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Appendix 2 - Processes Leading to PBAC Consideration - Annual Report for 2018-19

Introduction

This is the tenth annual report to the Parliament on the processes leading to the consideration by the Pharmaceutical Benefits Advisory Committee (PBAC) of applications for recommendation for listing of items on the Pharmaceutical Benefits Scheme (PBS).

This annual report has been prepared pursuant to subsection 99YBC(5) of the National Health Act 1953 (the Act), under which it is required that:

The Secretary must, as soon as practicable after June 30 in each year, prepare and give to the Minister a report on processes leading up to the Pharmaceutical Benefits Advisory Committee consideration, including:

a) the extent and timeliness with which responsible persons are provided copies of documents relevant to their submission to the Pharmaceutical Benefits Advisory Committee;

b) the extent to which responsible persons exercise their right to comment on these documents, including appearing at hearings before the Pharmaceutical Benefits Advisory Committee;

c) the number of responsible persons seeking a review of the Pharmaceutical Benefits Advisory Committee recommendation.

PBAC

The PBAC is established under section 100A of the Act and is an independent expert body appointed by the Australian Government. Members include doctors, health professionals, health economists, as well as industry and consumer nominees. Its primary role is to consider medicines for listing on the PBS and vaccines for inclusion on the National Immunisation Program (NIP). No new medicine can be listed unless the PBAC makes a positive recommendation to the Minister for Health (the Minister). The PBAC holds three scheduled meetings each year, usually in March, July and November.

When considering a medicine for listing, the PBAC takes into account the medical condition(s) for which the medicine was registered for use in Australia and its clinical effectiveness, safety and cost-effectiveness (‘value for money’) compared with other treatments, including non-medical treatments.

The PBAC has three sub-committees to assist with analysis and advice in these areas. They are the:

  • Economics Sub-Committee (ESC) which assesses clinical and economic evaluations of medicines submitted to the PBAC for listing, and advises the PBAC on the technical aspects of these evaluations;
  • Drug Utilisation Sub-Committee (DUSC) which assesses estimates on projected usage and the financial cost of medicines. It also collects and analyses data on actual use (including in comparison with different countries), and provides advice to the PBAC; and
  • Nutritional Products Working Party (NPWP) which advises the PBAC on matters relating to the effectiveness and use of therapeutic foods and nutritional products.

Roles of the PBAC

  • Recommends medicines and medicinal preparations to the Minister for funding under the PBS.
  • Recommends vaccines to the Minister for funding under the NIP (since 2006).
  • Advises the Minister and Department about cost-effectiveness.
  • Recommends maximum quantities and repeats on the basis of community use, and any restrictions on the indications where PBS subsidy is available.
  • Regularly reviews the list of PBS items.
  • Advises the Minister about any other matters relating to the PBS, including on any matter referred to it by the Minister.

Requirements of Section 99YBC of the Act

a) Extent and timeliness of the provision of relevant documents to responsible persons1
The PBAC provides applicants with documents relevant to their submissions in an orderly, timely and transparent fashion. This is achieved through the well established practice of providing applicants with documents relevant to their submissions six weeks before the applicable PBAC meeting. These documents are referred to as ‘commentaries’.

Applicants’ pre-subcommittee response(s) are received by the PBAC Secretariat five weeks before the relevant PBAC meeting. Following the meeting of PBAC subcommittees, the PBAC Secretariat provides relevant subcommittee papers to applicants two weeks before the relevant PBAC meeting. Sponsors then provide their responses to the PBAC Secretariat one week before the PBAC meeting.

Following the PBAC meeting, the PBAC Secretariat provides summary advice on the outcomes of PBAC consideration to the relevant sponsor half a week after the meeting, with detailed advice provided three weeks (positive recommendations) and five weeks (all other outcomes) after the relevant PBAC meeting.

Where requested, the PBAC Secretariat, the PBAC and its subcommittees provide informal access to departmental officers and formal access to the PBAC for applicants or their representative, including the option for the sponsor to appear before the PBAC in person.

b) Extent to which responsible persons comment on their commentaries
During 2018-19, the PBAC held three ordinary meetings (as is usual practice) and considered a total of 86 major submissions. For the:

  • July 2018 PBAC meeting, 30 applicants lodged major submissions. 30 sponsors responded to their commentaries.
  • November 2018 PBAC meeting, 29 applicants lodged major submissions. 29 sponsors responded to their commentaries.
  • March 2019 PBAC meeting, 27 applicants lodged major submissions. 27 sponsors responded to their commentaries and one sponsor withdrew its submission before responding to its commentary.

Consequently, of the 86 major submissions considered by PBAC in 2018-19, 86 applicants exercised their right to respond to their commentaries.

At a special meeting held in August 2018, the PBAC also considered options for listing PD(L)-1 checkpoint inhibitors for multiple cancer indications on the PBS. In late 2017, the Minister requested that the PBAC provide advice on options for listing PD-1 and PD-L1 checkpoint inhibitors for the treatment of multiple cancer indications on the Pharmaceutical Benefits Schedule. To inform the development of its advice, the PBAC published a discussion paper on 25 May 2018 and invited submissions from interested parties. A total of 28 submissions from a range of stakeholders were received and considered.

In December 2018, the PBAC provided its report on Options for listing PD(L)-1 checkpoint inhibitors for multiple cancer indications on the PBS to the Minister. The Minister welcomed the options proposed by the PBAC and requested a range of further work be conducted.2

c) Number of responsible persons seeking a review of PBAC recommendations
During the 2018-19 financial year, there were no requests to the PBAC for an Independent Review.

Number and category of applications for each PBAC meeting in 2018-19

The categories for applications are prescribed by the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009. Further information on the categories of submissions available at: www.legislation.gov.au/Details/F2009L04013

July 2018 PBAC Meeting

Category

Number

Major

30

Minor

26

Other

2

November 2018 PBAC Meeting

Category

Number

Major

29

Minor

22

Other

1

March 2019 PBAC Meeting

Category

Number

Major

27

Minor

30

Other

0

Number and category of withdrawn applications for each PBAC meeting in 2018-19

July 2018 PBAC Meeting

Category

Number

Reasons for withdrawal

Major

0

n/a

Minor

0

n/a

November 2018 PBAC Meeting

Category

Number

Reasons for withdrawal

Major

5

Decision by applicants – no reason provided

Minor

1

Decision by applicants – no reason provided

March 2019 PBAC Meeting

Category

Number

Reasons for withdrawal

Major

1

Decision by applicants – no reason provided

Minor

0

n/a

Number of responsible persons that responded to their commentaries, including appearing before PBAC meetings

All of the responsible persons who submitted a major submission to PBAC during 2018-19 responded to their commentary.

July 2018 PBAC Meeting

Number of major submissions

Number of responsible persons that responded to their commentaries

Number of responsible persons that appeared before PBAC

30

30

11

November 2018 PBAC Meeting

Number of major submissions

Number of responsible persons that responded to their commentaries

Number of responsible persons that appeared before PBAC

29

29

13

March 2019 PBAC Meeting

Number of major submissions

Number of responsible persons that responded to their commentaries

Number of responsible persons that appeared before PBAC

27

27

10

Number of pre-submission meetings held in 2018-193

Pre-submission meetings per month

Meetings held

2018

July

0

August

8

September

3

October

1

November

0

December

7

2019

January

8

February

4

March

3

April

4

May

15

June

1

Total

54

Footnotes

  1. Responsible person for a brand of a pharmaceutical item is defined by the National Health Act 1953 to be a person determined by the Minister under section 84AF to be the responsible person for the brand of the pharmaceutical item.
  2. Further information available at: www.pbs.gov.au/pbs/home
  3. Figures do not take into account extended meetings where two or more drugs are discussed within one meeting date.