Deadlines for integrated codependent submissions for meetings of MSAC and PBAC

Page last updated: 09 December 2016

2017 Meetings

Due DateESC February
PBAC March
MSAC April
ESC June
PBAC July
MSAC July
ESC October
PBAC November
MSAC November
Notification deadline1
COB Thur
8 September 2016
12 January 2017
11 May 2017
Lodgement deadline2
COB Thur
6 October 2016
9 February 2017
8 June 2017
Applicant provided commentary3 for any response
COB Wed
18 January 2017
17 May 2017
13 September 2017
Applicant response on commentary due
Noon Wed
25 January 2017
24 May 2017
20 September 2017
Joint ESC meeting date
8 February 2017
7 June 2017
5 October 2017
Applicant provided Joint ESC advice/report4 for any response
COB Wed
22 February 2017
21 June 2017
18 October 2017
Applicant comments on Joint ESC advice/report due
Noon Wed
1 March 2017
28 June 2017
25 October 2017
PBAC meeting date
8-10 March 2017
5-7 July 2017
1-3 November 2017
Applicant provided PBAC minutes5 for any response
COB Fri
17 March 2017
14 July 2017
10 November 2013
Applicant response for MSAC on PBAC minutes due
COB Thur
23 March 2017
20 July 2017
16 November 2017
MSAC meeting date
6-7 April 2017
27-28 July 2017
23-24 November 2017
Processes after PBAC and MSAC meetings6

1 Notification deadline

Each applicant is required to notify the department Department of Health at least 4 weeks before it wishes to lodge an integrated codependent submission to PBAC and MSAC. Applicants are encouraged to provide this information earlier if they are able to do so.

2 Lodgement deadline

Each applicant is required to lodge its integrated codependent submission to PBAC and MSAC for consideration by the Joint ESC on or before the Thursday in the week of the previous Joint ESC meeting. This means that the submission would be scheduled for consideration by the following meeting of the Joint ESC.

3 Commentary

A commentary (critique) providing an evaluation of each submission is undertaken by a health technology assessment group contracted by the Department of Health. The commentary assesses the appropriateness of the methodology used for identifying and evaluating evidence, whether the analysis undertaken by the applicant is unbiased, reproducible, transparent and well-documented, and the strength of the evidence supporting the conclusions drawn in the submission.

Applicants are provided the commentary for any response. Responses are due within one week of receipt of the commentary. If an applicant wishes to respond, it can do so in a separate document of up to ten pages (plus up to four further pages for figures and/or tables as necessary) for consideration at the Joint ESC, PBAC and MSAC meetings.

4 Joint ESC Advice/Report

The Joint ESC Advice/Report is the document that summarises the evidence and outlines the issues for PBAC and MSAC consideration discussed in the Joint ESC meeting and also addresses any response received from the applicant. It later forms the basis of substantive sections of the Public Summary Document of MSAC and of PBAC. Applicants are provided the opportunity to respond to the Joint ESC Advice/Report. Responses are due within one week of receipt of the Joint ESC Advice/Report. If an applicant wishes to respond, it can do so in a separate document of up to six pages for consideration at the PBAC and MSAC meetings.

5 PBAC minutes

The PBAC minutes provide the PBAC outcome, the reasoning in support of that outcome, and the evidentiary basis in support of the reasoning. In relation to an integrated codependent submission to PBAC and MSAC, it may also identify matters referred to MSAC for advice. If PBAC intends to recommend the medicine subject to MSAC supportive advice for the codependent service and/or refers matters to MSAC for advice, these minutes (or an abbreviated document for the purpose of informing MSAC and the applicant of the intended recommendation and/or the matters referred to MSAC) are ratified within one week for provision to the applicant. Applicants are then provided the opportunity to respond on the intended recommendation and/or the matters referred to MSAC. Responses are due within six days of receipt of the PBAC minutes. If an applicant wishes to respond, it can do so in a separate document of up to three pages for consideration at the MSAC meeting.

6 Processes after PBAC and MSAC meetings

Following the PBAC and MSAC meetings, the reporting of the outcomes of the meetings are managed according to the usual processes of each Committee, i.e. as per a submission to the PBAC and an application to MSAC, respectively. Applicants are therefore advised to refer to the relevant sections of the websites for the PBAC and MSAC.