Search Results Summary:
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About the Guidelines
The PBAC considers submissions from industry sponsors of medicines and medicinal products, medical bodies, health professionals, and private individuals and their representatives. However, for new
for different submissions and need to be re-evaluated case by case. Presence of effective therapeutic alternatives. This helps to determine the clinical need for the proposed medicine. Severity of the medical
pbac.pbs.gov.au/information/about-the-guidelines.html
Page last updated: September 2016
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P1.1 Listing fixed-dose combination products
The PBS subsidises medicines that improve health outcomes and provide value for money. Compliance with medication regimens is one factor that can influence the achievement of health outcomes
to which the consumer conforms to the agreed behaviours, with respect to timing, dosage and frequency of medication taking.53 Persistence – the duration of time from initiation to discontinuation of therapy
pbac.pbs.gov.au/product-type-1/p1.1_listing_fixed-dose_combination_products.html
Page last updated: September 2016
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3A.3 Population and setting
, confidence intervals). Relevant patient and clinical characteristics may include age, sex, ethnicity, medical condition and severity of the medical condition, and comorbidities. Indicate which patient
pbac.pbs.gov.au/section-3a/3a-3-population-and-setting.html
Page last updated: September 2016
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3A.7 Model validation
sources not used in the model (independent validation). For example, compare predicted clinical events with observed data on the natural history of the medical condition. Comment on and explain
pbac.pbs.gov.au/section-3a/3a-7-model-validation.html
Page last updated: September 2016
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Section 1 - Context
(O) Describe the biomarker5 (T) Describe the proposed test6 (O) Describe the medical condition or problem being managed7 (O) Describe the relevant clinical management pathways
6 (O) Medical condition or problem being managed
pbac.pbs.gov.au/product-type-4/section-1-context.html
Page last updated: September 2016
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4.1 Justification of the selection of data sources
A commissioned study may be used to fill a gap in the data, and may include medicine usage surveys; data from disease or condition registries; or dispensing and medical service claims. Clearly state
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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Appendix 2 Literature search methods
MeSH = medical subject headings
pbac.pbs.gov.au/appendixes/appendix-2-literature-search-methods.html
Page last updated: September 2016
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Section 4 - Use of the medicine in practice
First, estimate the number(s) of patients likely to be considered for the test (eg with the medical condition as defined). Second, based on the prevalence of the biomarker, estimate the proportion
pbac.pbs.gov.au/product-type-4/section-4-use-of-the-medicine-in-practice.html
Page last updated: September 2016
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4.3 Estimation of changes in use and financial impact of other medicines
1.2, and disaggregate by form and strength. Where the proposed medicine is replacing a medical procedure or has no comparator medicine, or where patients are receiving best supportive care
Page last updated: September 2016
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4.5 Estimated financial implications for the health budget
consultations and tests to confirm diagnosis of the medical conditiondetermine eligibility for the proposed medicine according to the requested restriction (see Subsection 1.4)determine whether any continuation
pbac.pbs.gov.au/section-4/4-5-estimated-financial-implications-for-the-health-budget.html
Page last updated: September 2016
