National Eczema Association Weighs In on Value Frameworks

Nearly 18 million Americans are living with atopic dermatitis (AD), the most common type of eczema that often appears as a red, itchy rash normally on the cheeks, arms and legs. AD can be challenging to manage because the rash is long-lasting and can flare up due to a variety of triggers. There are treatments available, two of which were recently approved by the Food and Drug Administration and under review by the Institute for Clinical and Economic Review (ICER), which will host a meeting on its AD report on May 25.

NPC President Dan Leonard recently sat down for a conversation with Julie Block, President and CEO of the National Eczema Association (NEA), a non-profit patient advocacy organization focused on improving the health and quality of life for individuals with eczema through research, support and education. Recently, NEA was involved in efforts to provide ICER with information about AD and patients’ experiences with the condition. Mr. Leonard chatted with Ms. Block about this experience and how the process could be improved. 

Dan Leonard (DL): First, please tell me a little bit about atopic dermatitis, the different ways it affects patients, and the treatment options that have been available up until now?

Julie Block (JB):  Atopic dermatitis (AD) is a chronic, inflammatory skin disease that usually starts in early infancy, but also affects a substantial number of adults.  There are approximately 17.8 million Americans with moderate to severe eczema or AD.  People with AD experience debilitating dry, itchy skin, impacting quality of life.  Scratching causes their skin to become inflamed, which sometimes results in infections. Many patients also experience oozing or weeping skin.  Medications used to treat AD sometimes causes patients’ skin to thicken.

AD is often accompanied by other atopic conditions like asthma and hay fever.  Pain, sleep loss, depression, and anxiety are also not uncommon.  Patients may have higher rates of absenteeism, diminished functioning at work and in school, and suicidal ideation.  It is also important to remember that its impact is not limited to the patients themselves, it impacts the entire family as well.  When children do not sleep, neither do their parents.

DL: How have you and your organization been involved in the ICER assessment process? How are you working to ensure that the AD patient voice will be heard in this process?

JB:  ICER contacted NEA and the Asthma and Allergy Foundation of America (AAFA) in October 2016 to inform us that they were preparing to do a study of two drugs for the treatment of AD, crisaborole and dupilumab, and to gain an understanding of AD’s impact on patients’ lives, as well as clinical outcomes and psychosocial impacts that are important to patients.  We provided them with patient perspectives, both in written form and via a live listening session with a patient who has severe AD, access to patient surveys, referrals to expert clinicians and researchers, and information about the changing medical landscape in this disease space.  We also provided them with access to a Burden of Disease Audit that NEA completed in 2016, which identifies significant knowledge gaps in our understanding of how AD impacts patients and society medically, socially, and economically.

We continue to work with ICER for patient input, and independently raise public awareness of AD as a serious, life-altering disease.  We regard ICER as a partner and have used ICER’s process to inform our own efforts to quantify AD’s disease burden, assess the value of health care innovations, and communicate our findings to patients, providers, insurers, and pharmaceutical companies.

DL: What are the types of issues that you hope ICER will address when it comes to AD?

JB:  Ideally, ICER’s analysis would address aspects of these drugs in measures that are relevant to patients’ perceptions of value, which are not always well captured in clinical and cost-effectiveness studies.  The main problem is the paucity of data on AD’s disease burden.  We are satisfied that ICER has taken every reasonable step to evaluate the clinical and cost-effectiveness of these medications that can be taken currently, but hope that ICER and other CER organizations will be able to more fully address the clinical and psychosocial aspects of AD in future analyses of AD drugs, when relevant data become available.

DL: Comment processes can be time consuming, regardless of the organization that’s seeking feedback. How could the process be improved or made easier for patient organizations?

JB:  There are a few things that could be done to improve the comment process and make it easier for patient advocacy organizations.  The timelines associated with these projects should acknowledge the resource limitations faced by many patient advocacy organizations, which typically tend to be small and under resourced to fully participate in a CER effort.  The organizers of these evaluation efforts might consider recruiting health economists either to work independently with the patient advocacy organizations or to independently review the research protocols and analytical findings at various stages of the process.  Although many patient advocacy organizations have access to medical experts, they often do not have access to health economists who can help them understand the analytical model and address concerns in how the analysis was conducted.

DL: Do you believe value assessment frameworks—whether it’s ICER’s or others—can align with the different needs of patients? What can value assessors do to ensure they are fully engaging with patient communities?

JB:  I think that it is possible for value frameworks to align with the needs of patients if the organizations conducting them are committed to the idea of patient centric care, their evaluation processes are transparent, and there are sufficient data to draw valid inferences about outcomes that are important to patients.  To assure these ends, the organizations conducting these assessments should invite patients and patient advocacy organizations to take part in the evaluation, not merely as observers or commenters, but as full partners.  Patients and patient advocates should be fully vested members of the organizations conducting the analyses and/or the committees that review the researchers’ findings.  At the very least, patients should have a voice in the final report by way of an official comment that is entered into the final draft of the report.

DL: Thanks so much for joining me for this conversation.

For additional information about the National Eczema Association, visit their website. For more about value framework assessments, check out NPC’s Guiding Practices for Patient-Centered Value Assessment and Current Landscape: Value Assessment Frameworks and watch the video from our conference, Assessing Value: Promise and Pitfalls.