6 Procedures for consideration of submissions

Page last updated: October 2016

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.

 

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