ISPOR
Amsterdam, The Netherlands
I had an opportunity to join the annual congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Amsterdam. This was by far the most important, and the most interesting, meeting for scientists, academics and industry working in the domain of economic evaluation in health care. The program was divided in pre-congress short courses and the symposium. I took two courses: “Transferability of cost-effectiveness data between countries” and “Applying mixed methods to establish content validity of PRO, CLINRO and OBSRO assessments”.
Although the number of countries requiring an economic dossier as part of the submission dossier for public reimbursement of new drugs is growing, the industry cannot conduct economic evaluations in every potential market. However, national decision makers require country-specific or region-specific data or estimates on health care costs and patient outcomes. More and more, they are only willing to accept foreign or international data when they are transferable to their own specific decision making context. However little guidance exists on how to do this. This course discussed the factors that make economic data more difficult to transfer from one country to other countries than clinical data, and focused on the report of the ISPOR Good Practices on Economic Data Transferability Task Force. Faculty discussed the transferability of health state valuations based on the EQ5D instrument and the transferability of lost productivity data.
Next, faculty reviewed the methods that have been presented to assess the transferability of foreign costs, effects, and cost-effectiveness estimates and their pros and cons. This topic was covered in a case-study while working in small groups. A stepwise procedure illustrated how to select a foreign cost-effectiveness model for adaptation to your own decision-making context. Finally, a detailed approach on how to adapt a cost-effectiveness model calculation was illustrated using the case of breast cancer treatment. During the course, faculty presented transferring issues encountered when assessing model-based economic evaluations.
The next course focused on establishing the content validity of patient-reported outcomes (PRO), clinical-reported outcomes (CLINRO), and observer-reported outcomes (OBSRO) assessments that are intended for use as the basis for medical product claims in the US and Europe. The evidences for supporting content validity take into account the recommendations of the FDA Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, and the EMA Reflection Paper on the Regulatory Guidance on the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products.
We defined the essential evidence needed for establishing and documenting content validity of assessments planned for use in applications for regulatory approval of desired medical product claims. Participants took part in several practical exercises that were part of the iterative process for determining and establishing evidence of content validity for instruments. Faculty referenced the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modifications PRO Task Force Report.
The 17th Annual ISPOR European Congress was a blast: more than 4700 congress attendees, over 2000 presentations, tens of parallels sessions, hundreds of poster presentations, great social events. This is, together with the humongous meeting of the American Telemedicne Association, the most impressive event that I took part in. It brings together experts in health economics to work on methodological issues in implementing innovation in health care systems around the world. Erasmus University, especially the group I am a part of – the Institute for Medical Technology Assessment – had several presentations. I aim at presenting our research on cost-effectiveness analysis of Motiva at future ISPOR meetings.
I had an opportunity to join the annual congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Amsterdam. This was by far the most important, and the most interesting, meeting for scientists, academics and industry working in the domain of economic evaluation in health care. The program was divided in pre-congress short courses and the symposium. I took two courses: “Transferability of cost-effectiveness data between countries” and “Applying mixed methods to establish content validity of PRO, CLINRO and OBSRO assessments”.
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| PROF. SEVERENS INTRODUCING PROF. EVERS' TALK |
Although the number of countries requiring an economic dossier as part of the submission dossier for public reimbursement of new drugs is growing, the industry cannot conduct economic evaluations in every potential market. However, national decision makers require country-specific or region-specific data or estimates on health care costs and patient outcomes. More and more, they are only willing to accept foreign or international data when they are transferable to their own specific decision making context. However little guidance exists on how to do this. This course discussed the factors that make economic data more difficult to transfer from one country to other countries than clinical data, and focused on the report of the ISPOR Good Practices on Economic Data Transferability Task Force. Faculty discussed the transferability of health state valuations based on the EQ5D instrument and the transferability of lost productivity data.
Next, faculty reviewed the methods that have been presented to assess the transferability of foreign costs, effects, and cost-effectiveness estimates and their pros and cons. This topic was covered in a case-study while working in small groups. A stepwise procedure illustrated how to select a foreign cost-effectiveness model for adaptation to your own decision-making context. Finally, a detailed approach on how to adapt a cost-effectiveness model calculation was illustrated using the case of breast cancer treatment. During the course, faculty presented transferring issues encountered when assessing model-based economic evaluations.
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| QUANTITATIVE Vs QUALITATIVE METHODS |
The next course focused on establishing the content validity of patient-reported outcomes (PRO), clinical-reported outcomes (CLINRO), and observer-reported outcomes (OBSRO) assessments that are intended for use as the basis for medical product claims in the US and Europe. The evidences for supporting content validity take into account the recommendations of the FDA Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, and the EMA Reflection Paper on the Regulatory Guidance on the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products.
We defined the essential evidence needed for establishing and documenting content validity of assessments planned for use in applications for regulatory approval of desired medical product claims. Participants took part in several practical exercises that were part of the iterative process for determining and establishing evidence of content validity for instruments. Faculty referenced the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modifications PRO Task Force Report.
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| BIG DATA IS BIG NEWS IN HEALTHCARE |
The 17th Annual ISPOR European Congress was a blast: more than 4700 congress attendees, over 2000 presentations, tens of parallels sessions, hundreds of poster presentations, great social events. This is, together with the humongous meeting of the American Telemedicne Association, the most impressive event that I took part in. It brings together experts in health economics to work on methodological issues in implementing innovation in health care systems around the world. Erasmus University, especially the group I am a part of – the Institute for Medical Technology Assessment – had several presentations. I aim at presenting our research on cost-effectiveness analysis of Motiva at future ISPOR meetings.
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