Australian Government HTA Processes
The Department of Health and Ageing (DoHA) has a legislative, policy and program framework to support the following functions:
- Assessment of the safety and efficacy of health technologies for market regulation to ensure that therapeutic goods are safe, perform as intended and are produced using appropriate quality controls before marketing approval is granted in Australia through the Australian Register of Therapeutic Goods (ARTG).
- Appraisal of the comparative safety, clinical and cost effectiveness of health technologies which informs decisions about:
- public funding of medical services (with or without a device), procedures and diagnostic technologies, pharmaceuticals and vaccines through the Medicare Benefits Schedule (MBS), the Pharmaceutical Benefits Scheme (PBS) and the National Immunisation Program (NIP) respectively;
- private health insurance reimbursement of prostheses through the Prostheses List; and
- Post market surveillance of these health care interventions to inform ongoing decisions about the marketing approval of therapeutic goods or the reimbursement of health technologies that prove not to be safe or do not perform as intended.
The Australian Government HTA system is complex and has many interdependencies. Each HTA agency has discrete functions that have evolved over time to respond to different needs. Individually, most of these processes function well and some processes are regarded as world leaders in their fields.
Map of current Australian Government HTA processes for market entry and for reimbursement processes
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Page currency, Latest update: 26 August, 2011
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