Dactylis glomerata with poa pratensis, lolium perenne, anthoxanthum odoratum and phleum pratense
Brand: Oralair®
PBAC's latest decision on Dactylis glomerata with poa pratensis, lolium perenne, anthoxanthum odoratum and phleum pratense: Not recommended (2016). Considered for 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).
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Adults, 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.
Therapy area
Immunology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Symptom reduction / allergic rhinitis control
Key trials
VO34.04, VO52.06, VO53.06, VO61.08
Comparator
placebo
Economic model
CUA
ICER note
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.
Why PBAC said no
Reasons cited in the latest PSD: 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