Cost Recovery Fees and Charges

ATAGI Pre-submission Evaluation Services

Charge

Fee applicable

Comments

Notice of Intent

$455

Included with certain fees, as stated.

Complex Application

$214,435

Notice of Intent fee included

Simple Application

$118,305

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

Notice of Intent fee included.

Pre-submission services

Charge

Fee applicable

Comments

1st Pre-Submission Meeting

$16,410

2nd Pre-Submission Meeting

$22,290

PBAC Evaluation Submission Services

Charge

Fee applicable

Comments

Notice of Intent

$455

Included with certain fees, as stated.

Category 1

$264,595

Notice of Intent fee included.

Category 2

$206,435

Notice of Intent fee included.

Category 3

$45,155

Notice of Intent fee included.

Category 4

$35,405

Notice of Intent fee included.

Resubmission - Standard re-entry pathway

$204,245

Notice of Intent fee included.

Resubmission – Facilitated resolution pathway

$280,175

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

Resubmission - Early re-entry pathway

$43,785

Notice of Intent fee included.

Resubmission - Early resolution pathway

$43,935

Notice of Intent fee included.

Committee Secretariat

$12,785

Notice of Intent fee included.

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

$6,830

Independent Review

$169,620

Positive Recommendation Pathways (also known as Pricing Services)

Charge

Fee applicable

Comments

Rebate Management fee

$8,980

Included in certain fees, as stated.

Pricing Pathway A

$148,955

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

Pricing Pathway B

$118,005

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

Pricing Pathway C

$78,215

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

Pricing Pathway D

$21,345

Notice of Intent fee included.

Pricing Secretariat

$13,225

Notice of Intent fee included.

List Management Services

Charge

Fee applicable

Comments

Deed Variations

$2,060

Deed Renewals

$11,230

Rebate Management fee is included.

Price increase / Brand premium request

$5,300

Ministerial determination request (Stockholding request)

$5,190

Ministerial discretion request

$7,350

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 – Pre-submission meeting requests

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 Submission Services with Notice of Intent

Applies to all evaluation categories with an Notice of Intent (excluding New Brands or New Oral Form/Generic submissions)

Invoicing point

Withdrawal for refund (Notice of Intent fee is not refundable)

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

If the Notice of Intent 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 (Notice of Intent fee is not refundable) for fee waivers and exemptions

When the department receives a Notice of Intent 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 Notice of Intent 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 (Notice of Intent fee is not refundable)

Notification of fee waiver/exemption

When the department receives the Notice of Intent, an invoice will be issues at least 10 business days before the submission due day.

If the Notice of Intent 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 a Notice of Intent with fee waiver or exemption requests, 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 Notice of Intent 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, the no invoice will be sent.

New Brands or New Oral Form/Generic submissions

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.

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

Invoicing point

Withdrawal for refund (Notice of Intent 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 waiver and exemptions

Withdrawal for refund (Notice of Intent 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, Ministerial determination request (Stockholding) 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.

Application has an active orphan drug designation status, and the applicant has not previously applied for an orphan drug fee exemption.

In terms of orphan drug designations, it is not only specific to the medicine, but also to the designated use of the medicine. Orphan drug designation for a medicine must be the same:

• Applicant or sponsor (cannot be transferred between applicants).

• Orphan indication for which designation was granted.

• Dosage form of the medicine.

67 (4)(a)

Orphan drug designation lapsed, the PBAC submission has been submitted in parallel with an application for the orphan drug to be registered on the ARTG and the applicant has not previously applied for an orphan drug fee exemption.

67(5)(b)(i) & (ii)

Orphan drug designation has lapsed; however, the orphan drug was registered on the ARTG within the last 12 months and the applicant has not previously applied for an orphan drug fee exemption.

67 (5)(c)

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 National Health Act 1953 (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 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 at the TGA; 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 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 ARTG 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 ARTG 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.

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:

Revenue

Cost of Goods Sold (COGS)

Gross Profit

LESS

Expenses e.g. Marketing, Advertising & Promotion (example only)

General & Administrative (example only)

Freight (example only)

Earnings before depreciation & taxes