All documents and minutes (PASC, ESC & MSAC) relating to MSAC 1530

Currently waiting for a response from Medical Services Advisory Committee, they should respond promptly and normally no later than (details).

Dear Medical Services Advisory Committee,

On behalf of the Alpha-1 Organisation Australia Inc and the thousands of patients affected by alpha-1 antitrypsin deficiency in Australia I would like copies of 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), in order to better understand the recommendation made and the process used in reaching this recommendation.

Yours faithfully,

Ian Saunders
Treasurer
Alpha-1 Organisation Australia Inc

FOI, Medical Services Advisory Committee

1 Attachment

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.

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Dear Riley,
Thank you for your response. It is obviously difficult to be specific when we don't know what documents exist, however we would like:
1. Grifols and CSL submissions
2. The Assessment Report
3, 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)
4. Economic evaluation documents which supported the assessment
Thank you once again for your assistance in this matter.
Yours sincerely,
Ian Saunders

Dear Riley
I had replied to your message once, but the response seems to have gone missing.
We would like:
1. Submissions by CSL and Grifols
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 (non-redacted) public report called “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
Yours sincerely,
Ian Saunders

FOI, Medical Services Advisory Committee

1 Attachment

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.

 

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