Search Results Summary:
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Section 4 Use of the medicine in practice
Special pricing arrangements
Where a special pricing arrangement has been offered, include spreadsheets (using the supplied template) that show the costs over six years with and without the special pricing arrangement in place
pbac.pbs.gov.au/section-4-use-of-the-medicine-in-practice.html
Page last updated: September 2016
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P2.1 Details of proposed product and its comparators (Section 1)
P2.1 Details of proposed product and its comparators (Section 1)
for the following medical conditions (Subsection 1.1): multifood allergypatients requiring products with modified carbohydrate, protein or fat for malabsorption or disorders of metabolismpatients requiring ketogenic
pbac.pbs.gov.au/product-type-2/p2-1-details-of-proposed-product-and-its-comparators-section.html
Page last updated: September 2016
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Appendix 6 Including nonhealth outcomes in a supplementary analysis
Production changes
In the context of health economics analyses, a production change is a change in total output value across society of productive work in the economy. Productivity is a function of output units (eg
pbac.pbs.gov.au/appendixes/appendix-6-including-nonhealth-outcomes-in-a-supplementary-analysis.html
Page last updated: September 2016
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Contents
Part B – Information requests for specific product types
Product type 1 – Fixed-dose combination products
pbac.pbs.gov.au/information/table-of-contents.html
Page last updated: September 2016
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Product type 2 – Nutritional products
Product type 2 – Nutritional products
This section applies to a submission for a nutritional product seeking subsidisation under the PBS. It includes requests for general additional information relating to nutritional products
pbac.pbs.gov.au/product-type-2-nutritional-products.html
Page last updated: September 2016
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4.4 Estimated financial impact for the PBS/RPBS or the NIP
For most medicines, this financial estimate uses the DPMQ or the DPMA with appropriate patient copayments removed. For vaccines to be funded under the NIP, the estimate is based on the price
pbac.pbs.gov.au/section-4/4-4-estimated-financial-impact-for-the-pbs-rpbs-or-the-nip.html
Page last updated: September 2016
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Product type 1 – Fixed-dose combination products
Part B – Information requests for specific product types
Product type 1 – Fixed-dose combination products
pbac.pbs.gov.au/product-type-1-fixed-dose-combination-products.html
Page last updated: September 2016
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4.5 Estimated financial implications for the health budget
Use the relevant spreadsheet of the standardised Excel workbook to calculate the aggregated sets of net financial implications. If the proposed medicine has a special pricing arrangement, show
the net financial implications with and without the special pricing arrangement.
pbac.pbs.gov.au/section-4/4-5-estimated-financial-implications-for-the-health-budget.html
Page last updated: September 2016
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P3.2 Clinical evaluation (Section 2)
As discussed in Subsection P1.1, the components of a vaccine combination product should have an additive (not necessarily synergistic) beneficial effectiveness. For a vaccine that combines antigens
, there should be no loss of beneficial effectiveness of each of the components. For example, if there is any reduction in titres for any components of a fixed combination vaccine product compared with its individual
pbac.pbs.gov.au/product-type-3/p3-2-clinical-evaluation-section-2.html
Page last updated: September 2016
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P2.2 Clinical evaluation (Section 2)
Additional Information Request Present trial or study data to support the use of the proposed product in patients (Section 2)
As a minimum, provide any available data arising from use of the proposed product in patients. This extends the assessment beyond a comparative review of nutritional content to inform a comparative
pbac.pbs.gov.au/product-type-2/p2-2-clinical-evaluation-section-2.html
Page last updated: September 2016
