Review of Authority Required Pharmaceutical Benefits Scheme Listings
Page last updated: 22 November 2024
Background
Under the Australian Government’s National Medicines Policy framework, the Department of Health (now the Department of Health and Aged Care) has conducted a Review of Authority Required Pharmaceutical Benefits Scheme (PBS) Listings. The objective of the Review was 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 2013 Review of Chemotherapy Funding Arrangements. This review found that Authority Required listings caused significant regulatory burden to prescribing medical oncologists. On 30 November 2013, when announcing the outcomes of the Chemotherapy Review, the then Prime Minister also announced the Government’s intention to review the Authority Required PBS Listings.
The Review of Authority Required PBS Listings built on the Pharmaceutical Benefits Advisory Committee’s (PBAC) consideration of a submission from the Australian Medical Association (AMA) that proposed amending the restriction level of several medicines from Authority Required to Authority Required (Streamlined). The PBAC agreed that there was merit to a review of Authority Required listings and recommended that all Authority Required listings be reviewed, to ensure that PBS restrictions appropriately reflect the level of monitoring required to manage the quality use of medicines and identified risks.
Scope of the Review
This Review considered criteria for the PBAC 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 with the most regulatory burden were considered first. These medicines were associated with the greatest number of telephone authority approval requests, or with the most complex written authority approval forms.
- Tranche 1: Medicines for the treatment of many types of cancer, multiple sclerosis and inflammatory arthritis were considered by the PBAC at its December 2014 special meeting.
- Tranche 2: Medicines for eye conditions, psychiatric conditions and cardiovascular disease were considered by the PBAC at its March 2015 meeting.
- Tranche 3: All remaining medicines not covered in the first two tranches, as well as medicines used in palliative care, were considered by the PBAC at its 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 its August 2015 Special meeting and
- select dermatological PBS listings at its December 2015 Special meeting.
Reference Group
The Reference Group was chaired by Emeritus Professor Lloyd Sansom AO, and had the following members:
|
Representative |
Role |
|---|---|
|
Drug Utilisation Sub-Committee |
Technical Expert |
|
Australian Medical Association |
Organisational Representative |
|
Royal Australian College of General Practitioners |
Organisational Representative |
|
Royal Australasian College of Physicians |
Organisational Representative |
|
Medical Oncology Group of Australia |
Organisational Representative |
|
Medicines Australia |
Organisational Representative |
|
Generic Medicines Industry Association |
Organisational Representative |
|
Society of Hospital Pharmacists of Australia |
Organisational Representative |
|
Pharmacy Guild |
Organisational Representative |
|
NPS MedicineWise |
Organisational Representative |
|
Council of Australian Therapeutic Advisory Groups |
Organisational Representative |
|
Medical Software Industry Association |
Organisational Representative |
|
Arthritis Australia |
Consumer Advocate |
|
Cancer Australia |
Consumer Advocate |
Terms of Reference
The PBAC considered the draft Terms of Reference and comments from stakeholders at its July 2014 meeting. Following the July 2014 PBAC meeting, the Minister 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.
Public Consultation on the draft Terms of Reference (closed)
Public Consultation on the draft Review Terms of Reference closed on Monday 16 June 2014. To view submissions please go to the Review of Authority Required PBS Listings Public Consultation Page.
Public Consultation on the Review (Closed)
Public consultation addressing the Review Terms of Reference closed on Wednesday 8 October 2014. To view submissions please go to the Public Consultation on Authority Required Medicines Page.
Opioids Roundtable
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. While opioids are not generally Authority Required medicines, requests for authority approvals for increased quantities and/or repeats of opioids are associated with substantial regulatory burden for clinicians and patients. 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 several unique factors relating to antibiotics listings on the PBS. These included managing risks to the community associated with antibiotic use and antimicrobial resistance, and the compatibility of antibiotic PBS 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 on Reviews is available on the Review’s website.
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