Cost-effectiveness analysis of house dust mite allergen immunotherapy in children with allergic asthma.

BACKGROUND: Cost-effectiveness studies evaluating allergen immunotherapy (AIT) in children are limited but needed to drive clinical and policy-making decisions such as reimbursement of new interventions. In this study, we compared the cost effectiveness of subcutaneous (SCIT) and sublingual immunotherapy (SLIT) tablets to the standard of care (SOC) treatment in children with house dust mite-driven (HDM) allergic asthma. METHODS: We developed a hypothetical Markov model based on the Global Initiative for Asthma (GINA) severity steps to compare the three strategies over a 10-year horizon divided by cycles of 6 months. SOC was used as a reference to calculate the incremental cost-effectiveness ratio (ICER). Deterministic and probabilistic sensitivity analyses were used to assess models' uncertainty. Other scenarios were evaluated to strengthen the presentation of results. RESULTS: The ICER for SCIT and SLIT tablets was 1281€ and 7717€, respectively. The cost-effectiveness threshold for Portugal was 18,482.80€; both treatment approaches were below this limit. The major contributors to these results were the AIT effects on reducing moderate and severe exacerbations and asthma controller medication. In the sensitivity analysis, SCIT revealed a higher probability of cost-effectiveness than SLIT. When including allergic rhinitis as comorbidity, ICER values reduced markedly, especially for SCIT intervention. CONCLUSIONS: AIT was cost effective in children with HDM-driven allergic asthma, especially when given by the subcutaneous route. The high probability of cost effectiveness, especially for SCIT, may drive future policy decisions and AIT-prescribing habits. AIT adherence greatly influenced the results highlighting the value of implementing strategies to promote adherence rates.

Clinical aspects of sublingual immunotherapy tablets and drops.

BACKGROUND: Sublingual immunotherapy (SLIT) is administered via tablets (SLIT-T) or liquid drops (SLIT-D). In North America, currently 4 SLIT-T formulations are approved by the US Food and Drug Administration for allergy immunotherapy, and SLIT-D is an off-label use of subcutaneous immunotherapy (SCIT) extracts. OBJECTIVE: To compare and contrast aspects of SLIT-T and SLIT-D, including physical characteristics, mechanism of action, dosing, efficacy, safety, adherence, and cost. DATA SOURCES: PubMed literature review (no limits), product prescribing information, and manufacturer websites. STUDY SELECTIONS: Publications related to physical characteristics, mechanism of action, dosing, efficacy, safety, and adherence. RESULTS: Published evidence indicates that tablet and drop formulations differ in regard to physical characteristics, dosing, and strength of evidence for efficacy. Whether there are any differences in absorption and mechanism of action between the 2 formulations is currently unknown. Optimal dosing, efficacy, and safety have been established for SLIT-T. In contrast, in North America there is little support for efficacy of SLIT-D from randomized double-blind, placebo-controlled trials, and dose ranges have not been appropriately evaluated. SLIT-T treats a single allergen, whereas in the United States SLIT-D often contains multiple allergens to treat polysensitization. The safety profiles of SLIT-T and SLIT-D appear similar, and both formulations are considered safer than SCIT. CONCLUSION: Professional guidelines should make a clear distinction between SLIT-T and SLIT-D in their recommendations to minimize confusion with the umbrella term SLIT.

Advances in allergen immunotherapy as a treatment of asthma.

Introduction: Specific immunotherapy is the only treatment acting on causes and not only on symptoms of respiratory allergy. It was first introduced as subcutaneous immunotherapy (SCIT) with the aim to induce immunological tolerance to the administered allergen(s). In the 1980s, sublingual immunotherapy (SLIT) was developed, mainly to improve the safety, which was a critical issue at that time.Areas covered: This article reviews the available literature, including a large number of randomized controlled trials, meta-analyses, and real-life studies as well, on the outcomes of SCIT and SLIT concerning the treatment critical issues of the two routes, that are efficacy, safety, cost-effectiveness, and compliance to treatment.Expert opinion: SCIT and SLIT are similarly effective in treating patients with respiratory allergy, providing, based on the induction of typical changes in the immunologic response, an early control of symptoms that steadily increases during the treatment and, once reached the recommended duration of 3 years, continues to work after stopping. This outcome is the major factor influencing the economic advantage of SCIT and SLIT over drug treatment.

Cost-effectiveness of the SQ HDM SLIT-tablet for the treatment of allergic asthma in three Eastern European Countries.

Summary: Background.The SQ® house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet (ACARIZAX®, ALK-Abelló A/S, Hørsholm, Denmark) is an allergy immunotherapy tablet for people with allergic respiratory disease. This analysis aims to assess the cost-effectiveness of the SQ HDM SLIT-tablet from the perspective of three Eastern European countries: Czech Republic, Poland and Slovakia. Methods.A cost-utility model per country was developed, which compared the SQ HDM SLIT-tablet as add-on to pharmacotherapy with pharmacotherapy alone in patients with HDM allergic asthma (AA) over a five year time horizon. The effectiveness of the two interventions was based on the results from a large-scale randomised controlled trial. In the models, annual costs and quality-adjusted life year (QALY) scores from the trial were extrapolated over a five year period, and the incremental cost-effectiveness ratios (ICERs) were estimated. One-way deterministic sensitivity and scenario analyses were undertaken. Results.The SQ HDM SLIT-tablet is cost-effective in all three markets over the five year time horizon (ICERs of less than € 10,000 per additional QALY). Treatment with the SQ HDM SLIT-tablet improves patient outcomes, with QALY gains of 0.35, versus pharmacotherapy only. In all three countries, the SQ HDM SLIT-tablet also incurs increased costs compared to pharma-cotherapy treatment only. The sensitivity analysis identified utility values from the clinical trial as the main driver of the model results. Conclusion.The SQ HDM SLIT-tablet is a cost-effective treatment option for people with HDM AA in three different health care settings in Eastern Europe.

The Future of Sublingual Immunotherapy in the United States.

Sublingual immunotherapy (SLIT) is a safe and effective treatment for allergic rhinitis (AR) and allergic rhinoconjunctivitis (ARC). The Food and Drug Administration (FDA) in the USA has approved three SLIT tablets for the treatment of AR and ARC in relation to pollen. Specifically, Grastek® and Oralair® are two formulations approved to treat patients suffering with AR/ARC to grass pollen, and Ragwitek™ is a formulation approved to treat patients suffering with AR/ARC to ragweed pollen. Although these approvals provide support for physicians to prescribe SLIT, barriers to prescribing SLIT still remain such as FDA approval for additional formulations, a standard dose and dosing schedule, and cost/insurance coverage. In order to further support the use of SLIT, research is currently being conducted to expand the indication for SLIT to other common comorbidities to AR/ARC. For example, allergic asthma, food allergies, and atopic dermatitis are other diseases which are being explored. The future of SLIT in the USA is unknown; however, education will be necessary for both providers and patients.

Selection of patients for sublingual versus subcutaneous immunotherapy.

Allergen immunotherapy is the sole treatment for IgE-mediated allergic diseases directed at the underlying mechanism. The two widely accepted administration routes are sublingual (SLIT) and subcutaneous (SCIT). We reviewed how patients should best be selected for immunotherapy and how the optimal administration route can be defined. Before deciding SCIT or SLIT, appropriate selection of patients for allergen immunotherapy (AIT) is mandatory. To be eligible for AIT, subjects must have a clear medical history of allergic disease, with exacerbation of symptoms on exposure to one or more allergens and a corresponding positive skin or in vitro test. Then the route of administration should be based on: published evidence of clinical and immunologic efficacy (which varies per allergic disease and per allergen); mono- or multi-allergen immunotherapy, for SLIT multi-allergen immunotherapy was not effective; safety: adverse events with SLIT are more frequent, but less severe; and, costs and patient preferences, closely related to adherence issues. All these are discussed in the article.

Allergy immunotherapy: what is the evidence for cost saving?

PURPOSE OF REVIEW: Given the widespread prevalence of allergic disease, its substantially associated clinical and economic burden, the unique disease-modifying benefits of allergy immunotherapy (AIT), and increased availability of sublingual immunotherapy (SLIT), a critical update of the evidence for AIT-related cost savings [for both subcutaneous immunotherapy (SCIT) and SLIT] is particularly relevant and timely. The present article reviews the evidence for SCIT-related and SLIT-related cost savings derived from a systematic review of the published literature. RECENT FINDINGS: Examined were 24 publications pertaining to the health economics of AIT. Except for one early study comparing the costs of AIT to symptomatic drug treatment (SDT), the remainder provide compelling evidence for AIT cost savings (whether SCIT or SLIT) over SDT. Furthermore, of the six studies comparing cost outcomes of SLIT to SCIT, four reported cost savings favoring SLIT. SUMMARY: This review, spanning research from Southern Europe, Scandinavia, Northern Europe, North America, and the Czech Republic, encompasses a range of perennial and seasonal allergic conditions, including allergic asthma, allergic rhinitis with or without asthma, and rhinoconjunctivitis with or without allergic rhinitis due to house dust mite, grass or ragweed pollen, or a mixture of various allergens. All but one study compellingly demonstrate cost savings conferred by AIT over SDT.