2019
DOI: 10.1016/j.therap.2018.12.002
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Early access to health products in France: Major advances of the French “Conseil stratégique des industries de santé” (CSIS) to be implemented (modalities, regulations, funding)

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Cited by 7 publications
(7 citation statements)
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“…Within their report on the implementation of the EMA-EUnetHTA work plan 2017–2021 EMA and EUnetHTA provide in-depth insights regarding their discussion of controversial methodological challenges [ 15 ]. Continuation of those discussions and clarification of evidence requirements within the regulatory and HTA framework including parallel early advice, early access schemes, as well as regulatory and HTAs is urgently required to ‘ensuring a strong EU voice globally’ in line with chapter 5 of the European Commission’s pharmaceutical strategy for Europe [ 13 , 16 , 17 ]. The management of uncertainty after successful EMA approval leading to additional national data requirements as a toll needed for covering the gaps and discrepancies between the regulatory and HTA data needs is another key challenge affecting any future oncology HTA within Europe [ 18 ].…”
Section: Discussionmentioning
confidence: 99%
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“…Within their report on the implementation of the EMA-EUnetHTA work plan 2017–2021 EMA and EUnetHTA provide in-depth insights regarding their discussion of controversial methodological challenges [ 15 ]. Continuation of those discussions and clarification of evidence requirements within the regulatory and HTA framework including parallel early advice, early access schemes, as well as regulatory and HTAs is urgently required to ‘ensuring a strong EU voice globally’ in line with chapter 5 of the European Commission’s pharmaceutical strategy for Europe [ 13 , 16 , 17 ]. The management of uncertainty after successful EMA approval leading to additional national data requirements as a toll needed for covering the gaps and discrepancies between the regulatory and HTA data needs is another key challenge affecting any future oncology HTA within Europe [ 18 ].…”
Section: Discussionmentioning
confidence: 99%
“…Within their report on the implementation of the EMA-EUnetHTA work plan 2017–2021 EMA and EUnetHTA provide in-depth insights regarding their discussion of controversial methodological challenges [ 15 ]. Continuation of those discussions and clarification of evidence requirements within the regulatory and HTA framework including parallel early advice, early access schemes, as well as regulatory and HTAs is urgently required to ‘ensuring a strong EU voice globally’ in line with chapter 5 of the European Commission’s pharmaceutical strategy for Europe [ 13 , 16 , 17 ].…”
Section: Discussionmentioning
confidence: 99%
“…Other schemes in Europe allow the pharmaceutical industry to access a market pre-authorization and derive revenue from a product, albeit for a short period of time. An example is the French Temporary Utilisation Program (Autorisation Temporaire d’Utilisation, ATU), which can be used for individuals or cohorts of patients and allows the manufacturer to set the price of the product freely for 1 year, with any variation in the price paid back if there is a difference post-launch ( 40 , 41 ).…”
Section: Discussionmentioning
confidence: 99%
“…To address financing limitations and accelerate access to orphan drugs with pending authorization or under development, several countries adopt alternative access schemes [26]. Examples are, compassionate use programs (CUP) provided by pharmaceutical companies and medical need programs (MNP), such as the French ' Autorisation Temporaire d'Utilisation d'extension' (ATU) [27][28][29]. In some instances, people living with a rare disease are treated with a medicinal product not yet indicated or authorized for their specific condition under, so-called, off-label use [30].…”
Section: Introductionmentioning
confidence: 99%