PBS Process Improvements – Frequently Asked Questions
Page last updated: 25 July 2019
Index
I am requesting a pre-submission meeting for a resubmission – which fee will I need to pay?
What should I do if I am unsure if my submission is a minor submission or a secretariat submission?
Does the new system apply to all submissions? Vaccines? Nutritional? Biosimilars? Generics?
What has changed for generic medicine listing applications?
How do I apply for an orphan exemption?
I am requesting a pre-submission meeting for a resubmission – which fee will I need to pay?
A pre-submission meeting application relating to a re-submission to the PBAC is considered under the Regulations as if it were a new application.
From 1 July, revised cost recovery arrangements for the PBS listing processes commenced. These arrangements now include fees for pre-submission meetings, which fall into two categories:
- First meeting relating to a submission
- Second or subsequent meeting relating to a submission
The fee for a second or subsequent meeting will only apply if a first meeting had been previously convened and invoiced in relation to the submission. Therefore, if a pre-submission meeting for a given submission had been held before 1 July 2019, a second meeting relating to this submission requested on or after 1 July 2019 will be charged the first meeting fee. Any subsequent meetings following an invoiced first meeting will be charged the second or subsequent meeting fee.
In instances where an applicant remakes or resends an application for a pre-submission meeting, either in the same or amended form, the Regulations apply to the resent application as if it were a new application.
Why is the fee for a second and subsequent pre-submission meeting higher than for the initial meeting?
An Activity based costing methodology has been applied to allocate costs to activities in line with the Australian Government Charging Framework and the Cost Recovery Guidelines.
Due to the more complex nature of issues for discussion, additional preparation time and a greater level of expertise are required for second and subsequent pre-submission meetings. This level of complexity is reflected in the higher fee for these meetings.
When should I have a pre-submission meeting and submit an Intent to Apply for my integrated co-dependent submission?
Pre-submission meetings are applicant-driven and the processes regarding requesting and participating in a pre-submission meeting are outlined in the Procedure Guidance for Pre-submission Meetings.
A pre-submission meeting for an integrated co-dependent submission should be convened at least 16 weeks before the relevant integrated co-dependent submission lodgement due date. This timeframe allows for pre-submission meeting outcomes to be prepared and acknowledged, and for the advice provided to be fully considered by the applicant in the development of their submission.
The Intent to Apply step is a mandatory requirement of the PBAC submission process and is required for all integrated co-dependent submissions at least 28 days before the relevant integrated co-dependent submission lodgement due date. Intent to Apply and lodgement dates for integrated co-dependent submissions are published in the MSAC calendar.
What should I do if I am unsure if my submission is a minor submission or a secretariat submission?
From 1 July 2019, major and minor submissions to the PBAC include a mandatory intent to apply step, however a secretariat submission does not require this step. If you are unsure whether your submission is a minor submission (and therefore requires an intent to apply to be submitted) or a secretariat submission, please contact the PBAC Secretariat via PBAC@health.gov.au prior to the deadline for lodging the intent to apply for minor submissions outlined in the PBAC calendar.
If any doubt remains about the submission category, applicants are encouraged to submit their application as a minor submission following the intent to apply process. In instances where the department determines that the application should have instead been made as a Committee Secretariat submission, the department will provide written notice to the applicant and any difference in fees will be refunded to the applicant.
If an applicant incorrectly categorises their submission as a secretariat submission and does not submit the intent to apply form, the department will be unable to accept the application as a minor submission for consideration at the requested PBAC meeting. The applicant will be required to re-submit their application following the Intent to Apply process and timelines for submission to the next PBAC meeting.
Does the new system apply to all submissions? Vaccines? Nutritional? Biosimilars? Generics?
From 1 July 2019, the process improvements for pre-submission meetings, intent to apply, and positive recommendation pathways applies to all submissions brought forward to the PBAC for consideration, which includes vaccines, nutritional products and biosimilars. Generic medicine listing applications are not impacted by these process changes. Note: ATAGI fees have been delayed to 1 July 2020.
What has changed for generic medicine listing applications?
From 1 July 2019, the department introduced an Application Form for Submission Services. This form was introduced to streamline submission services provided by the department and to align with revised cost recovery arrangements. Part C – Application for a new brand of an existing pharmaceutical item of the Application Form for Submission Services relates to generic medicine listing applications.
Completion of Part C is being phased in from 1 July and will become mandatory for all generic medicine listing applications submitted from 1 September 2019. For further information, please refer to the Cost Recovery Administrative Guidelines.
Part A – Intent to Apply and Part B – Application to accompany PBAC submission are not required for generic applications.
As generic medicine listing applications are not considered by the PBAC, these applications do not follow the new pricing pathways. Apart from the requirement to use the new form, there are no changes in processes for generic medicine listing applications. For further information on the Listing requirements, please refer to the Procedure Guidance: 5.7 New brand of existing pharmaceutical item submissions (not requiring PBAC consideration)
How do I apply for an orphan exemption?
An ‘orphan drug’ is one that is designated by the TGA to be an orphan drug under Regulation 16J of the Therapeutic Goods Regulations 1990, as described on TGA’s orphan drug eligibility criteria webpage. Previously, an exemption applied to all applications for PBS/NIP submission and pricing services made in respect of medicines that had an active orphan drug designation by the TGA. This no longer applies.
From 1 July 2019, medicines that have been designated by the TGA as orphan drugs (whether or not the designation is still in force) will be exempt from an evaluation fee for the first submission to the PBAC (i.e. once per therapy). An application for submission services must be made concurrently with the corresponding TGA registration application or within 12 months of the designated orphan drug being registered on the Australian Register of Therapeutic Goods (ARTG).
The PBAC submission process includes a mandatory Intent to Apply step which must occur at least 28 days prior to the relevant PBAC submission lodgement due date. Your intention to seek a fee exemption must be indicated through the Intent to Apply, and supporting evidence of orphan drug designation and date of TGA registration must be provided with your submission by the relevant PBAC submission lodgement due date as specified in the PBS calendar.
How is the department and industry working together to reduce listing timeframes by 2 months as required by the strategic agreement?
New and enhanced PBS listing processes aim to maximise efficiencies in processes between the applicant and the department, and to reduce the time taken in the negotiation phase. The first phase between the PBAC’s decision and provision of minutes to applicants in week 3, and the Government processes phase (of up to 26 weeks) are not impacted by the pathways proposed.
During 2019–20, the times taken by both the department and applicants to progress all active submissions through the various stages of negotiations will be captured and monitored, to measure the effectiveness of process improvements and to better understand the issues that impact upon timelines to listing.
The insights gained from the first 12 months of implementation will also inform development of future process improvements to achieve the two months, on average, reduction in time to listing across pathways.
What has changed in the pricing process? How will I know if I will be required to pay the old fees or the new fees for pricing services?
The procedure guidance for positive recommendation pathways provides applicants with more information on the post-PBAC processes and provides additional guidance to assist with progressing a listing as efficiently as possible.
The main change in process for applicants is the timing for receiving and paying for pricing services. Previously, applicants were issued an invoice upon a medicine being listed. To align with the revised cost recovery arrangements, applicants will be issued an invoice for the notice of intent for pricing and pricing pathway fee once the notice of intent for pricing form has been lodged. This shift in pay point brings the cost recovery arrangements for all PBS listing processes into alignment, and ensures the Department recovers costs for services provided to applicants regardless of the listing outcome. More information on the cost recovery processes for pricing services is outlined in the Cost Recovery Administration Guidelines.
Where an applicant has submitted a pricing package prior to 1 July 2019 and the sponsor and the department are actively working together to negotiate the terms of a listing, the pre-July 2019 fees will apply. Where a sponsor submits a pricing offer package post 1 July 2019, the new fees and payment terms will apply (regardless of when the PBAC made the positive recommendation).
The positive recommendation pathways procedure guidance outlines when a submission can become ‘inactive’, what does this mean?
A positive recommendation will be considered ‘inactive’ if an applicant does not submit their notice of intent for pricing form within 60 days of receiving the PBAC Minutes and after 12 months where:
- The applicant has not submitted a Notice of Intent for Pricing (unless an exception for not requiring to submit this form has been approved by the delegate)
- The applicant has submitted a Notice of Intent for Pricing but has not subsequently submitted a complete pricing offer package within 42 days
The purpose of the inactive status is for data monitoring and reporting purposes. This status does not impact on the applicant’s ability to begin price negotiations at any time up until the PBAC rescinds a recommendation. The PBAC’s positive recommendation will continue to remain valid until the Committee has formally rescinded the recommendation. There are no changes to this process.
What additional resources will be department be getting to implement the PBS Process Improvements and revised cost recovery arrangements?
The department is responsible for ensuring adequate resources are available to deliver the services committed to under the Strategic Agreement, including the PBS process improvements and associated cost recovery arrangements.
