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  • 1
    Online Resource
    Online Resource
    Essais cliniques exploratoires : quelles modalités de mise en œuvre, recommandations de mise en œuvre, champ d’application, cadre réglementaire ?
    Elsevier BV ; 2009
    In:  Therapies Vol. 64, No. 3 ( 2009-05), p. 149-153
    Details
    In: Therapies, Elsevier BV, Vol. 64, No. 3 ( 2009-05), p. 149-153
    Type of Medium: Online Resource
    ISSN: 0040-5957
    URL: Article
    DOI: 10.2515/therapie/2009018
    Language: French
    Publisher: Elsevier BV
    Publication Date: 2009
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  • 2
    Online Resource
    Online Resource
    Exploratory Clinical Trials: Implementation Modes & Guidelines, Scope and Regulatory Framework
    Elsevier BV ; 2009
    In:  Therapies Vol. 64, No. 3 ( 2009-05), p. 155-159
    Details
    In: Therapies, Elsevier BV, Vol. 64, No. 3 ( 2009-05), p. 155-159
    Type of Medium: Online Resource
    ISSN: 0040-5957
    URL: Article
    DOI: 10.2515/therapie/2009022
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2009
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  • 3
    Online Resource
    Online Resource
    Postlaunch evidence generation practices among health technology assessment bodies in Europe
    Cambridge University Press (CUP) ; 2022
    In:  International Journal of Technology Assessment in Health Care Vol. 38, No. 1 ( 2022)
    Details
    In: International Journal of Technology Assessment in Health Care, Cambridge University Press (CUP), Vol. 38, No. 1 ( 2022)
    Abstract: The term Postlaunch Evidence Generation (PLEG) refers to evidence generated after the launch or licensing of a health technology. The aim of this paper is to provide an overview of the implementation of these practices in the European Union in order to explore cross-border cooperation opportunities. Methods In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to all twenty-five dedicated work package (WP5B) partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with WP5B partners. Results Twelve Health TechnologyAssessment (HTA) bodies completed the survey. Of these, eleven reported procedures in place for official requests for PLEGs in their remit. In the large majority of cases, the requests are made at the time of the assessment/appraisal. Several agencies participate in the definition of the scope of the PLEG or review of its protocol. Data collection and analysis mainly lie with companies for pharmaceuticals, whereas it is more the responsibility of the HTA bodies for medical devices. Only one agency owns the data and is able to exchange them without asking permission. Conclusions Most agencies recommend European collaboration on PLEG commence once the evidence gaps have been defined or during the production of the HTA report in the case of European joint assessment.
    Type of Medium: Online Resource
    ISSN: 0266-4623 , 1471-6348
    URL: Article
    DOI: 10.1017/S0266462322000174
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2020486-3
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  • 4
    Online Resource
    Online Resource
    Early Dialogues for Pharmaceutical Products in European Network for Health Technology Assessment Joint Action 3: What Was Done and Where to Go in the Future
    Cambridge University Press (CUP) ; 2022
    In:  International Journal of Technology Assessment in Health Care Vol. 38, No. 1 ( 2022)
    Details
    In: International Journal of Technology Assessment in Health Care, Cambridge University Press (CUP), Vol. 38, No. 1 ( 2022)
    Abstract: The aim of this article is to describe the process, results, and experiences of European Network for Health Technology Assessment (EUnetHTA) Joint Action 3’s (JA3) Early Dialogue (ED) activities and to highlight opportunities for improving the processes. Methods A descriptive analysis of the steps of the EUnetHTA ED process and evaluation of the data from the EDs conducted by EU health technology assessment (HTA) bodies, published guidelines, and documents, as well as internal statistics. Results In JA3, an Early Dialogues Working Party (EDWP) was established, responsible for developing and improving processes and providing advice to pharmaceutical companies, supported by the ED Secretariat. From June 2017 to May 2021, 113 requests for pharmaceutical EDs were received and 38 conducted. The process was continuously optimized, and different approaches for involving patients were tested. Finally, a centralized procedure was chosen with the key documents produced by two responsible agencies and reviewed by the EDWP. Patient involvement was primarily done by interviewing a national patient representative to obtain general feedback on the disease and the planned study design. Conclusions During JA3, EDs were established as an efficient, successful product. Pharmaceutical companies benefited not only from the positions of the individual agencies for the national HTA, but also from the recommendations that were common to all HTA authorities. In addition, regarding the European HTA Regulation, it will be important to conduct Joint Scientific Consultations with a view toward future Joint Clinical Assessments and to further develop processes aligned with the high demand for consultation.
    Type of Medium: Online Resource
    ISSN: 0266-4623 , 1471-6348
    URL: Article
    DOI: 10.1017/S0266462322000083
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2020486-3
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  • 5
    Online Resource
    Online Resource
    OP12 Post-Launch Evidence Generation Among Health Technology Assessment Bodies In Europe
    Cambridge University Press (CUP) ; 2022
    In:  International Journal of Technology Assessment in Health Care Vol. 38, No. S1 ( 2022-12), p. S5-S5
    Details
    In: International Journal of Technology Assessment in Health Care, Cambridge University Press (CUP), Vol. 38, No. S1 ( 2022-12), p. S5-S5
    Abstract: The need for timely access to innovative technologies has placed a special focus on the development of policies and practices that can guarantee the availability whilst ensuring the safety of these technologies after launch or licensure. The aim of this paper is to present and discuss Post-Launch Evidence Generation (PLEG) practices among health technology assessment (HTA) bodies at the European level to explore cross-border collaboration opportunities. Methods In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to 25 partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with all partners of the dedicated work package. A quantitative analysis and a qualitative synthesis of the results was carried out. Results Twelve HTA bodies completed the survey. Of these, 11 reported procedures in place for official PLEG requests. In nine of the agencies, the requests are made at the time of the assessment/appraisal. Data collection and analysis mainly lies with companies for pharmaceuticals (60%) while it is more the responsibility of the HTA body for medical devices (75%). Only one agency reported owning the data and being able to exchange the data without asking permission. During the face-to face discussions, it was acknowledged that PLEG practices differ between countries depending on the topic concerned, but most rely on the usage of registries (mainly disease registries) for data collection. Most agencies estimated that a European collaboration could take place. Conclusions PLEG practices are in the remit of many European HTA bodies. Data sharing should be anticipated as only some own the data and can exchange them without asking permission. European collaboration on PLEG could commence once the evidence gaps have been defined or during the production of the HTA reports in the case of joint assessments.
    Type of Medium: Online Resource
    ISSN: 0266-4623 , 1471-6348
    URL: Article
    DOI: 10.1017/S026646232200071X
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2020486-3
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  • 6
    Online Resource
    Online Resource
    OP152 Level Of Agreement In EUnetHTA Joint Action 3 Early Dialogues
    Cambridge University Press (CUP) ; 2018
    In:  International Journal of Technology Assessment in Health Care Vol. 34, No. S1 ( 2018), p. 55-56
    Details
    In: International Journal of Technology Assessment in Health Care, Cambridge University Press (CUP), Vol. 34, No. S1 ( 2018), p. 55-56
    Abstract: A recent article reported a high level of commonality across European Health Technology Assessment bodies’ (HTABs) positions in former parallel scientific advice procedure. Since 2017, the EUnetHTA joint action 3 (JA3) offers a new early dialogue process involving a higher number of European HTABs. The present analysis aims to describe if the JA3 process modified the level of agreement across HTABs. Methods: A descriptive analysis of the written recommendations provided during every JA3 early dialogues coordinated by the French National Authority for Health (HAS) until November 2017 was conducted. The level of commonality for each HTAB position identified was assessed globally and by domain (population, comparator, outcomes, study design and health economics) and classified as follows: “full agreement” if all HTABs had the same position, “partial agreement” if more than half HTABs had the same position and “disagreement” in all other cases. Results: Four JA3 early dialogues were performed until November 2017: two in oncology, one in neurology and one in metabolic disorders. Between five and nine HTABs from eleven European countries participated. A total of forty-six positions were identified in these four early dialogues: ten on population, five on comparator, fifteen on outcomes, four on study design and twelve on health economics. Of the forty-six positions, full agreement was reached for twenty-eight positions, partial agreement for seventeen positions and only one disagreement was observed. The level of full agreements was highest for questions on comparators (five out of five) and population (nine out of ten) and lower for questions on health economics (six out of 12). Conclusions: Although the JA3 process substantially increased the number of HTABs participating in the early dialogues, this descriptive analysis suggests that the level of agreement remains very high. This may be facilitated by the high level of dialogue and coordination between HTAB ensured by the EUnetHTA process.
    Type of Medium: Online Resource
    ISSN: 0266-4623 , 1471-6348
    URL: Article
    DOI: 10.1017/S0266462318001629
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2018
    detail.hit.zdb_id: 2020486-3
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  • 7
    Online Resource
    Online Resource
    Access and price of cancer drugs: What is happening in France?
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 15_suppl ( 2017-05-20), p. 6623-6623
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 6623-6623
    Abstract: 6623 Background: The French National Authority for Health (HAS) is responsible for health technology assessment (HTA), providing opinion on drugs for reimbursement and pricing purposes. For all indications with a positive opinion for reimbursement, HAS assesses the clinical added value (CAV) on a 5-point scale for pricing negotiations based on clinical data. A major to moderate CAV leads to the highest prices, a minor CAV leads to a higher price than the comparator, and no CAV leads to lower price than the cheapest comparator. Countries increasingly face the policy challenge of harnessing the benefits of cancer drugs while managing healthcare budgets. In this context, we aimed to analyze cancer drugs assessment by HAS. Methods: a retrospective and descriptive analysis comparing all new hematology/oncology cancer indications versus all others new indications assessed by HAS between 2010 and 2015 has been conducted. Results: 87 cancer indications (60 drugs) have been evaluated, representing 17% (87/510) of all new drugs indications assessed by HAS. Almost all cancer indications (92%) obtained a favorable opinion for reimbursement. Seven (8%) had an unfavorable opinion versus 20% in other therapeutic areas. However, 5 of these 7 indications were related to a drug included on the list of reimbursed drugs for another indication and consequently drugs are available. Overall, only 2 drugs were not reimbursed: nintedanib in non small cell lung cancer and tegafur/gimeracil/oteracil in gastric cancer (no impact on survival and lack of results transposability). Of the 80 indications with a favorable opinion, 20 had a major to moderate CAV (25%), 32 a minor CAV (40%) and 28 have no CAV (35%). Major to moderate CAV are mostly composed of hematology drugs (12, 60%). The proportion of major to moderate CAV assessment is higher in oncology than in other therapeutic areas (66% vs. 30%). Conclusions: France benefits from a universal healthcare system offering wide coverage and large access to drugs. Almost all of the new hematology/oncology cancer drugs assessed had a favorable opinion and are fully reimbursed (100%) by health insurance. A high proportion (66%) of CAV is recognized in oncology. Nevertheless, the over DRG list can inadvertently limit access to these new cancer drugs.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.15_suppl.6623
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 8
    Online Resource
    Online Resource
    European collaboration on health technology assessment: looking backward and forward
    Cambridge University Press (CUP) ; 2022
    In:  International Journal of Technology Assessment in Health Care Vol. 38, No. 1 ( 2022)
    Details
    In: International Journal of Technology Assessment in Health Care, Cambridge University Press (CUP), Vol. 38, No. 1 ( 2022)
    Abstract: The establishment of health technology assessment (HTA) has been an important topic in Europe for many years. There have been a series of activities starting with first projects in 1994 leading to joint actions from the European Network of HTA (EUnetHTA) ending in 2021. This long interval of engagement with HTA structures, methodology, and processes by all member states led to a reliable basis for European collaboration in HTA. This article shows milestones and developments from EUR-ASSESS in 1994 through the progress of EUnetHTA and the accompanying EU-HTA-Network up to the recent elaboration of the EU-HTA-Regulation. With the EU-HTA-Regulation HTA collaboration is taken out of the trial phase of more than 15 years. Through the previous EU HTA collaboration, the appreciation and understanding of the differences and complexities behind the HTA processes in the EU healthcare systems have improved. It is now necessary to make the final steps toward a sustainable European Network for HTA.
    Type of Medium: Online Resource
    ISSN: 0266-4623 , 1471-6348
    URL: Article
    DOI: 10.1017/S026646232200006X
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2020486-3
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  • 9
    Online Resource
    Online Resource
    PP20 Assessment Of The First Software Combined With Telemonitoring Support
    Cambridge University Press (CUP) ; 2018
    In:  International Journal of Technology Assessment in Health Care Vol. 34, No. S1 ( 2018), p. 73-74
    Details
    In: International Journal of Technology Assessment in Health Care, Cambridge University Press (CUP), Vol. 34, No. S1 ( 2018), p. 73-74
    Abstract: More and more software programs, including those with medical device status, are coming into the market that aim to facilitate management of diabetic patients. In France, their coverage requires a positive opinion from the French National Health Agency (HAS) dedicated committee. To understand the utility of these products for patients, real-life experiments are in progress. Since the evaluation principles are similar for all medical devices, it was important to find out with this first connected software if specific methods or evaluation criteria are necessary. Methods: After obtaining CE marking, the manufacturer submitted a dossier to HAS outlining the clinical data and technical performance of the software. HAS assessed the dossier and the opinion of stakeholders (i.e. professionals and patient associations) in order to determine the actual clinical benefit of this software. At the same time, HAS set technical features in particular to secure patient data and limit access to only those involved in telemonitoring. Terms of prescription and use of this connected software had also been defined. Results: Two feasibility studies and one randomized controlled trial were analyzed. Specific clinical data demonstrated that the risk-benefit balance was positive in type 1 diabetic patients. Conclusions: In addition to the need to keep personal data confidential and to integrate the technology in the organization of healthcare, this assessment shows that randomized clinical trials are feasible and necessary to demonstrate the clinical benefit of connected software; however, specificities exist regarding data collection methods and the scope of healthcare organization that should be taken into account. A specific guide to connected medical devices for industry has been developed by HAS to help them build their application dossier for reimbursement. The second step for HAS is to develop guidelines on the specificities of the assessment of these connected devices.
    Type of Medium: Online Resource
    ISSN: 0266-4623 , 1471-6348
    URL: Article
    DOI: 10.1017/S0266462318001927
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2018
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  • 10
    Online Resource
    Online Resource
    Personalized Medicine: how to Switch from the Concept to the Integration into the Clinical Development Plan to Obtain Marketing Authorization
    Elsevier BV ; 2012
    In:  Therapies Vol. 67, No. 4 ( 2012-07), p. 349-357
    Details
    In: Therapies, Elsevier BV, Vol. 67, No. 4 ( 2012-07), p. 349-357
    Type of Medium: Online Resource
    ISSN: 0040-5957
    URL: Article
    DOI: 10.2515/therapie/2012051
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2012
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