Fees and charges - Frequently Asked Questions
Fees and charges - Frequently Asked Questions
Cost Recovery for Evaluation and Listing on the Pharmaceutical Benefits Scheme (PBS) & National Immunisation Program (NIP)
(Current as of 1 August 2010)
- PBS service fee application form: to accompany PBAC submission (Word 320 KB)
- National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009
- Explanatory Statement (Minute No. 42 of 2009)
- PBS Cost Recovery - Administrative Guidelines - Information for Applicants (PDF 101 KB)
When did cost recovery arrangements begin?
PBS cost recovery fees for the evaluation and listing of medicines, vaccines and other products or services on the PBS and NIP have applied since 1 January 2010.
Do I have to complete an application form?
Yes, an application form, provisionally titled ‘PBS service fee application form: to accompany PBAC submission’ (hereafter, the Application Form) will need to be completed for any submission to list a new drug or to extend an existing listing. A copy of the form is available here to download
The Application Form must be completed by the applicant, signed by an authorised person, and lodged with the submission to the PBAC Secretariat. It requires a ‘self assessment’ by the applicant as to the category of the submission to the PBAC.
- in most cases the category is reasonably evident to the applicant in the preparation of the submission to the PBAC. Should the applicant be unsure of the category they are encouraged to seek clarification from the PBAC Secretariat before submitting the application.
- the fee category ‘self assessment’ is not binding on the Department. The Department will determine the fee payable after consideration of the applicant’s ‘self assessment’ and advise in writing of the fee payable.
- if intending to apply for a fee exemption or a fee waiver, the applicant is required to nominate the fee category that would apply in the absence of the exemption or waiver.
Following receipt of the submission and accompanying Application Form by the Department, and following fee category assessment by Departmental staff, the Application Form will be separated from the submission. The information included on the Application Form will be used to initiate fee processing and will not be provided to the PBAC.
What are the submission categories?
The submission categories are defined in the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009.
The definitions in the Regulations are explained in the Explanatory Statement (Minute No. 42 of 2009).
The Regulations and the Explanatory Statement do not introduce any changes to the way the PBAC Secretariat currently evaluates submissions.
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PBS Cost Recovery Fee Category Description |
|
|---|---|
|
Submission Category |
Description |
|
PBAC Evaluation – Major (Regulations 2.3 - 2.6) |
In general, a major application seeks to list new drugs or medicinal preparations for PBS subsidy, or to make substantial changes to current listings. An application for a variation to an existing listing may also be major if it requires the PBAC to apply a health advantage test (as defined in Regulation 2.4). Major evaluations are complex evaluations of drugs for which PBS-listing may have significant financial implications. |
|
PBAC Evaluation – Minor (Regulations 2.7 – 2.11) |
In general, minor applications include those for new forms of an already listed drug or medicinal preparation, or changes to the conditions of their prescription or supply. These applications involve changes to existing items that do not have significant cost implications but which do require consideration by PBAC for clinical effectiveness and/or potential impact on the PBS. An otherwise major application may be deemed minor if it involves a resubmission (Regulation 2.10) or a medicinal food (Regulation 2.11). |
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PBAC Secretariat Listing (Regulations 2.12, 2.13)
|
These are a subset of minor applications that are straightforward and not considered as a separate agenda item at a meeting of PBAC. PBAC still decides the merit of each application. They may be considered in or out of session by PBAC. |
| Submission Category | Description |
|---|---|
|
Listing of a New Brand (Generic) Medicine (Regulation 2.14) |
Where a new product is listed on the PBS because it is bioequivalent or biosimilar and the price is already determined by an existing item. However, if the application is in respect of a product listed in Schedule 2 of the Regulations (currently somatropin and glucose indicators), it is deemed to be an exception under Regulations 2.9 and 2.13, and is classified as minor or PBAC Secretariat. |
|
Submission Category |
Description |
|---|---|
|
Independent Review (Regulation 4.3) |
Independent review is available for applicants where the PBAC has declined to recommend the listing of a new drug on the PBS or in certain circumstances where PBAC has not recommended the listing of an additional indication of an already listed drug – refer to the website http://www.independentreviewpbs.gov.au for additional information. |
What process must be followed for a major submission?
It is recommended, although not mandatory, that an authorised representative of the applicant contact the PBAC Secretariat for a preliminary discussion about the intended submission. At these pre-submission meetings, the Secretariat can provide advice on the application process and will provide guidance, where appropriate, on fee exemptions and waivers.
A PBS service fee application form: to accompany PBAC submission (the Application Form) must be downloaded from the www.pbs.gov.au website and completed by an authorised representative of the applicant. It is important that the Application Form is completed fully to reduce the risk of delay in processing of the submission.
On the Application Form, the applicant is required to nominate the fee category for the applicant’s submission. That is, the Major submission category should be selected. If intending to apply for a fee exemption or a fee waiver, the applicant is required to nominate the fee category that would apply in the absence of the exemption or waiver – in this case, the Major submission category.
See below for additional information on fee exemptions and fee waivers.
The submission is to be compiled in the usual manner, in accordance with the Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (the Guidelines). These Guidelines are periodically updated.
The Application Form should be forwarded to the PBAC Secretariat with the submission. The address for major submissions is:
| Mailing address: | Physical address: |
|---|---|
|
PBAC Secretariat |
PBAC Secretariat |
An applicant is not required to forward fee payment with the submission. Following receipt of the submission and a Departmental assessment of the fee category, a request for payment letter with an accompanying invoice will be forwarded to the Responsible Person nominated on the Application Form.
What process must be followed for a minor submission?
It is recommended, although not mandatory, that an authorised representative of the applicant contact the PBAC Secretariat for a preliminary discussion about the intended submission. At these pre-submission meetings, the Secretariat can provide advice on the application process and will provide guidance, where appropriate, on fee exemptions and waivers.
A PBS Service Fee Application Form.doc (the Application Form) must be downloaded from the www.pbs.gov.au website and completed by an authorised representative of the applicant. It is important that the Application Form is completed fully to reduce the risk of delay in processing of the submission.
On the Application Form, the applicant is required to nominate the fee category for the applicant’s submission. That is, the Minor submission category should be selected. If intending to apply for a fee exemption or a fee waiver, the applicant is required to nominate the fee category that would apply in the absence of the exemption or waiver – in this case, the Minor submission category.
See below for additional information on fee exemptions and fee waivers.
The submission is to be compiled in the usual manner, in accordance with the Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (the Guidelines). These Guidelines are periodically updated.
The Application Form should be forwarded to the PBAC Secretariat with the submission. The address for minor submissions is:
| Mailing address: | Physical address: |
|---|---|
|
PBAC Secretariat |
PBAC Secretariat |
On occasion, a PBAC Secretariat review of the submission will indicate that the submission is suitable for PBAC Secretariat Listing without referral to the PBAC. The applicant will be notified of this decision. The fee payment amount relevant to PBAC Secretariat Listing will apply.
An applicant is not required to forward fee payment with the submission. Following receipt of the submission and a Departmental assessment of the fee category, a request for payment letter with an accompanying invoice will be forwarded to the Responsible Person nominated on the Application Form.
What process must be followed to apply for listing of a new brand of an existing listed product (generic listing)?
In respect of listing of a new brand of an existing listed product it is not necessary that the applicant contact the PBAC Secretariat for a preliminary discussion about the intended submission. However, if there is any uncertainty about the nature of the submission (for example, where potential exists for the submission to fall within the minor submission category), the applicant is advised to contact the PBAC Secretariat for clarification. At these pre-submission meetings, the Secretariat can provide advice on the correct submission category and the relevant application process. The PBAC Secretariat can also provide guidance, where appropriate, on fee exemptions and waivers
Completion of a PBS SERVICE FEE APPLICATION FORM: TO ACCOMPANY PBAC SUBMISSION is not required for submissions for new brand (generic) listings.
An application for listing a new brand (generic) equivalent of an already-listed drug does not usually require a submission to PBAC. Applications should be sent to the Listing Unit within the Pharmaceutical Evaluation Branch. The Listing Unit Requirements outline the information that needs to be submitted for these applications. Further information can be obtained by contacting the Listing Unit.
The address for the Listing Unit is as follows:
| Mailing address: | Physical address: |
|---|---|
|
Listing Unit |
Listing Unit |
An applicant is not required to forward fee payment with the submission. Following receipt of the application and a Departmental assessment of the fee category, a request for payment letter with an accompanying invoice will be forwarded to the Responsible Person nominated by the applicant.
What are the pricing fee categories?
The pricing categories are defined in the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009.
The definitions in the Regulations are explained in the Explanatory Statement (Minute No. 42 of 2009).
The pricing assessment category will not necessarily be determined by the submission evaluation category, but will reflect the extent of the work required of the Pharmaceutical Benefits Pricing Authority.
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Pricing Category |
Description |
|---|---|
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Complex (Regulation 3.3)
|
‘Complex ’ negotiations are defined as those which: |
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Simple (Regulation 3.4) |
‘Simple’ negotiations are defined as those which: |
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Pricing Secretariat (Regulation 3.5) |
A pricing application that is considered as a PBAC Committee Secretariat Listing and is not considered by the PBPA. |
How much are the fees?
The fees are outlined in the Schedules to the National Health (Pharmaceutical and Vaccines – Cost Recovery) Regulations 2009 (the Regulations). The Regulations set out the cost recovery arrangements in detail, including the fees charged and requirements for fee exemptions and waivers.
The fees are based on an activity based costing model and volume estimates. The fees are as follows:
|
Application Point |
PBAC Evaluation - Major |
$A119,500 |
|
|
PBAC Evaluation – Minor |
$A12,500 |
|
|
PBAC Secretariat Listing |
$A1,000 |
|
|
Listing of a new brand of an existing listed product (generic) |
$A500 |
|
Pricing Point (after completion of pricing negotiations) |
Pricing - Complex |
$A25,000 |
|
|
Pricing - Simple |
$A6,000 |
|
|
Pricing - Secretariat Listing |
$A1,000 |
|
Independent Review Point |
Independent Review |
$A119,500 |
NOTE:
- No GST is payable on the fees.
Will the current processing trials undertaken jointly by Medicines Australia and the Department be affected by the introduction of fees for service?
The Department and Medicines Australia are trialling different ways of progressing submissions more quickly. Details of what is involved, how it will develop and whether it will become a permanent part of the way business is done is not yet known.
A guiding principle under cost recovery is that fees should reflect the cost of providing the service. Therefore, if a trial is initiated after the introduction of cost recovery, the applicable fee, as outlined above, may be charged. The Department is in continuing discussions with Medicines Australia. This advice will be updated as soon as possible.
When do I need to pay?
Three payment points have been identified.
1. when lodging a submission (includes resubmissions).
2. at completion of pricing negotiations (before listing).
3. at request for an independent review of a PBAC decision.
Fees are to be paid by the due date indicated in the invoice. The invoice will be sent by email and post. Please do not forward payments before an invoice is received from the Department. In some circumstances, where short timeframes are required before the Department incurs major expenses, for example undertaking an independent review, a 14 day terms of trade for payment will be required.
Will ad hoc price review submissions to the PBPA in relation to an existing listing incur a fee?
No fee will apply to ad hoc price reviews initiated by the Department. However, where an applicant company initiates a price review request, this action will fall under the cost recovery guidelines. The pricing fee category of complex, simple or PBPA Secretariat Listing will be applied depending on the amount of work involved.
How do I pay?
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 assigned by the Pharmaceutical Evaluation Branch 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. Each submission must be accompanied by an individual full payment; that is, if two submissions are lodged, two EFT payments must be made. Payments cannot be grouped into one, as each submission will have its own Unique Identifying Number.
Payment by instalment will not be accepted unless by prior agreement with the Department’s delegate. Partial payments may only be accepted in exceptional circumstances and must be agreed to, in advance, by the Department’s delegate.
What do I need to do if my company has a computerised financial control system and we need to add the Department of Health and Ageing to the system for payment processing purposes?
You should contact the PBS cost recovery team advising them of the issue and providing a copy of the form used by your company detailing the information required. The PBS cost recovery team can be contacted at their email address: PBScostrecovery@health.gov.au
Please allow at least a week for the provision of such information. Companies are welcome to lodge these requests before receiving an invoice from the Department.
What happens if an applicant withdraws a submission?
An applicant may withdraw a submission at any time after lodgement. If it is withdrawn in the first 14 days following receipt of advice of the fee payable, no fee is payable. If for any reason the fee has already been paid, the applicant is entitled to a full refund of any fees paid. If the submission is withdrawn after 14 days have passed from advice of the fee payable on the invoice (that is, on or after day 15), the full fee remains payable.
If the applicant wishes to withdraw a submission, the request must be in writing, on appropriate company letterhead and signed by a suitably authorised representative.
What are the critical times associated with lodgement fees?
Under the Regulations, some decisions or actions in respect of fee payments, whether decisions or actions on the part of the applicant or on the part of the Department, must occur within a prescribed period. This applies particularly where the Department is likely to incur significant expense in the event of delay.
In respect of decisions made by the applicant, critical time frames include:
|
Applicant seeking a full refund of a fee following withdrawal of the application |
Written notice of withdrawal must be forwarded to the Department within 14 days of receipt by the applicant of advice of the fee payable |
|
Applicant seeking internal review of a Departmental decision with regards to evaluation fee category |
Request for review must be made within 14 days of receipt by the applicant of Departmental invoice and notice of the evaluation category |
|
Applicant seeking internal review of a Departmental decision with regards to pricing fee category |
Request for review must be made within 14 days of receipt by the applicant of Departmental invoice and notice of the pricing category |
|
Applicant seeking internal review of a Departmental decision not to approve a request for fee waiver |
Request for review must be made within 14 days of receipt by the applicant of Departmental notice of the fee waiver decision |
What happens if the fee is not paid or is late?
If the lodgement fee has not been received by the due date, as outlined in the invoice’s terms of trade, the Department may halt further work on processing the submission until the fee is paid. Before work halts, or referral for debt recovery action, the Department will contact the applicant.
Unpaid fees shall be a debt owing to the Commonwealth and will be subject to standard Commonwealth debt recovery processes.
Are certain submissions exempt from fees?
Some submissions will be exempt from fees. These are detailed in Part 5.1 of the Regulations. An example of its application is no fee will be charged for submissions identified by the TGA as an ‘orphan drug’ or where a medicine is for ‘temporary supply’.
Temporary supply may be required where a listed PBS product manufacturer, or sponsor, has temporary difficulties in supplying a registered medicine which the Department deems essential for patient care.
If the TGA is willing to grant permission for temporary supply of a similar product through granting an exemption from entry in the Australian Register of Therapeutic Goods (ARTG) until normal supply of the registered medicine can be restored, the Department, on the recommendation of the PBAC, may list this product on the PBS on a temporary basis.
In a national emergency, the Secretary to the Department may consider the supply of a drug, medicinal preparation or vaccine to be necessary because of a public health event of national health significance; or, because of a public health emergency under section 2B or 12A of the Quarantine Act 1908, and may exempt submissions from cost recovery fees for the PBAC assessment and PBS or NIP listing process.
The applicant must provide supporting documentation at the time of lodgement to verify the status of exemption sought under the categories of ‘orphan drug’ or ‘temporary supply’.
Can fees be waived for certain submissions?
Yes, an applicant may apply to the delegate of the Secretary to waive the fee if the submission involves a public interest component and where payment of the fee would make proceeding with the application financially unviable. Further details on the exemption process may be found in Part 5.2 of the Regulations.
The applicant must provide supporting documentation at the time of lodgement with the application for waiver. The delegate may request further information from the applicant, and/or other sources, before making a decision.
The delegate will assess the application to waive the fee and is required to decide the fee payable (if any), or whether the fee is to be waived.
Can fees be waived before lodgement of a PBAC submission?
No, the fee cannot be waived before lodgement of a PBAC submission. The fee can only be waived on receipt of the actual submission. However, the Department can provide an early indication about whether a particular submission fits within the fee waiver requirements if discussed at a PBAC pre-submission meeting.
Pre-submission meetings to discuss the submission, including a possible fee waiver, can take place at most times before lodgement of the submission for PBAC consideration. Pre-submission meetings are not available in the week before the deadline for lodging a major submission.
Discussions on fee waiver at a pre-submission meeting should be supported by a short document containing information on what the medicine, vaccine or other product seeks to do, its benefit, the target population including estimated utilisation and a brief outline of the financial viability or otherwise of the application.
If the applicant has been invited to seek the listing of a medicine, vaccine or other product by either PBAC or one of the Department’s health working groups that information should also be presented at that time.
At the pre-submission meeting, senior PBAC Secretariat staff will be able to provide an initial, non-binding, assessment against the waiver criteria. The provisional assessment will permit the company to make a reasonably informed business decision whether or not to proceed with developing the submission.
A company may seek further meetings before lodging the application to ensure the submission still meets the ‘provisional fee waiver’ criteria as the business case and data develop over time.
Will there be capacity to review a fee decision?
Should the applicant disagree with the fee determination of the delegate, the regulations provide for a review process. Further details on rights of review can be found in Part 6 of the Regulations.