Pbac decision making criteria

  • How does PBAC work?

    Policy-based access control (PBAC) PBAC is an authorization approach that uses policies to determine user access privileges.
    Similar to how RBAC works, user roles and the associated permissions are reviewed to determine access, but additional attributes are also evaluated..

  • What are the objectives of PBAC?

    Its primary role is to recommend new medicines for listing on the PBS.
    No new medicine can be listed unless the committee makes a positive recommendation.
    The PBAC meets three times a year, usually in March, July and November..

  • What is the PBAC Pharmaceutical Benefits Advisory Committee?

    The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent statutory body established to make recommendations and give advice to the Minister about which drugs should listed on the Pharmaceutical Benefits Scheme.
    PBAC makes recommendations based on the effectiveness and cost-effectiveness of new drugs..

  • What is the role of the PBAC?

    The PBAC is established under the National Health Act 1953.
    Its primary role is to recommend to the Minister for Health which medicines should be subsidised under the PBS.
    The PBAC is required, under the Act, to consider the effectiveness and cost of the proposed medicine compared with existing therapies..

  • DPMA. dispensed price for maximum amount.
    DPMQ. dispensed price for maximum quantity.
Key factors influencing decision making by the PBACOverall confidence in the evidence and assumptions relied on in the submission.Equity.Presence of 

How does the PBAC evaluate economic outcomes?

The PBAC prefers that the economic evaluation is based on results from direct randomised trials (see Section 2), with any adjustments or additions to the trial data to account for differences in the population and setting, timeframe of analysis or outcomes of interest presented transparently in a stepped manner.

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What are the PBAC Guidelines changes?

The guidelines changes are intended to help clarify the information that will best support PBAC decision making, taking into account developments in health technology assessment and PBAC experience of submissions.
There is no substantive change in the key factors influencing decision making by the PBAC.

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What factors influence PBAC decision making?

PBAC decision making is influenced by five quantitative factors:

  1. Comparative health gain

Assessed in terms of both the magnitude of effect and clinical importance of effect.
,

Who is responsible for preparing a PBAC submission?

However, for new products or new indications, it is normally the sponsor or manufacturer who holds the data required for such a submission.
Sponsors usually engage public health and health economics experts to review the academic literature and help the company prepare a submission to the PBAC.


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