Search Results Summary:
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1.2 Clinical management
a literature review of relevant published clinical management guidelines (preferred). The PBAC prefers independent, up-to-date evidence-based clinical practice guidelines developed for Australia
pbac.pbs.gov.au/section-1/1-2-clinical-management.html
Page last updated: September 2016
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4.3 Estimation of changes in use and financial impact of other medicines
Base any disaggregation into proportions for the PBS and the RPBS, and by beneficiary type on the most recent 12 months of usage data from Services Australia . If the expected substitution
Page last updated: September 2016
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P3.1 Details of the proposed vaccine and its comparator (Section 1)
an individual against a disease that is not sufficiently prevalent in Australia to justify maximising the use of the proposed vaccine), or where vaccination relates to a higher disease risk associated with
Page last updated: September 2016
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Section 4 Use of the medicine in practice
different MBS items required with the use of the new medicine – change in MBS costs different restriction level from the currently listed medicine – change in Services Australia (previously called
pbac.pbs.gov.au/section-4-use-of-the-medicine-in-practice.html
Page last updated: September 2016
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1.4 Proposed PBS listing
Australia (Medicare). For ‘Authority Required (Streamlined)’ listings, prior approval is not required and prescribers declare the use is consistent with the restriction criteria by endorsing the prescription
pbac.pbs.gov.au/section-1/1-4-proposed-pbs-listing.html
Page last updated: September 2016
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2.5 Trial results: whole trial population
If the scoring algorithm has not been derived from the general population in Australia, consider presenting a sensitivity analyses using alternative scoring algorithms, if possible. If more than one
pbac.pbs.gov.au/section-2/2-5-trial-results-whole-trial-population.html
Page last updated: September 2016
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References
medicines in Australia: a national framework for reviewing codependent technologies. Med Decis Making 2013;33(3):333–42. Reitsma J, Rutjes A, Khan K, Coomarasamy A, Bossuyt P. A review of solutions
pbac.pbs.gov.au/information/references.html
Page last updated: September 2016
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Section 3 - Economic evaluation
. These analyses would explore the impact on the ICER of discrepancies in the agreement between the evidentiary standard test and other nominated reference standard tests that will be used in Australia to identify
pbac.pbs.gov.au/product-type-4/section-3-economic-evaluation.html
Page last updated: September 2016
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Section 2 - Clinical evaluation
This can be done using a QUADAS-2 assessment for each test accuracy study in terms of risk of bias and applicability for use in Australia on the domains of patient selection, index test, reference
pbac.pbs.gov.au/product-type-4/section-2-clinical-evaluation.html
Page last updated: September 2016