Search Results Summary:
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4.5 Estimated financial implications for the health budget
Information Requests Estimate the net change in the number of prescriptions processed by Services Australia for payment (and, if appropriate, the net change in the number of authorities by Services
Australia) for six years using the relevant spreadsheet of the Excel workbook (Subsection 4.5.1)Estimate the extent of net change in the number of each type of affected MBS items provided for six years
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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P2.1 Details of proposed product and its comparators (Section 1)
dietsinfant formula products, such as a formula used in infants younger than 12 monthsConfirm regulatory compliance with the Australia New Zealand Food Standards Code (Subsection 1.3)Provide additional
Present a table comparing the proposed product with the requirements of the Australia New Zealand Food Standards Code – Standard 2.9.1: Infant Formula Products , using the terminology of the code
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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4.1 Justification of the selection of data sources
The main sources of relevant data for the market-share approach are the PBS data, including those supplied by Services Australia and data for under-copayment use of PBS-listed medicines by general
, provide an estimate of the number of patients they treat, what proportion this is of the expected numbers of patients in Australia, and the health area and setting in which the respondents practise (eg
pbac.pbs.gov.au/section-4/4-1-justification-of-the-selection-of-data-sources.html
Page last updated: September 2016
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1.3 Regulatory process
All new pharmaceutical products must be registered on the Australian Register of Therapeutic Goods (ARTG) by the TGA before being marketed in Australia.
pbac.pbs.gov.au/section-1/1-3-regulatory-process.html
Page last updated: September 2016
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5.4 Basis for any claim for the ‘rule of rescue’
No alternative exists in Australia to treat patients with the specific circumstances of the medical condition meeting the criteria of the restriction. This means that there are no nonpharmacological
pbac.pbs.gov.au/section-5/5-4-basis-for-any-claim-for-the-rule-of-rescue.html
Page last updated: September 2016
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4.7 Quality use of medicines
The National Strategy for Quality Use of Medicines explains QUM in Australia.
pbac.pbs.gov.au/section-4/4-7-quality-use-of-medicines.html
Page last updated: September 2016
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1.1 Clinical issue addressed by the submission
(preferably include Australian datasets or studies involving Australian participants). Summarise the incidence and prevalence of the disease or condition in Australia using data from a reputable source
Select the comparator(s) in the context of the targeted Australian population, the current alternative therapies in Australia, and the therapies most likely to be replaced in clinical practice
pbac.pbs.gov.au/section-1/1-1-clinical-issue-addressed_by-the-submission.html
Page last updated: September 2016
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Section 1 - Context
List the other available test options that fall within the scope of the proposed MBS item descriptor. If other test options are available in Australia, or the evidentiary standard test is not
available in Australia, then provide a comparison of all available tests for the biomarker that fall within the scope of the requested MBS item descriptor.
pbac.pbs.gov.au/product-type-4/section-1-context.html
Page last updated: September 2016
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Forms
Forms relating to processing claims, paying benefits, or PBS stationery order forms can be found on the Services Australia website .
pbac.pbs.gov.au/information/forms.html
Page last updated: September 2016
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4.2 Estimation of use and financial impact of the proposed medicine
Estimate the units dispensed in the most recent 12 months of the relevant PBS market. This estimate should be based on data from Services Australia for the currently listed medicines.
Apply the proportions (available from the Services Australia website ) in each beneficiary type for the closest therapy that is currently listed (the main comparator, if it is PBS listed
pbac.pbs.gov.au/section-4/4-2-estimation-of-use-and-financial-impact-of-the-proposed-medicine.html
Page last updated: September 2016
