients, their caregivers and providers to ensure that their final report takes into consideration the unique needs of the RA population.
The AF has called for more transparency in ICER’s process and wants to make sure their value framework (measurement tool) includes robust input from patients, providers, and caregivers.
The Arthritis Foundation remains extremely concerned about ICER ‘s review process, and the initial recommendations as well as the following:
- The lack of strong patient and provider engagement throughout the process
- A very short time frame for review by the public
- No public process for how reports will be updated in the future
- The study population included in the analysis is very narrow and therefore it is NOT relevant to the entire RA population
- Many patients with RA are drastically underrepresented in the review
- Conclusions reached based on poor performance measures
- Lack of transparency on how the scoring for treatments is actually developed
- The absence of real world evidence (RWE) or patient experiences in the economic model
- Overall readability for patients and providers
Why is Engagement Important?
Engagement with ICER by patients, providers, and advocacy groups is important because insurers often follow the recommendations ICER puts forth on a drugs value, potentially affecting coverage options for patients.
Often, patient experiences are not captured in research or other evidence. ICER has developed a guide to help patients tell them what they should know about the patient experience. The Arthritis Foundation will comment on this guide.
If you want to share your patient story with ICER, please consider completing this patient participation document. These guides are open to public comment until April 3, 2017. Suggestions for improvement can be emailed to firstname.lastname@example.org.
The written and verbal commentary provided to ICER by the Arthritis Foundation helps to ensure the patients voice is heard. Including patients and provider input is imperative to developing any cost effectiveness review for life changing treatments. Read the following letters and commentary to see what we have submitted:
- April 3, 2017:
The patient voice is imperative to any cost effectiveness review for life changing treatments. The Arthritis Foundation continues to fight for YOU, the patient! We will continue to engage with ICER and any similar organizations to ensure access to any treatment deemed necessary by YOUR prescriber.
ICER'S Review Process for RA Drugs
The draft evidence report and voting questions posted publicly.
Public comment period opened.
ICER's proposed updates to the Value Assessment Framework and public comment period open.
Informational webinar on the proposed updates. Registration is available here.
Public Comment Period on Draft Evidence Report Closes
The revised evidence report was published for review of the New England CEPAC voting committee.
View the following documents:
ICER will hold a public meeting in Boston, MA to vote on the evidence presented. There will be a live webcast.
Public comment period ends for the updated framework and guides.
Final Evidence Report and Meeting Summary.