Evidence of efficacy of dexamfetamine
Dear Department of Health, Disability and Ageing,
I am writing to request access to the evidence of efficacy of dexamfetamine, as required for listing on the Pharmaceutical Benefits Scheme (PBS).
Other names: Dexamphetamine Sulfate, Dextroamphetamine, Dexamfetamine
PBS Listing:
1165H DEXAMFETAMINE (dexamfetamine sulfate)
Please provide all relevant information, including any studies, clinical trials, or other evidence that has been used to evaluate the efficacy of dexamfetamine for inclusion on the PBS.
Yours faithfully,
Zack
OFFICIAL
Good morning,
Acknowledgement of receipt of Freedom of Information request
I refer to your request received by the Department of Health, Disability
and Ageing (the department) for access to documents under the Freedom of
Information Act 1982 (FOI Act). You have requested access to:
[A]ccess to the evidence of efficacy of dexamfetamine, as required for
listing on the Pharmaceutical Benefits Scheme (PBS).
Other names: Dexamphetamine Sulfate, Dextroamphetamine, Dexamfetamine
PBS Listing:
1165H DEXAMFETAMINE (dexamfetamine sulfate)
Please provide all relevant information, including any studies, clinical
trials, or other evidence that has been used to evaluate the efficacy of
dexamfetamine for inclusion on the PBS.
The reference number for your request is FOI 26-2382. Please ensure that
you quote this number in future correspondence with us concerning this
request.
Timeframes
Your request was received on 1 November 2025. The statutory timeframe for
processing your request is 30 calendar days and you should expect to be
notified of a decision from the department on or before 1 December 2025.
The period of 30 days may be extended if the department needs to consult
third parties or for other reasons. We will advise you if this happens.
Request to exclude irrelevant information from your request
To assist with processing your request, can you also please advise by COB
7 November 2025, if you agree that information regarding any public
service employee names below Senior Executive Service level and direct
telephone numbers of all staff will be excluded from the scope of your
request under s22(1)(a)(ii) of the FOI Act
Other Information
The department may impose a charge for the work involved in providing
access to the documents. If this request attracts a charge you will be
notified in writing.
Unless you advise otherwise any draft and duplicate documents will be
excluded from the scope of your request.
Please note that information released under the FOI Act may later be
published online on our disclosure log
[1]www.health.gov.au/resources/foi-disclosure-log, subject to certain
exceptions. (For example, personal information will not be published where
this would be unreasonable.)
You can contact the FOI team via email at [2][email address] or by phone
on 02 6289 1666, should you have any questions.
Kind regards,
Jordan
Administration Officer – Freedom of Information Section
Commercial and Information Law Branch
Legal Division | Corporate Operations Group
Australian Government Department of Health, Disability and Ageing
T: 02 6289 1666| E: [3][email address]
This email comes to you from Ngunnawal Country
Location: Level 3
PO Box 9848, Canberra ACT 2601, Australia
The Department of Health, Disability and Ageing acknowledges First Nations
peoples as the Traditional Owners of Country throughout Australia, and
their continuing connection to land, sea and community. We pay our
respects to them and their cultures, and to all Elders both past and
present.
OFFICIAL
OFFICIAL
Good morning,
I am reaching out to you in relation to FOI 26-2382 you have lodged with
the department.
I note in the previous email it was advised that your request was received
by the department on 1 November 2025. I note this was a clerical error and
should be 2 November 2025, and you should expect a decision on or before 2
December 2025 accordingly.
Apologies for any confusion caused, if you have any questions or concerns,
please don’t hesitate to reach out.
Kind regards,
Jordan
Administration Officer – Freedom of Information Section
Commercial and Information Law Branch
Legal Division | Corporate Operations Group
Australian Government Department of Health, Disability and Ageing
T: 02 6289 1666| E: [1][email address]
This email comes to you from Ngunnawal Country
Location: Level 3
PO Box 9848, Canberra ACT 2601, Australia
The Department of Health, Disability and Ageing acknowledges First Nations
peoples as the Traditional Owners of Country throughout Australia, and
their continuing connection to land, sea and community. We pay our
respects to them and their cultures, and to all Elders both past and
present.
OFFICIAL
From: FOI <[email address]>
Sent: Wednesday, 5 November 2025 9:09 AM
To: Zack <[FOI #13957 email]>
Subject: Freedom of Information Request 26-2382 – Acknowledgement of
Receipt [SEC=OFFICIAL]
OFFICIAL
Good morning,
Acknowledgement of receipt of Freedom of Information request
I refer to your request received by the Department of Health, Disability
and Ageing (the department) for access to documents under the Freedom of
Information Act 1982 (FOI Act). You have requested access to:
[A]ccess to the evidence of efficacy of dexamfetamine, as required for
listing on the Pharmaceutical Benefits Scheme (PBS).
Other names: Dexamphetamine Sulfate, Dextroamphetamine, Dexamfetamine
PBS Listing:
1165H DEXAMFETAMINE (dexamfetamine sulfate)
Please provide all relevant information, including any studies, clinical
trials, or other evidence that has been used to evaluate the efficacy of
dexamfetamine for inclusion on the PBS.
The reference number for your request is FOI 26-2382. Please ensure that
you quote this number in future correspondence with us concerning this
request.
Timeframes
Your request was received on 1 November 2025. The statutory timeframe for
processing your request is 30 calendar days and you should expect to be
notified of a decision from the department on or before 1 December 2025.
The period of 30 days may be extended if the department needs to consult
third parties or for other reasons. We will advise you if this happens.
Request to exclude irrelevant information from your request
To assist with processing your request, can you also please advise by COB
7 November 2025, if you agree that information regarding any public
service employee names below Senior Executive Service level and direct
telephone numbers of all staff will be excluded from the scope of your
request under s22(1)(a)(ii) of the FOI Act
Other Information
The department may impose a charge for the work involved in providing
access to the documents. If this request attracts a charge you will be
notified in writing.
Unless you advise otherwise any draft and duplicate documents will be
excluded from the scope of your request.
Please note that information released under the FOI Act may later be
published online on our disclosure log
[2]www.health.gov.au/resources/foi-disclosure-log, subject to certain
exceptions. (For example, personal information will not be published where
this would be unreasonable.)
You can contact the FOI team via email at [3][email address] or by phone
on 02 6289 1666, should you have any questions.
Kind regards,
Jordan
Administration Officer – Freedom of Information Section
Commercial and Information Law Branch
Legal Division | Corporate Operations Group
Australian Government Department of Health, Disability and Ageing
T: 02 6289 1666| E: [4][email address]
This email comes to you from Ngunnawal Country
Location: Level 3
PO Box 9848, Canberra ACT 2601, Australia
The Department of Health, Disability and Ageing acknowledges First Nations
peoples as the Traditional Owners of Country throughout Australia, and
their continuing connection to land, sea and community. We pay our
respects to them and their cultures, and to all Elders both past and
present.
OFFICIAL
OFFICIAL
Dear Zack,
I refer to your request received by the Department of Health, Disability
and Ageing (department) seeking access to the following under the Freedom
of Information Act 1982 (Cth) (FOI Act):
I am writing to request access to the evidence of efficacy of
dexamfetamine, as required for listing on the Pharmaceutical Benefits
Scheme (PBS).
Other names: Dexamphetamine Sulfate, Dextroamphetamine, Dexamfetamine
PBS Listing:
1165H DEXAMFETAMINE (dexamfetamine sulfate)
Please provide all relevant information, including any studies, clinical
trials, or other evidence that has been used to evaluate the efficacy of
dexamfetamine for inclusion on the PBS.
The statutory due date for your request is currently 2 December 2025.
Publicly available information
The relevant business area within the department has identified resources
that are publicly available, which may provide you with the information
you are seeking access to in your request.
Dexamphetamine was initially listed on the PBS in 1959. For more
information, please refer to page 132 of
[1]1959-11-01-PBS-Schedule-Medical-Practitioners.pdf. There has not been a
recent evaluation of efficacy of dexamphetamine for inclusion on the PBS.
The following resources provide information about dexamfetamine:
• Therapeutic Goods Administration (TGA) Australian Product Information
document for DEXAMFETAMINE – [2]pdf
• TGA Consumer Medicine Information summary for DEXAMFETAMINE: [3]TGA
Consumer Medicine Information (Prescription Medicine) Template
The department further notes that in May 2018, the Drug Utilisation Sub
Committee of the Pharmaceutical Benefits Advisory Committee completed a
review of the utilisation of the use of ADHD medications. A copy of the
review is available here: [4]adhd-dusc-prd-2018-05-final.pdf.
Seeking your agreement to withdraw
In light of the above information, we kindly request your confirmation by
COB 19 November 2025 as to whether:
1. you agree to withdraw your request with the department; or
2. you wish to proceed with your request and be issued a decision on
access.
Please note that withdrawing your request will waive any review rights
under the FOI Act.
Further assistance
Should you have any queries or require further clarification, please do
not hesitate to contact the department’s FOI Section at
[5][Department of Health, Disability and Ageing request email].
We otherwise look forward to receiving your response by COB 19 November
2025.
Kind regards,
Hannah
Lawyer – Freedom of Information Section
Commercial and Information Law
Legal Division | Corporate Operations Group
Australian Government Department of Health, Disability and Ageing
T: 02 6289 1666 | E: [6][email address]
PO Box 9848, Canberra ACT 2601, Australia
Please note that this email and attachments may contain confidential or
legally privileged information. Please consult with the Legal Division
before disclosing any part of this email, or attachment, outside the
Department. If you receive this email in error, please delete it and
contact the sender immediately.
OFFICIAL
OFFICIAL
Dear Zack,
Thank you for your email and confirming that you withdraw FOI request
26-2382.
The department will take no further action in relation to this request.
Kind regards,
Hannah
Lawyer – Freedom of Information Section
Commercial and Information Law
Legal Division | Corporate Operations Group
Australian Government Department of Health, Disability and Ageing
T: 02 6289 1666 | E: [1][email address]
PO Box 9848, Canberra ACT 2601, Australia
Please note that this email and attachments may contain confidential or
legally privileged information. Please consult with the Legal Division
before disclosing any part of this email, or attachment, outside the
Department. If you receive this email in error, please delete it and
contact the sender immediately.
OFFICIAL