Evidence of efficacy of Lisdexamfetamine
Dear Department of Health, Disability and Ageing,
I am writing to request access to the evidence of efficacy of Lisdexamfetamine, as required for listing on the Pharmaceutical Benefits Scheme (PBS).
Please provide all relevant information, including any studies, clinical trials, or other evidence that has been used to evaluate the efficacy of Lisdexamfetamine 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 Lisdexamfetamine, as required for
listing on the Pharmaceutical Benefits Scheme (PBS).
Please provide all relevant information, including any studies, clinical
trials, or other evidence that has been used to evaluate the efficacy of
Lisdexamfetamine for inclusion on the PBS.
The reference number for your request is FOI 26-2383. 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 (For example, personal information will not be published where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 26-2383 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 9:08 AM
To: Zack <[FOI #13958 email]>; FOI
<[email address]>
Subject: Freedom of Information Request 26-2383 – 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 Lisdexamfetamine, as required for
listing on the Pharmaceutical Benefits Scheme (PBS).
Please provide all relevant information, including any studies, clinical
trials, or other evidence that has been used to evaluate the efficacy of
Lisdexamfetamine for inclusion on the PBS.
The reference number for your request is FOI 26-2383. 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
Good afternoon Zack,
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).
Seeking Agreement to Withdraw
The relevant business area within the department has identified that the
information you may be seeking is already publicly available. Please refer
to the links below for more details:
o [1]Lisdexamfetamine: Capsule containing lisdexamfetamine dimesilate
20mg, 30mg, 40mg, 50mg, 60mg, 70mg; Vyvanse® - March 2020
o [2]Lisdexamfetamine: Capsule containing lisdexamfetamine dimesilate 20
mg, 40 mg and 60 mg; Vyvanse® - July 2019
o [3]Lisdexamfetamine Dimesilate, capsules, 30 mg, 50 mg & 70 mg,
Vyvanse® - July 2014
o [4]Lisdexamfetamine, capsules, 30 mg, 50 mg, and 70 mg, Vyvanse® -
July 2013
Additionally, please find attached the TGA AusPar document, which is also
publicly available.
In light of the above, we kindly ask you to confirm by COB 7 November 2025
whether:
o You wish to withdraw your request, noting that the information
provided is sufficient; or
o You wish to continue with your FOI request irrespective of the
information provided.
If you have any questions or require further clarification, please do not
hesitate to contact us.
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: [5][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 10:48 AM
To: FOI <[email address]>; Zack
<[FOI #13958 email]>
Subject: RE: Freedom of Information Request 26-2383 – Acknowledgement of
Receipt [SEC=OFFICIAL]
OFFICIAL
Good morning,
I am reaching out to you in relation to FOI 26-2383 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: [6][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 <[7][email address]>
Sent: Wednesday, 5 November 2025 9:08 AM
To: Zack <[8][FOI #13958 email]>; FOI
<[9][email address]>
Subject: Freedom of Information Request 26-2383 – 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 Lisdexamfetamine, as required for
listing on the Pharmaceutical Benefits Scheme (PBS).
Please provide all relevant information, including any studies, clinical
trials, or other evidence that has been used to evaluate the efficacy of
Lisdexamfetamine for inclusion on the PBS.
The reference number for your request is FOI 26-2383. 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
[10]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 [11][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: [12][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
Dear FOI,
Thank you for pointing me to the documents. I withdraw my request.
To save the departments time in future would the following urls be the best place to search for similar documents in future?
https://www.pbs.gov.au/info/industry/lis...
https://www.tga.gov.au/resources/austral...
Yours sincerely,
Zack
OFFICIAL
Good afternoon Zack,
Thank you for confirming and providing the expedient response.
You are correct, the two links you are referring to would be the best
place to find the information you are looking for in most cases.
Apologies if any formatting in previously provided links were not visible
or did not work via the right to know portal. You may also find this
portal helpful too:
[1]https://www.ebs.tga.gov.au/
If you are unable to find the information you are seeking on the
previously provided portals please feel free to lodge a fresh FOI request
or alternatively, reach out via general enquiry at
[2][email address]
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
Dear FOI,
Thanks, your links did come through.
Just confirming again I have withdrawn my request and thank you for providing the information on finding it in the future.
Yours sincerely,
Zack