Cost Recovery Fees and Charges from 1 July 2019

Page last updated: 2 July 2019

The Pharmaceutical Benefits Scheme (PBS) provides timely, reliable and affordable access to necessary medicines for Australians. The National Immunisation Program (NIP) aims to reduce the incidence of vaccine-preventable diseases and protect individuals and the Australian community.

Cost Recovery involves the Australian Government charging the non-government sector for some or all of the efficient costs of a specific government activity. That activity may include the provision of goods, services or regulation, or a combination of them.

The Cost Recovery Implementation Statement (CRIS) for listing medicines on the PBS and designated vaccines on the NIP provides information on how the Department of Health is implementing the revised cost recovery arrangements announced by the Australian Government in December 2018.

Revised cost recovery arrangements from 1 July 2019 include:

  • introduction of fees for the first stage of the PBS process improvements as agreed under Clause 10 of the 2017 Strategic Agreement between the Australian Government and Medicines Australia (MA)

    • Changes to pre-submission meetings to improve guidance and support and submission quality for complex submissions
    • Introduction of a mandatory Intent to Apply process for submissions requiring evaluation
    • Introduction of transparent pricing pathways including a mandatory Notice of Intent step following a positive PBAC recommendation
  • staged increase in existing PBAC cost recovery fees over two years
  • introduction fees for existing sponsor driven services which were not previously cost recovered
    • Price increase request
    • Ministerial discretion request
  • revised fee exemption for submissions identified by the TGA as an ‘orphan drug’ for the first submission to the PBAC within 12 months of TGA registration
  • consistent charging approach across the PBS processes.

In response to feedback received in February 2019 on the draft consultation CRIS, introduction of the new post-listing deed management fee and the Australian Technical Advisory Group on Immunisation (ATAGI) pre-submission evaluation fees were delayed until July 2020. Information on the pre-submission evaluation fees for ATAGI has been included for information only in the below Cost Recovery Implementation Statement (CRIS). The ATAGI fees were included in the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Amendment Regulations 2019 made in April 2019. These fees were subsequently delayed to commence on 1 July 2020 in the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Amendment (Vaccine Advice) Regulations 2019. Both amending regulations came into force on 1 July 2019.

Fee structure and invoice timing

Pre-submission services

From July 2019

Invoicing point

Withdrawal for refund (prior notice is not refundable)

Invoicing term

Notification of fee waiver/exemption

1st pre-submission meeting

 16,090

Within 14 days after the department  receives the meeting application and briefing papers.

Whichever earlier before 15th day after the applicant is invoiced, or the last business day before the meeting.

28 days after the invoicing date.

NA

2nd or subsequent

pre-submission meeting

21,090

NA

Submission services

Major including Intent to Apply

179,510

Within 14 days after the department  receives the application unless prior notice is exempted, then invoice will be issued within 21 days.

Within 14 days after the applicant is invoiced.

28 days after the invoicing date, or automatically extended by 14 days (i.e. 42 days in total) for a waiver application.

Within 21 days after a waiver/exemption application is received.

Minor including Intent to Apply

27,310

28 days after the invoicing date

Minor

26,920

Within 21 days after the department  receives the application.

Committee secretariat

 5,940

Generics

2,910

Within 21 days after the department  receives the application.

Within 14 days after the applicant is invoiced.

28 days after the invoicing date.

Pricing services

Pricing Pathway A including Notice of Intent

119,310

Within 14 days after the department receives the application unless prior notice is exempted, then invoice will be issued within 21 days.

Within 14 days after the applicant is invoiced.

28 days after the invoicing date, or automatically extended by 14 days (i.e. 42 days in total) for a waiver application.

Within 21 days after a waiver/exemption application is received.

Pricing Pathway B including Notice of Intent

92,530

Pricing Pathway C including Notice of Intent

58,180

Pricing Pathway D including Notice of Intent

13,550

Pricing Secretariat including Notice of Intent

6,140

List management services

Price increase request

2,330

Within 14 days after the department receives the application.

Within 14 days after the applicant is invoiced.

28 days after the invoicing date.

Within 14 days after a waiver/exemption application is received.

Ministerial discretion request

3,480

Industry feedback

Cost recovery - Initial proposal

Feb-18

Industry feedback

Change

Full cost recovery

Not supported as proposed.

Partial cost recovery agreed by Government.

Increase existing fees

Agreed in-principle with the need for cost recovery fees to reflect the current true costs of PBS listing activities.

Government agreed to increase existing fees over two years to reduce the impact on sponsors.

Requested a staged approach.

Introduce levy

Not supported.

Government agreed not to include.

Remove automatic orphan drugs exemption

Not supported.

Government agreed to revised orphan drug fee exemptions for initial submissions to the PBAC lodged within 12 months of registration on the ARTG.

Commencement date of July 2018

Not supported as insufficient time for budgeting and planning.

Government agreed to delay to 1 July 2019.

Cost Recovery – CRIS consultation

Feb-19

Industry feedback

Change

New fees for Pre‑submission meetings, Intent to Apply and Positive Pathways (Stage 1 PBS processes improvements)

Changes developed in consultation with industry - no significant issues raised.

Government agreed new fees to support new processes will apply full from 1 July 2019.

New fees for sponsor requested changes - price increases and ministerial discretion requests

No significant issues raised.

Government agreed new fees will be charged in full from 1 July 2019.

New fee - deed management

Needs further clarification/better description.

Government agreed to delay until 1 July 2020.

New fees – ATAGI vaccines evaluation

Acknowledged that vaccine advice should be cost recovered but requested further clarity on the new ATAGI process improvements (and estimated fees) and staged introduction.

Government agreed to delayed process improvements and fees until 1 July 2020.

Payments

Payment should be made by electronic funds transfer (EFT) to the account nominated on the invoice. A request for payment letter, which will accompany the invoice, will advise the applicant of a Unique Identifying Number to identify the application throughout the fee process. The invoice number must be entered in the free text portion of the EFT transaction when paying.

Fees must be paid in full at the time of payment. Payment by instalment will not be accepted unless by prior agreement with the Department. Partial payments may only be accepted in exceptional circumstances and must be agreed to, in advance, by the Department.

Contact the Cost Recovery Unit

Email: pbscostrecovery@health.gov.au

 

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