LIST OF RECOMMENDATIONS
Recommendation 1
6.40 The
committee recommends that the Australian Government initiate a comprehensive
review of the system for the registration and subsidisation of medicines. The
review should examine:
- all available
pathways for the registration and listing of new medicines, or new indications
for medicines already registered on the ARTG and listed on the Pharmaceutical
Benefits Scheme, including making provision for utilisation of assessments
conducted by comparable overseas regulators; provision for clinicians and/or
patient groups to apply for an extension of existing registrations to
additional indications, managed access programs and risk-sharing, and the
adoption of more flexible evidential requirements;
- options for improving
the operation of assessment processes including:
- enhancing engagement
with sponsors and other stakeholders to better tailor their applications to the
requirements of the PBAC, including consideration of pre-application planning
meetings;
- applying tiered
assessment processes as a means of matching resources to the complexity of
applications;
- encouraging greater
cooperation between the PBAC, the TGA and the Medical Services Advisory
Committee, including examination of options for enhancing the operation of
parallel processing arrangements; and
- ensuring greater
transparency throughout the assessment process;
- options for expanding
the post-market review of medicines;
- enhancing and
formalising mechanisms for consumers and clinicians to play a more central and
substantial role in the evaluation of new medicines and new indications for
already listed medicines, including:
- consideration of options
for expanding consumer and clinician representation on the PBAC;
- enhancing existing
avenues for stakeholder input, including the use of consumer and patient
hearings; and
- avenues for
incorporating public perspectives on overarching moral, ethical and opportunity
cost considerations into PBAC decision making processes, including
consideration of models employed by comparable overseas regulators; and
- options for ensuring
that the necessary administrative and technical resources are available to
support the implementation of an enhanced PBAC system.
Recommendation 2
6.41 The
committee recommends that the Australian Government commission a review of
current data collection mechanisms for cancer medicines, including
identification of:
- obstacles to the
integration of existing databases and potential avenues for addressing these;
- opportunities to
incorporate data from post-market evaluations; and
- avenues for capturing
data relating to the off-label use of cancer medicines.
Recommendation 3
6.42 The
committee recommends that the Australian Government establish a Steering
Committee to examine the feasibility of establishing a national register of
cancer medicines.
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