Montelukast SodiumAPX-MONTELUKAST
Prevention of exercise-induced asthma, as an alternative to adding salmeterol xinafoate or eformeterol fumarate in children aged 6 to 14 years whose asthma is otherwise well controlled while receiving optimal dose inhaled corticosteroid, but who require short-acting beta-2 agonist use 3 or more times per week for prevention or relief of residual exercise-related symptoms.
Decisions on record
- Meeting Jul 2009 Recommended Asthma
- Meeting Dec 2001 Recommended Asthma treatment no PSD
Access path
- TGA registered · APX-MONTELUKAST
TGA label narrower than the PBS population
- Jul 2009Recommended · restricted
vs salmeterol xinafoate and eformoterol fumarate (long-acting…
- PBS listing · Authority Required (STREAMLINED)
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated
Decision context
Populationchildren aged 6 to 14 years with frequent intermittent or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2009 | Recommended · restricted | salmeterol xinafoate and eformoterol fumarate (long-acting beta-agonists) | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other (FEV1) |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to exercise-induced asthma prevention in children aged 6–14 years with specific controller inadequacy; TGA label covers broader chronic asthma prophylaxis and treatment in children over 2 years.