GRADE-ing the Benefit/Risk Equation in Food Immunotherapy

Abstract

Purpose of Review We reviewed the existing evidence base to desensitisation for food allergy, applying the Grading of Recommendations, Assessment, Development and Evaluation approach to discuss whether desensitisation is likely to become part of routine treatment for patients with food allergy. Recent Findings Desensitisation for food allergy to peanut, egg and cow’s milk is efficacious, but whether such interventions are cost-effective is less clear, due to the issues over a sustained desensitisation effect and the increase in allergic reactions occurring in patients on treatment. Few studies have assessed the change in health-related quality of life associated with treatment, and most have not considered discordance between parent-reported changes in health-related quality of life (HRQL) outcomes compared to those of the patients themselves; none to date have controlled for the improvement in HRQL occurring after initial challenge which will confound outcomes. Summary The lack of longer-term safety and cost-effectiveness data, as well as an absence of current consensus in the reporting of patient-relevant outcomes, must be addressed in order to be able to recommend the introduction of desensitisation as a routine treatment in healthcare systems.

SF‐6Dv2 preference value set for health utility in food allergy

“…Because food allergy is associated with a rare but constant and plausible risk of life‐threatening allergic reactions from accidental exposure to the food, the burden of the disease stems mainly from its impact on the quality of life of patients and their families. This has been shown repeatedly in both qualitative and quantitative studies 1‐6 . Since strict avoidance of contact with the allergen is the current mainstay of treatment, there is a need for constant vigilance 2 .…”

“…Food‐allergic children are also at increased risk of bullying 8,9 . The uncertainty which stems from patients’ lack of knowledge of actual disease severity as well as from extrinsic factors from the social environment, such as the risk of cross‐contamination of food products, reliance on third parties for care (eg, educators), adequacy, and lack of consistency of food labeling, leads to a sense of loss of control 2‐4,7 …”

“…In practice, it has been shown that patients with a specific disease can ascribe different weights to the various aspects of health addressed in the questionnaire (health dimensions) 12‐15 . Another limit is the lack of a social dimension in the two previously used generic questionnaires since food‐related limitations have repeatedly been identified as an important part of disease burden in qualitative studies 1‐4,7,16,17 …”

“…8,9 The uncertainty which stems from patients' lack of knowledge of actual disease severity as well as from extrinsic factors from the social environment, such as the risk of cross-contamination of food products, reliance on third parties for care (eg, educators), adequacy, and lack of consistency of food labeling, leads to a sense of loss of control. [2][3][4]7 Given the low direct health cost of food allergy (few hospitalization, emergency room visits or deaths and low cost of medication with avoidance relatively to other diseases), motivation to introduce new therapeutic options to the clinical arsenal are mostly motivated by the indirect and intangible cost of disease. As new interventions are being developed to manage and treat food allergy, policy-makers will require objective measures of these intangible costs to decide how to best invest in this area in a fair manner when comparing to other disease states.…”

Patients’ Perspectives and Needs on Novel Food Allergy Treatments in the United States

“…Thus, there appears to be some positive psychosocial impact of OIT and EPIT on patients and families, but additional research is needed to further understand what aspects of immunotherapy contribute to QoL improvements. For example, Duca and colleagues [ 35 •] conducted a cost-benefit analysis of food immunotherapy and raised important questions regarding the mechanism by which immunotherapy positively impacts QoL: is all improvement front-loaded by the information gained from an OFC prior to clinical trial participation, is it due to increased contact with the allergy team which may increase food allergy knowledge and self-efficacy, is it due to desensitization, or is it a combination of these factors? The actual impact on food allergy-related QoL is unclear and is likely to be dependent on both families’ pre-existing food allergy-related QoL while following an avoidance diet and their expectations for the ways in which QoL will change.…”