Php276 - A Review of the Impact of Integrated Scientific Advice for the Optimisation of Evidence Generation for Hta Appraisals

Ng, Thomas; Ziomek, J.; Delaitre-Bonnin, C.; Bending, MW

doi:10.1016/j.jval.2018.09.1170

Cited by 2 publications

(4 citation statements)

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“…Of these 26 articles, seven were narrative or non-exhaustive systematic reviews describing the approaches for ED/SA followed by different HTA organizations ( 4 , 10 , 15 , 17 , 19 , 21 , 24 ) (see Supplementary material 3 ). From those reviews, four ( 14 , 18 , 20 , 23 ) were conference abstracts, so not much information could be obtained from them. Nevertheless, those reviews were used to identify the HTA organizations that offered formal ED/SA procedures.…”

Section: Resultsmentioning

confidence: 99%

“…Nine associated articles were identified in the European Network for Health Technology Assessment (EUnetHTA) – ( 8 , 9 , 11 , 18 , 20 , 25 , 29 – 31 ), of which most related to the parallel advice given by the European Medicines Agency (EMA) and EUnetHTA (see Supplementary material 3 ). EUnetHTA's website was also consulted to verify that there were no current changes in the services offered and defined in the articles.…”

Section: Resultsmentioning

confidence: 99%

“…In the systematic review, nine references related to EUnetHTA were identified ( 8 , 9 , 11 , 18 , 20 , 25 , 29 – 31 ). The focus of these articles was the description of the EUnetHTA Joint SA in parallel with EMA, except for two references ( 25 , 31 ) that also included multi-HTA EDs' examples.…”

Section: Resultsmentioning

confidence: 99%

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A systematic review of the early dialogue frameworks used within health technology assessment and their actual adoption from HTA agencies

Ibargoyen-Roteta

Galnares-Cordero²,

Benguria-Arrate³

et al. 2022

Front. Public Health

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IntroductionEarly advice in the process of developing health technologies allows manufacturers to plan their production and transfer to health care systems more accurately. This review aims to describe frameworks used within HTA and their current use by HTA Agencies.Material and methodsWe carried out a systematic literature review in Pubmed, Embase, Scopus, and WoS, including all references published in Spanish and English. This was last updated in March 2022. We extracted all available information regarding the organizations involved, services offered, types of technology, collaborators involved, fees, output and impact. Websites of several HTA organizations and Google were also searched in order to update and complete the information obtained from this generic search.ResultsFive-hundred and forty one articles were identified and screened, of which 26 met the eligibility criteria and were selected. Seven of them were non-systematic reviews that described two or more HTA organizations. Ten studies were focused on the advice offered by individual organizations, and eight described the EMA and EUnetHTA parallel or joint advice. We found variations in the technology assessed, services offered, stage of development and costs for advisory services.ConclusionsEarly and scientific advice would help manufacturers focus their product development on what is needed for the management of specific diseases. Most of the examples or services found refer to drugs as well as to some medical devices and diagnostics. A common definition of the type of advice that could be offered for different health technologies by HTA bodies to ascertain health care systems and manufacturers' needs, in addition to the timeline in which that advice needs to be given, would help HTA bodies provide the right support at the right time.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020219401, PROSPERO CRD42020219401.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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A systematic review of the early dialogue frameworks used within health technology assessment and their actual adoption from HTA agencies

Ibargoyen-Roteta

Galnares-Cordero²,

Benguria-Arrate³

et al. 2022

Front. Public Health

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“…Study sponsors should take advantage of scientific consultation processes where available to help guide evidence generation throughout a product's lifecycle. Scientific advice provides an essential function in allowing HTA bodies and regulators to work with stakeholders to ensure that plans for evidence generation deliver information that supports and improves decision making in both premarket and postmarket settings [28,29].…”

Section: Plan Studies Prospectively and Engage In Early Scientific Advice Proceduresmentioning

confidence: 99%

The use of nonrandomized evidence to estimate treatment effects in health technology assessment

et al. 2021

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Health technology assessment (HTA) is increasingly informed by nonrandomized studies, but there is limited guidance from HTA bodies on expectations around evidence quality and study conduct. We developed recommendations to support the appropriate use of such evidence based on a pragmatic literature review and a workshop involving 16 experts from eight countries as part of the EU’s Horizon-2020 IMPACT-HTA program (work package six). To ensure HTA processes remain rigorous and robust, HTA bodies should demand clear, extensive and structured reporting of nonrandomized studies, including an in-depth assessment of the risk of bias. In recognition of the additional uncertainty imparted by nonrandomized designs in estimates of treatment effects, HTA bodies should strengthen early scientific advice and engage in collaborative efforts to improve use of real-world data.

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Php276 - A Review of the Impact of Integrated Scientific Advice for the Optimisation of Evidence Generation for Hta Appraisals

Cited by 2 publications

References 0 publications

A systematic review of the early dialogue frameworks used within health technology assessment and their actual adoption from HTA agencies

A systematic review of the early dialogue frameworks used within health technology assessment and their actual adoption from HTA agencies

The use of nonrandomized evidence to estimate treatment effects in health technology assessment

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