Good morning Mr Saunders,

I refer to your request received by the Department of Health and Aged Care
(the department) on 22 May 2024 for access to documents under the Freedom
of Information Act 1982 (FOI Act). You have requested access to:

All documents associated with MSAC 1530 - Purified human alpha1-proteinase
inhibitor (A1-PI) for the treatment of alpha1-proteinase inhibitor
deficiency, leading to chronic obstructive pulmonary disease (COPD).

The department has reviewed the scope of your request and believes that in
its current form there could be an unreasonable diversion of resources to
process your request.

Taking this into consideration, we are contacting you to help you clarify
the scope of your request.

Scope clarification

Narrowing to certain types of documents

Your request is very broad in nature and will include a very large number
of documents. You may wish to consider narrowing the types of documents
you are requesting, such as submission documents etc.

In addition, you may wish to exclude correspondence of a general
administrative nature from your request. 

Narrowing timeframes

You may also wish to consider specifying a time-frame for the requested
correspondence, for example 1 Jan 2018 – 31 March 2020.

We would be grateful if you could review the above and provide a response
by close of business 27 May 2024.

Kind regards,

Riley

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal Division | Corporate Operations Group

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

show quoted sections

Good afternoon Mr Saunders,

Acknowledgement of receipt of Freedom of Information request

We refer to your emails of 25 May 2024 and 29 May 2024 clarifying the
scope of your request.

We confirm the scope of your request has been updated as follows:

The following documents associated with MSAC 1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD):

1. Grifols and CSL submissions

2. The full Assessment Report related to the MSAC submission (around 2017
- 2018)

3. The economic analysis carried out relating to cost/benefit of
augmentation therapy

4. The full (unredacted) public report "1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD) from 2018

The reference number for your request is FOI-5155. Please ensure that you
quote this number in future correspondence with us concerning this
request.

Timeframes

Your request was received on 22 May 2024. 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 21 June 2024. 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.

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, and

·         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.

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,

Hannah

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal and Assurance Division

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [3][email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

show quoted sections

Good morning Mr Saunders,

I refer to your request of 22 May 2024 to the Department of Health and
Aged Care (department), seeking access under the Freedom of Information
Act 1982 (Cth) (FOI Act) to the following documents:

The following documents associated with MSAC 1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD):

1. Grifols and CSL submissions

2. The full Assessment Report related to the MSAC submission (around 2017
- 2018)

3. The economic analysis carried out relating to cost/benefit of
augmentation therapy

4. The full (unredacted) public report "1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD) from 2018

Notice of Third Party Consultation

Documents have been identified in the scope of your request which contain
information relating to third parties. It has been determined that it
would be appropriate to consult with the affected third parties under
section 27 of the FOI Act prior to a decision on access to those documents
being made.

Section 15(6) of the FOI Act allows the timeframe for processing your
request to be extended by 30 days to facilitate this consultation.
Accordingly, the statutory due date for your request is now 21 July 2024.

The department will continue processing your request and provide you with
a decision on access as soon we are able to do so.

Relevant provisions

The FOI Act, including the provisions referred to in this email, can be
accessed from the Federal Register of Legislation website:
[1]www.legislation.gov.au/Series/C2004A02562.

If you require clarification of any of the matters discussed in this email
you should contact the department’s FOI Section by email at
[2][email address].

Kind regards,

Riley

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal Division | Corporate Operations Group

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

From: FOI <[email address]>
Sent: Thursday, May 30, 2024 12:03 PM
To: 'Ian Saunders' <[FOI #11435 email]>
Subject: TRIM: Freedom of Information Request 5155 – Acknowledgement of
Receipt [SEC=OFFICIAL]

Good afternoon Mr Saunders,

Acknowledgement of receipt of Freedom of Information request

We refer to your emails of 25 May 2024 and 29 May 2024 clarifying the
scope of your request.

We confirm the scope of your request has been updated as follows:

The following documents associated with MSAC 1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD):

1. Grifols and CSL submissions

2. The full Assessment Report related to the MSAC submission (around 2017
- 2018)

3. The economic analysis carried out relating to cost/benefit of
augmentation therapy

4. The full (unredacted) public report "1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD) from 2018

The reference number for your request is FOI-5155. Please ensure that you
quote this number in future correspondence with us concerning this
request.

Timeframes

Your request was received on 22 May 2024. 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 21 June 2024. 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.

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, and

·         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.

Please note that information released under the FOI Act may later be
published online on our disclosure log
[3]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 [4][email address] or by phone
on 02 6289 1666, should you have any questions.

Kind regards,

Hannah

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal and Assurance Division

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [5][email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

show quoted sections

Good morning Mr Saunders,

I refer to your request to the Department of Health and Aged Care (the
department) of 22 May 2024 seeking access to the following under the
Freedom of Information Act 1982 (Cth) (FOI Act):

The following documents associated with MSAC 1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD):

1. Grifols and CSL submissions

2. The full Assessment Report related to the MSAC submission (around 2017
- 2018)

3. The economic analysis carried out relating to cost/benefit of
augmentation therapy

4. The full (unredacted) public report "1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD) from 2018

The statutory due date for your request is currently 21 July 2024.

Request for extension of time

Section 15AA of the FOI Act permits the department to extend the statutory
processing timeframe, with your agreement, for a period of up to 30
calendar days.

To ensure that department has undertaken all reasonable steps to identify
all documents relevant to your request, and for the decision maker to make
a well-balanced decision on access to any such documents identified, the
department is seeking your agreement to an extension of 21 calendar days.

If you agree to this extension, the statutory due date will then be 11
August 2024. The department will, however, continue to process your
request as quickly as possible.

It would assist if you could please advise by close of business 19 July
2024 if you agree to this extension of time. If we do not hear from you by
this date or if you do not agree to the extension, the department may
consider seeking an extension of time from the Office of the Australian
Information Commissioner (OAIC) under section 15AB of the FOI Act.

We thank you for your ongoing patience and cooperation as we continue to
process your request.

If you have any questions regarding any of the matters discussed in this
email, please do not hesitate to contact the FOI Section at
[1][email address].

Kind regards

Riley

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal Division | Corporate Operations Group

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [2][email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

From: FOI <[email address]>
Sent: Thursday, June 13, 2024 9:41 AM
To: 'Ian Saunders' <[FOI #11435 email]>
Subject: TRIM: Freedom of Information Request 5155 - Notification of
Affected Third Party Consultation [SEC=OFFICIAL]

Good morning Mr Saunders,

I refer to your request of 22 May 2024 to the Department of Health and
Aged Care (department), seeking access under the Freedom of Information
Act 1982 (Cth) (FOI Act) to the following documents:

The following documents associated with MSAC 1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD):

1. Grifols and CSL submissions

2. The full Assessment Report related to the MSAC submission (around 2017
- 2018)

3. The economic analysis carried out relating to cost/benefit of
augmentation therapy

4. The full (unredacted) public report "1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD) from 2018

Notice of Third Party Consultation

Documents have been identified in the scope of your request which contain
information relating to third parties. It has been determined that it
would be appropriate to consult with the affected third parties under
section 27 of the FOI Act prior to a decision on access to those documents
being made.

Section 15(6) of the FOI Act allows the timeframe for processing your
request to be extended by 30 days to facilitate this consultation.
Accordingly, the statutory due date for your request is now 21 July 2024.

The department will continue processing your request and provide you with
a decision on access as soon we are able to do so.

Relevant provisions

The FOI Act, including the provisions referred to in this email, can be
accessed from the Federal Register of Legislation website:
[3]www.legislation.gov.au/Series/C2004A02562.

If you require clarification of any of the matters discussed in this email
you should contact the department’s FOI Section by email at
[4][email address].

Kind regards,

Riley

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal Division | Corporate Operations Group

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [5][email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

From: FOI <[6][email address]>
Sent: Thursday, May 30, 2024 12:03 PM
To: 'Ian Saunders' <[7][FOI #11435 email]>
Subject: TRIM: Freedom of Information Request 5155 – Acknowledgement of
Receipt [SEC=OFFICIAL]

Good afternoon Mr Saunders,

Acknowledgement of receipt of Freedom of Information request

We refer to your emails of 25 May 2024 and 29 May 2024 clarifying the
scope of your request.

We confirm the scope of your request has been updated as follows:

The following documents associated with MSAC 1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD):

1. Grifols and CSL submissions

2. The full Assessment Report related to the MSAC submission (around 2017
- 2018)

3. The economic analysis carried out relating to cost/benefit of
augmentation therapy

4. The full (unredacted) public report "1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD) from 2018

The reference number for your request is FOI-5155. Please ensure that you
quote this number in future correspondence with us concerning this
request.

Timeframes

Your request was received on 22 May 2024. 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 21 June 2024. 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.

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, and

·         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.

Please note that information released under the FOI Act may later be
published online on our disclosure log
[8]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 [9][email address] or by phone
on 02 6289 1666, should you have any questions.

Kind regards,

Hannah

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal and Assurance Division

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [10][email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

show quoted sections

Good afternoon Mr Saunders,

I refer to your request to the Department of Health and Aged Care (the
department) of 22 May 2024 seeking access to the following under the
Freedom of Information Act 1982 (Cth) (FOI Act):

The following documents associated with MSAC 1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD):

1. Grifols and CSL submissions

2. The full Assessment Report related to the MSAC submission (around 2017
- 2018)

3. The economic analysis carried out relating to cost/benefit of
augmentation therapy

4. The full (unredacted) public report "1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD) from 2018

The statutory due date for your request is currently 11 August 2024.

Request for extension of time

Section 15AA of the FOI Act permits the department to extend the statutory
processing timeframe, with your agreement, for a period of up to 30
calendar days.

To ensure that department has undertaken all reasonable steps to identify
all documents relevant to your request, and for the decision maker to make
a well-balanced decision on access to any such documents identified, the
department is seeking your agreement to an extension of 9 calendar days.

If you agree to this extension, the statutory due date will then be 20
August 2024. The department will, however, continue to process your
request as quickly as possible.

It would assist if you could please advise by COB 5 August 2024 if you
agree to this extension of time. If we do not hear from you by this date
or if you do not agree to the extension, the department may consider
seeking an extension of time from the Office of the Australian Information
Commissioner (OAIC) under section 15AB of the FOI Act.

We thank you for your ongoing patience and cooperation as we continue to
process your request.

If you have any questions regarding any of the matters discussed in this
email, please do not hesitate to contact the FOI Section at
[1][email address].

Kind regards,

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal Division | Corporate Operations Group

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

--------------------------------------------------------------------------

From: Ian Saunders [2][FOI #11435 email]
Sent: Thursday, July 18, 2024 10:10 PM
To: FOI [3][email address]
Subject: TRIM: RE: TRIM: Freedom of Information Request 5155 -
Notification of Affected Third Party Consultation [SEC=OFFICIAL]

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear FOI,

We accept your proposed delay to this FoI request.

Yours sincerely,

Ian Saunders

show quoted sections

Good afternoon Mr Saunders,

We refer to your FOI request received on 22 May 2024.

Please find attached a decision on access together with the documents
referred to in that decision that are not subject to third party review
rights.

If you have any queries in relation to this decision, please contact the
FOI Section on the details below.

Kind regards,

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal Division | Corporate Operations Group

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

From: FOI <[email address]>
Sent: Thursday, May 30, 2024 12:03 PM
To: 'Ian Saunders' <[FOI #11435 email]>
Subject: TRIM: Freedom of Information Request 5155 – Acknowledgement of
Receipt [SEC=OFFICIAL]

Good afternoon Mr Saunders,

Acknowledgement of receipt of Freedom of Information request

We refer to your emails of 25 May 2024 and 29 May 2024 clarifying the
scope of your request.

We confirm the scope of your request has been updated as follows:

The following documents associated with MSAC 1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD):

1. Grifols and CSL submissions

2. The full Assessment Report related to the MSAC submission (around 2017
- 2018)

3. The economic analysis carried out relating to cost/benefit of
augmentation therapy

4. The full (unredacted) public report "1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD) from 2018

The reference number for your request is FOI-5155. Please ensure that you
quote this number in future correspondence with us concerning this
request.

Timeframes

Your request was received on 22 May 2024. 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 21 June 2024. 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.

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, and

·         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.

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,

Hannah

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal and Assurance Division

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [3][email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

show quoted sections

Good afternoon Mr Saunders,

We refer to our decision issued on 20 August 2024 relevant to your FOI
request 5155.

In this decision we advised that six documents captured within the scope
of your request were subject to third party review rights. These review
rights have now run out and as such we can release these documents to you.

Please see attached the complete document bundle relevant to this request.

If you have any queries in relation to these documents, please contact the
FOI Section on the details below.

Kind regards,

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal Division | Corporate Operations Group

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [1][email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

From: FOI <[email address]>
Sent: Tuesday, August 20, 2024 4:17 PM
To: 'Ian Saunders' <[FOI #11435 email]>
Subject: TRIM: Your FOI request 5155 – Decision on access [SEC=OFFICIAL]

Good afternoon Mr Saunders,

We refer to your FOI request received on 22 May 2024.

Please find attached a decision on access together with the documents
referred to in that decision that are not subject to third party review
rights.

If you have any queries in relation to this decision, please contact the
FOI Section on the details below.

Kind regards,

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal Division | Corporate Operations Group

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [2][email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

From: FOI <[3][email address]>
Sent: Thursday, May 30, 2024 12:03 PM
To: 'Ian Saunders' <[4][FOI #11435 email]>
Subject: TRIM: Freedom of Information Request 5155 – Acknowledgement of
Receipt [SEC=OFFICIAL]

Good afternoon Mr Saunders,

Acknowledgement of receipt of Freedom of Information request

We refer to your emails of 25 May 2024 and 29 May 2024 clarifying the
scope of your request.

We confirm the scope of your request has been updated as follows:

The following documents associated with MSAC 1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD):

1. Grifols and CSL submissions

2. The full Assessment Report related to the MSAC submission (around 2017
- 2018)

3. The economic analysis carried out relating to cost/benefit of
augmentation therapy

4. The full (unredacted) public report "1530 - Purified human
alpha1-proteinase inhibitor (A1-PI) for the treatment of alpha1-proteinase
inhibitor deficiency, leading to chronic obstructive pulmonary disease
(COPD) from 2018

The reference number for your request is FOI-5155. Please ensure that you
quote this number in future correspondence with us concerning this
request.

Timeframes

Your request was received on 22 May 2024. 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 21 June 2024. 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.

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, and

·         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.

Please note that information released under the FOI Act may later be
published online on our disclosure log
[5]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 [6][email address] or by phone
on 02 6289 1666, should you have any questions.

Kind regards,

Hannah

FOI Case Officer – Freedom of Information Section

Legal Advice and Legislation Branch

Legal and Assurance Division

Australian Government Department of Health and Aged Care

T: 02 6289 1666 | E: [7][email address]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health and Aged Care 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.

show quoted sections