scholarly journals Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports

BMJ ◽  
2015 ◽  
Vol 350 (feb26 5) ◽  
pp. h796-h796 ◽  
Author(s):  
M. Kohler ◽  
S. Haag ◽  
K. Biester ◽  
A. C. Brockhaus ◽  
N. McGauran ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Retrospective Analysis ◽  
Technology Assessment ◽  
Market Entry ◽  
Health Technology ◽  
New Drugs ◽  
Journal Publications ◽  
Assessment Reports

scholarly journals Developing a quality management system for the European Network for Health Technology Assessment (EUnetHTA): toward European HTA collaboration

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Miriam Luhnen ◽  
Sari Susanna Ormstad ◽  
Anne Willemsen ◽  
Chaienna Schreuder-Morel ◽  
Catharina Helmink ◽  
...  
Keyword(s):  
Quality Management ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Management System ◽  
Quality Management System ◽  
Health Technology ◽  
European Network ◽  
Joint Work ◽  
Working Groups ◽  
Assessment Reports

Abstract Objectives The European Network for Health Technology Assessment (EUnetHTA) was established in 2006 and comprises over eighty organizations from thirty European countries. In its fifth project phase (Joint Action 3), EUnetHTA set up a quality management system (QMS) to improve the efficiency and standardization of joint work. This article presents EUnetHTA's new QMS and outlines experiences and challenges during its implementation. Methods Several working groups defined processes and methods to support assessment teams in creating high-quality assessment reports. Existing guidelines, templates, and tools were refined and missing parts were newly created and integrated into the new QMS framework. EUnetHTA has contributed to Health Technology Assessment (HTA) capacity building through training and knowledge sharing. Continuous evaluation helped to identify gaps and shortcomings in processes and structures. Results Based on a common quality management concept and defined development and revision procedures, twenty-seven partner organizations jointly developed and maintained around forty standard operating procedures and other components of the QMS. All outputs were incorporated into a web-based platform, the EUnetHTA Companion Guide, which was launched in May 2018. Concerted efforts of working groups were required to ensure consistency and avoid duplication. Conclusions With the establishment of a QMS for jointly produced assessment reports, EUnetHTA has taken a significant step toward a sustainable model for scientific and technical collaboration within European HTA. However, the definition of processes and methods meeting the numerous requirements of healthcare systems across Europe remains an ongoing and challenging task.

OP157 Quo Vadis Romanian Health Technology Assessment?

2018 ◽  
Vol 34 (S1) ◽  
pp. 57-57
Author(s):  
Adrian Pana ◽  
Ioana Cristina Cosa
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Impact Analysis ◽  
Negative Impact ◽  
Health Technology ◽  
Evaluation Framework ◽  
New Drugs ◽  
Ministry Of Health ◽  
Healthcare Budget ◽  
Health Technologies

Introduction:The Romanian healthcare system has been struggling to use a more transparent approach in evaluating health care technologies for more than 10 years. No systemic and satisfactory approach to evaluate health technologies was implemented until the present. The objective of the presentation is to describe the characteristics of the HTA system used by the Romanian healthcare authority as well as the consequences of the drug assessments by using the actual Romanian health technology assessment (HTA) evaluation framework, from the initiation in May 2014 to the end of year 2017.Methods:The drug reimbursement context and the healthcare legislation regarding HTA evaluation were studied. A critical appraisal of the scorecard was conducted, taking into consideration general principles of the health technology assessment. A descriptive analysis covering the assessment drug reports issued by the National Agency for Drug and Medical Devices (NADMD) issued between May 2014 and December 2017 was presented, together with the decision made by the Ministry of Health and the Romanian government.Results:During the analyzed period of time, more than 10 updates of the reimbursement list were implemented by the Ministry of Health. By November 2017, more than 180 drugs (new INN, new indications or fix dose combinations) were included in the reimbursement system with conditional or unconditional reimbursement; more than 230 reports were assessed by the NADMD. While the new drugs reimbursed between May 2014 and November 2017, in the most part demonstrated cost savings, a lot of new innovative drugs proposed to be evaluated were rejected since the drugs had no comparators on the Romanian market and their costs were considered to have a negative impact on the healthcare budget.Conclusions:The rapid HTA assessment has many strengths, by using a proper scorecard. Limitations and weakness of the actual scorecard were identified, mainly regarding the lack of a basic budget impact analysis which must include at least the direct healthcare cost, as well as the imported results of different healthcare environments that are not matching the Romanian context. Opportunities to implement a more rapid and accurate HTA evaluation are identified since the scorecard could be updated in order to address the HTA general principles.

scholarly journals Database combinations to retrieve systematic reviews in Overviews of reviews: A methodological study

2020 ◽  
Author(s):  
Käthe Goossen ◽  
Simone Hess ◽  
Carole Lunny ◽  
Dawid Pieper
Keyword(s):  
Confidence Interval ◽  
Health Technology Assessment ◽  
Systematic Reviews ◽  
Technology Assessment ◽  
Health Technology ◽  
Bibliographic Databases ◽  
Health Related ◽  
Inclusion Rate ◽  
Reference Checking ◽  
Assessment Reports

Abstract Background When conducting an Overviews of Reviews on health-related topics, it is unclear which combination of bibliographic databases authors should use for searching for SRs. Our goal was to determine which databases included the most systematic reviews and identify an optimal database combination for searching systematic reviews. Methods A set of 86 Overviews of Reviews with 1219 included systematic reviews was extracted from a previous study. Inclusion of the systematic reviews was assessed in MEDLINE, CINAHL, Embase, Epistemonikos, PsycINFO, and TRIP. The mean inclusion rate (% of included systematic reviews) and corresponding 95% confidence interval were calculated for each database individually, as well as for combinations of MEDLINE with each other database and reference checking. Results Inclusion of systematic reviews was higher in MEDLINE than in any other single database (mean inclusion rate 89.7%; 95% confidence interval [89.0–90.3%]). Combined with reference checking, this value increased to 93.7% [93.2–94.2%]. The best combination of two databases plus reference checking consisted of MEDLINE and Epistemonikos (99.2% [99.0–99.3%]). Stratification by Health Technology Assessment reports (97.7% [96.5–98.9%]) vs. Cochrane Overviews (100.0%) vs. non-Cochrane Overviews (99.3% [99.1–99.4%]) showed that inclusion was only slightly lower for Health Technology Assessment reports. However, MEDLINE, Epistemonikos, and reference checking remained the best combination. Among the 10/1219 systematic reviews not identified by this combination, five were published as websites rather than journals, two were included in CINAHL and Embase, and one was included in the database ERIC. Conclusions MEDLINE and Epistemonikos, complemented by reference checking of included studies, is the best database combination to identify systematic reviews on health-related topics.

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