PBAC's latest decision on Salbutamol sulfate: Not recommended (2010). Considered for patients who are unable to achieve coordinated use of other metered dose inhalers containing salbutamol or patients at risk of an acute asthma episode.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2010
Submissions
1
2010 → 2010
Eligible population
patients who are unable to achieve coordinated use of other metered dose inhalers containing salbutamol or patients at risk of an acute asthma episode
Therapy area
Respiratory
Evidence base
RCT, Cost-minimisation
Key trials
Giannini (2000), Cates (2006)
Comparator
Airomir Autohaler (breath-actuated device) and salbutamol nebules/nebuliser solution
Economic model
Cost-minimisation
ICER note
Cost comparison analysis presented (three scenarios with cost-savings reported), but no formal ICER calculated. Analysis based on assumption of equivalent clinical effectiveness.
Why PBAC said no
Reasons cited in the latest PSD: 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