Dactylis Glomerata With Poa Pratensis, Lolium Perenne, Anthoxanthum Odoratum And Phleum Pratense
Treatment of moderate to severe allergic rhinitis/rhinoconjunctivitis caused by grass pollen in adults, adolescents and children above the age of five years who have inadequate response to standard medical management (antihistamines and nasal corticosteroids).
From the public summary
6.40 The submission presented a modelled cost-effectiveness analysis comparing Oralair® with placebo for the treatment of patients with moderate to severe allergic rhinoconjunctivitis.PSD · Jul 2016
6.41 A summary of the model structure and rationale is presented in Table 9.PSD · Jul 2016
6.35 The submission described Oralair® as superior to placebo in terms of efficacy, with an acceptable safety profile. The ESC considered that the efficacy claim may be reasonable in terms of symptom reduction, however the magnitude of the change associated with treatment with Oralair® over placebo was small overall.PSD · Jul 2016
The pre-PBAC response argued that these reactions “typically occur shortly after the first dose is taken, mainly during the first month of treatment, and are generally transient in nature. Patients who can tolerate Oralair® during the first month are unlikely to experience further adverse reactions and are likely to comply with ongoing treatment.”PSD · Jul 2016
6.4 The PBAC noted and welcomed the input from Allergy & Anaphylaxis Australia (A&AA). The comments described a range of benefits of treatment with allergen immunotherapies including the lessening of the overall burden allergic rhinitis on the patient including the impact on their quality of life. The comments noted the cost of Oralair® and other immunotherapies put these products out of reach for many patients.PSD · Jul 2016
Cost-effectiveness
No ICER explicitly stated in the document. The submission was compared to placebo on a cost-effectiveness basis, but no numeric ICER value is provided in the public summary.
Decision context
PopulationAdults, adolescents and children above the age of five years with moderate to severe grass pollen allergic rhinitis/rhinoconjunctivitis, confirmed by positive cutaneous test and/or positive titre of specific IgE to grass pollens (Meadow, Cocksfoot, Rye, Sweet vernal or Timothy), with inadequate response after antihistamines and nasal corticosteroids trialled for one pollen season.
Why it was knocked back
- geographic limitation to temperate southern Australian grasses with limited effectiveness in tropical/subtropical regions; restriction wording concerns (overly generalised symptoms, lack of minimum reaction/titre specification, ambiguous timeframe for prior treatment trial, potential for off-season initiation); potential for off-label use earlier in treatment algorithm despite positioning as last-line therapy; no direct comparison with likely clinical alternatives (subcutaneous immunotherapies, symptomatic treatments); clinical benefit assessment methodology unclear in routine practice; concerns about disease-modifying claims and appropriate duration of treatment
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Not recommended | placebo | — | RCT · Symptom reduction / allergic rhinitis control |
Consumer voice
Allergy & Anaphylaxis Australia highlighted the benefits of allergen immunotherapies in reducing allergic rhinitis burden and improving quality of life, while noting that cost barriers and grass pollen ubiquity limit access and management, and emphasized the convenience advantage of sublingual tablets over injections.
The comments described a range of benefits of treatment with allergen immunotherapies including the lessening of the overall burden allergic rhinitis on the patient including the impact on their quality of life. Consumer comments · PSD