Medication persistence and adherence in allergy immunotherapy (AIT) has been reported to be lower in real life than in clinical studies, 1 with manufacturers' sales figures often indicating poorer adherence and persistence than postmarketing studies. 2,3 This might result from patients tending to be more compliant when their behavior is being recorded, which is commonly known as the Hawthorne effect. The low risk of anaphylaxis and serious adverse reactions with sublingual immunotherapy (SLIT) 4,5 has resulted in orodispersible SLIT-tablets being approved in Europe and the United States for self-administration provided that the first dose is tolerated under medical supervision. For many patients, self-administration of SLIT-tablets is an advantage over injection during subcutaneous immunotherapy (SCIT). However, dosing regimen and frequency of physician's office visits differ considerably between the 2 administration routes, and efficacy and safety profiles of individual products administered through each route vary widely. Because these factors have been reported to affect persistence and adherence, 6 we compared medication persistence and adherence with a SLIT-tablet versus SCIT products in patients with grass pollen allergy over a 3-year period from treatment initiation. This retrospective cohort study used prescription renewal rates for a 75,000 standardized quality units tablet (SQ-T), 2,800 BAU grass pollen SLIT-tablet, and 100 to 100,000 SQ-U/mL or 600 to 30,000 SQ1/mL suspension for subcutaneous injection from the German IMS Health Disease Analyzer database for the period of January 2006 to August 2014 to obtain an accurate picture of persistence and adherence in real life. More information about the products and database can be found in the Methods section in this article's

BackgroundGrass allergen immunotherapy (AIT) reduces symptom severity in seasonal allergic rhinoconjunctivitis (ARC) but its impact on general health-related utility has not been characterised for the purposes of economic evaluation. The aim of this study was to model the preferred measure of utility, EQ-5D index, from symptom severity and estimate incremental quality adjusted life years (QALYs) associated with SQ-standardised grass immunotherapy tablet (GRAZAX®, 75,000 SQ-T/2,800 BAU, ALK, Denmark).MethodsData were analysed from five consecutive pollen seasons in a randomised placebo controlled trial of GRAZAX®. Binomial and Gaussian mixed effects modelling related weekly EQ-5D index score to daily symptom and medication scores (DSS & DMS respectively). In turn, daily EQ-5D index was estimated from ARC symptoms and medication use.ResultsDSS and DMS were the principal predictors of ‘perfect’ health (EQ-5D = 1.000; binomial) and ‘imperfect’ health (EQ-5D < 1.000; Gaussian). Each unit increase in DSS and DMS reduced the odds of ‘perfect’ health (EQ-5D = 1.000) by 27% and 16% respectively, and reduced ‘imperfect’ health by 0.17 and 0.13, respectively. Gender remained the only other significant main fixed effect (Male odds ratio [OR] = 1.82). Incremental estimated EQ-5D index utility for GRAZAX® was observed from day -30 to day +70 of the pooled pollen season; mean daily utility for GRAZAX® = 0.938 units (95%CI 0.932-0.943) vs. 0.914 (0.907-0.921) for placebo, an incremental difference of 0.0238 (p < 0.001). This translates into an incremental 0.0324 Quality Adjusted Life Years over the five year study period.ConclusionsARC symptoms and medication use are the main predictors of EQ-5D index. The incremental QALYs observed for GRAZAX® may not fully describe the health benefits of this treatment, suggesting that economic modelling may be conservative.

BackgroundAsthma affects an estimated 300 million people worldwide with the condition associated with significant healthcare utilisation costs and a large impact on patient quality of life. The SQ® HDM SLIT-tablet (ACARIZAX®, Hørsholm, Denmark) is a sublingually administered allergy immunotherapy tablet for house dust mite allergic asthma and allergic rhinitis and has recently been licensed in Europe.ObjectiveTo assess the cost-effectiveness of ACARIZAX plus pharmacotherapy versus placebo plus pharmacotherapy in patients with house dust mite allergic asthma that is uncontrolled by inhaled corticosteroids, in a German setting. Eligible patients should also have symptoms of mild to severe allergic rhinitis.MethodsA cost utility analysis was undertaken, based on the results of a European phase III randomised controlled trial, in which ACARIZAX was compared with placebo with both treatment groups also receiving pharmacotherapy in the form of inhaled corticosteroids and short-acting β2-agonists. Cost and quality-adjusted life years from the trial were extrapolated over a nine year time horizon and the incremental cost-effectiveness ratio calculated to compare treatment options.ResultsACARIZAX plus pharmacotherapy was estimated to generate 6.16 quality-adjusted life years per patient at a cost of €5658, compared with 5.50 quality-adjusted life years (QALYs) at a cost of €2985 for placebo plus pharmacotherapy. This equated to an incremental cost of €2673, incremental QALYs of 0.66 and an incremental cost-effectiveness ratio (ICER) of €4041. The ICER was, therefore, substantially lower than the €40,000 willingness-to-pay threshold per QALY adopted for the analysis. Deterministic sensitivity analyses indicate the results are most sensitive to the utility score of ACARIZAX patients during years 2 and 3 of treatment.ConclusionThis analysis indicates that ACARIZAX plus pharmacotherapy is cost-effective compared with placebo plus pharmacotherapy for house dust mite allergic asthma patients in Germany. If a disease-modifying effect can be proven the results of this analysis may underestimate the true benefits of ACARIZAX.

BackgroundAllergy immunotherapy is an effective treatment for patients with allergic rhinitis whose symptoms are unresolved with pharmacotherapy. Allergy immunotherapy for grass pollen-induced allergic rhinitis is available in three modalities: subcutaneous immunotherapy and sublingual immunotherapy as a tablet or drop. This study aimed to understand trends in allergy immunotherapy prescribing and practice patterns for grass allergies in adult and paediatric patients in Germany.MethodsA retrospective cohort study was conducted using IMS Disease Analyzer in Germany. Patients with an allergy immunotherapy prescription for grass pollen (Anatomical Therapeutic Chemical [ATC] classification code V01AA02) from September 2005 to December 2012 were included in the study. General Practitioners (GPs), dermatologists, Ear, Nose and Throat (ENT)-specialists, paediatricians and pneumologists were included as the allergy immunotherapy prescribing physicians in the study. Descriptive analyses were conducted on patient characteristics at index and prescribing physician specialty; a test for trend was conducted for timing of initiation of first allergy immunotherapy prescription in each annual prescribing season.ResultsEighteen thousand eight hundred fifty eligible patients were identified during the study period. The majority of patients received subcutaneous immunotherapy; however, the proportion of patients receiving sublingual immunotherapy tablets increased from 8 % in 2006/2007 to 29 % in 2011/2012 (p < 0.001). Initiation of subcutaneous immunotherapy and Oralair® generally peaked during each prescribing year in two seasons (September-October and January) while GRAZAX® prescriptions peaked in autumn (September-October). ENT-specialists and dermatologists were the largest allergy immunotherapy prescribers in adults, while paediatricians and ENT-specialists were the largest prescribers of allergy immunotherapy in paediatric patients.ConclusionsSubcutaneous immunotherapy remained the dominant allergy immunotherapy modality for grass pollen-induced allergic rhinitis in Germany for adult and paediatric patients; however, there was a marked increase in proportion of patients receiving sublingual immunotherapy tablets from 2006/2007 to 2011/2012, after their introduction to the market in 2006. ENT-specialists, dermatologists and paediatricians were responsible for the majority of prescribing. The predominance of particular modalities within certain physician specialties likely reflects different treatment goals or needs.

BackgroundAllergic rhinitis is a global health problem that burdens society due to associated health care costs and its impact on health. Standardized quality (SQ®) house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet is a sublingually administered allergy immunotherapy tablet for patients with persistent moderate to severe HDM allergic rhinitis despite use of allergy pharmacotherapy.ObjectiveTo assess the cost-effectiveness of SQ HDM SLIT-tablet in Germany for patients suffering from HDM allergic rhinitis.MethodsA pharmacoeconomic analysis, based on data collected in a double-blinded, phase III randomized placebo-controlled trial (n=992), was undertaken to compare SQ HDM SLIT-tablet in addition to allergy pharmacotherapy to placebo plus allergy pharmacotherapy. Quality-adjusted life year (QALY) scores and health care resource use data recorded in the trial were applied to each treatment group and extrapolated over a nine-year time horizon. A series of scenarios were used to investigate the impact of changes on long-term patient health for both treatment groups, which was measured by annual changes in QALY scores. Deterministic and probabilistic sensitivity analyses were also performed.ResultsIn the base case analysis, compared with allergy pharmacotherapy, SQ HDM SLIT-tablet led to a QALY gain of 0.31 at an incremental cost of €2,276 over the nine-year time horizon, equating to an incremental cost-effectiveness ratio of €7,519. The treatment was cost-effective for all scenarios analyzed; however, results were sensitive to changes in individual parameter values during the deterministic sensitivity analysis.ConclusionSQ HDM SLIT-tablet in addition to pharmacotherapy is cost-effective compared with allergy pharmacotherapy plus placebo for the treatment of persistent moderate to severe HDM allergic rhinitis that is not well controlled by allergy pharmacotherapy.