When are RCTs required for breakthrough drugs, HDEs? JAMA study investigates

11 September 2019 - A new study in JAMA Network Open finds that drugs and medical devices approved by the ...

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The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018

10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...

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As value assessment frameworks evolve, are they finally ready for prime time?

9 September 2019 - Value assessment frameworks have emerged as tools to assist health care decision makers in the United States ...

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Patient Voice Aotearoa calls for PHARMAC reform

28 August 2019 - Patient Voice Aotearoa has launched a petition calling for the Minister of Health to initiate an ...

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Incorporating affordability concerns within cost-effectiveness analysis for health technology assessment

27 August 2019 - New framework considers the scale, time profile, and uncertainty of budget impacts. ...

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Pharmacists demand audit over Gliatilin’s insurance benefit

27 August 2019 - A pharmacists’ group demanded an audit against the Ministry of Health and Welfare and the Health ...

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Developing real-world data and evidence to support regulatory decision-making

26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...

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Former FDA Commissioners seek to expand use of RWE in regulatory, payment decisions

21 August 2019 - A new report from the Bipartisan Policy Center makes recommendations to expand the use of real-world ...

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ICER Proposes Updates to 2020 Value Assessment Framework Methods and Procedures

21 August 2019 - Reflecting experience with current framework, benchmarking with other HTA groups, and public input, proposals include new emphasis ...

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Lack of transparency hampers cancer drug debate

19 August 2019 - The current debate raging over cancer drug funding is emotional, and the different agenda of lobby ...

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ICER's value framework and patient feedback: Q&A with Steve Pearson

15 August 2019 - ICER invites all patient organizations and the general public to attend a webinar to learn more ...

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The evolution of real world studies

9 August 2019 - The use of real-world evidence is evolving quickly. ...

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DHB backs PHARMAC in making ‘hard calls’

7 August 2019 - Hauora Tairawhiti has a role of supporting drugs-funding agency PHARMAC in its ‘‘hard calls” but not ...

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Multi-criteria decision analysis for health technology assessment: addressing methodological challenges to improve the state of the art

28 July 2019 - Multi-criteria decision analysis concepts, models and tools have been used increasingly in health technology assessment, with several ...

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Stories of patient involvement impact in health technology assessments: a discussion paper

24 July 2019 - As more health technology assessment bodies seek to implement patient involvement, there is a desire to learn ...

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