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Encouraging the Regulatory Evaluation of Off-Patent Repositioned Medicines in Australia /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Encouraging the Regulatory Evaluation of Off-Patent Repositioned Medicines in Australia // Katrina Louise Perkin.
作者:	Perkin, Katrina Louise,
面頁冊數:	1 electronic resource (543 pages)
附註:	Source: Dissertations Abstracts International, Volume: 86-12, Section: B.
Contained By:	Dissertations Abstracts International86-12B.
標題:	Generic drugs. -
電子資源:	https://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=32018089
ISBN:	9798286413102

Encouraging the Regulatory Evaluation of Off-Patent Repositioned Medicines in Australia /
Perkin, Katrina Louise,

Encouraging the Regulatory Evaluation of Off-Patent Repositioned Medicines in Australia /Katrina Louise Perkin. - 1 electronic resource (543 pages)

Source: Dissertations Abstracts International, Volume: 86-12, Section: B.

Australia's National Medicines Policy (NMP) aims to ensure medicines, including complementary, over-the-counter, prescription medicines, vaccines and gene therapies, meet agreed standards of quality, safety and efficacy. The Therapeutic Goods Administration (TGA) is responsible for medicines evaluation to ensure the benefits of use outweigh risks prior to approval. Following approval, medicines can be used beyond approved limits. This is known as off-label use.Sometimes prescription medicines are used off-label where approved treatments for a condition are not available or have not been effective. This is an example of medicine repositioning in the clinical setting. Medicine repositioning can occur at various stages of a medicine's lifecycle, however it commonly occurs when a medicine has been on the market for years and is off-patent (no longer protected by a legally enforceable intellectual property right).There are certain downsides of medicine repositioning in the clinical setting. Firstly, patients receive medicines without a risk/benefit evaluation by the TGA. Secondly, without TGA evaluation and approval, these medicines are not eligible for Commonwealth Government cost subsidisation, making access to these off-patent repositioned medicines unaffordable for some patients.Off-patent prescription medicines that are used for off-label indications are the focus for this thesis. Unless otherwise explained, these medicines will be referred to as 'off-patent repositioned medicines' forthwith.There is limited understanding of how off-patent repositioned medicines are used across the Australian health system and what changes might be made to promote medicines evaluation and affordable access. Informed policy responses rely on an assessment of the best available evidence and the production of intentional strategies for reform. This thesis reviewed and synthesised multiple sources of secondary data to explore ways to encourage the evaluation of off-patent repositioned medicines in order to create a novel policy model to improve medicine evaluation and access.An initial scoping review found that the extent of off-patent repositioned medicine use across Australia is greater than previously thought. In addition, state and territory funded patient access varies because safety, efficacy and cost effectiveness are evaluated at the local level rather than nationally. Analysis of medicine evaluation processes and policies found that while regulatory pathways in Australia and comparable international jurisdictions permit the evaluation of off-patent repositioned medicines, complexity and cost limit use of these systems. In particular, the presence or absence of three key drivers (evidence generation, application submission and revenue generation) either facilitate or impede evaluation of repositioned medicines. This means that in practice, when patent protection expires, a medicine sponsor is unlikely to seek regulatory approval for repositioned medicines due to effort and unrecoverable costs.Evidence shows that stakeholders in Australia are advocating for better access to repositioned medicines for patients and changes to the regulatory system to promote medicine repurposing. However, without the potential for revenue generation, sponsors of off-patent repositioned medicines are unlikely to invest in evidence generation and application submission to enable medicines evaluation.The findings of the studies conducted enabled the development of a draft policy framework which aims to facilitate affordable patient access to safe and effective off-patent repositioned medicines. Through generation of the clinical evidence necessary to enable the evaluation of off-patent repositioned medicines, the policy framework removes barriers to the submission of clinical evidence in a medicines evaluation application and creates avenues for revenue generation post approval. The utility of the draft policy framework was tested with experts via a modified Delphi consultation. Consensus was reached on characteristics of a policy model specifically designed to facilitate evidence generation, application submission and revenue generation for off-patent repositioned medicines. The novel policy framework translates key drivers of medicines evaluation into practice in the Australian context.This thesis highlights the drivers of medicines evaluation in order to identify the barriers specific to off-patent repositioned medicines. Strategic reforms that concurrently incentivise evidence generation, application submission and revenue generation could potentially improve affordable patient access to safe and effective off-patent repositioned medicines in Australia. The novel policy framework presented should help to improve the quality use of medicines and alignment with broader NMP objectives.

English

ISBN: 9798286413102Subjects--Topical Terms:

731170
Generic drugs.

Encouraging the Regulatory Evaluation of Off-Patent Repositioned Medicines in Australia /
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