Cost Recovery Fees and Charges

Page last updated: 3 September 2020

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.

The Australian Technical Advisory Group on Immunisation (ATAGI) advises the Minister for Health on the NIP and other immunisation issues.

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) provides information on how the Department of Health (the department) implements cost recovery for:

  • Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) for medicines seeking to be listed on the Pharmaceutical Benefits Scheme (PBS); or vaccines to be listed on the National Immunisation Program (NIP).
  • Applicant-driven PBS listing and list management activities.

The 2020-21 CRIS is now available and provides further detail for cost recovery implementation for PBAC and ATAGI activities.

Changes from 1 July 2020

From 1 July 2020, in addition to the agreed increase to existing fees as described in the 2019-20 CRIS, there are three key changes to the 2020-21 fees:

  • Reduced Australian Technical Advisory Group on Immunisation (ATAGI) fees: to reflect efficient costs.
  • Further delay of the deed management related fees.
  • Introduction of an Intent to Apply step for PBAC secretariat submissions (Committee secretariat submissions): all Committee secretariat submissions lodged after 28 July 2020 will require an Intent to Apply form. This will result in an increase to the 2020-21 evaluation fee for these submissions.

Minor amendments to the National Health (Pharmaceutical and Vaccines—Cost Recovery) Regulations 2009 have been made to support these changes and to further clarify the department’s cost recovery administrative processes. An Explanatory Statement outlining details of all the changes is available below.

For further information regarding the 2020-21 cost recovery arrangements and regulations, please refer to:

Fee structure and invoice timing

Fees and Charges from 1 July 2020

All fees include an Intent to Apply/Notice of Intent fee unless otherwise stated.

Fees and Charges from 1 July 2020

Pre-submission services

Charge

Fee applicable

Comments

1st Pre-Submission Meeting

$16,290

-

2nd Pre-Submission Meeting

$21,360

-

ATAGI Pre-submission Evaluation Services

Charge

Fee applicable

Comments

Complex Submission

$180,950

-

Simple Submission

$103,270

-

PBAC Evaluation Submission Services

Charge

Fee applicable

Comments

Intent to Apply / Notice of Intent

$400

Included with certain fees, as stated.

Major Submission

$225,180

Intent to apply fee included.

Minor Submission

$40,470

Intent to apply fee included.

Committee Secretariat Submission

$11,280

Intent to apply fee included.

Generic Submission

$5,320

-

Independent Review

$224,780

-

Positive Recommendation Pathways (also known as Pricing Services)

Charge

Fee applicable

Comments

Pricing Pathway A

$120,810

Intent to apply fee included.

Pricing Pathway B

$93,700

Intent to apply fee included.

Pricing Pathway C

$58,920

Intent to apply fee included.

Pricing Pathway D

$19,910

Intent to apply fee included.

Pricing Secretariat

$10,890

Intent to apply fee included.

List Management Services

Charge

Fee applicable

Comments

Price increase / Brand premium request

$2,370

-

Ministerial discretion request

$3,540

-

Details of invoicing timing

Details of invoicing timing

ATAGI Pre-Submission Services
Applies to both Simple and Complex ATAGI Pre-Submission Services.

Invoicing point

Withdrawal for refund (prior notice is not refundable)

Invoicing term

Notification of fee waiver/exemption

Within 15 business days after the department receives intent to request ATAGI advice.

Whichever earlier before 11th business day after the applicant is invoiced, or the last business day before the meeting

20 business days after the invoicing date.

Wavier and exemption requests for ATAGI advice considered as part of PBAC submission process

Pre-Submission Services
Applies to 1st pre-submission meeting and 2nd or subsequent pre-submission meetings.

Invoicing point

Withdrawal for refund (prior notice is not refundable)

Invoicing term

Notification of fee waiver/exemption

Within 10 days after the department receives the meeting application and briefing papers.

Whichever earlier before 11th business day after the applicant is invoiced, or the last business day before the meeting.

20 business days after the invoicing date.

NA

NA

Major and Minor Submission Services with Intent to Apply
Applies to Major submissions and Minor submissions with an intent to apply.

Invoicing point

Withdrawal for refund (prior notice is not refundable)

Invoicing term

Notification of fee waiver/exemption

Within 10 business days after the department receives the application unless prior notice is exempted, then invoice will be issued within 15 business days.

Within 10 business days after the applicant is invoiced.

20 business days after the invoicing date, or automatically extended by 10 business days (i.e. 30 business days in total) for a waiver application.

Within 15 business days after a waiver/exemption application is received.

Other Submission Services
Applies to Minor submissions without an intent to apply, Committee Secretariat submissions and Generic submissions.

Invoicing point

Withdrawal for refund (prior notice is not refundable)

Invoicing term

Notification of fee waiver/exemption

Within 15 business days after the department receives the application.

Within 10 business days after the applicant is invoiced.

20 business days after the invoicing date.

Within 15 business days after a waiver/exemption application is received.

Pricing Services
Applies to Pricing Pathways A, B, C and D and Pricing Secretariat services.

Invoicing point

Withdrawal for refund (prior notice is not refundable)

Invoicing term

Notification of fee waiver/exemption

Within 10 business days after the department receives the application unless prior notice is exempted, then invoice will be issued within 15 business days.

Within 10 business days after the applicant is invoiced.

20 business days after the invoicing date, or automatically extended by 10 business days (i.e. 30 business days in total) for a waiver application.

Within 15 business days after a waiver/exemption application is received.

List Management Services
Applies to Price increase requests, Brand Premium requests and Ministerial discretion requests.

Invoicing point

Withdrawal for refund (prior notice is not refundable)

Invoicing term

Notification of fee waiver/exemption

Within 10 business days after the department receives the application.

Within 10 business days after the applicant is invoiced.

20 business days after the invoicing date, or automatically extended by 10 business days (i.e. 30 business days in total) for a waiver application. 

Within 10 business days after a waiver/exemption application is received.

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.

If required, please enter your purchase order number in the appropriate field on application forms to ensure this is included on your invoice.

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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