Q. What is health technology assessment?
Health Technology Assessment (HTA) encapsulates a range of processes and mechanisms that use scientific evidence to assess the quality, safety, efficacy, effectiveness and cost effectiveness of health service delivery. The process is commonly applied to pharmaceuticals (including vaccines), medical devices, medical procedures, and public health approaches.
Q. What is the objective of the HTA Review?
The HTA Review will examine Commonwealth HTA processes and make recommendations about options for improving process efficiency and reducing regulatory burden that can act as impediments to medical innovation. This is without compromising timely and affordable patient access to medical services and devices that: a) are demonstrated to be safe, effective and cost effective; and b) deliver improved health outcomes and value for money.
The HTA Review will canvass opportunities for reform, consistent with the Government’s policy objectives for the in-scope HTA processes.
Q. What is the scope of the HTA Review?
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.
The HTA Review will have regard to the outcomes of earlier reviews
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Q. What will not be examined by the HTA Review?
The HTA Review will not examine PBAC processes except where there is an interface between MSAC and PBAC. The HTA Review will not specifically examine processes for regulation or subsidy of blood or blood products or state and territory government HTA processes.
Q. Who is conducting the HTA Review?
The Department of Health and Ageing will conduct the HTA Review in consultation with key stakeholders, including industry representatives, government representatives, medical professionals, insurers and consumers.
Q. Why is the Australian Government undertaking the HTA Review?
In recent years, a number of reviews
have highlighted the need for systemic review of current HTA processes in Australia. Specifically, the “Rethinking Regulation – Report of the Taskforce on Reducing Regulatory Burdens on Business, January 2006” (the Banks Review) recommended that:
“The Australian Government should undertake a system-wide, independent and public review of health technology assessment, with the objective of reducing fragmentation, duplication and unnecessary complexity, which can delay the introduction of beneficial new medical technologies. Health technology assessment processes and decisions should also be made more transparent, in line with good regulatory practice.”
The Australian Government is committed to reducing the level of unnecessary or poorly designed regulation and contributing to improved productivity and future living standards.
Q. How can stakeholders participate in the HTA Review?
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Effective public consultation is important in ensuring a comprehensive and informed report to the Minister for Health and Ageing, Nicola Roxon MP and the Minister for Finance and Deregulation, Lindsay Tanner MP on the findings of the HTA Review. Interested parties may participate in the HTA Review through the following processes:
- a public submissions process – the Department is calling for submissions against the HTA Review terms of reference through the Department’s website
- focus groups with stakeholders in major capital cities to provide an opportunity for discussion and clarification of issues to be considered during the HTA Review – notification of venues and dates will be on the HTA Review website at a later date; and
- key stakeholders have been invited to participate on a stakeholder reference group.
Where required, the Department will hold bilateral discussions with key stakeholders.
Q. What is the role of the Medical Technology Stakeholder Reference Group (MTSRG) and what is its membership?
The MTSRG will be chaired by a Deputy Secretary from the Department of Health and Ageing and comprise key Australian Government and non-government stakeholders to ensure comprehensive consultation with key stakeholders in identifying issues and developing policy solutions to address the HTA Review Terms of Reference.
The MTSRG is an important forum to allow comprehensive consultation with key stakeholders in identifying issues and developing policy solutions to address the Terms of Reference of the HTA Review.
The MTSRG will include representatives from the following Government and non-government stakeholder groups:
Q. How do I make a submission to the HTA Review and where should I send my submission? Can I send a hard copy?
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- Australian Health Insurance Association
- Australian Medical Association
- Australian Private Hospitals Association
- Consumers Health Forum of Australia
- Department of Finance and Deregulation
- Department of Health and Ageing
- Department of Innovation, Industry, Science and Research
- Department of the Prime Minister and Cabinet
- Department of Veterans’ Affairs
- Medical Technology Association of Australia
- Medicines Australia
- National Health and Medical Research Council
- Royal Australian and New Zealand College of Radiologists
- Royal Australian College of Surgeons
- Royal Australasian College of Physicians
- Royal College of Pathologists of Australasia
- The Treasury
The Commonwealth Department of Health and Ageing (the Department) is inviting submissions from interested parties to the HTA Review. The discussion paper
provides information on the scope and context of the HTA Review to assist in informing submissions, and provides a brief overview of Australian health technology assessment (HTA) processes to identify issues on which the Department is seeking comment. However, submissions may comment on any matters relevant to the HTA Review terms of reference, and are not limited to issues canvassed in the discussion paper.
There is no specified format for submissions. However, submissions should provide commentary on one, some or all of the terms of reference. Where possible, supporting data and documentation should be provided. This is a public review and the Department seeks to have as much information as possible on the public record. However, submissions may comment on any matters relevant to the HTA Review terms of reference, and are not limited to issues canvassed in the discussion paper.
It is preferred if submissions are sent electronically to email@example.com
by email as a text document (.txt), a Microsoft Word document (.doc) or similar text format, rather than Adobe Portable Document Format (.pdf), to ensure accessibility by screen readers.
Alternatively, submissions may also be sent by mail as either a hard copy or CD to:
Attn: HTA Review
Department of Health and Ageing
GPO Box 9848
Canberra ACT 2601
The Department will consider all submissions to the HTA Review. The HTA Taskforce will acknowledge receipt of all submissions.
Q. What is the timeframe for accepting submissions for the HTA Review?
Submissions will be accepted until close of business on Friday 22 May 2009.
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Q. How long will the HTA Review take?
The Department is due to present its report of the HTA Review to the Minister for Health and Ageing, the Hon Nicola Roxon MP and the Minister for Finance and Deregulation, the Hon Lindsay Tanner MP, in late 2009.
Q. Will submissions be published on the HTA Review website?
Unless otherwise indicated in the submission, it is planned that all submissions will be published on the HTA Review website. If you wish for any information contained in your submission to be treated as confidential, please explicitly and clearly identify that information, and outline the reasons why you consider it to be confidential. Confidential information will not be published.
Q. How long will submissions remain on the HTA Review website?
Submissions may remain on the website until the end of the 2010-11 financial year.
Q. My submission may include attachments. Will these be published? Will they be considered in the HTA Review?
The Department may receive submissions with attachments, including DVDs, PowerPoint presentations, books, journal articles, previously published reports, dissertations, extracts from newspapers, magazines and other material. The Department will consider all information received as part of the HTA Review. However, given the volume of material received, the attachments to submissions will not be published on the Department’s website.
Q. Who can I contact if I need to ask any questions about the HTA Review?
Please send enquiries regarding the HTA Review to firstname.lastname@example.orgTop of page