We appreciate the opportunity ICER allows for stakeholders, including patient advocates and patients themselves, to comment on ICER’s draft evidence report and voting questions on Chimeric Antigen Receptor T-Cell (CAR-T) for B-Cell Cancers. In assessing ICER’s draft evidence report and voting questions, we choose to view through the lens of a patient, and gauge how the assessment would impact their access to the therapy under review, the future innovation of this and other therapies, and the reforms that may be needed in ensuring utilization of both. With this as our guide, we must first state our serious concerns and enduring objections.
The ICER website states: ‘Patients are at the core of ICER’s mission to help provide an independent source of analysis of evidence on effectiveness and value to improve the quality of care that patients receive.”
Though we acknowledge ICER has made some improvements in relations with patients and advocates, this draft evidence falls short of both the letter and the spirit of ICER’s stated core and mission.
It’s Far Too Early
As long as ICER insists on reviewing therapies at what we believe are questionable times – generally right before a new therapy comes to market – then the evaluation will remain fundamentally flawed. Attempting to create a value framework for a therapy in its infancy fails any serious attempt at the scientific method, and ultimately serves to cheat patients by impacting undetermined coverage policies that could suppress patient access. We strongly encourage ICER once again to commit to developing a standard for when it will assess new therapies, and we believe that it should allow a significant period of time to gather real world data within the analysis.
Updating Assessments
It is unwise for ICER to continue to resist consensus calls to update early assessments in a way that is consistent with logic and practice. If ICER continues to assess treatments right before or as they hit the market – which is not a reliable standard – what will be the determining factor for how often you will reassess your findings? Without a standard in place for updating patient data, ICER cannot claim to truly be helping patients.
Lack of Meaningful Patient Engagement
While we acknowledge ICER’s work with some selected organizations, an authentic patient perspective is obviously absent – and profoundly so in this case. In our experience, so many patients living with chronic and life-threatening illnesses develop an advanced scientific knowledge in their specific disease and are experts in its impact on their body. This is also absolutely true among the parents of younger patients. And yet, these vital voices of value are consistently excluded from your “expert panel.” Does living with a disease and in many instances fighting for your life not qualify as a worthwhile expertise?
Beyond Clinical Value
While we understand ICER’s purpose in evaluating the clinical and economic data for selected therapies, trying to create a universal assessment in a precision medicine world is simply not possible for certain therapies and certain types of patients. Surely, ICER should understand this. We respect and encourage the trend toward value and will continue to lead meaningful conversations and a deeper dialogue around its impact for patients. We believe patients voices need to be a part of defining and assessing the value of their treatment plan and the cost of all aspects of their treatment plan with their doctors.
Budget Impact Analysis
How can ICER possibly assess a budget impact analysis on something with so many unknown outcomes and variables? The only budget analysis anyone should really be assessing is the patient’s out of pocket costs across the board. Patients Rising Now believes that by focusing on those unsustainable numbers, the societal budget impact will automatically be addressed by creating a more transparent, easier to understand payment system for patients.
It is for these reasons – and others – that we call on your organization to reexamine and reassess its current course and gain very needed credibility among the entire health care ecosystem that supports the crucial truth of patient access.