Review of Health Technology Assessment in Australia
On 27 February 2010, the Minister for Health and Ageing, the Hon Nicola Roxon, and the then Minister for Finance and Deregulation, the Hon Lindsay Tanner, publicly released the Report of the Review of Health Technology Assessment in Australia (HTA Review), and announced the government’s acceptance of 13 of the 16 HTA Review recommendations.
The HTA Review recommended a strategic policy framework to guide Australian Government HTA processes for market entry and HTA for reimbursement in Australia into the next decade. It also recommended key improvements to the way new health technologies, procedures and services are assessed for public and private funding, in line with international best practice.
Key Messages from the HTA ReviewThe HTA Review recommended that Australian Government HTA processes should:
- all follow a set of shared objectives and principles;
- be part of an open, transparent, integrated system;
- make information easily available from a central website, including more information on health technology assessment and decision-making;
- provide improved opportunities for sponsor and stakeholder input, including expanded options for seeking review of decisions;
- operate through a single entry point to assist stakeholders by receiving, guiding and monitoring all applications for reimbursement;
- be more flexible in dealing with novel and complex technologies by coordinating assessments and allowing different aspects of complex technologies to be assessed at the same time;
- speed up Medical Services Advisory Committee assessments by allowing sponsors to supply their own assessments and have these critiqued;
- simplify administration of the Prostheses List by streamlining administrative processes and removing duplication; and
- reform post-market surveillance of health technologies to strengthen patient safety and value for money for taxpayers.
HTA Review RecommendationsThe HTA Review recommended:
Recommendation 1That the impact of the proposed changes to the Australian Government Health Technology Assessment (HTA) system approved by the Australian Government be evaluated within three years of the Government’s response to this review.
Recommendation 2That 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.
Recommendation 3That the Australian Government HTA system be guided by the vision, goal, objectives and principles articulated in the HTA Review report.
Recommendation 4That DoHA establish a website for Australian Government HTA processes by July 2010 which:
- describes the roles, responsibilities and relationships between the different HTA processes;
- facilitates access to all related Australian Government HTA websites to ensure that policy and guidance for all Australian Government HTA processes are easily accessible; and
- regularly publishes reports on agreed performance and activity data to clearly demonstrate the performance of the system and focus attention on areas requiring performance improvement.
Recommendation 5That the procedural fairness and consistency of Australian Government HTA processes be improved by 2011, by:
- establishing independent review mechanisms and opportunities for re-submissions in a consistent manner for Australian Government HTA processes (where they are currently not available);
- establishing independent review mechanisms and opportunities for re-submissions in a consistent manner for Australian Government HTA processes (where they are currently not available);
- updating operating procedures for administering Australian Government HTA processes including by publishing specific milestones and timeframe targets for each individual HTA process;
- improving public disclosure of Australian Government HTA processes including advisory committee membership, performance and activity data, and assessment and appraisal outcomes (including the rationale for those outcomes);
- establishing and publicising specified communication points with applicants throughout each process, including providing opportunities for pre-lodgement meetings; and
- adopting and implementing transparent and consistent policies and procedures for the management of conflict of interest for all external parties involved in Australian Government HTA processes.
Recommendation 6That in order to improve the efficiency of HTA, DoHA establish a single entry point (SEP) by July 2010 to receive applications for subsidy under the Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Schedule (PBS) and Prostheses List. The role of the SEP will be to:
- provide a single point of contact to help applicants throughout the HTA process;
- determine the most appropriate advisory committee(s) to appraise the technology;
- identify the most appropriate assessment pathway for an application, including by maintaining and reinforcing current processes where these are the most efficient for the technologies submitted to a particular process;
- conduct an initial risk and impact assessment and determine the most appropriate methodology to be used in assessing the technology;
- ensure the timely assessment and appraisal of co-dependent and hybrid technologies, or technologies being assessed concurrently for both public and private reimbursement and coordinate the provision of comprehensive advice to the Minister for Health and Ageing (the Minister);
- achieve synergies through sharing and sustaining HTA expertise across the advisory committee secretariats; and
- develop and report on the achievement of performance targets for HTA for reimbursement.
Recommendation 7That applicants have the option of applying to different HTA processes concurrently. Finalisation of each HTA process may be subject to the completion of a critical antecedent process (such as inclusion on the Australian Register of Therapeutic Goods (ARTG) prior to MBS or Prostheses List listing). This will require procedures to be put in place by July 2010 to allow the efficient flow of information between HTA processes (including from the TGA to other HTA agencies, subject to confidentiality constraints).
Recommendation 8That the Therapeutic Goods Administration (TGA), in the context of international harmonisation:
- continue its role as the independent national regulator solely responsible for assessing the safety, quality and efficacy of therapeutic goods for entry on the ARTG and marketing in Australia;
- respond to the issues raised in consultations regarding third party conformity assessment by July 2010, with a view to implementing changes agreed by government by 2011;
- increase the rigour of regulatory assessment of higher risk medical devices by 2011, to ensure an appropriate level of evidential review is undertaken to ensure safety, quality and efficacy of these devices prior to entry on the ARTG and to provide a sound evidence basis for Australian Government HTA processes; and
- develop protocols by July 2010 for sharing information with other HTA agencies through the SEP (subject to commercial-in-confidence constraints) on the outcomes of its safety assessments.
Recommendation 9That by July 2010, the Medical Services Advisory Committee (MSAC) strengthen and streamline its operations and improve the flexibility of its regulatory processes by:
- providing advice to the Minister based on a critique of an applicant’s comparative clinical and economic evaluations, as an alternative to the current process and in the context of agreeing specific timeframes for assessment with the applicant;
- ensuring that data collection requirements supporting a recommendation for interim funding for a professional service for listing on the MBS are sufficiently rigorous and reliable to provide a sound basis for a final decision on funding;
- ensuring that its advice to the Minister addresses all aspects of the proposed change to the MBS, especially in regard to the proposed MBS item descriptor and fee; and
- streamlining current processes for accessing expert advice to improve timeliness of assessment processes and set a target of all advisory panels being established within six weeks of accepting an application.
Recommendation 10That in order to reduce regulatory costs:
- the terms of reference for the Prostheses List Advisory Committee (formerly Prostheses and Devices Committee (PDC)) and its subcommittees be revised by July 2010 so that it is clear that its assessments of prostheses only consider clinical effectiveness (including comparative cost and comparative safety); and
- channels of communication between the TGA and PDC should be formalised to ensure that any concerns the PDC encounters regarding the intrinsic safety of prostheses are immediately referred to the TGA and dealt with appropriately.
Recommendation 11That the PDC be restructured by July 2010 to ensure that its membership is balanced and:
- includes individuals with expertise in current clinical practice, health policy and health economics;
- includes representation from health consumers, health service providers, and the health insurance and health technology industries; and
- has an independent chair.
Recommendation 12That the arrangements for the Prostheses List be changed by 2011, with appropriate consultation, to:
- accept applications on a continuous basis, but still make the Prostheses List every six months;
- establish and maintain groups of products with similar clinical effectiveness;
- abolish the negotiation of benefits for individual listed products, and instead establish and maintain a single (benchmark) benefit for the products included in each group, with sponsors being required to accept this benefit in order to be listed;
- abolish the negotiation, setting or publication of maximum benefits, to eliminate the potential for gap payments for patients who have Private Health Insurance (PHI); and
- permit the establishment of new product groups (or sub-groups) where a sponsor establishes clear superiority of their product compared to those in an existing group.
Recommendation 13 - The implementation of this recommendation is subject to further consideration by Government.That, in order to improve the contribution of post-market surveillance to patient safety, the TGA take steps to increase the rate of reporting of adverse events, including by health service providers and consumers.
Recommendation 14 - The implementation of this recommendation is subject to further consideration by Government.That, in order to improve the contribution of post-market surveillance to the sustainability of the health system and the longer-term regulatory efficiency of HTA processes, DoHA explore options for consideration by government in 2011 to facilitate the expansion and use of post-market surveillance data to inform safety, effectiveness and reimbursement decisions for devices and procedures.
Recommendation 15 - The implementation of this recommendation is subject to further consideration by Government.That registers for high-risk implantable medical devices and/or procedures be established, with:
- key stakeholders such as clinicians, health consumers and industry to participate in governance of and contribution to registries;
- establishment of mechanisms to apply data from the register to future HTA;
- the feasibility, benefits and methodologies for data linkage to be explored in a pilot project in regard to a particular device identified by the high-risk implantable devices register;
- consideration of how developments in e-health and data linkage could improve the efficiency of the post-market surveillance of medical technology more generally; and
- the development of criteria, the identification of opportunities and the consideration of strategies for improvements in public investment in medical devices.
Recommendation 16That the Australian Health Ministers’ Conference be asked to consider the need for a national approach to HTA processes, including processes required to evaluate blood and blood products.
HTA Review ImplementationThe HTA Review presents a feasible, staged reform agenda with recommendations one to 12 (inclusive) and 16 able to be implemented within existing departmental resources in the short to medium term, during 2010-2012. Recommendations 13, 14 and 15 – relating to improving post-market surveillance of health technologies – cannot be implemented within existing funding levels and are subject to further consideration by government. For an update on the implementation of the HTA Review recommendations click here.
Conduct of the HTA ReviewOn 18 December 2008, the Minister for Health and Ageing, the Hon Nicola Roxon MP, and the then Minister for Finance and Deregulation, the Hon Lindsay Tanner MP, announced the HTA Review as a Better Regulation Ministerial Partnership.
The HTA Review was one of several 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 was to recommend options for improving process efficiency and reducing the regulatory burden for Australian Government 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.
Terms of Reference for the HTA ReviewThe HTA Review reported on the following matters:
- Simplification and better co-ordination of Australian Government HTA processes (as identified in the Review scope), which included:
- 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-dependent and hybrid technologies
HTA Review ScopeThe Australian Government HTA processes in-scope for the HTA Review were:
- regulation of therapeutic goods for market entry, currently undertaken by the Therapeutic Goods Administration (TGA);
- approval of funding under the Medicare Benefits Schedule (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.
Stakeholder consultationThe HTA Review conducted comprehensive consultation with all key stakeholders throughout the Review to identify issues and canvass options for reform under the terms of reference,
- calling for and receiving 86 public submissions;
- the development of options papers in response to issues raised to seek further input and direction about the scope of the reforms required;
- conducting two rounds of bilateral meetings with peak agencies and focus groups with stakeholders on issues emerging during the Review and options for reform;
- enabling key stakeholder input into identifying issues and developing policy solutions to address the HTA Review terms of reference through an Inter-Departmental Committee and a Medical Technology Stakeholder Reference Group (MTSRG). Peak agencies for the medical technology industry, representative colleges of health professionals, private health insurers, private hospitals and consumers were represented on the MTSRG; and
- engaging the Consumers’ Health Forum of Australia (CHF) to consult with consumers to ensure a comprehensive consumer response to policy issues relevant to the HTA Review.
HTA Review outcomesPublished documents from the HTA Review including the final Report, the Regulation Impact Statement, submissions received, discussion and options papers and the reports from the focus groups can be sourced through the following link:
For more information on the HTA Review click here.
Better Regulation Ministerial PartnershipThe Australian Government’s Better Regulation agenda reflects its commitment to micro-economic reform to drive productivity growth by engendering a culture of continuous regulatory improvement - where regulation is efficient and fit for purpose. Better Regulation will reduce the regulatory costs to Australian business, and the not-for-profit sector, supporting productivity, employment and economic growth.
The Minister for Finance and Deregulation has portfolio responsibility for this agenda, and is leading a number of better regulation initiatives at both the Australian Government and inter-jurisdictional level through the Council of Australian Governments process.
The HTA Review was conducted as a Better Regulation Ministerial Partnership between the Minister for Health and Ageing and the Minister for Finance and Deregulation.
The benefits of greater patient safety and more sustainable health financing arrangements through the use of HTA should outweigh the costs of such regulation. However, where HTA processes cause unnecessary costs or delays, because they are inefficient, uncoordinated or poorly targeted, there may be little net public benefit. The Australian Government acknowledges that additional costs and delays in achieving return on investment may appropriately occur with the assessment of the safety and efficacy of new health technologies prior to sale in Australia, or with the evaluation of their cost effectiveness before government subsidises their use.
The HTA Review identified opportunities to streamline the assessment and approvals process for health technology products, therapeutic goods and medicines both for government funding and to enable them to be released into the Australian market. HTA Review recommendations aim to strike an appropriate balance not only by reducing costs to business but also by improving patient access to safe, effective and cost-effective health technologies through better regulation.
Further information about Better Regulation Ministerial Partnerships
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Page currency, Latest update: 09 November, 2011