Utility elicitation in adults and children for allergic rhinoconjunctivitis and associated health states.

PURPOSE: Allergic rhinitis and asthma symptoms are detrimental to health-related quality of life (HRQoL). Health technology appraisal agencies often require cost-utility analysis when assessing new interventions. Appropriate utility estimates, which quantify the value of different conditions in cost-utility analyses, are scarce for allergic rhinitis and asthma health states. This study aimed to generate utilities for allergic rhinitis and asthma health states from a European general population sample of adults and children. METHODS: Health state descriptions incorporating symptoms, impact of symptoms on daily life and symptom treatment were developed using clinical guidelines. Descriptions were amended with clinician and patient input, and incorporated into a survey in which each health state was followed by a standard gamble (adults) or visual analogue scale (children) item. The survey was distributed to samples of adults and children aged 8 to 11 from four European countries that were stratified to represent the general population within that country. RESULTS: 1454 adults and 1082 children completed the survey. Mean health utilities ranged from 0.635 to 0.880 and those elicited in children were lower (0.635 to 0.705) than those elicited in adults (0.812 to 0.880). Disutilities assessing the impact of increased allergic rhinitis severity and comorbidities were also greater in children than in adults. CONCLUSIONS: Symptoms of allergic rhinitis and asthma were valued as having a clinically meaningful impact on HRQoL. Children valued health states as poorer than adults, and further research should investigate whether this reflects true preferential differences or results from methodological and/or comprehension differences between the two groups.

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.

Allergic rhinoconjunctivitis in the Australian population: burden of disease and attitudes to intranasal corticosteroid treatment.

BACKGROUND: Allergic rhinoconjunctivitis (AR/C) is a global health problem causing significant morbidity and has a major impact on quality of life (QOL) and health expenditure. Despite the widespread prevalence, the overall health impact of AR/C may be underappreciated. The results of a survey designed to capture the burden of allergic rhinitis within the Asia-Pacific region have been published recently. Of particular note when evaluating treatment in this region was the fact that despite the value of intranasal corticosteroid (INCS) use, only a small percentage of patients used them. Whether this same trend is present within the population of Australian sufferers is unknown. This study examines the burden of AR/C and explores use of, and attitudes, to INCS sprays in the Australian population. METHODS: Three hundred three completed interviews from adults and children who had physician-diagnosed AR/C and who were symptomatic or had received treatment in the previous 12 months were analyzed for QOL measures and attitudes to INCS use. RESULTS: Most patients surveyed had received their diagnosis from a general practitioner (GP), and in most cases, a GP provided the majority of ongoing medical care. Only 8% of respondents had consulted a relevant specialist. Diagnostic tests had not been performed in 55% of respondents. The major symptoms causing most distress were nasal congestion and ocular symptoms. The burden of AR/C was considerable; 42% described significant work or school interference because of symptoms, one-third reporting moderate-to-extreme interference with sleep. Despite the significant impact on QOL reported by this sample, 17% had never used INCS and 27% had not used them in the previous 12 months. Respondents' knowledge about INCSs was poor. CONCLUSION: AR/C is a common disease associated with significant morbidity and impairment of QOL. Improvement in diagnosis, management, and patient education is needed.

Allergic rhinoconjunctivitis: burden of disease.

Even though there is no mortality associated with allergic rhinoconjunctivitis (AR), there is significant morbidity in sufferers of this condition. The exact number of patients with AR is difficult to ascertain, with studies showing ranges from 9 to 42% of the population. Recently, the Allergies in America survey found that 14.2% of the adult U.S. population has been diagnosed with AR. It is well established that AR has a profound influence on the patient's quality of life. Not only do people with AR complain of rhinorrhea, nasal congestion, sneezing, itching, and associated eye problems disturbing, but they also have impaired emotional wellbeing and social functioning. Costs are a major burden in AR studies showing at least $6 billion/year. Although most attention related to costs in AR have been evaluating direct costs due to physician consultation and medical treatment, it is now clear that indirect costs are a major aspect of total costs in AR, especially for American businesses. Indirect costs include absenteeism from work or school because of illness and decreased productivity when at work or presenteeism. AR should be treated seriously by the medical community. Proper treatment of AR patients should not only greatly improve their quality of life, but also bring down health care costs, especially indirect ones, associated with this condition.

Cost-effectiveness of GRAZAX for prevention of grass pollen induced rhinoconjunctivitis in Southern Europe.

BACKGROUND: Allergic rhinoconjunctivitis is a global health problem. Around 14 million people in Spain, France, Italy, and Austria suffer from grass pollen induced allergic rhinitis. Standard care only provides symptoms relief, while allergen specific immunotherapy (SIT) treats the underlying cause of the disease. Grazax from ALK-Abelló is a new, tablet-based, effective route of SIT for home treatment. The objective was to assess the cost-effectiveness of Grazax in four Southern European countries. METHODS: A prospective pharmacoeconomic analyses was carried out alongside a multinational, clinical trial measuring the efficacy of Grazax. Pooled data on resource use and health outcomes were collected. A societal perspective was adopted, and the analysis had a nine-year time horizon. The primary outcome measure was quality adjusted life years (QALYs). RESULTS: Grazax was superior to standard care for all efficacy endpoints, including QALYs gained, and resulted in significantly less use of rescue medication and fewer hours missed from work. Grazax was cost-effective for all countries for an annual price in the range of 1500 euros - 1900 euros. The result was improved by inclusion of future costs of asthma and exclusion of Spanish trial centers which experienced an exceptionally low pollen season. CONCLUSION: The analysis illustrates that allergen SIT with Grazax for grass pollen induced rhinoconjunctivitis is a cost-effective intervention in Southern Europe.

Cost-effectiveness of grass allergen tablet (GRAZAX) for the prevention of seasonal grass pollen induced rhinoconjunctivitis - a Northern European perspective.

BACKGROUND: The prevalence of allergic rhinoconjunctivitis has increased dramatically. Seventeen million people in the United Kingdom, Germany, the Netherlands, Sweden, Denmark, Norway and Finland suffer from grass pollen induced allergic rhinitis. Symptomatic therapy with antihistamines and topical steroids is partially effective but allergen-specific immunotherapy by injection or sublingual routes is superior. The grass allergen tablet (GRAZAX) is a new allergen-specific immunotherapy for home administration. OBJECTIVE: To assess the cost-effectiveness of the grass allergen tablet compared with symptomatic medication in seven Northern European countries. METHODS: A prospective pharmacoeconomic analysis was carried out alongside a multinational clinical trial. Pooled data on resource use and health outcomes were collected. A societal perspective was adopted, and the analysis had a 9-year time horizon. The outcome measure was Quality Adjusted Life Years (QALYs). RESULTS: The grass allergen tablet was clinically superior to symptomatic treatment, producing statistically significant differences for all efficacy end-points, including the number of QALYs gained - 0.976 vs. 0.947 QALYs gained. There was a significantly higher usage of the rescue medications loratadine and budesonide, and more hours missed from work (production loss), in the symptomatic treatment group. The cost per QALY gained in the grass allergen tablet group was similar in the seven countries (euro 12,930 to euro 18,263 for an annual cost of the grass allergen tablet of euro 1500). The analysis showed that the grass allergen tablet was cost-effective for all countries for an annual treatment cost below euro 2200. CONCLUSION: The pharmacoeconomic analysis illustrated that allergen-specific immunotherapy with the grass allergen tablet is a cost-effective intervention for the prevention of grass pollen induced rhinoconjunctivitis in Northern European countries, for a tablet price below euro 6. In Germany for example the price of the tablet is euro 2.95 corresponding to a yearly treatment cost of euro 358 - based on a 9-year time horizon.

Health economic impact of olopatadine compared to branded and generic sodium cromoglycate in the treatment of seasonal allergic conjunctivitis in the UK.

OBJECTIVE: This study estimated the health economic impact of olopatadine (Opatanol) compared to branded cromoglycate (Opticrom) and generic sodium cromoglycate in the treatment of seasonal allergic conjunctivitis (SAC) in the UK. DESIGN AND SETTING: This was a modelling study performed from the perspective of the UK's National Health Service (NHS). METHODS: A decision model was constructed depicting the management of SAC sufferers who are 4 years of age or above over a typical allergy season of 4 months and considers the decision by a GP to initially treat a patient with olopatadine, branded or generic cromoglycate. The analysis assumed both drugs to be equally effective. Consequently, a cost-minimisation analysis was performed to identify the least costly alternative. MAIN OUTCOME MEASURES AND RESULTS: Starting treatment with olopatadine is expected to lead to a healthcare cost of 92 pounds sterling (95% CI: 46 pounds sterling; 150 pounds sterling) over 4 months compared to 109 pounds sterling (95% CI: 65 pounds sterling; 166 pounds sterling) with branded cromoglycate and 95 pounds sterling (95% CI: 51 pounds sterling; 152 pounds sterling) with generic cromoglycate, resulting in a 16% and 3% reduction in healthcare costs respectively over 4 months of treatment. This cost-difference is primarily due to fewer GP visits among olopatadine-treated patients. CONCLUSION: Use of olopatadine instead of branded or generic cromoglycate affords an economic benefit to the NHS. Hence, within the limitations of the model, olopatadine is the preferred first-line treatment for use in SAC sufferers, since it is expected to lead to fewer GP visits, thereby releasing healthcare resources for alternative use.

Pharmacotherapy of allergic eye disease.

Allergic eye disease is a term that refers to a number of disease processes that affect about one-fifth of the world's population. Although the more advanced forms of the disease can be sight threatening, the most disabling effects are due to the clinical manifestations, and hence quality of life, with some patients having seasonal exacerbations of their symptoms, whereas others have symptoms that are present throughout the year. Recent increased understanding of the cellular and mediator mechanisms that are involved in the various disease manifestations has greatly facilitated the development of more effective treatment options. Newer topical medications are being used that have multiple actions, such as an antihistaminic effect coupled with mast-cell stabilisation, and which require reduced daily dosing due to their longer duration of action. With greater research into newer therapies and more effective modes of delivery, improved healthcare outcomes with a lower economic burden will be achieved for patients with allergic eye disease.

The economic and quality of life impact of seasonal allergic conjunctivitis in a Spanish setting.

INTRODUCTION: Seasonal allergic conjunctivitis (SAC) is a highly prevalent condition that exacts a range of costs from its sufferers. The aim of this study was to examine quality of life (QoL) and economic consequences of SAC amongst private health care patients in Spain. METHODS: 201 sufferers of SAC and 200 controls were recruited from four private eye clinics and one public hospital in five Spanish cities: Alicante, Madrid, Albacete, Las Palmas de Gran Canarias and Valladolid. Participants were between 10 and 80 years of age and Spanish speaking. All potential participants were asked selected questions and sorted into one of the two groups or excluded. Sufferers were administered a set of four questionnaires by researchers consisting of the EQ-5D Health Questionnaire, the National Eye Institute (US) Visual Functioning Questionnaire 25 (VFQ-25), the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and a Health Economic and Demographic Questionnaire (HEDQ). Control participants self-administered the full EQ-5D and VFQ-25 and abbreviated versions of the RQLQ and HEDQ. RESULTS: The groups were comparable in terms of age and sex, but sufferers had a significantly higher hourly income than controls (p = 0.02). Sufferers exhibited a significantly higher incidence of asthma, nasal symptoms, perennial allergic conjunctivitis, food allergies and other allergies (p < 0.01 for all comorbidities). Sufferers returned significantly lower quality of life scores than controls in all EQ-5D domains other than mobility (p = 0.14). SAC VFQ-25 scores were significantly less than in controls in the overall vision (p < 0.01), distance vision (p < 0.01), ocular pain (p < 0.01), mental health (p = 0.01), role limitations (p < 0.01), and dependency (p = 0.01) domains. Mean scores for the activity domain of the RQLQ were greater in the sufferer group than the control group (P < 0.01) . The total mean per-sufferer cost of SAC amongst our sample of private patients was 348.50 Euros. DISCUSSION: Sufferers experienced QoL reductions in general health and specific aspects of vision as a result of their SAC. In relative terms, the per-capita economic cost of the condition was higher than in a previous public health care study. This was ascribed to sufferers' willingness-to-pay for symptom alleviation. The unexpectedly high expenditure of the proportion of SAC sufferers who receive private health care serves to highlight the importance of SAC as a costly condition. It also illustrates the need to account for both private and public heath care modalities when attempting to ascribe a total cost to a medical condition.

The burden of atopy and asthma in children.

BACKGROUND: There has been a world-wide increase in the prevalence of atopic diseases. These atopic diseases, including asthma, allergic rhinoconjunctivitis and atopic eczema/dermatitis, are common in childhood and create a challenge of management for physicians and parents. METHODS: MEDLINE was searched for articles related to atopy, allergy asthma, allergic rhinoconjunctivitis and atopic eczema/dermatitis. RESULTS AND CONCLUSIONS: The conditions of asthma, allergic rhinoconjunctivitis and atopic eczema/dermatitis cause very significant burdens regarding the discomfort to the affected individual, management problems for the parent and physician and the economic cost to the family and the nation.

Economic and quality-of-life impact of seasonal allergic conjunctivitis in Oxfordshire.

PURPOSE: The purpose of this study was to examine the economic and quality-of-life (QoL) impact of seasonal allergic conjunctivitis (SAC) from the individual patient perspective. SETTING: The study population was drawn from the general public of Oxfordshire, England. METHODS: Participants were recruited from either general practices or the casualty department of the Oxford Eye Hospital (OEH). All persons who were between 16 and 80 years of age and English speaking were eligible for enrollment in the study. The inclusion criteria for cases was that participants: 1) experienced itchy, bloodshot and watering eyes at some time between February and August every year since 1999, and 2) considered it likely that this was in response to seasonal allergens. Controls were drawn from the same sources and were age- and sex-matched to cases. Participants completed the EQ-5D Health Questionnaire, the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), the National Eye Institute (U.S.) Visual Functioning Questionnaire 25 (VFQ-25), and a specially developed Health Economic and Demographic Questionnaire. RESULTS: Most participants in both groups were female (67.5% in the SAC and 70% in the control group, P=0.565). Weekly earnings were lower in the SAC group (P<0.001), as the SAC group also worked fewer hours per week (P<0.001). Participants with SAC also experienced a greater degree of pain and discomfort as measured by the EQ-5D (P=0.018) and a lower perception of health using the EQ-VAS (P=0.039). Statistically significant differences between both groups were detected in all domains of the VFQ-25, except general and colour vision, although the differences were thought to be clinically significant only for the ocular pain domain. The RQLQ scores were also all found to differ significantly between groups (P<0.001). The total of both the public health care and private out-of-pocket costs of SAC in our study population ranged on average between pound sterling 64.61 for a pensioner to pound sterling 123.69 for a person with SAC in paid employment. CONCLUSIONS: SAC is a costly, highly prevalent, chronic condition associated with significant reductions in both ocular and general quality of life, as well as ongoing out-of-pocket expenses and health care costs. Medications that reduce this demand on health care systems and out-of-pocket expenses by patients could be of potential importance in reducing the overall economic and health burden of illness posed by SAC.

Daily cost of ophthalmic solutions used to treat allergic conjunctivitis in Japan.

PURPOSE: To estimate the daily cost of various ophthalmic solutions used in Japan for treating allergic conjunctivitis, including nine anti-allergic drugs and six anti-inflammatory drugs. METHODS: The drops contained in one bottle of each solution were counted. The cost per drop was calculated by dividing the government-controlled standard prices by the total number of drops in one bottle, and the daily cost of therapy was calculated by multiplying the cost per drop by the number of drops to be given per day. RESULTS: The total number of drops of the anti-allergic drugs in a bottle ranged from 108 to 169 and that of the anti-inflammatory drugs from 100 to 145. The information in the package insert for these solutions recommends application 2-4 times daily. The price of the antiallergic drugs studied ranged from $6.35 to $8.38 and that of the anti-inflammatory drugs studied from $2.02 to $5.20. The daily cost of the anti-allergic drugs studied varied considerably, from $0.26 to $0.57; for the anti-inflammatory drugs the range was from $0.12 to $0.20. Variations in the total number of drops per bottle and in the recommended dosage affect the daily cost of ophthalmic solutions. CONCLUSIONS: At current prices, the volume of a drop and the dosage had a greater effect on the daily cost than the price of a bottle. Daily cost data may be helpful in selecting ophthalmic products for treating allergic conjunctivitis in settings where the prices of a given drug are relatively uniform.

Direct expenditures for the treatment of allergic rhinoconjunctivitis in 1996, including the contributions of related airway illnesses.

BACKGROUND: Previous estimates of the national economic burden of allergic rhinoconjunctivitis (AR/AC) have relied on data analyses in which AR/AC was the primary International Classification of Diseases-ninth revision-Clinical Modification (ICD-9-CM)-coded diagnosis. These studies ignore the costs when AR/AC was a secondary diagnosis to other disorders such as asthma and sinusitis. OBJECTIVE: We sought to determine the national direct cost of illness for AR/AC. METHODS: An expert panel used the Delphi technique to estimate the proportion of visits coded by other primary ICD-9-CM diagnoses in which AR/AC was a significant secondary comorbid condition. The costs of this proportion were deemed to be "attributable" to AR/AC and were added to the costs when allergic rhinitis and allergic conjunctivitis were the primary diagnoses. RESULTS: The cost when AR/AC was the primary diagnosis was $1.9 billion (in 1996 dollars). The cost when AR/AC was a secondary diagnosis was estimated at $4.0 billion, giving an estimate of $5.9 billion for the overall direct medical expenditures attributable to AR/AC. Outpatient services (63%, $3.7 billion), medications (25%, $1.5 billion), and inpatient services (12%, $0.7 billion) accounted for the expenditures. Children 12 years and younger accounted for $2.3 billion (38.0%). CONCLUSION: Upper airway allergy is an expensive disease process because of its readily apparent manifestations as AR/AC and its contribution to other airway disorders.