Final Report Summary - P4-MEDICINE@EU (Evaluation of a Best Practice Model for Personalized Health Care within Public Health Genomics)
The recent developments in basic and health sciences as well as related technologies will allow to shift from ‘one size fits all’ strategies towards more personalized interventions in the whole spectrum of health care. In addition, there is the shift from a late curative paradigm to an early preventive one in order to address the challenges of the 21st century, i.e. chronic complex diseases. All these will challenge the health care delivery systems in a fundamental way.
To meet this challenge, GENAR Institute for Public Health and Genomics Research, which was established in Ankara/Turkey in 2004, developed a practice model in personalized health care to combat complex diseases, called 'Gentest' (2004-2008). The researcher played a major role in its development. The practice model has been piloted by authorized practitioners (physicians/or dieticians) as a service to 500 individuals since 2008. It had been identified as a best practice model in Europe by the Public Health Genomics European Network (PHGEN) in 2008 based on the characteristics of the practice model being comprehensive (containing various factors such as personal, medical, lifestyle, and genetic information), multidisciplinary, prevention orientated and implemented through health professionals.
The main research objective of this project has been to thoroughly assess the practice model from the European policy (framework) perspective, as well as the European (policy) context from the personalized health care perspective in order to prepare for the future implementation of the practice model in Europe for public health purposes. Thus, the European challenges of the project have been twofold: (1) to analyze how to adapt the practice model for the implementation in European health systems by applying Health Technology Assessment (HTA) and Health Services Research (HSR) methodologies, and (2) to prepare policymaking in Europe for the implementation of personalized interventions by analyzing the current EU policies, regulations and practices. The practice model developed by GENAR has been used as an example to assess if and how such a personalized intervention can be implemented in Europe. By this, the project P4-Medicine@EU served the ultimate goal of assuring the timely and effective integration of personalized healthcare into European policy frameworks improving human health, quality of life and performance, and extending life span, while reducing the health care costs.
Following the logics of these twofold European challenges, the project initially had two specific objectives, which corresponds to two work packages (WPs): 1) Assessment of the current policy framework in Europe for the implementation of a personalized health care model (WP1), and 2) Assessment of the practice model from the policy perspective in Europe (WP2). A third work package (WP0) was added in the initial period of the project to provide an exploratory exercise prior to WP1 and WP2: a 'mapping study' based on semi-structured interviews and exploring opinions and topics regarding the implementation of personalized health care. Thus, WP0 was added to check in a non-systematic/exploratory way, whether these opinions and reported tasks has been covered by WP1 and WP2.
For WP0 (mapping study), a non-systematic literature search was carried out and 22 semi-structured interviews with opinion leaders and experts from relevant fields were conducted. The study revealed four domains related to personalized health care: science, industry, health care, and society. In line with the research objective of the work, the focus of WP0 has been on the health care domain.
For WP1 (Assessment of the current policy framework in Europe for the implementation of a personalized health care model) two key European policies were identified to be investigated: 1) the Directive and proposed Regulation on Data Protection, and 2) the Cross-Border Healthcare Directive.
Looking from the perspective of EU legislations to protection and circulation of data in Europe, it is seen that, the recent proposal for Data Protection Regulation (2012/0011(COD)) with the amendments made by the LIBE Committee of the European Parliament (22.10.2013) may seriously impede use of health care data for even research purposes, due to the restrictions proposed on the use of health data. On the other hand, the Cross-border Healthcare Directive (2011/24/EU) plays a facilitating role for the circulation of data in Europe, with the voluntary networks on e-Health and Health Technology Assessment (HTA).
For WP2 (Assessment of the practice model from the policy perspective in Europe) three subtasks had been defined: 1) Assessment of how the criteria "benefit" and "cost-effectiveness" are handled in reimbursement decisions on innovations in the primary care setting in the UK and in Germany, 2) SWOT analysis of 'Gentest', and 3) Comparison of 'Gentest' with other tests utilizing genetic information to combat complex diseases.
For successful implementation of personalized interventions in European health systems, reimbursement decision-making processes and criteria, which show a great variability within Europe, are of significant importance. An assessment on how the criteria „benefit“ and „cost-effectiveness“ are handled in reimbursement decisions in the UK and Germany (subtask 1) was carried out to exemplify one of the HTA criteria in two distinct health systems in Europe. In the historical context, the main criterion in the UK has been ‘cost-effectiveness’, whereas for Germany it has been ‘benefit’. Economic evaluation for reimbursement decision-making entered the scene rather new in Germany, and differs from the UK. In the UK, the emphasis has been on cost-effectiveness, because there is a finite budget for health, both in the national level and local commissioner level. Within this fixed budget, inclusion of one service in benefit package means that another one should be taken out. On the other hand, ‘benefit’ has been the main criteria in Germany because according to its legislation, a person cannot be prohibited access to care only based on cost grounds. Economic evaluation is carried out to for example set a ceiling price within a therapeutic group to attain efficiency in that group. This is rooted in the fact, that fixed predetermined budgets have not been set for the funders in Germany.
The SWOT analysis of 'Gentest' (subtask 2) identified strengths, weaknesses, opportunities and threats of 'Gentest'. Addressing major chronic complex diseases in a single test combining genetic information, anthropometric and lifestyle factors etc., and potentially empowering individuals to manage their health are among the strengths. Currently not being up to date in terms of genetic markers, lack of cost-effectiveness and no follow-up of the 500 individuals are weaknesses. One of the main opportunities is development of a software to collect information and generate 'Gentest' reports. Also, data generated with its potential population wide application in primary care can create a feedback loop to research providing valuable insights to health and diseases. A main threat is the limited knowledge and skills of the health workforce on genomics and its contribution to more targeted health interventions.
For comparison of 'Gentest' with other tests utilizing genetic information to combat complex diseases (subtask 3), a non-systematic search strategy in the internet and PubMed was used to identify such tests. The criteria used for comparison included: inputs of the intervention (test), conditions and health areas covered, involvement of the health professional (before and after the intervention), assessment areas, results and recommendations provided in the report, follow-up, turnaround time and costs. Compared with the ten applications selected, 'Gentest' is an example of a comprehensive approach (utilizing personal and family health history, lifestyle factors, biomarkers and genotype etc.) for combatting complex diseases, which provides holistic personalized lifestyle and medical advice to individuals via authorized (trained) health professionals. On the other hand, in comparison with some of these tests, 'Gentest' has been developed before 2008. Thus, it does not include new genetic polymorphisms as an input, it does not provide a follow-up of individuals, and the validity of the test has not been proofed yet.
The P4-Medicine@EU project demonstrated that for the implementation of innovations such as personalized interventions in European health systems the assessment needs to be conducted in a bilateral way representing two perspectives of European policy research: (1) assessment of the technology (intervention) itself in the various European health systems by using existing frameworks such as HTA, as well as (2) assessment of the European policy framework.
To meet this challenge, GENAR Institute for Public Health and Genomics Research, which was established in Ankara/Turkey in 2004, developed a practice model in personalized health care to combat complex diseases, called 'Gentest' (2004-2008). The researcher played a major role in its development. The practice model has been piloted by authorized practitioners (physicians/or dieticians) as a service to 500 individuals since 2008. It had been identified as a best practice model in Europe by the Public Health Genomics European Network (PHGEN) in 2008 based on the characteristics of the practice model being comprehensive (containing various factors such as personal, medical, lifestyle, and genetic information), multidisciplinary, prevention orientated and implemented through health professionals.
The main research objective of this project has been to thoroughly assess the practice model from the European policy (framework) perspective, as well as the European (policy) context from the personalized health care perspective in order to prepare for the future implementation of the practice model in Europe for public health purposes. Thus, the European challenges of the project have been twofold: (1) to analyze how to adapt the practice model for the implementation in European health systems by applying Health Technology Assessment (HTA) and Health Services Research (HSR) methodologies, and (2) to prepare policymaking in Europe for the implementation of personalized interventions by analyzing the current EU policies, regulations and practices. The practice model developed by GENAR has been used as an example to assess if and how such a personalized intervention can be implemented in Europe. By this, the project P4-Medicine@EU served the ultimate goal of assuring the timely and effective integration of personalized healthcare into European policy frameworks improving human health, quality of life and performance, and extending life span, while reducing the health care costs.
Following the logics of these twofold European challenges, the project initially had two specific objectives, which corresponds to two work packages (WPs): 1) Assessment of the current policy framework in Europe for the implementation of a personalized health care model (WP1), and 2) Assessment of the practice model from the policy perspective in Europe (WP2). A third work package (WP0) was added in the initial period of the project to provide an exploratory exercise prior to WP1 and WP2: a 'mapping study' based on semi-structured interviews and exploring opinions and topics regarding the implementation of personalized health care. Thus, WP0 was added to check in a non-systematic/exploratory way, whether these opinions and reported tasks has been covered by WP1 and WP2.
For WP0 (mapping study), a non-systematic literature search was carried out and 22 semi-structured interviews with opinion leaders and experts from relevant fields were conducted. The study revealed four domains related to personalized health care: science, industry, health care, and society. In line with the research objective of the work, the focus of WP0 has been on the health care domain.
For WP1 (Assessment of the current policy framework in Europe for the implementation of a personalized health care model) two key European policies were identified to be investigated: 1) the Directive and proposed Regulation on Data Protection, and 2) the Cross-Border Healthcare Directive.
Looking from the perspective of EU legislations to protection and circulation of data in Europe, it is seen that, the recent proposal for Data Protection Regulation (2012/0011(COD)) with the amendments made by the LIBE Committee of the European Parliament (22.10.2013) may seriously impede use of health care data for even research purposes, due to the restrictions proposed on the use of health data. On the other hand, the Cross-border Healthcare Directive (2011/24/EU) plays a facilitating role for the circulation of data in Europe, with the voluntary networks on e-Health and Health Technology Assessment (HTA).
For WP2 (Assessment of the practice model from the policy perspective in Europe) three subtasks had been defined: 1) Assessment of how the criteria "benefit" and "cost-effectiveness" are handled in reimbursement decisions on innovations in the primary care setting in the UK and in Germany, 2) SWOT analysis of 'Gentest', and 3) Comparison of 'Gentest' with other tests utilizing genetic information to combat complex diseases.
For successful implementation of personalized interventions in European health systems, reimbursement decision-making processes and criteria, which show a great variability within Europe, are of significant importance. An assessment on how the criteria „benefit“ and „cost-effectiveness“ are handled in reimbursement decisions in the UK and Germany (subtask 1) was carried out to exemplify one of the HTA criteria in two distinct health systems in Europe. In the historical context, the main criterion in the UK has been ‘cost-effectiveness’, whereas for Germany it has been ‘benefit’. Economic evaluation for reimbursement decision-making entered the scene rather new in Germany, and differs from the UK. In the UK, the emphasis has been on cost-effectiveness, because there is a finite budget for health, both in the national level and local commissioner level. Within this fixed budget, inclusion of one service in benefit package means that another one should be taken out. On the other hand, ‘benefit’ has been the main criteria in Germany because according to its legislation, a person cannot be prohibited access to care only based on cost grounds. Economic evaluation is carried out to for example set a ceiling price within a therapeutic group to attain efficiency in that group. This is rooted in the fact, that fixed predetermined budgets have not been set for the funders in Germany.
The SWOT analysis of 'Gentest' (subtask 2) identified strengths, weaknesses, opportunities and threats of 'Gentest'. Addressing major chronic complex diseases in a single test combining genetic information, anthropometric and lifestyle factors etc., and potentially empowering individuals to manage their health are among the strengths. Currently not being up to date in terms of genetic markers, lack of cost-effectiveness and no follow-up of the 500 individuals are weaknesses. One of the main opportunities is development of a software to collect information and generate 'Gentest' reports. Also, data generated with its potential population wide application in primary care can create a feedback loop to research providing valuable insights to health and diseases. A main threat is the limited knowledge and skills of the health workforce on genomics and its contribution to more targeted health interventions.
For comparison of 'Gentest' with other tests utilizing genetic information to combat complex diseases (subtask 3), a non-systematic search strategy in the internet and PubMed was used to identify such tests. The criteria used for comparison included: inputs of the intervention (test), conditions and health areas covered, involvement of the health professional (before and after the intervention), assessment areas, results and recommendations provided in the report, follow-up, turnaround time and costs. Compared with the ten applications selected, 'Gentest' is an example of a comprehensive approach (utilizing personal and family health history, lifestyle factors, biomarkers and genotype etc.) for combatting complex diseases, which provides holistic personalized lifestyle and medical advice to individuals via authorized (trained) health professionals. On the other hand, in comparison with some of these tests, 'Gentest' has been developed before 2008. Thus, it does not include new genetic polymorphisms as an input, it does not provide a follow-up of individuals, and the validity of the test has not been proofed yet.
The P4-Medicine@EU project demonstrated that for the implementation of innovations such as personalized interventions in European health systems the assessment needs to be conducted in a bilateral way representing two perspectives of European policy research: (1) assessment of the technology (intervention) itself in the various European health systems by using existing frameworks such as HTA, as well as (2) assessment of the European policy framework.