4.1 Types of submissions
There are six submission types for listing medicines on the PBS and vaccines on the NIP. These are described in general terms below. Procedures for resubmission pathways are outlined in Section 9, and procedures for reconsideration of a recommendation are outlined in Section 5.7.
The National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2022 (Refer Part 3: Submission Services) prescribes the requirement for categorising submissions. The descriptions below are a general guide only and in relation to cost recovery matters, this guide does not take precedence over the Cost Recovery Regulations.
Applicants who are uncertain of the appropriate submission category should contact the PBAC Secretariat for advice (refer to contact details in Appendix A). Where a submission is considered by the department to be misclassified, the department will review and reclassify the submission. The process for determining a submission category is outlined in the Cost Recovery Administrative Guidelines.
The department may choose to not accept a submission on the basis it is considered incomplete and does not contain the information required by the PBAC for decision making. The department will notify applicants within 10 business days after lodgement, if their submission is not accepted – refer to the Cost Recovery Administrative Guidelines for more information.
All submissions to the PBAC should adhere, where relevant, to the structure and information requirements set out in the PBAC Guidelines.
4.1.1 Category 1 submissions
These submissions require the PBAC to assess the magnitude of clinical improvement or toxicity reduction, the incremental cost and the comparative costs and outcomes where an economic evaluation is required to support a claim of cost-effectiveness, cost-utility or cost‑minimisation.
Category 1 submissions involve a request for PBS or NIP listing of one or more of the following:
- A first in class medicine or vaccine, and/or a medicine or vaccine for a new population.
- A first-in-class medicine or vaccine represents a drug or vaccine with a unique mechanism of action that has not been considered by the PBAC.
- A new population could include a disease or medical condition not previously considered by the PBAC.
- A disease is intended to cover whole diseases when all stages and genetic subtypes are considered.
OR
- A drug with a codependent technology that requires an integrated codependent submission to the PBAC and MSAC.
OR
- A drug or designated vaccine with a TGA Provisional determination related to the proposed population.
4.1.2 Category 2 submissions
These submissions require the PBAC to assess the magnitude of clinical improvement or toxicity reduction, the incremental cost and the comparative costs and outcomes where an economic evaluation is required to support a claim of cost-effectiveness, cost-utility or cost‑minimisation.
Category 2 submissions generally relate to a request for PBS or NIP listing of a new medicine or new vaccine, a new indication of a currently listed medicine or vaccine, or to make material changes to a currently listed indication and do not meet the criteria for a Category 1 submission.
They may also relate to a request for the PBAC to reconsider an existing recommendation where there is a change to the clinical, economic and/or financial information most recently relied on by the PBAC.
A Category 2 submission may be required for a new form or strength of an already-listed medicine or vaccine that is not bioequivalent to an existing listed form of the medicine or vaccine. This may be necessary to demonstrate that the new form delivers similar clinical outcomes to the existing form.
Examples:
A new medicine for a condition that is currently treated OR a new vaccine against a disease for which there is a current vaccine.
OR
A listed medicine for an additional condition OR a listed vaccine for an additional population.
OR
One or more material changes to an existing listing that requires a full evaluation (clinical, economic and financial evaluation).
4.1.3 Category 3 submissions
Category 3 submissions generally relate to requests to change existing listings that do not change the population or cost-effectiveness of the medicine or vaccine that do not meet the criteria for a Category 4 submission. This includes requests to enter into a deed or vary an existing deed.
Although the PBAC will assess the clinical need for and clinical effectiveness of the requested listing, an economic evaluation is not necessary to support the claims made in the submission. Additionally, the financial estimates do not require the PBAC to assess any substantial financial implications for the supply of a listed medicine or designated vaccine.
They may also relate to a request for the PBAC to reconsider an existing recommendation where there is no change to the clinical, economic or financial information most recently relied on by the PBAC.
As PBAC advice is required on a case-by-case basis regarding the potential for schedule equivalence for biosimilar listings, Category 3 submissions are also appropriate for a new biosimilar brand of an existing pharmaceutical item with no indication changes.
PBAC advice may also be required through a Category 3 submission process in some other circumstances (e.g. requests for PBS listing of nutritional products (medicinal foods) or some new brands of existing pharmaceutical items with an unusual presentation; or advice on potential equivalence, substitution, or issues related to quality use of medicines).
Examples:
A new biosimilar medicine where the reference medicine is already listed for the same population.
OR
A medicinal food. A food that is a therapeutic good within the meaning of paragraphs (a) and (b) of the definition of therapeutic goods in Section 3 of the Therapeutic Goods Act 1989).
OR
A change to an existing listing that does not change the population or cost effectiveness of the treatment; and is not a Category 4 submission.
OR
The request is to change the restriction level of a listed medicine (e.g. Restricted benefit, Authority Required – in writing, Authority Required – telephone/electronic, Streamlined Authority).
OR
The request is to amend or vary an existing deed (e.g. changes to a Risk Share Arrangement).
4.1.4 Category 4 submissions
Category 4 submissions involve a request for one or more of the following:
- Listing of a new pharmaceutical item of a listed medicine.
- Consideration as an exempt item (Exempt item as per subsection 84AH of the National Health Act 1953).
- Including a listed medicine on the prescriber bag, or varying an existing prescriber bag listing.
- A change to the existing, or the addition of a new form or manner of administration of a listed medicine.
- A change to the maximum quantity and/or number of repeats of a listed medicine.
- A change or addition to the prescriber type(s) of a listed medicine.
Refer to section 4.1.6 and 5.8 for applications that seek the listing a new oral form of an existing pharmaceutical item.
4.1.5 Committee secretariat submissions
Committee secretariat submissions relate to applications where the requested listing changes do not require the PBAC to consider comparative effectiveness, cost-effectiveness or clinical need:
- there is no difference in patient safety or population for the new pharmaceutical item in the submission compared to an already-listed pharmaceutical item; and
- there is no financial effect associated with the proposed change to the PBS.
4.1.6 Application for a new brand, or new oral form, of an existing pharmaceutical item
Applications that do not require PBAC consideration for listing an additional brand (a generic medicine) or new oral form of an existing TGA-approved and PBS-listed pharmaceutical item should be lodged directly to the department. Evidence of equivalence from the TGA must also be provided.
4.1.7 General correspondence to the PBAC
Individuals, organisations and consumers may raise issues for consideration by the PBAC. The format of these submissions is not specified unless there is a requirement to advise the Government of an expected change in government expenditure on the PBS or NIP.
