Salbutamol SulfateAsmol CFC-Free

Cost comparison analysis presented (three scenarios with cost-savings reported), but no formal ICER calculated. Analysis based on assumption of equivalent clinical effectiveness.

Populationpatients who are unable to achieve coordinated use of other metered dose inhalers containing salbutamol or patients at risk of an acute asthma episode

• Uncertain clinical benefit (Space Chamber not used in clinical trials; small trial with 18 subjects not powered for non-inferiority; Cochrane review relates to acute asthma not chronic asthma; no safety data specific to Space Chamber), uncertain cost-effectiveness (cost-saving claim unlikely to eventuate in practice; patients achieving desired health outcome with autohaler unlikely to switch; restrictive prescribing assumptions unrealistic), uncertain utilisation, policy concerns regarding PBS mechanism for spacer subsidy, brand-specific restriction issues, lack of evidence of clinical need for PBS subsidy, failure to demonstrate health benefit to patients or society

Label narrower than PBS population — PBAC restricts to patients unable to coordinate MDI use or at risk of acute asthma; TGA label covers all asthma/COPD bronchospasm relief.