House Dust Mite Allergen Extract
Treatment of allergic rhinitis caused by house dust mites in adults and adolescents above 12 years with moderate to severe symptoms inadequately controlled or intolerant to symptomatic treatments.
From the public summary
7.1 The PBAC did not recommend the listing of house dust mite American with house dust mite European (referred to by the trade name Actair®) on the PBS for allergic rhinitis due to house dust mites. In reaching this conclusion, the PBAC considered that the magnitude of clinical benefit was unclear, and the estimate of cost-effectiveness as presented in the submission was unknown.PSD · Jul 2016
7.2 The PBAC considered that the hearing and consumer input clarified that the appropriate and intended place in therapy for Actair® is as later line therapy in patients with persistent moderate to severe forms of allergic rhinitis due to house dust mites – that is, after patients have tried and failed to control symptoms using symptomatic drug treatments, followed by the addition of corticosteroids.PSD · Jul 2016
6.41 The submission presented a modelled cost-effectiveness analysis comparing Actair® with placebo for the treatment of patients with moderate to severe allergic rhinitis.PSD · Jul 2016
6.42 A summary of the model structure and rationale is presented in Table 8.PSD · Jul 2016
6.35 The submission described Actair® as superior in terms of comparative efficacy over placebo, with an acceptable safety profile. The ESC did not consider the claim to be well supported. There are no well-established MCIDs for the assessed outcomes, and the modest reductions achieved in symptom scores may not be clinically significant.PSD · Jul 2016
The ESC considered that these adverse events may encourage poor adherence to the treatment which could result in reduced relative effectiveness of Actair® (compared with patients who were being closely monitored in the trials). 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.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 existing immunotherapies put these products out of reach for many patients.PSD · Jul 2016
Cost-effectiveness
No ICER was calculated. The submission was based on a cost-effectiveness comparison with placebo, but the PSD does not report a numeric ICER value.
Decision context
PopulationAdults and adolescents above 12 years with moderate to severe allergic rhinitis due to house dust mites who have inadequate response or intolerance to antihistamines and nasal corticosteroids after 12 months of trial.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Not recommended | placebo | — | RCT · Symptom score |
Consumer voice
Allergy & Anaphylaxis Australia highlighted benefits of allergen immunotherapies in reducing burden of allergic rhinitis and improving quality of life, noted cost barriers to access, and emphasized advantages of sublingual tablet administration 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
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to moderate-to-severe symptoms with inadequate response to antihistamines and nasal corticosteroids after 12 months trial; TGA label includes all diagnosed patients regardless of severity or prior treatment.