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HTA Policy Framework

Efficient and effective HTA processes are crucial to supporting sustainable management in the growth of subsidised health technologies. Consistent application of evidence across Australian Government HTA processes is an important element in ensuring stakeholder confidence and certainty in how these processes are implemented and the outcomes achieved.

The Australian Government HTA agencies are the Therapeutic Goods Administration (TGA), the Medical Services Advisory Committee (MSAC), the Pharmaceutical Benefits Advisory Committee (PBAC) and the Prostheses List Advisory Committee (PLAC - formerly the Prostheses and Devices Committee). These agencies have complex and inter-dependent relationships. Each entity has discrete functions and responds to different policy needs.

The Australian Government has accepted two recommendations from the 2009 HTA Review that provide a policy framework for HTA processes for market entry and reimbursement in Australia. Recommendation 2 of the HTA Review Report provides:

"That the rigorous consideration of evidence be consistently applied across all Australian Government HTA processes to ensure sustainability of the Australian Government’s health financing arrangements."

This recommendation provides a new level of consistency and certainty for applicants wanting government funding.

Vision for a sustainable, efficient Australian Government HTA system
Goal of Australian Government HTA processes
Objectives of Australian Government HTA processes
Principles underpinning Australian Government HTA processes

The policy framework includes a vision, goal, objectives and principles which provide a systematic and consistent approach to HTA, and an explicit, high-level statement of direction for the implementation and integration of the current HTA functions to form a coherent system.

The policy framework assists with:

promoting a shared and consistent approach across Australian Government HTA processes for market entry and for reimbursement;
clearer delineation of roles and responsibilities of each component of the Australian Government HTA system, including the expert advisory committees and secretariats;
improved transparency for applicants and other parties interested in the outcomes of HTA;
encouraging a consumer and patient focus without increasing regulatory burden on applicants;
more robust performance measurement and accountability;
more efficient use of clinical and HTA expertise;
reducing unnecessary or poorly designed regulation; and
facilitating and encouraging links between HTA and broader health system goals.

Vision for a sustainable, efficient Australian Government HTA system

The vision articulates an aspiration for Australian Government HTA processes at the highest level:

Australians have timely, equitable and affordable access to the cost-effective health technologies needed to manage their health.

Goal of Australian Government HTA processes

The goal articulates how, and on what basis, Australian Government HTA processes contribute to the Australian health system:

The goal of Australian Government HTA processes is to maximise beneficial health outcomes to the Australian population within the overall funds available whilst being cognisant of the other important goals of the health system.

Objectives of Australian Government HTA processes

The objectives articulate the approach to informing robust decisions:

That Australian Government HTA processes use the best available evidence and efficient methods to inform robust decisions about market entry and the subsidised use of health technologies. The Australian Government HTA system should also continually improve the evidence base for assessment and operate according to agreed principles.

Principles underpinning Australian Government HTA processes

Australian Government HTA processes reflect the following principles:

Principle	Description
Sustainable	Assessments and appraisals contribute to a sustainable Australian health system through informing evidence-based decisions about the subsidised use of health technologies Appraisals inform, and are informed by, evidence from post-market monitoring of subsidised health technologies to guide the continued investment or disinvestment in these technologies An HTA workforce with up-to-date skills and expertise is built and maintained
Transparent, accountable and independent	Assessments and appraisals are undertaken objectively and impartially Functions, roles and responsibilities are clearly defined and evident to all interested parties Processes and information requirements are publicly communicated and clearly explained Involved parties are kept informed of the progress of applications throughout the assessment and appraisal processes Processes are fairly and consistently applied, and provide all interested parties with an opportunity to contribute Applicants and other parties are able to seek access to an independent review mechanism of Australian Government HTA assessment and appraisal processes The outcomes of appraisals meet the information needs of Australian Government decision-makers Advice and recommendations arising from appraisals (with supporting facts and reasons) are publicly disclosed Key activity and performance data are reported
Consultative and reflective of Australian community values	Takes into account broader societal perspectives on health technology, including access, equity and the financial impacts on consumers Structured consultation occurs with interested parties, including consumers Appraisals consider the impact of health technologies on the other relevant aspects of the health system as reflected in government policy and in Australian community values
Administratively efficient	Process duplication is minimised by co-ordination to share relevant information and expertise Regulatory burden and costs are minimised (without diminution of scientific rigour and health system sustainability) Assessment and appraisal processes are streamlined to provide a timely outcome The HTA workforce is expert, experienced and equipped to process the full range of applications received
Flexible and fit for purpose	Processes and methodologies should be adaptable to technological change The full range of current and emerging types of health technologies can be appropriately assessed Applications are efficiently directed, assessed and managed through the relevant process(es) The assessment of a health technology is commensurate with the risk of harm to the patient and cost to the Australian Government and community Appraisals inform any risk sharing arrangements considered between the Australian Government and applicants
Informed by robust and relevant evidence	Assessments are based on a systematic review of the best available evidence and aligned with contemporary clinical practice Assessments utilise internationally generated evidence where relevant to the Australian context Assessments consider appropriate comparators within the relevant Australian clinical context Assessments and appraisals are informed by multi-disciplinary expertise to ensure their overall credibility Methodologies for assessing health technologies are continually reviewed and updated in the light of validated Australian and international developments

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Page currency, Latest update: 02 February, 2011