The Help for Hay Fever community pharmacy-based pilot randomised controlled trial for intermittent allergic rhinitis.

Management of intermittent allergic rhinitis (IAR) is suboptimal in the UK. An Australian community pharmacy-based intervention has been shown to help patients better self-manage their IAR. We conducted a pilot cluster RCT in 12 Scottish community pharmacies to assess transferability of the Australian intervention. Trained staff in intervention pharmacies delivered the intervention to eligible customers (n = 60). Non-intervention pharmacy participants (n = 65) received usual care. Outcome measures included effect size of change in the mini-Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) between baseline, 1-week and 6-week follow-up. Trial procedures were well received by pharmacy staff, and customer satisfaction with the intervention was high. The standardised effect size for miniRQLQ total score was -0.46 (95% CI, -1.05, 0.13) for all participants and -0.14 (95% CI,-0.86, 0.57) in the complete case analysis, suggesting a small overall treatment effect in the intervention group. A full-scale RCT is warranted to fully evaluate the effectiveness of this service.

Next generation immunotherapy for tree pollen allergies.

Tree pollen induced allergies are one of the major medical and public health burdens in the industrialized world. Allergen-Specific Immunotherapy (AIT) through subcutaneous injection or sublingual delivery is the only approved therapy with curative potential to pollen induced allergies. AIT often is associated with severe side effects and requires long-term treatment. Safer, more effective and convenient allergen specific immunotherapies remain an unmet need. In this review article, we discuss the current progress in applying protein and peptide-based approaches and DNA vaccines to the clinical challenges posed by tree pollen allergies through the lens of preclinical animal models and clinical trials, with an emphasis on the birch and Japanese red cedar pollen induced allergies.

Budget impact model of a 5-grass sublingual immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis.

OBJECTIVE: Allergic rhinitis (AR) is a chronic disease with a substantial clinical and economic burden. This study estimated the potential budget impact (BI) associated with market entry of Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Tablet for Sublingual Use ('5-grass SLIT tablet') for patients aged 10-65 with grass pollen-induced AR. METHODS: A budget impact model was constructed to estimate the potential BI from a US payer perspective. The model calculated pharmacy, medical, and total (pharmacy + medical) costs per-member-per-month (PMPM) with and without market entry of the 5-grass SLIT tablet, considering a 3-year time horizon. The target population was determined using an epidemiological approach and existing literature. The treatment market shares without 5-grass SLIT tablet entry were derived from an analysis of de-identified insurance claims data. Pharmacy costs and medical utilization rates and costs were obtained from the claims data analysis and existing literature. One-way sensitivities were conducted for key model inputs. RESULTS: Using an illustrative example of a hypothetical health plan with one million members, the estimated target population of AR patients aged 10-65 was 26,320. On a PMPM basis, pharmacy costs increased by $0.36, $0.44, and $0.51, while total costs (after medical cost offsets) increased by $0.15, $0.18, and $0.22 in the first, second, and third years following entry of the 5-grass SLIT tablet, respectively. Results were most sensitive to changes in the compliance rate, treatment duration, and price. The BI will vary from the base case example when alternative, payer-specific inputs are used. CONCLUSIONS: Using base case inputs, use of the 5-grass SLIT tablet to treat grass pollen-induced AR increased the pharmacy budget for a hypothetical third-party payer. Higher pharmacy costs were partially offset by lower medical budget due to reduced resource use compared with existing treatments.

[About Minimization of Expenses on Allergy Diagnosis in Children: Analysis of Consistency of in Vitro- and in Vivo-Allergic Examinations Results].

UNLABELLED: High morbidity rate of atopic diseases among children, including high importance of grass pollen as a sensitizing agent, determine the relevance ofstudies on diagnostic examination systems for appointment of adequate therapy. The research of the most relevant allergens for patients to excludeof duplicating and uninformative tests became urgent after development of a new type of diagnostic tests that does not require expensive equipment. The objective of this research was to evaluate the results of in vitro- and in vivo-diagnostic examinations of children with various forms of atopic disease caused by pollen of meadow grasses, and to choose the most significant prognostic parameters for the diagnosis. METHODS: 277 children aged 4-16 years with various forms of atopic disease were included in the study. There were performed skin prick tests and determination of IgE-antibodies levels to allergen extracts of cocksfoot (g3), meadow fescue (g4), timothy grass (g6). RESULTS: In the studied group of patients 32-50% of children have antibodies to grass allergens. There was a close correlation of antibody response on the investigated allergens, quantitative coincidence of IgE-antibodies to g3 andg4 allergens levels. IgE (g6) concentration was close to the IgE(g3) and IgE(g4) levels (85.0 ± 21.6%). Analysis of the skin tests results showed that 44% of patients have a positive response to grass allergens, and in vivo-tests results coincide with serologicaltests results, mostly in a qualitative sense. The most significant relationship was noted between in vivo and in vitro-tests in the results of testing the response to meadow fescue pollen. CONCLUSION: Based on these data IgE concentration index to meadow fescue allergens can be used as a prognostic marker to determine the sensitization of patients with different nosology forms of allergy and can help to improve allergic diagnostics.

[Socio-economic impact of allergic rhinitis and perspectives of appropriate therapy]. / Sozioökonomische Auswirkungen der allergischen Rhinitis und Perspektiven einer adäquaten Therapie.

Allergic rhinitis is a very common disease that causes high economic costs. Furthermore inadequate treatment can lead to bronchial asthma. Against this background, drugs for the treatment of allergic rhinitis should be evaluated from a comprehensive medical-economic perspective. The new combination of an antihistamine and a corticosteroid, introduced in the market in 2013, emerges as useful pharmaceutical alternative, both with regard to the medical outcome parameters as well as cost-effectiveness.

Estimation of health-related utility (EQ-5D index) in subjects with seasonal allergic rhinoconjunctivitis to evaluate health gain associated with sublingual grass allergen immunotherapy.

BACKGROUND: Grass 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). METHODS: Data 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. RESULTS: DSS 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. CONCLUSIONS: ARC 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.

Decision-making analysis for allergen immunotherapy versus nasal steroids in the treatment of nasal steroid-responsive allergic rhinitis.

BACKGROUND: The purpose of the study was to determine the age at which initiation of specific subcutaneous immunotherapy (SCIT) becomes more cost-effective than continued lifetime intranasal steroid (NS) therapy in the treatment of allergic rhinitis, with the use of a decision analysis model. METHODS: A Markov decision analysis model was created for this study. Economic analyses were performed to identify "break-even" points in the treatment of allergic rhinitis with the use of SCIT and NS. Efficacy rates for therapy and cost data were collected from the published literature. Models in which there was only incomplete improvement while receiving SCIT were also evaluated for economic break-even points. The primary perspective of the study was societal. RESULTS: Multiple break-even point curves were obtained corresponding to various clinical scenarios. For patients with seasonal allergic rhinitis requiring NS (i.e., fluticasone) 6 months per year, the age at which initiation of SCIT provides long-term direct cost advantage is less than 41 years. For patients with perennial rhinitis symptoms requiring year-round NS, the cut-off age for SCIT cost-effectiveness increases to 60 years. Hypothetical subjects who require continued NS treatment (50% reduction of previous dosage) while receiving SCIT also display break-even points, whereby it is economically advantageous to consider allergy referral and SCIT, dependent on the cost of the NS prescribed. CONCLUSION: The age at which SCIT provides economic advantages over NS in the treatment of allergic rhinitis depends on multiple clinical factors. Decision analysis models can assist the physician in accounting for these factors and customize patient counseling with regard to treatment options.

Intranasal corticosteroids: the role of patient preference and satisfaction.

Allergic rhinitis (AR) is a disease with a significant global burden, associated with many comorbidities and quality-of-life issues. Overwhelming evidence shows that intranasal corticosteroids are the most effective treatment for AR to control the disease, decrease comorbidities, and decrease costs. Poor adherence is a major barrier to achieving control of AR. This article addresses patient preferences and satisfaction regarding intranasal corticosteroids and factors leading to better adherence. We review and summarize the published literature. Factors affecting patient preference and, ultimately, adherence include a variety of sensory components such as odor, taste, comfort of delivery, delivery devices (aerosol versus aqueous) and patient cost. The intensity of adverse sensory attributes is negatively correlated with patient preference and the likelihood of adherence. Selection of an intranasal steroid (INS) with patient preference and satisfaction in mind can influence patient outcomes and cost. Providers need to assess each patient to determine which inhaled INS will lead to the best adherence, thereby improving outcomes in our patients and ultimately reducing the overall global burden of this disease.

'Help for Hay Fever', a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial.

BACKGROUND: Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based 'goal-focused' intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT). METHODS/DESIGN: A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome measures relate to changes in symptom severity, productivity, medication adherence and self-efficacy. Quantitative data about accrual, retention and economic measures, and qualitative data about participants' experiences during the trial will be collected to inform the future RCT. DISCUSSION: This work will lay the foundations for a definitive RCT of a community pharmacy-based 'goal-focused' self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013. TRIAL REGISTRATION: Current Controlled Trials ISRCTN43606442.

Economic evaluation of 5-grass pollen tablets versus placebo in the treatment of allergic rhinitis in adults.

BACKGROUND: Allergen immunotherapy (AIT) is aimed at modifying the immune response to a causative allergen, thereby reducing clinical symptoms and symptomatic medication intake and improving quality of life. Long-term AIT research has led to the development of 5-grass pollen tablets, currently indicated for the treatment of grass pollen-induced allergic rhinitis (AR). METHODS: A post-hoc analysis was conducted using the Average Adjusted Symptom Score (AAdSS) to compare the effect of treatment of AR with 5-grass pollen tablets versus placebo treatment. Using the results of the VO34.04 and VO53.06 trials and economic data, cost-effectiveness analysis of 5-grass pollen tablet treatment was performed from the Italian third-party payer perspective with cost data derived from a study of 2008 updated to 2011. Also a societal perspective was considered by using the costs related to the losses of productivity by following the human capital approach. Using the results of the analysis, the estimated receiver-operating characteristic curve was plotted to evaluate medication effectiveness in terms of quality-adjusted life years (QALYs) and a decision tree constructed to model the possible outcomes and costs for adults and paediatric patients with a low, medium, and high AAdSS. Finally, probabilistic sensitivity analysis was conducted to test the robustness of the results as well as their consistency at an assumed cost-effectiveness threshold of € 30,000/QALY. RESULTS: The results indicate that compared to the placebo, the 5-grass pollen tablet treatment provides a benefit of 0.127 QALYs in medium AAdSS patients and of 0.143 QALYs in high AAdSS patients. The 5-grass pollen tablet treatment was found to cost € 1,024/QALY for patients with a medium AAdSS and € 1,035/QALY for patients with a high AAdSS. Of all the simulations performed in the probabilistic sensitivity analysis, 99 % indicated that the incremental cost-effectiveness ratio of the 5-grass pollen tablet treatment was below the threshold of € 30,000/QALY in patients with medium and high AAdSS, whereas it was found to be dominated in 67 % of simulations related to patients with low AAdSS. CONCLUSION: The 5-grass pollen tablet is a cost-effective treatment for adult AR patients with a medium or high AAdSS. This finding should be carefully considered when deciding the management strategy for these patients.

Incremental healthcare utilization and expenditures for allergic rhinitis in the United States.

OBJECTIVE: Determine incremental increases in healthcare expenditures and utilization associated with allergic rhinitis (AR). METHODS: Patients reporting a diagnosis of AR were extracted from the 2007 Medical Expenditure Panel Survey medical conditions file and linked to the consolidated expenditures file. AR patients were then compared to non-AR patients determining differences in healthcare utilization: office visits, emergency facility visits, and prescriptions filled, as well as differences in healthcare expenditures: total healthcare costs, office-based costs, prescription medication costs, and self-expenditures using demographically and comorbidity adjusted multivariate models. RESULTS: An estimated 17.8 ± 0.72 million adult patients reported AR in 2007 (7.9 ± 0.3% of the U.S. population). The additional incremental healthcare utilizations associated with AR relative to non-AR patients for office visits, emergency facility visits, and number of prescriptions filled were 3.25 ± 0.40, 0.01 ± 0.02, and 8.95 ± 0.80, respectively (P < .001, .787, and <.001, respectively). Similarly, additional healthcare expenditures associated with AR for total healthcare expenses, office-based visit expenditures, prescription expenditures, and self-expenditures were $1,492 ± 346, $461 ± 122, $876 ± 126, and $168 ± 25, respectively (all P < 0.001). CONCLUSIONS: AR is associated with substantial incremental increases in healthcare utilization and expenditures due to increases in office-based visits and prescription expenditures. As a commonly prevalent and costly disease, AR would be a prime target for guideline development and standardization of care.

Ciclesonide for the treatment of seasonal allergic rhinitis.

Allergic rhinitis is considered one of the most common afflictions of humans, affecting up to 30% of the world's population, and is increasing in incidence. Primary symptoms, comorbid conditions and complications of this disorder exact a significant toll, resulting in an enormous physical, social and economic impact on society. Single-season allergic rhinitis accounts for approximately 20% of cases of allergic rhinitis with another 40% having mixed seasonal-perennial presentations. Management of this disorder encompasses several treatment options, with intranasal corticosteroids recommended as first-line treatment in moderate-to-severe seasonal allergic rhinitis in current practice parameters. Ciclesonide is the most recently approved product in this category for the management of seasonal allergic rhinitis and is the subject of this article.

Outcomes and cost comparison of three therapeutic approaches to allergic rhinitis.

BACKGROUND: Allergic rhinitis (AR) is a global health problem because of its increasing impact on economics, society, and the individual's quality of life. This study compares the outcomes and cost of three intranasal therapeutic approaches to the treatment of AR. METHODS: This was a retrospective cohort study using propensity scores to achieve balanced cohorts. The study population included patients ≥16 years of age with at least one intranasal prescription claim, without concurrent nasal polyps or sinusitis. Health care use and costs, airway infections, pharmacy costs, and indicators of unsatisfactory treatment (i.e., treatment augmentation or switching) were evaluated in the 1-year follow-up period using a claims database. RESULTS: Data from 141,190 patients in intranasal antihistamines (INA) therapy, intranasal steroids (INS) therapy, and intranasal combination therapy (ICT) cohorts were analyzed. The INA cohort showed the lowest rate of change in treatment (switching or augmentation). Switching rates were lowest in the INS therapy cohort, whereas augmentation was lowest in the INA cohort. AR- and asthma-related medication costs were significantly lower in the INA cohort. No differences were observed in airway infections and overall health care costs. Concurrent chronic obstructive pulmonary disorder and asthma were the strongest predictors of health care cost and respiratory infection in the follow-up period. CONCLUSION: A change in treatment was noted in ∼⅓ of the entire study population. None of the treatments had a remarkable effect on health care costs or the occurrence of airway infections. The INA treatment cohort had lower AR- and asthma-related medication costs.

Inadequate health insurance coverage: a major factor in premature discontinuation of subcutaneous immunotherapy for allergic rhinitis.

We conducted a study of 155 patients with allergic rhinitis who prematurely discontinued subcutaneous allergen immunotherapy to determine the reasons for their discontinuation. The most commonly cited factor, which was cited by 62 patients (40.0%), was the issue of cost-specifically, inadequate or nonexistent insurance coverage. Studies have shown that subcutaneous allergen immunotherapy is more cost-effective than pharmacologic treatment for patients with allergic rhinitis. Therefore, improved insurance coverage for this treatment of proven efficacy would not only improve quality of life, it would also be economically beneficial to the healthcare system in general.

Determinants of patient compliance in allergic rhinoconjunctivitis.

PURPOSE OF REVIEW: Noncompliance to the prescribed therapeutic regimen is a worldwide problem, especially for diseases in which symptoms can vary with different patient factors and with seasons. The consequences are poor health outcomes, progression of disease and increased healthcare costs. Reviews conducted across countries and addressing different diseases are consistent in estimating noncompliance between 30 and 50%. To implement strategies and interventions that enhance compliance, a comprehensive analysis of its determinants is essential. RECENT FINDINGS: Lack of efficacy was reported as the number one reason for discontinuing the intake of medications prescribed for nasal allergies. Studies on glucocorticosteroids, allergen-specific immunotherapy and antihistamines highlighted the importance of patient education, demographic factors, duration of therapy, side-effects and treatment costs, as well as minor details, such as taste and odour, in improving compliance. SUMMARY: The variation in the methodologies used and the durations of treatments assessed in current compliance research in the field of allergic rhinoconjunctivitis decreases the comparability of results. Therefore, a clear definition of compliance measured in clinical trials with allergic rhinoconjunctivitis sufferers is needed. Moreover, a gold standard for measuring and reporting compliance should be determined to enable better interstudy comparability of the rates and determinants of compliance.

The economic impact of allergic rhinitis and current guidelines for treatment.

OBJECTIVE: To describe the economic burden of allergic rhinitis treatment and current guidelines for treatment. DATA SOURCES: Review articles and original research were retrieved from MEDLINE, OVID, PubMed (1950-November 2009), personal files of articles, and bibliographies of located articles that addressed the topic of interest. STUDY SELECTION: Articles were selected for their relevance to the burden of allergic rhinitis and current guidelines for treatment. Publications included reviews, treatment guidelines, and clinical studies. RESULTS: Despite the common symptoms of allergic rhinitis, its impact on patient quality of life, and the huge cost to society and individuals of treatment, including pharmacotherapy, many patients do not adhere to their medication regimens because the medications do not adequately address their symptoms or are otherwise problematic for them to use. CONCLUSIONS: The economic impact of allergic rhinitis is substantial; the total direct medical cost of allergic rhinitis is approximately $3.4 billion, with almost half of this cost attributable to prescription medications. Multiple treatment options are available, and these were reviewed to provide an update on effectiveness and adverse effects that may affect patient adherence.

Allergic rhinitis: Direct and indirect costs.

Allergic rhinitis is one of the most common conditions affecting both children and adults. Along with the burden of the disease and decrease in quality of life associated with allergic rhinitis, there are high costs related to the disorder. Costs due to allergic rhinitis can be divided into two categories: direct costs that are related to monies spent on the course of managing the disease and indirect costs that are due to missing work and decreased productivity due to the illness. There are also the costs associated with the comorbidities of allergic rhinitis, such as sinusitis and asthma, which are classified as "hidden" direct costs. Management of allergic rhinitis involves allergen avoidance, proper pharmacologic therapies, and allergen immunotherapy. These treatments add to the direct cost of the condition and need to be evaluated to determine their cost-effectiveness in the control of the patient's nasal allergies. This article reviews the latest data on cost issues in allergic rhinitis and information of cost-effectiveness of treatments for this condition.