Post-market Review of Authority Required PBS Listings
Page last updated: 29 April 2016
Background
Under the Australian Government’s National Medicines Policy framework, the Department of Health has conducted a Post-market Review of Authority Required PBS Listings. The objective of the Review is to improve patient safety and care by reducing red tape and administrative burden for health professionals.
The need for a review of the PBS Authority System was identified in the Review of Chemotherapy Funding Arrangements, where it was found that Authority Required listings caused significant regulatory burden to prescribing medical oncologists. As part of the announcement of the outcomes of the Chemotherapy Review on 30 November 2013, the Prime Minister announced the Government’s intention to review the Authority Required PBS Listings.
This Review built on the Pharmaceutical Benefits Advisory Committee’s (PBAC) consideration of a submission from the Australian Medical Association (AMA) that recommended the movement of a number of medicines from Authority Required to Authority Required (Streamlined). The PBAC agreed that there was merit to a review of Authority Required listings and built on the AMA’s proposal by recommending that all Authority Required listings be reviewed. This would ensure that restrictions appropriately reflect the level of monitoring required to manage the quality use of medicines and the identified risks.
Scope of the Review
This Review considered criteria to determine Authority Required listings, and reviewed all Authority Required listings, with the objective of reducing the administrative burden on prescribers and dispensers of PBS listed medicines.
The Review was undertaken in three tranches. Authority Required medicines resulting in the greatest regulatory burden were considered first. This is defined as those medicines representing the greatest number of phone authority requests, or with the most complex written access forms.
- Tranche 1: The PBS listings with the highest regulatory burden include drugs for the treatment of many types of cancer, multiple sclerosis, rheumatoid arthritis and other arthritis medicines. These were considered by the PBAC at a December 2014 special meeting.
- Tranche 2: Treatments for eye conditions, psychiatric conditions and cardiovascular disease were considered by the PBAC at the March 2015 meeting.
- Tranche 3: All remaining Authority Required medicines not covered in the first two tranches, as well as medicines used in palliative care, were considered by the PBAC at the July 2015 meeting.
A full list of the Authority Required medicines considered as part of this Review is available below, broken into the three tranches as considered by the PBAC:
In addition to the three tranches of Authority Required medicines, the PBAC also considered:
- antibiotic and opioid PBS listings at the August 2015 Special meeting and
- select dermatological PBS listings at the December 2015 Special meeting.
Next steps
Implementation of PBAC recommendations made under the Review is occurring via a stepwise process. Some PBAC recommendations will take longer to implement due to the time required to implement IT system changes.
To date, deregulatory savings of approximately $2.3 million have been reported. Further deregulatory savings will be reported as recommended changes to the restriction level of PBS listed medicines are implemented.
The Review Report is to be finalised and provided to Government. Once the Minister for Health has given approval for publication, the Review Report and the PBAC Minutes will be published on this web page.
The Department appreciates the valuable contributions made by organisations and individuals who provided submissions or comments during this Review.
Terms of Reference
The PBAC considered the draft Terms of Reference and comments from stakeholders at
the July 2014 PBAC meeting.
Following the July 2014 PBAC meeting the Minister for Health approved the final Terms
of Reference for the Review.
- Review the criteria used by the PBAC to determine if a medicine should be recommended as Authority Required or Authority Required (Streamlined) on the PBS including the advantages and disadvantages of an Authority Required or Authority Required (Streamlined) listing.
- Systematically review the current Authority Required listings according to the proposed criteria to ensure this is applied consistently to all PBS Authority listed medicines.
- Use the review to explore how to best use available secondary health data sources to provide information on the utilisation of Authority Required and/or Authority Required (Streamlined) PBS items.
Authority Review Reference Group Membership
The Reference Group is chaired by Emeritus Professor Lloyd Sansom AO, and has the following members:Top of page
- Representative – Drug Utilisation Sub-Committee
- Representative – Australian Medical Association
- Representative – Royal Australian College of General Practitioners
- Representative – Royal Australasian College of Physicians
- Representative – Medical Oncology Group of Australia
- Representative – Medicines Australia
- Representative – Generic Medicines Industry Association
- Representative – Society of Hospital Pharmacists of Australia
- Representative – Pharmacy Guild
- Representative – NPS MedicinesWise
- Representative – Council of Australian Therapeutic Advisory Groups
- Representative – Medical Software Industry Association
- Representative - Consumer Advocacy Group
- Representative - Consumer Advocacy Group
Public Consultation on Terms of Reference
The Terms of Reference submission process closed on Monday 16 June 2014. The public submissions are available at the Post-market Review of Authority Required PBS Listings Public Consultation Page.
Public Consultation on the Authority Required medicines
The Authority Required medicines submission process closed on Wednesday 8 October 2014. The submissions are available on the Public Consultation on Authority Required Medicines Page.
Opioids Roundtable
Through the Review, the Department identified that around 30% of the telephoned authority requests to the Department of Human Services (Medicare), or 1.8 million calls per year, are for increased quantities and/or repeats of eight opioids. This represents a substantial regulatory burden for a broad range of clinicians and patients. While opioids are not generally Authority Required medicines, the issue of regulatory burden could not be adequately addressed without reviewing the current PBS listings for opioids under a quality use of medicines framework.
The Department held an Opioids Roundtable meeting in Canberra on Wednesday, 27 May 2015, to assist the PBAC to form recommendations to the Minister on the PBS listings for opioids. The opioid group of PBS subsidised medicines includes, but is not limited to, morphine, oxycodone and codeine. The Roundtable brought together health professionals, researchers, consumer groups, industry and government to seek ways to reduce regulatory burden on health professionals, improve patient care, and to continue to manage the risk of opioid misuse and diversion.
The Outcomes Statement from the Opioids Roundtable is available below:
Antibiotics Roundtable
Through the Review, the Department identified a number of unique factors relating to antibiotics listings on the PBS. These include managing risks to the community associated with antibiotic use and antimicrobial resistance, and compatibility of antibiotic listings with accepted treatment guidelines. While antibiotics are not generally Authority Required medicines, the issues of regulatory burden and quality use of medicines could not be adequately addressed without reviewing the current PBS listings for all antibiotics under a quality use of medicines framework.
The Department held an Antibiotics Roundtable meeting in Canberra on Monday, 18 May 2015, to assist the PBAC to form recommendations to the Minister on the PBS listings for antibiotics. The Roundtable brought together health professionals, researchers, consumer groups, industry and government to seek ways to reduce regulatory burden on health professionals, improve patient care, and to continue to manage the risk of antimicrobial resistance.
The Outcomes Statement from the Antibiotics Roundtable is available below:
Further Information
Further information regarding Post-market Reviews is available through the Reviews page.
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