Workpackage 6:

Socio-economic factors: Non-invasive prenatal diagnostic and neonatal screening tools

1. to develop an internationally agreed HTA Framework for early assessment of NIPD tests, and an underpinning technology innovation framework to map scientific and other factors which may influence NIPD technology development;
2. to identify and review available evidence (using best practice guidelines) to address questions prioritised in the HTA Framework, including issues of multiracial society;
3. to produce early-HTA reports to support decision-making by policy makers/ third-party payers on NIPD introduction, and to develop economic models;
4. to collect additional data in partner countries (including views of key stakeholders);
5. to develop NIPD simulation models for use by policy makers to provide early demonstration of the costs and financial or other benefits of NIPD technologies in different country contexts;
6. to establish a world-wide panel of experts (policy makers, clinicians, scientists and others) to consider NIPD test implementation i.e. the optimal conditions within health care systems and clinical practice for the introduction of these new non-invasive diagnostic tests;
7. to provide information for public/ citizen HTA awareness programmes, and to develop training materials for bio-scientists to improve their understanding of HTA;
8. to disseminate information about NIPD and potential for implementation at international conferences and seminars and publish our findings;
9. to promote harmonization in Europe and beyond for implementation of NIPD innovations.

WP6 activities are concentrated on those NIPD tests most likely to have a major impact on policy-making and/or public health programmes. These objectives also link to the aims of the new EC initiative – EUnetHTA. This pan-European integration activity aims to improve multinational use of HTA findings. This initiative will further increase the relevance of SAFE socio-economic outputs. All WP6 objectives require co-operation and collaboration in order to develop common methodology and data standardisation across partner countries. Resulting benefits will include harmonization of appraisal mechanisms and improved guidelines for implementation of NIPD tests.

The European Commission reviewers at the 12 month review reported that this WP is essential for the development of the NoE. This is because the activities of WP6 will influence the introduction of SAFE tests, since the aim of WP6 is to undertake early-health technology assessment in order to identify and explore factors that might govern successful introduction of these new technologies.
Medical care is changing dramatically in all parts of the world due to scientific advances; it is becoming more ambitious, more effective, but also more expensive. Health technology assessment has increased in importance because of this, and is now viewed as an important tool for dealing with questions of limited resources, difficult choices for health care provision throughout the western world, and increasingly the developing world also.
Health technology assessment (HTA) can be defined as:
"evaluation of the costs, effectiveness and broader social and ethical implications of a new technology"
Governments world-wide are seeking such evidence on new health care interventions. Purchasers of health care (e.g. third-party payers such as insurance companies) are becoming more concerned with the health gain which their money can buy. Patient organisations now demand new technologies that have passed such cost-effectiveness hurdles. At the delivery end of health care, hospitals and physicians are increasingly required to identify priorities for future technological and service investment, based on what real benefits they bring to patients at what costs. Last, but not least, industry has come to realise the value of technology assessment as a means of informing decision-making about product development, and for positioning new medical technologies in the global market.

Gathering data to enable prospective health technology assessment and economic modelling of these emerging technologies in different countries will be essential if the SAFE Network of Excellence is to achieve its aim:
" To implement routine and cost-effective non-invasive prenatal diagnosis (NIPD) and neonatal screening (NS) through the forging of long-term partnerships"

What tests will WP6 focus on?

The workpackage will address in turn the most likely applications of SAFE diagnostic advances. Initially, we will focus on two main areas i.e. NIPD tools for diagnosis of fetal RhD blood group status, and new tools for diagnosis of Mendelian genetic disorders such as the haemoglobinopathies. The former represents a 'new' technology starting to diffuse in some countries and not others, and the latter is an 'emergent' technology that the scientific partners have identified as moving forward within the medium-term future.
Other SAFE scientific objectives - development of non-invasive prenatal diagnosis for fetal chromosome anomalies (e.g. Down syndrome) and for pregnancy related disorders (e.g. preeclampsia and pre-term labour) - will be the main focus later in months 31-60.

What does WP6 consist of?

The workpackage will address in turn the most likely applications of SAFE diagnostic advances. Initially, we will focus on two main areas i.e. NIPD tools for diagnosis of fetal RhD blood group status, and new tools for diagnosis of Mendelian genetic disorders such as the haemoglobinopathies. The former represents a 'new' technology starting to diffuse in some countries and not others, and the latter is an 'emergent' technology that the scientific partners have identified as moving forward within the medium-term future.Other SAFE scientific objectives - development of non-invasive prenatal diagnosis for fetal chromosome anomalies (e.g. Down syndrome) and for pregnancy related disorders (e.g. preeclampsia and pre-term labour) - will be the main focus later in months 31-60.

Which SAFE countries will be involved?

From the start, our strategy has been to establish an HTA-infrastructure within the NoE which will support the continuation of a successful NIPD HTA network beyond the lifetime of SAFE. As part of this process, we aim to raise awareness of HTA and educate all SAFE scientific partners who are interested in order to improve their understanding of HTA, long recognised as an important gap in EC countries.
Baseline surveys have enabled us to identify a number of interested partners. A cross-section of countries from within the NoE, covering different health system and funding contexts, have been selected to work collaboratively on economic modelling. For the first emerging technology (NIPD RhD), our aim is to produce case studies (including economic modelling) from the Netherlands, Germany, UK, India, and France. For the next area of application (haemoglobinopathy NIPD) we would hope to work with partners from Greece, Cyprus, Spain and Italy also.

What are our activities?

1.Intergrating Activities
-Comprehensive web-based presence: Socio-economic Forum, online/sharing of ideas, online questionnaires etc
-Training in health technology assessment (HTA) of NIPD e.g. for scientists
-Co-ordinated programme of economic modelling across countries
-Sharing data to obtain generalisable conclusions

2. Jointly Executed Research:
-World-wide Delphi Panel - to identify key questions for technology transfer and/ or diffusion of NIPD
-Early-HTA report on NIPD RhD to put SAFE on the map
-Further e-HTA reports on NIPD of haemoglobinopathies, chromosome anomalies (e.g. Down syndrome), pregnancy complications
-Linkage between NIPD, neonatal screening, pre-implant genetic diagnosis & carrier screening

3.Spreading of Excellence:
-Technology transfer: EU/ world-wide
-Dissemination of socio-economic findings to appropriate professional bodies/health professionals
-Parent/ patient communication & public consultation
-e-learning via website for scientists & policy makers
-Industry knowledge transfer

What external networks is WP6 building?

The aim of implementing routine and cost-effective NIPD and neonatal screening requires the forging of long-term partnerships beyond the SAFE Network. Numerous links of this type have been established during the first year through the selective identification and recruitment of Delphi Panel members from key organisations world-wide, thus raising the international profile of SAFE.

The Delphi Panel has members from 92 organisations world-wide. These include:

• HTA Agencies, Health Ministry leads and Healthcare Insurers in 22 countries;
• Lead Physicians, Patient organisations, Legal/ Ethical experts, Epidemiologists, and Laboratory Standards Groups (e.g. ISO);
• Industrial partners in SAFE and European industry groups (e.g. EUCOMED, European Diagnostic Manufacturers Association);
• 36 SAFE scientists and 5 Advisory Board members

The Delphi Panel is expected to continue their collaboration beyond the period of Community financial support. The objective is to build a Virtual World-wide Network, including SAFE partners, which can inform future implementation of routine and cost-effective SAFE genetic tests.
Links have been established with our sister NoE, Eurogentest. In particular, with Unit 3: Clinical Genetics, Community Genetics and Public Health (including Activity 7: Health Technology Assessment and Clinical Validation of Genetic Testing); Unit 4: Ethical, Legal and Social Issues; Unit 5: Research and Emerging Technologies (including Activity 13: Validation of diagnostic methods and novel technologies); and Unit 6 (Education). A formal link has also been set up with the International Network of Agencies for Health Technology Assessment (INAHTA), and with the international early warning health technology assessment organisations (i.e. Euroscan). We are discussing with Euroscan the best ways in which our early-HTA findings on SAFE tests can be disseminated.
In future, additional links will be developed as we identify the requirements for further partners world-wide

How will WP6 findings be disseminated?

Information will be dissemination via the central web site to all partners, and linked to an open discussion forum. Interested partners and policy makers from other countries will be able to access this information, together with a framework (produced by the international Delphi panel of experts) which will help them to consider translation of findings to their own nationalcontexts. International workshops will also be held, including the use of web-based delivery.

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1. Develop research on evaluation of NIPD technologies for fetal sexing
2. Finalize national and joint publications of RhD NIPD
3. International survey of HTA agencies to identify national assessments of new prenatal testing strategies for common chromosome anomalies.
4. Standardise protocols for HTA and economic evaluation of NIPD tests in trials

WP 6 Milestones
M6.35 Paper on refined & validated framework for early aprisal of new fetal genetic tests (Aug 08)
M6.39 Evaluation of simulation performance (RhD NIPD) (April 08)
M6.43 Elicit feedback on SAFE NIPD early-HTA educational materials (Sep 07)
M6.50 International survey of HTA agencies to identify national assessments of new prenatal testing strategies for common chromosome anomalies (April 08)
M6.51 Development of bid for external funding for appraisal of NIPD tests for Down syndrome (June 08)
M6.52 Policy Briefing on NIPD tests for preterm (Aug 08)
M6. 54 Standardise protocols for HTA and economic evaluation of NIPD tests in trials (April 08)
M6.55 Development of bid for external funding (July 08)
M6.56 Literature Review on sex selection practices and India and China (May 08)

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Achivements

Publications

1. L Osipenko, K Freeman, A Szczepura, S Urbaniak, A Haverkamp, G Bonsel, C Krauth Economic evaluation of RhD NIPD technology in the UK, Germany and the Netherlands: cross-comparison study
2. L Osipenko, A Szczepura, A Haverkamp, G Bonsel, C Krauth Universal Fetal Genotyping of RHD Negative Pregnancies– How Cost-Effective? BMJOnline http://www.bmj.com/cgi/eletters/bmj.39518.463206.25v1
3. Freeman K., Szczepura A., Osipenko, L Diagnostic accuracy of non-invasive fetal RhD genotyping tests: A systematic review of the quality of published studies European Journal of Obstetrics & Gynecology and Reproductive Biology (in press)
4. Leeza Osipenko Non-invasive fetal sexing: Medical test or a new tool for sex selection? (submitted for publication) Diversity in Health and Social Care
5. Leeza Osipenko Implementation of your new prenatal diagnostic tests based on fetal DNA in maternal blood, Science & Public Affairs
6. Osipenko, L. Freeman K., Szczepura A., Economic evaluation of routine RHD typing of fetal DNA in maternal plasma to target use of antenatal anti-D prophylaxis in RhD negative pregnant women in England and Wales.
7. Freeman K., Review of the literature reporting evidence on the scientific validity and diagnostic accuracy of NIPD for haemoglobinopathies. Click here to download
8. Freeman K. Home testing in prenatal care – new gender testing kits: What lessons can be learnt from previous technologies? Click here to download
9. Freeman K. Preliminary Overview of the International Context for NIPD for Fetal Chromosome Aneuploidy Click here to download

Presentations

Presentations for Advisory Board meetings:

• 5-7 Sep 05: Prof. Ala Szczepura
• RhD Delphi Qs Sep 05: Prof Ala Szczepura

Presentations for General Assembly:

• WP5 – 7 Sep 05 : Prof. Ala Szczepura
• PR Initiatives Sep 05 : Dr Leeza Osipenko
• WP5 – 7 Mar 05 : Prof. Ala Szczepura
• WP5 – 7 Sep 04 : Prof. Ala Szczepura

Posters

1. Freeman K, Szczepura A. Osipenko L, Health Technology Assessment of Non-Invasive (NI) RhD Testing. Research Day July 2006 University of Warwick, UK
2. Freeman K. Shortcomings in the reporting of diagnostic accuracy of RhD NIPD. HTAi Conference, June 2007 Barcelona, Spain
3. Osipenko L Non-Invasive Prenatal RhD Testing, Can healthcare systems afford it? HTAi Conference, June 2007 Barcelona, Spain
4. Osipenko L. Prenatal Technology Adoption. System Dynamics Conference. July 2008, Boston, USA
5. Osipenko L Non-invasive fetal DNA tests: New tool for sex selection? May 16, 2008 University of Warwick. Gender Away-Day
6. Osipenko L Early Heath Technology Assessment: Non-invasive prenatal diagnostic tests. August 7, 2008 University of Warwick. CSRI

Invited Talks

1. Szczepura A. Osipenko L. Workpackage 6: Socio-economic Aspects SAFE GA. February 2006 Tarragona, Spain
2. Osipenko L., Szczepura A. Policy Development through Optimal HTA Case Studies. HTAi Conference. Adelaide Australia, July, 2006
3. Osipenko L, Freeman, K, Szczepura A. Economic evaluation RhD NIPD: Population Model UK. SAFE GA January, 2007, Bristol, UK
4. Szczepura A. SAFE Socio-Economic Framework – Questions for RhD NIPD WP6 Workshop September 2007, Kenilworth, UK
5. Freeman K. Quality of International Publications on RhD NIPD Test Performance – What Needs to Change?
   WP6 Workshop September 2007, Kenilworth, UK
6. Osipenko L. RhD NIPD in the UK. WP6 Workshop, September 2007, Kenilworth, UK
7. Osipenko L. RhD NIPD Simulation. WP6 Workshop, September 2007, Kenilworth, UK
8. Osipenko L. Economic Modelling Group Meeting. December 2007, Amsterdam, NL
9. Szczepura A. Economic Considerations: Routine NIPD for fetal RhD status. SAFE-RCOG Rhesus Study group
   March 2008 London, UK
10. Osipenko L. Non-invasive fetal DNA tests: New tool for sex selection? The Warwick South Asia Workshop:Theme: Science, Health and Society: South Asians & Reproductive Health April 2008, University of Warwick, UK
11. Osipenko L. Economic Evaluation of RhD NIPD technology in the UK, Germany and the Netherlands
    SAFE GA May 2008, Tarragona Spain
12. Osipenko L. Economic Evaluation of RhD NIPD technology in the UK, Germany and the Netherlands: Cross-comparison study. HTAi Conference. July 2008. Montreal, Canada
    

Evaluation of Web Teaching tool developed by WP5

Development of teaching materials on HTA

Conferences & Workshops

WP6 is an active participant of the SAFE integration activities. Also, our members have been participating in a number of international meetings and conferences to present or advance (create new collaborations, collect data, learn new things) our work on the SAFE project.

Below is the list of various events that our members attended in the past:

• June 2005 - HTAi Conference. Rome, Italy
• Sept 2005 – SAFE General Assembly. Trento, Italy
• Jan 2006 – Workpackage 6 workshop. Amsterdam, NL
• Feb 2006 – SAFE General Assembly. Tarragona, Spain
• May 2006 – PhD Workshop, Zandvoort, NL
• July 2006 –Personalised Medicines Symposium Warwick, UK
• July 2006 - HTAi Conference – Adelaide, Australia
• July 2006 - System Dynamics Conference – Nejmegen, NL
• May 2006- ESHG-Safe Workshop Amsterdam, NL
• Nov 2006- Economics of Genetic Technologies Seminar - Oxford, UK
• Dec 2006- Meeting with Stavros Petrou – Oxford, UK
• Dec 2006 - Meeting with Ananda van den Heuvel (WP7)- Amsterdam, NL
• Dec 2006 - Meeting with Prof. Gouke Bonsel - Amsterdam, NL
• Jan 2007 - SAFE General Assembly (PhD Workshop, SSIG meeting) – Bristol, UK
• March 2007 – Goettingen Workshop on RhD NIPD Standardization, Germany
• April 2007- WP6 Fellow visit to Trento, Italy to collaborate with WP5 on RhD NIPD
• May 2007- Workpackage 5 workshop
• May 2007 – Meeting with Yiming Wang from China. Warwick, UK
• June 2007 – HTAi Conference. Barcelona, Spain
• July 2007 – System Dynamics Conference. Boston, USA
• Sept 2007 – WP 6 Workshop, Kenilworth, UK
• December 2007 – Economic Modelling Group meeting, Amsterdam, NL
• March 2008 – RCOG meeting on non-invasive prenatal testing
• April 2008 – Economic Modelling Group meeting, University of Warwick, UK
• May 2008 – GA in Tarragona, Spain
• July 2008 – HTAi Conference. Montreal, Canada.

Upcoming events:

• Nov 5-6, 2008 – WP6 Workshop, University of Warwick, UK

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