Economic Evaluation of 5-Grass Pollen Tablets Versus Placebo in the Treatment of Allergic Rhinitis in Adults

Ruggeri, Matteo; Oradei, Marco; Frati, Franco; Panina-Bordignon, Paola; Romão, Cristina; Dell’Albani, Ilaria; Incorvaia, Cristoforo; Cicchetti, Americo

doi:10.1007/s40261-013-0067-z

Cited by 22 publications

(20 citation statements)

References 19 publications

(26 reference statements)

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“…A clinically significant improvement was a gain of ‡1.45 points in the AAdSS. In comparison to placebo, results indicate that OA is a cost-effective treatment option for adults with AR and a medium or high AAdSS, providing a benefit of 0.127 or 0.143 QALYs, respectively, with corresponding costs of e1024 and e1035 per QALY [67]. These findings may have important implications when deciding on the most appropriate management strategy for patients with AR who manifest moderate-to-severe symptoms.…”

Section: Health Economics Profilementioning

confidence: 91%

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Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience

Didier

Wahn

Horak

et al. 2014

Expert Review of Clinical Immunology

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OralairÒ (OA) (Stallergenes, Antony, France) is a unique pre-and co-seasonal 5-grass-pollen sublingual immunotherapy tablet launched in 2008, and now approved in 31 countries worldwide for the treatment of grass-pollen allergic rhinitis and rhinoconjunctivitis. OA is the first oral treatment with a consistent, well-balanced allergen extract that mimics natural exposure and sensitization. A wealth of data exists from over 5 years of clinical and realworld experience demonstrating the efficacy and safety of OA for grass-pollen-allergy treatment. OA is highly effective from the first pollen season in all patient subgroups, including children and those with comorbid mild asthma, irrespective of sensitization status and symptom severity. OA also has sustained long-term benefits for symptom control and quality of life. This article provides an overview of the pharmacodynamics and pharmacology of OA; its efficacy, safety, tolerability and cost-effectiveness for the treatment of allergic rhinitis and rhinoconjunctivitis and its role in clinical practice. Allergic rhinitis (AR) is a common chronic inflammatory illness, characterized by rhinorrhea, nasal congestion, sneezing, nasal and ocular pruritis and watery eyes [1]. Inhalation of allergens by sensitized individuals triggers the IgE-mediated release of inflammatory mediators and cytokines, leading to a rapid appearance of symptoms [2]. AR has historically been classified as 'seasonal' or 'perennial' depending on whether symptoms occur with seasonal exposure to aeroallergens or are present throughout the year. Seasonal AR is most commonly attributed to plant pollen and other outdoor allergens, while perennial AR is associated with indoor allergens, such as dust mites, mold, cockroaches and pet dander, although it can also be associated with pollen in areas where this is prevalent year-round [3,4].In 2001, the WHO-sponsored Allergic Rhinitis and its Impact on Asthma meeting produced guidelines proposing an alternative classification of the condition into 'intermittent' or 'persistent' AR, and grading symptoms as 'mild' or 'moderate/severe' [5]. Globally, the prevalence of seasonal ('hay fever') and perennial AR ranges from 7 to 42 and 1 to 13%, respectively, with the former being more common in children than adults [6]. The length of exposure to seasonal allergens is dependent on geographic location and climatic conditions [4]; in Europe, the main pollen season typically occurs from March to July, with slight variations according to latitude [7].Approximately 500 million people worldwide [6], including an estimated 30-60 million in the USA [4] 1309Drug Profile suffer from AR, and its prevalence is increasing in most countries [2]. It is estimated that from 10 to 30% of adults and up to 40% of the pediatric population have AR [3,9]. While AR does not directly lead to mortality, it places a considerable burden on affected individuals, who often have a reduced quality of life (QoL), compared with non-sufferers [10]. The physical symptoms of AR can cause sleep disturbance...

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Section: Health Economics Profilementioning

confidence: 91%

“…A post hoc analysis of data from the VO34.04 and VO53.06 clinical trials used the AAdSS to compare AR treatment with OA versus placebo, and its cost-effectiveness [67]. A clinically significant improvement was a gain of ‡1.45 points in the AAdSS.…”

Section: Health Economics Profilementioning

confidence: 99%

Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience

Didier

Wahn

Horak

et al. 2014

Expert Review of Clinical Immunology

View full text Add to dashboard Cite

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“…Studies show the economic benefit in the use of AIT [93][94][95]. Hankin et al did a retrospective [1997][1998][1999][2000][2001][2002][2003][2004][2005][2006][2007][2008][2009] Florida Medicaid claims analysis comparing mean 18-month health care costs of adult and pediatric patients with newly diagnosed AR who received de novo SCIT and were continuously enrolled for 18 months or more versus matched control subjects not receiving SCIT [96].…”

Section: Most Important: What Does the Patient Prefer!mentioning

confidence: 99%

Selection of Patients for Sublingual Versus Subcutaneous Immunotherapy

Larenas‐Linnemann

Blaiss

2014

Immunotherapy

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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.

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“…It was concluded that Oralair™ was a cost‐effective and cost‐saving alternative to Grazax™ and SCIT in Germany . However in a study conducted in Italy, Oralair™ was found to be cost ineffective in patients with mild allergic rhinitis .…”

Section: Discussionmentioning

confidence: 99%

Sublingual or subcutaneous immunotherapy for seasonal allergic rhinitis: an indirect analysis of efficacy, safety and cost

Dranitsaris

Ellis

2014

Evaluation Clinical Practice

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Rationale, aims and objectives The standard of preventive care for poorly controlled seasonal allergic rhinitis (AR) is subcutaneous immunotherapy (SCIT) with allergen extracts, administered in a physician's office. As an alternative to SCIT, sublingual immunotherapy (SLIT) is now an option for patients with seasonal AR. Oralair™, a SLIT tablet containing freeze-dried allergen extracts of five grasses [cocksfoot (Dactylis glomerata), meadow grass (Poa pratensis), rye grass (Lolium perenne), sweet vernal grass (Anthoxanthum odoratum) and timothy grass (Phleum pratense)], and Grazax™, a SLIT tablet containing a standardized extract of grass pollen allergen from timothy grass (P pratenase), are two such agents currently available in many countries. However, headto-head comparative data are not available. In this study, an indirect comparison on efficacy, safety and cost was undertaken between Oralair™, Grazax™ and SCIT. Methods A systematic review was conducted for double-blind placebo-controlled randomized trials evaluating Oralair™, Grazax™ or SCIT in patients with grass-induced seasonal AR. Using placebo as the common control, an indirect statistical comparison between treatments was performed using meta regression analysis with active drug as the primary independent variable. An economic analysis, which included both direct and indirect costs for the Canadian setting, was also undertaken. Results Overall, 20 placebo-controlled trials met the study inclusion criteria. The indirect analysis suggested improved efficacy with Oralair™ over SCIT [standardized mean difference (SMD) in AR symptom control = −0.21; P = 0.007] and Grazax™ (SMD = −0.18; P = 0.018). In addition, there were no significant differences in the risk of discontinuation due to adverse events between therapies. Oralair™ was associated with cost savings against year-round SCIT ($2471), seasonal SCIT ($948) and Grazax™ ($1168) during the first year of therapy. Conclusions Oralair™ has at least non-inferior efficacy and comparable safety against SCIT and Grazax™ at a lower annual cost.

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Economic Evaluation of 5-Grass Pollen Tablets Versus Placebo in the Treatment of Allergic Rhinitis in Adults

Cited by 22 publications

References 19 publications

Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience

Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience

Selection of Patients for Sublingual Versus Subcutaneous Immunotherapy

Sublingual or subcutaneous immunotherapy for seasonal allergic rhinitis: an indirect analysis of efficacy, safety and cost

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