Cost Recovery Fees and Charges

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

Pre-Submission Services

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.

PBAC Evaluation Category Submission Services with Intent to Apply

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)

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.

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.

Pricing Services

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

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

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

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.

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 for the product

(Price x est. sales volume)

Less Cost of goods sold

Less Overhead costs*

= Net profit