The post-market review of COPD medicines recommended by the PBAC in August is now open for public comment.

The review was given the green light following concerns about the multiple use of a number of new combinations available on the PBS, including long-acting muscarinic antagonist (LAMA)/LABA and LABA/inhaled corticosteroid (ICS) combinations.

The terms of reference for the review are:

1. Compare the prescribing restrictions for PBS-listed COPD medicines for consistency with the current clinical guidelines.
2. Review the clinical outcomes that are most important or clinically relevant to people with COPD and the extent to which these outcomes are included in the evidence previously provided to PBAC on the cost-effectiveness of these medicines.
3. Review the published literature on the efficacy and safety of monotherapy and combinations of LABA/LAMA, ICS/LABA and LAMA + ICS/LABA (separate items or fixed dose combinations) for treatment of COPD that PBAC has not previously considered.
4. Review the published literature on the safety of prolonged (> 6 weeks) ICS use for COPD that PBAC has not previously considered.
5. Analyse the current utilisation of PBS listed COPD medicines to identify the extent of co-prescribing and use that is inconsistent with clinical guidelines and/or PBS restrictions. Evaluate if the current utilisation of multiple therapies and the latest evidence relating to safety and efficacy justifies a review of cost-effectiveness for some or all medicines indicated for COPD.

Public consultation on the draft Review Terms of Reference will be open between 16 October 2015 and 30 October 2015.