Knowledge base
Archived articles from Synergus RWE, kept for reference.
122 articles
Unlocking Real-World Evidence utilising lab results – case study in Kidney disease in Denmark
LABKA and RLRR: Denmark’s Rich Laboratory Data Sources Denmark has a long tradition of comprehensive health registries, and the laboratory databases LABKA and RLRR are prime examples. LABKA (the Clinical Laboratory…
Integration of Treatment council to The Danish Healthcare Quality Institute (DHQI) - Impacting Medtech and Diagnostics
The integration of the Treatment Council (Behandlingsrådet) into the Danish Healthcare Quality Institute (DHQI) provides an important development for Medtech and Diagnostics. The DHQI has a broader scope, including:…
EU HTA for IVD's
With the new European HTA regulation coming into play for medical devices and diagnostics, one of the big questions is what impact these evaluations would have on market access for IVD products. The utility of HTA for…
EU HTA for Medtech
With the new European HTA regulation for medical devices and diagnostics, one of the big questions is what impact these evaluations would have on market access for Medtech products. Except for Belgium and France, other…
Germany is introducing 20 % performance-based pricing on digital health
Several changes are ongoing regarding the German DIGA process for Digital Health solutions. One of the more interesting aspects is the introduction of a performance-based payment for at least 20% of the total…
Real-World data provide essential insights about Myeloma
Characteristics of patients outside typical RCTs: “The overall incidence and median age were both higher than in most previous studies, indicating a more complete coverage of older patients. Myeloma survival in Sweden…
R-RCT from the Obesity registry resolve uncertainty about comparative effectiveness
In the recently published BEST trial(1,2), a Registry-based Randomized Clinical Trial (R-RCT), they answered the uncertainty of comparative efficacy and safety for two surgical interventions. Based on this study,…
Swedish drug registry – Data since 2005 and perfect linkage to other datasets
Sweden established the Prescribed drug registry was established July 2005, covering the whole Swedish population. (1) Through the personal identity number(2) it can be seamlessly linked to other data sets: The more than…
Denmark Aims for "Digital First"
Denmark is one of the leading countries in Europe in the utility of digital health as an integral part of healthcare delivery. December 2023, an agreement was established to invest 500 Million DKK in the following…
Class IIb and III – Clarify Eligibility for 137 (h) prior to submitting NUB in Germany!
In a recent post by G-BA, they reinforced to the hospitals are required to submit a 137(h) application for medical devices of class IIb or III, unless G-BA already has clarified that the product is not eligible. It is…
France: Temporary reimbursement pending results from clinical trial
France offers a pathway called PECT (The Prise en Charge Transitoire ) for temporary reimbursement off valuable and innovative medical devices and services pending completion of ongoing clinical trial. The aim is to…
Medical Device and EU HTA Regulation - Norwegian perspective
Norway has developed a national system with mini-HTA and national evaluations that include medical devices and diagnostics. The system is governed by the 4 regional health companies with the responsibility of specialist…
France includes organisational benefits in the assessment of Digital solutions
In the LPPR process for Medical Devices, which also is applicable for therapeutic digital solutions, the focus would be on traditional outcomes, where these would be the most frequent: “mortality reduction in the short,…
Teaser about what is possible with Danish RWE studies
Access to rich high-quality data for RWE-studies can provide insights beyond what is typically feasible in traditional clinical trials. Denmark has a rich real-world-data environment that allows for linkage between…
France has the most extensive scope of reimbursement for digital solutions in Europe
With the creation of the fast-track solution for digital health (PECA) and the permanent pathway for remote monitoring (TLS), France has also clarified that Digital solutions with a therapeutic benefit should follow the…
France creates a permanent pathway for remote monitoring solutions
France has been a pioneer in the evaluation of how to find a way to utilize remote monitoring / telemedicine, including several pilot programs: 2009: Article 78 HPST law 2014: Article 36 LFSS (ETAPES experimentation)…
France launches fast-track process for reimbursement of digital solutions
France has a long history of testing different programs to include digital health in the healthcare. Inspired by the German DiGA solution, they are in the process to introduce a pathway for conditional reimbursement…
Comparing RWD : Finland vs Sweden
There is rivalry between Finland and Sweden in Sweden in sports. But who has the best Real-World-Data? In a recent webinar about the RWE opportunity in Finland, we included a section where we discussed similarities and…
Danish Real World Data sources - National Registries
Denmark provides several national registries and disease / intervention registries. One of the unique benefits that Denmark provides is the speed of access. In best case scenario, data can be provided in 2 months. One…
Finnish Real World-World data sources – National registries
Finnish Real World-World data sources – National registries Finland provides a broad range of national Real-World-Data set that can be utilized for research. Below is a summary of the most essential data-sets, including…
Swedish Real-World data sources – National registries
Swedish Real-World data sources – National registries This is the first blogpost in a series about the available Real-World Data sets in Sweden focusing on the national registries. Seamless linkage is essential To…
High quality RWE - Registry based randomized clinical trials
There is an increasing need to develop high-quality evidence to support decision makers. There are many important improvements that require such big trials that they are never done. In the recent decade there has been a…
High-quality RWE – Transparency about data quality
The foundation for high-quality RWE is the ability to define the right variables, the ability to collect and finally the ability to transparently report the quality of the data. The ability to succeed with this very…
Reimbursement may not be the primary barrier for digital health!?
What can we learn from the critique of the insurance companies regarding the German DiGA experience? I am the first to recognize that there is a significant gap in most healthcare system regarding the process to…
The German NUB process, the most risky process for a start-up?
For many medical device companies, the German NUB process to fund innovative medical devices used in the hospitals, has been known as the most attractive option for a European launch. This is a brief overview of how the…
The best real-world data setting for diabetes research – How much data is required?
The Swedish setting provides an extremely rich data set with very high quality for diabetes research. The foundation is the national diabetes registry (NDR) that covers 92,7% of all patients in the country diagnosed…
Five digital solutions approved for temporary reimbursement in Germany – Up to 2000 €/year in reimbursement
Germany has launched a reimbursement process for digital solutions focused on the patient and with regulatory class I or IIa according to the MDR. If you are interested to learn more about the process, these recorded…
Do we know what the problem is that we are trying to solve regarding the COVID-19 Pandemic?
Do we know what the problem is that we are trying to solve regarding the COVID-19 Pandemic? This question may at first sound offensive; isn’t it obvious? The obvious things which are important: Traditional health care…
Close to 400 diagnostic and digital health solutions to fight COVID-19, how we do select the right one?
We are continuing our work towards creating an understanding of the available diagnostic and digital solutions to fight the COVID-19 pandemic. Our focus is still to identify the existing solutions to shortly shift…
Solutions to fight the COVID-19 pandemic
Thank you to all of you who have contacted us after our post yesterday and provided more information about different type of solutions. We have added several new companies to the analysis. The current priority in our…
What is the status of diagnostic and digital health solutions to fight the corona pandemic?
We have started a project to analyse the landscape of evolving digital health solutions to address the current pandemic regarding the corona virus. We hope that we will be able to trigger a collaboration across…
Status update: Digital Health Frameworks in Europe
We are continuing our work to collect data from HTA agencies regarding dedicated frameworks. After the initial distribution of the survey, this is our current status. Green: Response received from all agencies Yellow:…
How will the payer view the value of a digital solution in Germany?
How will the payer view the value of a digital solution in Germany? Coming back after an intense and inspiring day in Heidelberg about the new regulation for reimbursement of digital health I am very encouraged to see…
Evaluation of assessment methodologies by HTA’s specific to Digital Health in Europe
We have initiated a project to evaluate the HTA methodologies specific to Digital Health solutions (DHS) in Europe. With the increasing use of DHS and the different characteristics they have compared to drugs and…
The French program for telemedicine / digital health – Analysis of development
Don’t miss our upcoming webinar about French Digital Health on February 19 th . The purpose of introduction of telemedicine by France government is not to replace the face-to-face medical procedures in the past, but to…
Internship report about the use of data science in Oncology
We are happy to share the results from the intership by Laila Mehkri MD, MPH, Health Economics, Project Management,
Can RWE contribute to investigate and contain the current outbreak of novel coronavirus?
Early this month, Chines National Medical Products Administration published guideline 1 for applying real-world evidence (RWE) to support drug development as the No.1 announcement of this year. According to this…
Understanding European Payer Readiness for Patient Centric Digital Health
As announced in a previous blog post, Synergus RWE initiated an internal project examining the readiness of reimbursement systems across Europe to support patient-centric digital health in Dementia / Alzheimer’s This…
More than 60 data-sets in England for real-world evidence
More than 60 data-sets in England for real-world evidence Many are aware of the CPRD data-set and Hospital Episode Statistics (HES) which indeed are valuable. However, there are more than 60 data-sets in England for…
Transferring Outcomes Data: The Illusion of Simplicity - Variation in stroke health outcomes and healthcare delivery
This blogpost takes stroke care as an example to demonstrate the differences observed in health outcomes and resource distribution, 1-year post-stroke. This example is based on data from Sweden, categorized by region.…
Digital Health Strategic Insights - Selecting the right solution in the basket of options
This is the second blog in our series regarding strategic insights about the key-methodological aspects concerning the introduction of new digital solutions. In this second blog, we address the issue of selecting the…
Understanding the landscape of disease management tools in Heart Failure
As previously announced, we have started this project to evaluate innovative disease management tools in heart failure (HF) with the objective of bringing insights and further recommendations for decision-makers. You…
Transferring Outcomes Data: The Illusion of Simplicity - A Case Study comparing Breast Cancer outcomes and care delivery
Breast Cancer – Part 3 In this blog series we are analysing different aspects of the transferability of disease outcomes, either from RCT to Real-World setting or between different settings/countries. If you missed the…
Digital Health – Are we wasting the potential?
We are starting a new blog-series related to the key-methodological aspects concerning the introduction of new digital solutions. In this first blog, we raise issues as to why we as an industry, need to engage in order…
Transferring Outcomes Data for National Decision Making: The Illusion of Simplicity - The whole world should use validated Swedish Data, or maybe not….
This blog is part of our series on the issues related to the transferability of outcomes, for national decision making. You can follow this link to read our other blog posts on this topic. The ongoing discussion about…
Transferring Outcomes Data for National Decision Making: The Illusion of Simplicity What is the HTA perspective on transferability?
This is a blog in our series about the issues relating to the transferability of outcomes for national decision making. Click on this link to get the other posts related to this topic. In this blog post we will provide…
Transferring Outcomes Data for National Decision Making: The Illusion of Simplicity
Variation in outcomes and health care delivery Breast Cancer – Part 2 In this blog-post series we are analysing different aspects about transferability of outcomes, either from RCT to Real-World setting or between…
New EU Guidance: App’s and Software solutions with therapeutic purpose will be in class 2a or higher – Time to align evidence development strategies for regulators and payers.
The recent release of the new EU guidance reinforces the role that software in many instances, will be classified as medical devices / IVDs (In Vitro Diagnostics) in a high-risk class. Refer to the details of this new…
Transferring Outcomes Data for National Decision Making: The Illusion of Simplicity - Understanding why healthcare delivery is a significant issue
This blog is part of our series on the issues related to the transferability of outcomes, for National decision making. You can follow this link to read our other posts within this topic. To illustrate the impact and…
Transferring Outcomes Data: The Illusion of Simplicity
As previously announced , we have started a project that will look at issues relating to “Methodological aspects of evaluating transferability of Real World Evidence results between countries / settings”. As part of…
CPRD – Probably the most utilized data-set in Europe for Real World Evidence studies?
More than 2300 scientific publications have been generated from the CPRD database. This would probably make it the most utilized data-set for RWE research. As of September 2019, 1600+ GP practices in the UK have…
Digital Solutions in Rheumatoid Arthritis (RA) – More than 30 companies, have we missed any?
Since starting this project to identify different digital solutions that address Rheumatoid Arthritis, we have discovered some innovative solutions which are highlighted in this blogpost. In identifying these solutions,…
The use of Data-science in Oncology
This first blog post on the topic of ‘the use of data-science in oncology’ considers how rapidly data-science in oncology is evolving throughout the lifecycle of oncology drugs. The aim of this project / publication is…
Digital Solutions in Melanoma Cancer - Engaging the Patient
This is the fifth interim report from our current project on digital solutions in oncology engaging the patient. More details about the project can be found here . Through this work, we aim to share results based on our…
European payer readiness for patient-centric care: Case study of digital health in Dementia / Alzheimer’s
Early in 2019, Synergus RWE conducted an exploratory internal project analysing current digital health solutions for Dementia / Alzheimer’s disease. The primary objective of this project was to develop an understanding…
Digital Solutions in Rheumatoid Arthritis (RA) – Project Introduction
During the recent HTAi meeting in Cologne, our CEO ( Mattias Kyhlstedt ) had the opportunity to discuss with an HTA organisation about the ongoing projects at Synergus RWE. These are projects that involve analysing…
Digital Solutions in Throat Cancer - Engaging the Patient
This is the fourth interim report from our current project on digital solutions in oncology engaging the patient. More details about the project can be found here . Through this work, we aim to share results based on…
Digital Solutions in Lung Cancer - Engaging the Patient
This is the third interim report from our current project about digital solutions in oncology engaging the patient. You can read more about the project here . Through this work, we will continue to share early results…
Digital solutions in Oncology engaging the patient - Interim report about breast cancer
This is the second interim report from our current project about digital solutions in oncology engaging the patient. You can read more about the project here: Project introduction First report about prostate cancer…
Digital solutions in Oncology engaging the patient - Interim report about prostate cancer
This is the first interim report from our current project about digital solutions in oncology engaging the patient. You can read more about the project here:…
Mortality and Cause of death variable in Oncology
Context of blog – European Payer perspective While developing this blog, I realized how important it is to clarify the perspective with which you review a certain question. My perspective, even though initially not…
Flatiron vs Sweden – How does the oncology data registers compare?
The potential use of data from Flatiron to support regulatory and reimbursement applications in oncology has stirred up quite an interest in the field. The current developments we have been seeing prove the potential of…
5 key-steps to unlock the potential for the new attractive reimbursement opportunity in Germany
5 key-steps to unlock the potential for the new attractive reimbursement opportunity in Germany The recent change that was announced in Germany regarding the process for innovation funding will become effective 2020. In…
Data Science in Oncology
The intersection between data science and oncology will increase in importance with precision medicine. We have launched a project to address this topic. Initially we aim to identify and map the companies in this…
Digital solutions in oncology engaging the patient
We are happy to announce the start of a project to analyze digital solutions in oncology engaging the patients. We are performing this project in collaboration with Abdulrahman Yahia. The aim of this 8-week project is…
German reimbursement opportunity for medical devices re-opens 2020 !
A change to the German legislation regarding the introduction of new innovative medical devices have just been implemented as of May 1 st . The new law will be applicable as of 2020. It is not clear how all aspects of…
Interim report – Digital solutions for mental health
We are excited to share an interim update of the on-going analysis of digital solutions for mental health. If you are interested in the topic, have a look at the interactive dash-board below which includes the 103…
Final report – Digital solutions in Alzheimer and Dementia
We are happy to share the result of an internal project we have done to analyse the digital solutions in Alzheimer and Dementia. The aim with the project was to evaluate if it was possible to create an overview of the…
Why should I care to engage in the project about Digital Solutions for Mental Health?
This blog is aiming towards the health companies which offer digital solutions for mental health. The objective is to encourage you to participate in a short survey we are carrying out in the project (it will take 5-10…
How will AI impact the healthcare system when applied to imaging?
AI is exciting and will impact many dimensions in healthcare. We are trying to understand how the technical ‘feature’ can be translated to change in the healthcare delivery. We have hypothesized the following scenarios:…
Managed entry agreements / Coverage with Evidence Development – The new home-run for device, diagnostic and digital health start-ups!?
With the evolving evidence requirements for the introduction of new technologies, I would suggest that we should evaluate how we see a successful journey for a start-up company. Historically, most of the start-ups we…
Combination of app-based data collection linked to rich data-sets provides a unique (largely untapped) gold mine
Many have heard that the Nordic Countries have good opportunities for real world evidence studies. From the activity we can observe, it appears that the opportunity is not fully understood by industry. There is a large…
How E-health interventions are addressing and transforming mental health care?
One of the areas in which E-health has a particular potential in, is the ability to provide care for patient with different types of mental health. In this project we aim to analyze new innovative companies, primarily…
Correlation between midlife cardiovascular fitness and development of dementia, demonstrating how important Real World Evidence is to answer important question.
Last week I read an interesting study that evaluated the impact of greater cardiovascular fitness in midlife is associated with decreased dementia risk in women. The study shows a stunning decrease in the risk of…
Interim update: Alzheimer / Dementia – Innovative Disease Management Tools
We have identified more than 50 companies that provide different solutions to improve how Dementia and Alzheimer is managed. Don’t miss the previous post about shifting the focus to the patient and the care giver. In…
6 E-health projects funded by G-BA in Germany (1,3-19,6 million €)
G-BA has an innovation fund that provides funding to specific projects. These are the 6 programs relating to e-health that they have provided funding for: ERIC – Enhanced Recovery after Intensive Care: 6.8 million €…
Introduction to e-health reimbursement in the Netherlands
With this blog post is a brief update about the pathway the Dutch Government did chose to accomplish a swift introduction of e-health in the healthcare environment. If you want to learn more, don’t miss the upcoming…
13 quality registries in Sweden with more than 90% coverage
The ministry of health is regularly reviewing the quality of the data in the quality registries. In this latest review they reviewed 42 quality registries (out of more than 100). 13 of these registries has a coverage…
New project: Disruptive healthcare companies using AI and impact on healthcare delivery?
There are great hopes that new ways of using healthcare data in combination with artificial intelligence will drastically improve the delivery of health care in the future. Do we really understand what the change will…
Shifting focus to the patient and caregiver – Update regarding analysis of innovative disease management tools in Alzheimer
We are currently doing a project with the aim to analyse new companies which are developing disease management tools (DMT) of Alzheimer and Dementia. The objective of this project is to gain understanding in how these…
The Model for Assessment of Telemedicine (MAST) – Leveraging EUnetHTA framework to assess the value of e-health / telemedicine
This blog is to provide a brief background to the coming webinar by Dr Kristian Kidholm about the topic “HTA evaluation of e-health solutions ” based on the The Model for Assessment of Telemedicine (MAST). The MAST…
Examples of e-health and disease management reimbursement in France
Next week (31st of January) we have a webinar that will provide insights in how to establish reimbursement for e-health and disease management in France. This is a brief update about the two programs that exist, what…
Supporting medicines for children in the EU: Clinical trials and RWE
The European Medicines Agency (EMA) recently released a report into the differences of medications and medicines on children and infants. The Paediatric Regulation, which was introduced in 2007 and requires…
There is more than one validated RWD data source!?
In a recent tweet from the International Society for Pharmacoepidemiology (@ICPE) it was stated from a company that they had the only validated real-world evidence platform that enables reproducible, transparent safety…
Norwegian real-world evidence: CNS Disorders
Norway not only has a rich source of oil but has a rich supply of real world data sources (RWDs), especially when in concerns the central nervous system! Such registries have been used for a number of studies and…
Norwegian real-world evidence: Oncology
Norway not only has a rich source of oil but has a rich supply of real world data sources (RWDs), especially when in concerns oncology! Such registries have been used for a number of studies and publications. This is…
Comparability, Completeness and Validity: the Norwegian Cancer Registry Data
Decision makers are generally used to evaluating data according to its internal validity, as has been the case for RCTs, however by doing this, understanding for the specifics for a disease or intervention can be…
Norwegian real-world evidence
Norway has a rich of real world data sources, which have been used for research and publications. When we focus on Norway’s mandated/national registries, we find a rich source of interesting and varied high-quality…
Registries for shunt implantation
We believe that real world evidence is a significant question for the future. However there is a challenge to identify the available data-sets and the scientific evidence generated. We are in the process to develop a…
Synergus analyzed the data and recommendations from 10 latest HTA reports in Sweden
Synergus’ analysis included the 10 latest HTA reports by different national and regional HTA bodies in Sweden. The reports covered various disease areas and technology areas, most of them related to treatment and…
Value-based health care in bariatric surgery
This is a summary of the pilot study regarding the development of a value-based monitoring platform for bariatric surgery in Sweden. Initial analysis of data To understand the relevant outcomes, historical data from…
Where is the best quality real world data regarding Atrial Fibrillation in Europe?
The aim of our review is to uncover which real world datasets, based on patient / disease based registries, exist in Europe regarding atrial fibrillation . We also aim to understand how these differ in the ability to…
Stuck in DRG/ZE negotiations in Germany?
Many medical device manufacturers have found themselves caught in a trap where there is a DRG and/or ZE (add-on payment) available for their technology but where the insurance companies refuse to pay this fee. Through…
GKV-Spitzenverband says more high-risk medical devices should be assessed by G-BA in § 137h
Background With the introduction of § 137h SGB V in 2016, the German legislator introduced a systematic early assessment of new medical devices based on high-risk methods in the hospital sector. If a hospital applies…
Where is the best quality real world data regarding Rheumatoid Arthritis in Europe?
The aim of our review is to uncover which real world datasets, based on patient / disease based registries, exist in Europe regarding rheumatoid arthritis . We also aim to understand how these differ in the ability to…
Where is the best quality real world data regarding Stroke in Europe?
The aim of our review is to uncover which real world datasets, based on patient / disease based registries, exist in Europe regarding stroke. We also aim to understand how these differ in the ability to conduct outcomes…
Where is the best quality real world data regarding MS in Europe?
The aim of our review is to uncover which real world datasets, based on patient / disease based registries, exist in Europe regarding MS. We also aim to understand how these differ in the ability to conduct outcomes…
Overview of registry based randomized clinical trials
In our journey to create insight in the utility, we have made a search for registry based randomized clinical trials. Below is a summary of what we have identified so far. We will continue to updated the list as we…
Value-based health care in stroke
This is a summary of the pilot study regarding the development of a value-based monitoring platform for stroke care in Sweden. Initial analysis of data To understand the relevant outcomes, historical data from 2010 on…
Where is the best quality real world data regarding Diabetes in Europe?
The aim of our review is to uncover which real world datasets, based on patient / disease based registries, exist in Europe regarding diabetes. We also aim to understand how these differ in the ability to conduct…
Value-based health care in diabetes care
This is a summary of the pilot study regarding the development of a value-based monitoring platform for diabetes care in Sweden. Initial analysis of data To understand the relevant outcomes, historical data from 2010 to…
Where is the best quality real world data regarding Breast Cancer in Europe?
The aim of our review is to uncover which real world datasets, based on patient / disease based registries, exist in Europe regarding breast cancer. We also aim to understand how these differ in the ability to conduct…
Value-based health care in breast cancer care
This is a summary of the pilot study regarding the development of a value-based monitoring platform for breast cancer care in Sweden. Initial analysis of data To understand the relevant outcomes, historical data from…
Where is the best quality real world data regarding Heart Failure in Europe?
The aim of our review is to uncover which real world datasets, based on patient / disease based registries, exist in Europe regarding heart failure. We also aim to understand how these differ in the ability to conduct…
Which European country has the best quality Real World Data for specific diseases / intervention?
We have started several projects that aim to understand which patient / disease registries have the ability to be used in outcomes research. Even though the title would imply a broader perspective, our current focus is…
A registry-based randomized clinical trial for heart failure treatment using the Swedish Heart Failure Registry
Electronic health records and clinical cardiovascular quality registries provide opportunities for pragmatic clinical trial (PCT) and registry-based prospective randomized clinical trials (RRCTs). Simplified regulatory,…
Registry based Randomized Clinical Trials with significantly lower cost. The method for the future?
The randomized clinical trial (RCT) is a powerful tools for clinical researchers, which evaluates the effectiveness of new (or established) treatments while accounting for the effects of unmeasured confounders and…
The era of personalized medicine: when HEOR meets AI
Personalized medicine (or precision or stratified medicine as new terms introduced nowadays) is recently defined as: “Treatments targeted to the needs of individual patients on the basis of genetic, biomarker,…
2016 Overview of HTA reports for Medical Devices and In-Vitro Diagnostics
HTA plays an increasingly important role for Medical Device and IVD companies. Below is a summary of the HTA Dynamics during 2016, followed by the same data for 2015. The total amount of HTA evaluations have reduced…
The first submissions for NUB-related benefit assessments for high-risk medical devices
Background With the introduction of § 137h to the SGB V, hospitals have to hand in an extensive value dossier comprising information on the current scientific knowledge of the technology to the Federal Joint Committee…
The ability to demonstrate savings in the real world is very relevant for payer
The value of real world data is frequently debated. This is very much dependent on the perspective of the person who is reviewing the data. If you are able to use real world data to demonstrate to a payer that they can…
Value based health care – Already here, but still a long journey to connect to payments
In a recent report by the Economist, Sweden was pointed out as the leading country in the world in terms of being prepared for value based health care (VBHC). Click here to see the report. The high quality patient…
HTA evaluations for imaging devices
We have recently reviewed the number of HTA reports regarding imaging modalities. We can see somewhat of a reduction during 2015 compared to 2014. The trend for the first 4 months of 2016 would indicate an increase…
Introduction of benefit assessment requires complete rethink about how to handle nub-applications for new interventions
There are many aspects that are changing with the introduction of the new 137h process to assess the benefit of the new innovations coming to market. We will provide more information about all of these changes in a…
The changing landscape in Germany regarding HTA assessments
The changing landscape in Germany regarding HTA assessments The German landscape for introduction of new technologies and drugs is changing dramatic. For drugs, the introduction of the Amnog process has been a drastic…
HTA evaluations in the United Kingdom
An overview of the HTA activity by different organisations in the United Kingdom. For NICE, we have only included the reports, we consider to be HTA like evaluation and not clinical guidelines. In the last 12 months,…
Dutch HTA
An overview of the HTA activity by the Dutch Zorginstituut, who will now have the important role of beeing EUnetHTA Secretariat. In the last 12 months, the 3 most frequent companies in the reports have been Pfizer,…
French HTA evalutions
The French Haute Autorité de Santé is one of the HTA organisations in Europe with most publications. 3,6% of their publications are HTA reports and 96,4 % are reimbursement evaluations of individual drugs or…
Nordic HTA activity
In the below graphs, you can see the HTA activity in the Nordic countries. Particullary interesting to see the increased used of mini-HTA assessments in Norway and Sweden. HTA Update
Health technology assessments of in-vitro diagnostic tests
This study revealed similarities in evidence requirements for in-vitro diagnostic tests in health technology assessments in England and France. However, economic evidence is not a part of French assessments of new codes…
Use of generic quality of life measures in reports from NICE
We are evolving the insight in the data we have in our HTA update search platform. In this analysis we looked at the occurrence of the two major quality of life measures, EQ-5D and SF-36, in reports from NICE in the…
More than 50% of health technology assessments of medical devices in Europe are performed outside INAHTA members
In total 301 out of 573 HTAs performed in 2013-2014 for medical devices in Europe were originated from non-INAHTA members. Countries with the most reports published by non-INAHTA members are Denmark (86%), Netherlands…