4.1 Types of submissions
There are four different types of submissions for listing medicines on the PBS and vaccines on the NIP. These are described in general terms below.
The National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 (see Section 4.4) set out rules for categorising submissions. The descriptions below should only be considered as a general guide and in relation to cost recovery matters this guide does not take precedence over the Cost Recovery Regulations.
Sponsors who are uncertain of the type of submission required should contact the department with a request for further information (refer to contact details in Appendix A). Where a submission has been made and is considered by the department to be misclassified, the department will review and reclassify the submission.
All submissions to the PBAC must adhere to the structure and information requirements set out in the Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Committee. However, not all submissions will require information in response to all parts of the PBAC Guidelines (e.g. minor and minor committee secretariat submissions). Most requests for listing a new brand of existing pharmaceutical item do not require consideration by the PBAC.
Major submissions are required to be submitted 17 weeks before the PBAC meets.
Minor submissions (including committee secretariat submissions) are required to be submitted 11 weeks before the PBAC meets.
Submissions for a new brand of an existing pharmaceutical item that do not need to be considered by the PBAC are forwarded directly to the department (see Section 4.1.4 for details).
4.1.1 Major submission
Major submissions generally relate to requests for the listing of a new medicine or vaccine, a new indication for a currently listed medicine, or to make material changes to a currently listed indication where an economic model is required to support a claim of cost-effectiveness, cost-utility or cost‑minimisation.
A resubmission is classified as a major submission where a new or updated economic model is necessary to support the claims made in the submission, or if there are other changes to the submission that require evaluation.
In unusual cases a major submission may be required for a new form or strength of an already-listed medicine that is not bioequivalent to an existing listed form of the medicine. This may be necessary to demonstrate that the new form delivers similar clinical outcomes to the existing form.
Major submissions may also include submissions requiring a codependent technology to be listed on the Medicare Benefits Schedule (these are also referred to as integrated codependent technology submissions).
4.1.2 Minor submission
Minor submissions generally relate to requests to change existing listings that do not change the population or cost-effectiveness of the treatment, or the listing of a new form or strength of an already-listed medicine that has a bioequivalence or equivalence statement from the TGA. An economic model (or revised model) is not necessary to support the claims made in the submission. As PBAC advice is required on a case by case basis regarding the potential for schedule equivalence for biosimilar listings, minor 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 minor submission process in some other circumstances (e.g. some resubmissions and some new brands of existing pharmaceutical items with an unusual presentation, potential equivalence, substitution or quality use of medicines issues).
4.1.3 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.
4.1.4 New brand of an existing pharmaceutical item
This submission type is for listing an additional brand (a generic medicine) of an existing TGA-approved and PBS-listed pharmaceutical item where there is no requirement for consideration by the PBAC as a minor submission. (See section 4.1 2 for those requiring aminor submission). Evidence of equivalence from the TGA must be provided.
4.1.5 General correspondence to the PBAC
Individuals, organisations and other consumers may raise issues for consideration by the PBAC. These may not have evidence for evaluation. 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.