Cost Recovery Fees and Charges

Page last updated: 11 May 2022

This page provides details on:

Background on cost recovery for PBS and NIP listings

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 CRIS for the 2021-22 financial year reflects the fee structure effective from 1 July 2021.

Cost recovery arrangements from 1 July 2021

Amendments to the National Health (Pharmaceutical and Vaccines—Cost Recovery) Regulations 2009 (2009 Regulations) came into effect on 1 July 2021 to support the annual indexation of cost recovery fees. The 2009 Regulations were due to sunset automatically on 1 April 2022 and the department remade the 2009 Regulations prior to the automatic sunsetting date. The new National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 (Regulations) and an Explanatory Statement outlining details of the new Regulations is available below:

For further information regarding the 2021-22 cost recovery arrangements and regulations, please refer to:

Fees and Charges from 1 July 2021

All fees include a non-refundable deposit for the Intent to Apply or Notice of Intent for Pricing, unless otherwise stated.

Pre-submission services

Charge

Fee applicable

Comments

1st Pre-Submission Meeting

$15,700

 

2nd Pre-Submission Meeting

$21,350

 

ATAGI Pre-submission Evaluation Services

Charge

Fee applicable

Comments

Complex Application

$181,500

 

Simple Application

$103,560

Requests for ‘simple’ ATAGI applications must be sought in writing.

PBAC Evaluation Submission Services

Charge

Fee applicable

Comments

Intent to Apply / Notice of Intent for Pricing

$430

Included with certain fees, as stated.

Category 1

$225,120

Intent to Apply fee included.

Category 2

$170,050

Intent to Apply fee included.

Category 3

$43,360

Intent to Apply fee included.

Category 4

$33,980

Intent to Apply fee included.

Resubmission - Standard re-entry pathway

$167,980

Intent to Apply fee included.

Resubmission – Facilitated resolution pathway

$240,570

Deposit of $72,440 included (Intent to Apply fee + workshop fee).

Resubmission - Early re-entry pathway

$42,010

Intent to Apply fee included.

Resubmission - Early resolution pathway

$42,160

Intent to Apply fee included.

Committee Secretariat

$12,270

Intent to Apply fee included.

Generic Submission - New brand or new oral form of existing pharmaceutical item

$6,500

 

Positive Recommendation Pathways (also known as Pricing Services)

Charge

Fee applicable

Comments

Rebate Management fee

$8,340

Included in certain fees, as stated.

Pricing Pathway A

$142,540

Notice of Intent for Pricing fee and the Rebate Management fee is included.

Pricing Pathway B

$112,810

Notice of Intent for Pricing fee and the Rebate Management fee is included.

Pricing Pathway C

$74,680

Notice of Intent for Pricing fee and the Rebate Management fee is included.

Pricing Pathway D

$20,460

Notice of Intent for Pricing fee included.

Pricing Secretariat

$12,690

Notice of Intent for Pricing fee included.

List Management Services

Charge

Fee applicable

Comments

Deed Variations

$1,980

 

Deed Renewals

$10,410

Rebate Management fee is included.

Price increase / Brand premium request

$5,080

 

Ministerial discretion request

$7,090

 

Details of invoicing timing

ATAGI Pre-Submission Services

Applies to both Simple and Complex ATAGI Pre-Submission Services.
Invoicing point Withdrawal for refund Notification of fee waiver/exemption
Within 15 business days after the department receives intent to request ATAGI advice. Within 10 business days after the applicant is invoiced. Within 15 business days after the department receives request for fee waiver and fee exemption requests for ATAGI advice through the notice of intent or the ATAGI application if the notice of intent is not required.

Pre-Submission Services

Applies to 1st pre-submission meeting and 2nd or subsequent pre-submission meetings.
Invoicing point Withdrawal for refund Notification of fee waiver/exemption

Within 10 business days, except where an application is received more than 30 business days before the intended meeting date.

If a decision  to hold a pre-submission meeting is made more than 30 business days before the intended meeting date, then the invoice will be issued within 20 business days before the scheduled meeting date.

Before the end of the last business day before the meeting is to be held. N/A

PBAC Evaluation Category Submission Services with Intent to Apply

Applies to all evaluation categories with an intent to apply (excluding New Brands or New Oral Form/Generic submissions).
Invoicing point

Withdrawal for refund (Intent to Apply fee is not refundable)

When the department receives the Intent to Apply, an invoice will be issued at least 10 business days before the submission due day.

If the Intent to Apply is not required, an invoice will be issued within 15 business days after the day the submission is received.

By the submission due date or within 10 business days after the applicant is invoiced (whichever is later)

Notification/invoicing point for fee waivers and exemptions Withdrawal for refund (Intent to Apply fee is not refundable) for fee waivers and exemptions

When the department receives an Intent to Apply with a fee waiver or exemption request, the invoice will be issued at least 5 business days before the submission due day if the fee waiver or exemption is not granted.

If the Intent to Apply is not required and the department receives the submission with a fee waiver or exemption request, the invoice will be issued within 15 business days after the day the submission is received if the fee waiver or exemption is not granted.

If the fee exemption/waiver request is granted, then no invoice will be sent.

Within 10 business days after the notification and invoice is sent, and this is only applicable to applications which a fee exemption/waiver is not granted.
Invoicing point for Facilitated Resolution Pathway Withdrawal for refund (Intent to Apply fee is not refundable) Notification of fee waiver/exemption

When the department receives the Intent to Apply, an invoice will be issued at least 10 business days before the submission due day.

If the Intent to Apply is not required, an invoice will be issued within 15 business days after the day the submission is received.

On or before the last business day before the scheduled workshop date.

When the department receives an Intent to Apply with a fee waiver or exemption request, the invoice will be issued at least 5 business days before the submission due day if the fee waiver or exemption is not granted.

If the Intent to Apply is not required and the department receives the submission with a fee waiver or exemption request, the invoice will be issued within 15 business days after the day the submission is received if the fee waiver or exemption is not granted.

If the fee exemption/waiver request is granted, then no invoice will be sent.

New Brands or New Oral Form/Generic submissions
Invoicing point Withdrawal for refund (Intent to Apply fee is not refundable) Notification of fee waiver/exemption
Within 15 business days after the department receives the application. Within 10 business days after the applicant is invoiced. 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 (Notice of Intent for Pricing fee is not refundable)

Within 10 business days after the department receives the Notice of Intent. If the Notice of Intent is not required, the invoice will be issued within 15 business days after the day the pricing application is received. Within 10 business days after the applicant is invoiced.
Notification/Invoicing point for fee waivers and exemptions Withdrawal for refund (Notice of Intent for Pricing fee is not refundable) for fee waivers and exemptions
Within 15 business days after the department receives the applicant’s request for a fee waiver or exemption, the invoice will only be issued if the fee waiver or exemption is declined. Within 10 business days after the applicant is invoiced.
Rebate Management Fee

When the applicant withdraws their application; or the department ceases pricing services, and a new deed arrangement has not been entered into.

List Management Services

Applies to Deed Variations, Deed Renewals, Price increase requests, Brand Premium requests and Ministerial discretion requests.
Invoicing point Withdrawal for refund Notification of fee waiver/exemption
Within 15 business days after the department receives the application Within 10 business days after the applicant is invoiced. Within 15 business days after a waiver/exemption application is received.
Rebate Management Fee* Deed renewal requests only

When the applicant withdraws their application and a new deed arrangement has not been entered into.

Payments

The preferred method for paying the fees for all PBAC submissions (except Pricing Services submissions) is via the Health Products Portal (HPP) using Government EasyPay. For further information on paying invoices through the HPP, see the Using the HPP - quick reference guide. Other payment methods are specified on the invoice. If paying by EFT, you must include the invoice number in the free text portion of the transaction to allow identification of your payment. If you wish to make other arrangements for paying the fee, please contact the department using the contact details provided on the invoice. If you require a receipt, please request one by emailing CRM@health.gov.au.

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.

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

All payment terms are 28 days after invoice date. 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.

Fee exemptions

An application for ATAGI advice, submission services, a pricing pathway or list management application will be exempt from cost recovery fees if it meets the criteria for exemption as outlined in Section 67 of the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 (Regulations).

All fee exemption requests must include in the application reasons why Section 67 of the Regulations would apply. This can be addressed in a cover letter accompanying the application or submission, stating which subsection of the Regulations would apply for the application or submission, along with supporting evidence.

Orphan drug designation

An ‘orphan drug’ is one that is designated by the TGA under Regulation 16J of the Therapeutic Goods Regulations 1990, as described on TGA’s orphan drug eligibility criteria webpage.

If an applicant is applying for a fee exemption under subsection 67(4) of the Regulations for orphan drug designations, the applicant must provide the TGA letter showing a valid orphan drug designation for the same medicine and indication, or provide evidence that the application has been listed on the Australian Register of Therapeutic Goods (ARTG) within the prior 12 months and had a valid orphan drug designation at the time of listing.

Please note that fee exemptions do not apply to pre-submission services and Independent Review services.

Regulations reference

Fee exemption category

Full exemption category as per the Regulations

67(1)(a)

Temporary supply

A drug that is exempt from entry in the Australian Register of Therapeutic Goods because of an approval granted under section 19A of the Therapeutic Goods Act 1989

67(1)(b)

Public health events

If the Secretary considers that the supply of a drug, medicinal preparation or vaccine is necessary for the management of:

  1. a public health event of national significance; or
  2. a biosecurity emergency that is declared to exist under subsection 443(1) of the Biosecurity Act 2015; or
  3. a human biosecurity emergency that is declared to exist under subsection 475(1) of the Biosecurity Act 2015;

67(2)(a)

Price reductions

to offer a price reduction

67(2)(b)

Responsible person name change

to change the name of the responsible person

67(2)(c)

Vary a determination under ss9B(2)

to vary a determination under subsection 9B(2) of the Act so that a vaccine ceases to be a designated vaccine

67(2)(d)

Revoke a determination under ss9B(2)

to revoke a determination under subsection 9B(2) of the National Health Act 1953 (Act)

67(2)(e)

Vary an arrangement under ss100(2)

to vary an arrangement under subsection 100(2) of the Act so that a drug or medicinal preparation ceases to be covered by the arrangement

67(2)(f)

Revoke an arrangement under ss100(2)

to revoke an arrangement under subsection 100 (2) of the Act

67(2)(g)

Vary a declaration under ss101(4AAA)

to vary a declaration under subsection 101 (4AAA) of the Act so that a drug or medicinal preparation ceases to be a listed drug

67(2)(h)

Revoke a declaration under ss101(4AAA)

to revoke a declaration under subsection 101 (4AAA) of the Act

67(2)(i)

To decrease the existing pack quantity with no price implications

to decrease the pack quantity (the existing pack quantity) of a listed brand of a pharmaceutical item if the amount that is to be the appropriate maximum price of the decreased pack quantity to be agreed under section 85AD of the Act will be calculated proportionally based on the approved ex manufacturer price of the existing pack quantity on the day before the agreement under that section takes effect

67(2)(k)

Vary a declaration, determination, arrangement or other legislative instrument at the request of Services Australia, TGA or Government

to vary a declaration, determination, arrangement or other legislative instrument made under section 9B or Part VII of the Act:

  1. at the request of Services Australia or the Therapeutic Goods Administration; or
  2. that is a mandated change because of a Government initiative.

67(4),(5)&(6)

Orphan drug designation for first time submissions to PBAC only, within the first 12 months of being included on the Australian Register of Therapeutic Goods (ARTG)

Exemption for submission services relating to designated orphan drugs

(4) No fee is payable under this instrument for submission services provided in response to a person’s submission proposing a therapy involving the use of one or more drugs or medicinal preparations if:

(a) on the day the submission is given to the Department, subsection (5) applies to each of those drugs or medicinal preparations; and

(b) this subsection has not already applied to submission services provided in response to an earlier submission by the person proposing the same therapy involving the use of any of those drugs or medicinal preparations.

(5) This subsection applies to a drug or medicinal preparation (the drug) on a day if:
 

(a) on that day, the drug is a designated orphan drug; or
 

(b) both:
 

(i) on that day, the Secretary is yet to decide whether to include the drug in the Australian Register of Therapeutic Goods in response to an application made by the person on or before that day; and
 

(ii) were the drug to be so included, the registration fees for doing so would be waived under paragraph 45(12)(c) of the Therapeutic Goods Regulations 1990 because the drug is a designated orphan drug; or

(c) less than 12 months before that day, the drug was included in the Australian Register of Therapeutic Goods and the registration fees for doing so had been waived under paragraph 45(12)(c) of the Therapeutic Goods Regulations 1990 because the drug was a designated orphan drug.

Fee waivers

An applicant may apply to the delegate of the Secretary to waive the fee for ATAGI advice, submission services, pricing services or list management services if the application involves a public interest component and where payment of the fee would make proceeding with the application financially unviable.

In preparing a fee waiver request application, the applicant is required to provide sufficient evidence to allow a delegate to be satisfied that under section 68 of the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022 that:

  1. the submission involves the public interest; and
  2. payment of fees would make the submission financially unviable.

It is recommended the applicant includes all relevant information and supporting evidence for the department to consider the facts and circumstances of their individual application. This can be addressed in a cover letter accompanying the application.

Supporting documentation should include:

To address the public interest criterion:

To address the financial unviability criterion:

How the application involves the public interest, which may include but are not limited to applications where the drug or vaccine:

  • represents a suitable therapy for a patient population that is not large enough to make the application financially viable; or
  • is to be used for palliative care, as a paediatric medicine, or for medical treatment of Aboriginal and/or Torres Strait Islander peoples.

What the medicine, vaccine or other product seeks to do and its benefit, for example:

  • If the PBAC or one of the department’s health working groups has encouraged the applicant to seek PBS/NIP listing of a medicine, vaccine or other product, the supporting documentation should include this information.
  • Provide sufficient justification to satisfy the delegate of how the product offers a benefit over other items listed on the PBS/NIP.

The target population including estimated utilisation, for example:

  • Include a summary on population type, prevalence patient splits etc.

A brief outline of the anticipated financial viability of the application:

  • The applicant should provide evidence of how payment of the fee would make the application financially unviable.
  • It is recommended that details of the company’s profit and loss for the product over a period of five to six years or over the lifecycle of the product be included.
  • The extent to which the fee that has been requested to be waived would be returned through expected revenue from future PBS/NIP listing.
  • Costs directly attributable to the product should be included, and while other costs not included in the production of the product may be included, this would need to be made clear and detailed.

 

  • If other costs are included (i.e. overhead costs), this must be able to be justified with additional supporting documentation, such as through a further breakdown to show the category split such as head office costs, storage and transportation costs or sales costs.

An example of how financial unviability could be presented is shown in the table below:


 

Example of how financial unviability could be presented:

 

Year 1

$

Year 2

$

Year 3

$

Year 4

$

Year 5

$

Year 6

$

Revenue for the product

(Price x est. sales volume)

 

 

 

 

 

 

Less Cost of goods sold

 

 

 

 

 

 

Less Overhead costs*

 

 

 

 

 

 

= Net profit

 

 

 

 

 

 

*While not required, if included, overhead costs would need to be justified, and a further breakdown showing the split between categories required.

Contact the Cost Recovery Unit

Email: pbscostrecovery@health.gov.au

 

 

 

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