The final terms of reference for the post-market review of COPD medicines is now open for public comment.

The PBAC considered the draft Review Terms of Reference and comments from stakeholders at the December 2015 PBAC meeting.

Following the December 2015 PBAC meeting the Minister for Health approved the final Terms of Reference for the Review:

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 evidence 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 ICS use in monotherapy and in combination with LABA and/or LAMA 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.
6. 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.

Medicines to be included in the COPD Review are:

• Medicines listed on the PBS for the treatment of COPD only:
  • Aclidinium
  • Glycopyrronium
  • Indacaterol
  • Indacaterol + Glycopyrronium
  • Tiotropium
  • Umeclidinium
  • Umeclidinium + Vilanterol
• Medicines listed on the PBS for the treatment of COPD and asthma:
  • Beclomethasone
  • Budesonide
  • Budesonide + Eformoterol
  • Ciclesonide
  • Eformoterol
  • Fluticasone
  • Fluticasone + Eformoterol
  • Fluticasone + Salmeterol
  • Fluticasone + Vilanterol
  • Ipratropium
  • Prednisone
  • Salmeterol
  • Salbutamol
  • Terbutaline

To make a submission visit the Public Consultation page.