Post-market Review of Chronic Obstructive Pulmonary Disease (COPD) Medicines

Page last updated: 29 May 2017

Background

COPD is characterised by a chronic inflammation of the lung tissue, and obstruction of the airways that cannot be fully reversed by medication.  Air flow obstruction leads to symptoms such as wheezing, shortness of breath, chest tightness, coughing, and production of excess mucus. Symptoms can be exacerbated by irritants such as infection or exposure to noxious particles or gases, most commonly cigarette smoke.

A number of medicines are available to reduce the symptoms of COPD, and to reduce the frequency and severity of exacerbations.  The primary medicines are bronchodilators (beta2-agonists, anti-cholinergics/muscarinic agonists, phosphodiesterase inhibitors and methylxanthines) to reduce airway obstructions, and inhaled corticosteroids to reduce inflammation.

In October 2013, the Drug Utilisation Sub-Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee (PBAC) reviewed the Pharmaceutical Benefits Scheme (PBS) utilisation of indacaterol and budesonide/efomoterol for COPD.  The review of indacaterol utilisation identified co-administration of multiple long-acting beta agonist (LABA) products in some patients, which was considered a significant quality use of medicines issue.

The review of budesonide/eformoterol found a trend towards higher initiations in winter which the DUSC considered may indicate use for the treatment of respiratory tract infections or cough, a quality use of medicines issue. The relevant DUSC meeting outcome statement is available below:

 In July 2014, when considering the submissions for indacaterol/glycopyrronium and umeclidinium/vilanterol the PBAC noted that while forced expiratory volume in 1 second (FEV1) has previously been accepted as a surrogate outcome in the treatment of COPD, the PBAC were concerned that this may not translate into clinically meaningful benefits to patients. These submissions did not provide evidence of reductions in exacerbations or hospitalisations, outcomes that the PBAC considered could also be used to demonstrate effectiveness. The PBAC further noted concerns by the DUSC that the introduction of these fixed dose combinations may lead to patients being initiated on the combination product earlier than clinically appropriate and without adequate titration of the individual components. Further information is available in the PBAC Public Summary Documents for July 2014 for these medicines.

In August 2015, the PBAC recommended a Post-market Review of COPD Medicines, noting that a number of new combinations, including long-acting muscarinic antagonist (LAMA)/LABA and LABA/inhaled corticosteroid (ICS) combinations, have been listed recently on the PBS and that there was concern about use of multiple products.

The purpose of the Post-market Review of COPD Medicines is to review the utilisation, safety, efficacy and cost-effectiveness of PBS listed COPD medicines, and to address quality use of medicines concerns associated with the apparent use of multiple products.  This Review was approved by the Minister for Health on 28 September 2015.

The Review is being carried out under the Australian Government’s post-market monitoring programme, which aims to ensure the continued safe, cost-effective and quality use of medicines listed on the PBS.

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
    • Theophylline.

Consultation on Draft Terms of Reference (closed)

Public consultation on the draft Review Terms of Reference was open between 16 October and 13 November 2015.  To view submissions please go to the Public Consultation page.

Final Terms of Reference

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.

Public Submissions addressing the final Terms of Reference (closed)

Public consultation addressing the final Review Terms of Reference was open between 4 March and 22 April 2016. To view submissions please go to the Public Consultation page.

Stakeholder Forum

A Stakeholder Forum was held in Sydney on 21 March 2017. Pharmaceutical sponsors of COPD medicines listed on the PBS, representatives of peak bodies, consumer organisations, and individuals who provided a submission to the Review were invited to participate. The Stakeholder Forum Summary is provided below:

Public Consultation on Draft Report

The draft COPD Review Report is available below for public comment until 13 June 2017. Please provide any comments by email to the COPD Review Secretariat. Please note that comments are limited to six pages. Some commercial-in-confidence data has been redacted from the draft Report.

The draft Report is provided in seven parts, in DOCX or PDF format, in the table below:

Accessibility

The documents on this page may not be accessible. If you need assistance please email the COPD Review Secretariat.

Draft COPD Review Report

Part Number

Title

Word version

PDF version

1

Executive Summary

Part 1 (Word 264KB)

Part 1 (PDF 398KB)

2

Background and ToR 1

Part 2 (Word 275KB)

Part 2 (PDF 964KB)

3

ToR 2

Part 3 (Word 139KB)

Part 3 (PDF 519KB)

4

ToR 3

Part 4 (Word 839KB)

Part 4 (PDF 1.6MB)

5

ToR 4

Part 5 (Word 2.6MB)

Part 5 (PDF 2.5MB)

6

ToR 5

Part 6 (Word 739KB)

Part 6 (PDF 1.5MB)

7

ToR 6

Part 7 (Word 71KB)

Part 7 (PDF 179KB)

The appendices for the draft Report are available on request to the COPD Review Secretariat.

Review Process

This Review will follow the Post-market Review Framework available on the Reviews website. This process includes public consultation on the draft Terms of Reference, an opportunity to provide submissions to the Review, and an opportunity to comment on the draft Review Report.

Further Information

Further information on post-market reviews is available on the Reviews website.

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