Terms of Reference
HTA Review Scope
The objective of the HTA Review is to recommend options for improving process efficiency and reducing regulatory burden for Commonwealth HTA processes to facilitate medical innovation without compromising timely and affordable patient access to medical services and devices.
On 18 December 2008, the Minister for Health and Ageing, the Hon Nicola Roxon MP, and the Minister for Finance and Deregulation, the Hon Lindsay Tanner MP, announced the HTA Review as a Better Regulation Ministerial Partnership.
The HTA Review will be one of the first Better Regulation Ministerial Partnerships to be undertaken by the Australian Government, as part of its commitment to deregulation, to reduce costs to business and consumers, and contribute to the Government’s productivity agenda.
The objective of the HTA Review is to recommend options for improving process efficiency and reducing regulatory burden for Commonwealth HTA processes to facilitate medical innovation without compromising timely and affordable patient access to medical services and devices that:
- are demonstrated to be safe, effective and cost effective; and
- deliver improved health outcomes and value for money.
The HTA Review will be conducted by the Department of Health and Ageing, informed by a stakeholder reference group and public submissions process. The HTA Review will result in a report from the Department to the Minister for Health and Ageing (in consultation with the Minister for Finance and Deregulation) identifying process improvements and broader HTA policy reforms in line with the HTA Review terms of reference. The report is expected to be delivered in late 2009.
Terms of Reference
The HTA Review is to report on the following matters:
- Simplification and better co-ordination between the Commonwealth HTA processes (as identified in the Review scope), which includes:
- consideration of a single entry point and tracking system for applications for market registration and funding;
- making time to affordable access as short as possible for new technologies while maintaining or improving the rigour of evaluation processes; and
- examination of the feasibility of conducting concurrent assessments for market registration and funding and coverage purposes, noting current work in this area.
- Improving role clarity and addressing duplication between processes, where it exists, including consideration of consolidating functions with the Australian HTA system.
- Reviewing post marketing surveillance mechanisms to ensure the ongoing safety, and efficacy of medical devices.
- Strengthening transparency and procedural fairness in the assessment, decision making and fee negotiation arrangements for processes (as outlined in the Review scope) through improved communication with stakeholders about process, methodologies, outcomes and performance against key indicators.
- Enhanced arrangements for assessment of co-dependent1 and hybrid technologies2
HTA Review Scope
The Commonwealth HTA processes in-scope for the HTA Review are:
- regulation of therapeutic goods for market entry, currently undertaken by the Therapeutic Goods Administration (TGA) ;
- approval of funding under the Medicare Benefits Scheme (MBS), currently informed by the Medical Services Advisory Committee (MSAC) and relevant implementation consultative committees;
- listing of prostheses for private health insurance coverage, as currently informed by the Prostheses and Devices Committee (PDC); and
- listing of hybrid and co-dependent technologies as currently informed by the MSAC, Pharmaceutical Benefits Advisory Committee (PBAC) and PDC.
Submissions are now Closed
The Department of Health and Ageing called for submissions from interested individuals and organisations from 27 March - 29 May 2009. The public submission process has now closed.
The Department has completed the publication of submissions received for the HTA Review.