6 Procedures for consideration of submissions
The PBAC is a statutory body whose membership and roles are prescribed in the National Health Act 1953. The committee undertakes a number of functions including:
- recommend medicines to the Minister for Health for funding under the PBS, and whether the medicine is only available under special supply arrangements (s100 of the National Health Act)
- recommend vaccines to the Minister for Health for funding under the NIP
- recommend the circumstances in which a medicine be funded (ie restriction wording, access with authority)
- advise the Minister for Health about cost-effectiveness (value for money) which includes cost (overall budget implications)
- advise the Minister for Health on particular matters related to exempt items, combination items and therapeutic groups
- advise the Minister for Health on provisions for early supply
- advise the Minister for Health about any other matters relating to the PBS/NIP. This includes regular advice on:
- arrangements for risk sharing and managed access
- price disclosure ‘no reducution’ items
- recommending the maximum quantities (maximum amounts for chemotherapy infusibles) and repeats
- schedule equivalence (for substitutability at the point of dispensing)
- bioequivalence and biosimilarity
- review of PBS items.
