Search Results Summary:
-
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
If no currently listed product is available, use standard medical management (this could include special dietary restrictions) as the main comparator. This should be clearly and consistently defined
pbac.pbs.gov.au/product-type-2/p2-1-details-of-proposed-product-and-its-comparators-section.html
Page last updated: September 2016
-
2.8 Interpretation of the clinical evidence
important and patient-relevant. Both trials reported a similar improvement in survival. For most patient-relevant outcomes (use of pain medication, tumour-related symptoms), [proposed medicine] showed
pbac.pbs.gov.au/section-2/2-8-interpretation-of-the-clinical-evidence.html
Page last updated: September 2016
-
1.1 Clinical issue addressed by the submission
. Standard medical management. If the proposed medicine is for a target population for which there are no currently listed PBS medicines, or the proposed medicine will be used in addition to – rather
than replace – a medicine, the comparator would usually be standard medical management. Standard medical management would need to be clearly defined and could include a non-listed medicine, a surgical procedure
pbac.pbs.gov.au/section-1/1-1-clinical-issue-addressed_by-the-submission.html
Page last updated: September 2016
-
3A.6 Health care resource use and costs
medicines (direct costs of treatment and medicines used to treat adverse reactions) medical services, including procedures hospital services diagnostic and investigational services community-based
services any other direct medical costs.
pbac.pbs.gov.au/section-3a/3a-6-health-care-resource-use-and-costs.html
Page last updated: September 2016
-
4.6 Identification, estimation and reduction of uncertainty
if the proposed medicine treats a medical condition for which the alternatives are considered to be substantially inferior to the proposed medicine (eg in terms of effectiveness, tolerability, patient acceptability
than expected from the randomised trials, particularly if trials are truncated. Patients might be treated more or less often than expected, particularly in the case of medical conditions with episodic
pbac.pbs.gov.au/section-4/4-6-identification-estimation-and-reduction-of-uncertainty.html
Page last updated: September 2016
-
P3.1 Details of the proposed vaccine and its comparator (Section 1)
by the National Health and Medical Research Council, following its preparation by the Australian Technical Advisory Group on Immunisation (ATAGI), and is updated online annually. Where relevant, chapters
. If an alternative vaccine is available but not currently funded, seek the advice of the department. If there is currently no vaccine available, the main comparator would usually be standard medical management.
Page last updated: September 2016
-
P4.1 Overview of information requested in codependent submissions
The key to the evaluation of codependent technologies is to establish the basis of the codependency claim. 55 Make the relationship between the test for the biomarker (investigative medical service
a request to create or amend the MBS item for the proposed investigational medical service corresponding to the proposed medicine proposed wording for the MBS item descriptor (which should reflect
Page last updated: September 2016
-
References
E. Adherence to long-term therapies: evidence for action: World Health Organization, 2003. Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA et al. Medication compliance and persistence
for industry: patient-reported outcome measures – use in medical product development to support labeling claims. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center
pbac.pbs.gov.au/information/references.html
Page last updated: September 2016
-
Section 3 - Economic evaluation
consultations with medical personnel regarding the test results and treatment planning50 (O) costs of retesting and nonassessable results51 (O) costs for adverse events associated with testing52 (O) costs
care resources (eg diagnostic, medical, hospital, allied health)
pbac.pbs.gov.au/product-type-4/section-3-economic-evaluation.html
Page last updated: September 2016
-
Product type 2 – Nutritional products
, and additional information for specific medical conditions. This section also provides additional guidance for identifying a main comparator for a nutritional product.
pbac.pbs.gov.au/product-type-2-nutritional-products.html
Page last updated: September 2016
