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Health Technology Assessment Review

Discussion Paper 1- A Conceptual Framework for Commonwealth HTA Processes

Discussion Paper 1 – A Conceptual Framework for Commonwealth HTA Processes (PDF 77 KB)
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Disclaimer

The proposals for reform to Commonwealth Health Technology Assessment (HTA) processes as outlined in this Discussion Paper represent a range of responses to the issues raised in submissions to the HTA Review and during stakeholder consultation. The Discussion Papers are intended to stimulate discussion at the forthcoming consultations and any proposal presented or omitted should not be taken to represent the policy position of the Government. The HTA Review is required to put forward proposals that can be sustained within existing funding levels and that are consistent with Government policy objectives.

Introduction

Health technology assessment (HTA) is a key tool for the Australian Government to inform its reimbursement decisions in order to achieve its overall objective of delivering a safe, effective and efficient health care system that is fiscally sustainable in the longer term.

As in many countries, Australian Government policy regarding subsidised access to medical procedures, devices and medicines requires demonstrated comparative safety, effectiveness and cost effectiveness to inform decisions regarding health care funding.

This paper describes the current Commonwealth system for HTA for market regulation and HTA for reimbursement, and provides a proposed way forward to maintain and improve the elements of Australia’s Commonwealth HTA system for the future. More specific details of how this might occur are explored in Discussion Papers 2 to 5.

Current Australian Government management of access to and funding of health technologies

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 products 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);
• assessment 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 (PL); and
• post market surveillance of these health care interventions to inform ongoing decisions about the marketing approval of therapeutic products or the reimbursement of health technologies that prove not to be safe or do not perform as intended.

Resources to support these functions are managed by different Divisions within DoHA, and by the Therapeutic Goods Administration (TGA).
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Concerns Raised in HTA Review Consultations
Concerns raised by stakeholders in public consultations about the current overall Commonwealth approach to HTA in Australia included:

• the lack of a strategic, systematic and integrated framework for Commonwealth HTA functions including the absence of practical linkages between the HTA advisory committees assessing health technologies, and their assessment within a holistic model of care;
• insufficient recognition and adoption, where appropriate, of international developments in assessing health technologies; and
• insufficient coordination between Commonwealth HTA functions and those of State and Territory governments.

Proposal 1 Conceptual Framework for Commonwealth HTA Processes

In the light of concerns about the coordination and management of Commonwealth HTA processes, there may be benefit in explicitly defining the vision, goal, scope and principles for an overall HTA system. This might provide a benchmark against which to assess other more specific changes and also facilitate a common approach to the various elements of the system.

The following proposed vision, goal and underpinning principles for an overall Commonwealth HTA system have been formulated by drawing on views expressed by stakeholders during the HTA Review consultation process. These principles aim to reflect a system that is consistent with the Government’s regulatory reform agenda and Better Regulation Ministerial Partnership between the Minister for Health and Ageing, the Hon Nicola Roxon MP, and the Minister for Finance and Deregulation, the Hon Lindsay Tanner MP.

Proposed vision for a Commonwealth HTA system

Commonwealth HTA in Australia should be recognised as an international leader in the field – providing a structure and capability to ensure the timely and equitable access to cost effective health care interventions for the Australian community, and which achieve optimal health outcomes within available resources.

Proposed goal and objective of a Commonwealth HTA System

The proposed explicit primary goal for the Commonwealth HTA system is to maximise beneficial health outcomes within the health budget.¹

¹The proposed goal:

• could be more than the means by which this primary goal is achieved;
• encompasses the central concept of opportunity cost;
• focuses on provision of health care resources and health outcomes, not indirect outcomes of health via changes in production (i.e. emphasises the full health care system perspective over the societal perspective);
• could be open to how the availability of health care funds is determined, and
• could include other goals of the health care system, such as equity of access according to capacity to benefit, promoting innovation to achieve the primary goal, and being flexible to deal with rare conditions.
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Proposed underpinning principles of Commonwealth HTA in Australia

The Commonwealth HTA system in Australia should be:

Principle	Descriptor
1. Independent and consultative	HTA processes should independently verify evidence in the Australian health care context. HTA processes and advice should be informed by appropriate consultation.
2. Transparent and accountable	A clear distinction of roles should be evident between applicants, process administrators, affected health professionals, evaluators, advisory committees, payers and policy-makers in terms of their powers/functions in the HTA process. A clear explanation of HTA processes (including the assessment 2 , appraisal and decision making steps, the expertise and criteria applied to perform each step, timelines and how each step is consistently applied) should be publicly available (where appropriate). HTA processes should be procedurally fair throughout the assessment leading up to the reimbursement decision by explaining clearly what information is needed and how a decision will be made, conducting an unbiased assessment and giving relevant stakeholders appropriate opportunities to contribute. HTA advisory committee appraisals, recommendations and advice should incorporate wide, multidisciplinary stakeholder input, while remaining consistent and credible, and adhering to pre-agreed timelines and key performance indicators. There should be public disclosure of HTA advisory committee appraisals, advice and recommendations (with facts and reasons leading to these recommendations) and of subsequent reimbursement decisions.
3. Efficient	HTA processes should be seamless and minimise duplication. HTA processes should be managed as a single system that anticipates and manages assessment issues. HTA processes should minimise regulatory cost remaining cognisant of the need to ensure scientific rigour and sustainability of the health care system. HTA processes should share information and expertise (including independent evaluator and clinical expertise).

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For the purpose of this Discussion Paper, the term:

• “assessment” means “the evidence base to consider the health technology”;
• “appraisal” means “the consideration of the evidence and other relevant factors by the advisory committee”; and
• “decision-making” means “the final funding decision”.

Principle	Descriptor
4. Informed by best available evidence and aligned with contemporary clinical practice	HTA appraisals should be based upon research evidence as well as informed by contemporary clinical practice and societal values. HTA appraisals should have regard to all relevant comparators that are used inter-dependently within a clinical model of care. HTA appraisals should take into account globally harmonised evidence requirements and should apply internationally collaborative evidence in order to remain relevant to the Australian context.
5. Flexible and fit for purpose	HTA processes should be able to identify and accommodate emerging health care interventions (through horizon scanning) and changing clinical practices. Assessment methodologies should be continually reviewed and updated in the light of validated innovations and developments. HTA processes should ‘triage’ applications so that the appropriate type of assessment (e.g. full versus targeted assessment/brand versus generic assessment) is undertaken.
6. Capable and manages risk effectively	HTA appraisals should consistently apply rigorous analytical methods while reflecting patient and fiscal risks associated with adoption of a health care intervention. HTA appraisals should inform risk sharing arrangements between government and applicants where appropriate.
7. Sustainable	The HTA system should contribute to the sustainability of the broader health system through the identification of safe, clinically effective and cost effective health care interventions for consideration for reimbursement as well as the identification of health care interventions that are of questionable clinical and/or cost effectiveness that should be considered for disinvestment. The HTA system should provide suitable incentives to build and sustain a HTA workforce with up to date skills.

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Commonwealth HTA functions

Overview

A proposed approach to future HTA governance of functions and elements of a HTA system is outlined below. HTA processes should provide the necessary synergies to deliver access to safe, effective and cost effective health technologies to the Australian community.

A diagrammatic representation of the proposed Commonwealth HTA functions is at Attachment A.

Scope of HTA coverage

In the short term, the Commonwealth HTA system would continue to assess:

• medical services;
• surgical interventions;
• diagnostic technologies (including pathology);
• devices;
• vaccines;
• drugs;
• hybrid technologies; and
• co-dependent technologies.

In the longer term, and consistent with any future Australian Government policy decisions about the scope of health care intervention types it is prepared to consider funding, the Commonwealth HTA system could be expanded to also assess, for example:

• health care prevention;
• clinical models of care (including their integration with technology);
• medical aids and appliances;
• blood and blood products and services;
• cell therapies and other biologics;
• other emerging health care interventions; and
• health care system guidance.

The resource implications of expanding Commonwealth and HTA sector capacity and capability would also need to be addressed.

Horizon scanning

Commonwealth HTA processes should include a horizon scanning mechanism to be able to proactively identify and respond to new and emerging technologies and to adapt to changes in models of clinical care.
These horizon scanning activities would inform any impending health care intervention ‘pipeline’ and highlight where assessment of these health care interventions may be focussed to meet the needs of the health care system, whilst aligning with national health priorities. Top of page

HTA for market entry

The TGA’s role of evaluating the intrinsic safety, clinical effectiveness and efficacy for the market regulation of therapeutic products is an important contributor to the Commonwealth HTA functions for reimbursement (noting that the ARTG includes some therapeutic products not seeking HTA for reimbursement).
Evidence received and assessments made by the TGA in its market regulation role can usefully inform the Commonwealth’s HTA processes - particularly the safety and effectiveness of therapeutic products which may inform the comparative assessments made during the HTA for reimbursement phase.

HTA for reimbursement

HTA is the prime means by which the Australian Government makes informed decisions about public and private reimbursement of health care interventions. These health care interventions are required to satisfy demonstrated comparative effectiveness and cost effectiveness requirements.

Reimbursement decision

Decisions about reimbursement of health care interventions by payers (Australian Government and private health insurers) would be informed by recommendations and advice from HTA advisory committees. Decision makers would also consider the broader financial implications of funding each health care intervention to ensure longer-term sustainability of the health care system.

Listing

The creation and maintenance of schedules and listings of health care interventions through the MBS, PBS and the PL would be at the discretion of the Minister for Health and Ageing, Cabinet or a delegate of the Minster for Health and Ageing and implemented through legislative instruments. Listing is the mechanism that makes health care interventions available to the Australian community.
Post implementation management - post market surveillance (PMS)
Post market (and post reimbursement) surveillance of health care interventions would provide routine quality assurance processes including:

• post market surveillance (PMS);
• maintenance of benefits; and
• the balance of investment with disinvestment.

PMS is important because:

• it can provide valuable new evidence on the performance of a health care intervention on an ongoing basis, especially where pre market and pre reimbursement evidence is limited; and
• the information collected will inform ongoing investment recommendations such as:

• should a health care intervention continue to be publicly funded or privately funded?
• should the eligible population be reviewed?
• should price (benefit) paid for health care interventions increase, decrease or stay the same?
• should a health care intervention be removed from the market (disinvestment)?

Discussion Papers 2 to 5 provide more detailed proposals.
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