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HEALTH POLICIES ABOUT GENE & CELL THERAPIES IN FRANCE, GERMANY, ITALY, UNITED KINGDOM, SPAIN, PORTUGAL AND TURKEY

Yıl 2020, Cilt 4, Sayı 2, 49 - 67, 31.12.2020

Öz

Objective: Genetic diseases constitute the majority of rare diseases. The Orphanet portal for rare diseases lists more than 5800 diseases in its database. Rare diseases of genetic origin are less common than other diseases. The current treatment costs of these diseases cause a high budget impact on health systems. Gene and cell therapies are targeting the innovating treatment methods to cure the underlying diseases rather than the symptoms. Researchers, health care industries, small and medium-sized enterprises companies, as well as major pharmaceutical companies, are paying more attention to gene and cell therapies. European countries are highly invested in gene and cell therapy research. This study aims to provide information on trends and health policies in Europe.
Methods: The study followed an inductive research approach with secondary data search which was collected from different online sources to perform areviow on the regulatory process, reimbursement, pricing decisions, and regenerative therapy market.
Results: The United Kingdom, Germany, Italy, Portugal, Spain, and France follow the European Medicines Agency regulatory process for market approval. Turkey does not follow the European Medicines Agency and does not have any defined regulation authority for gene and cell therapy. France, Germany, and the United Kingdom have recently published updated health technology assessment reports. Portugal and Spain do not have nationally approved gene and cell therapy practices, however, have initiated research resource on cellular and gene therapies. The United Kingdom and Germany are the most advanced in the commercialization and legalization of gene and cellular therapies in selected countries.
Conclusion: European countries have variable pricing, reimbursement, and market access regulations apart from the common European Medicines Agency regulations. Improved gene and cell therapy regulations have proven the clinical effectiveness of new treatments. Academic research centers, small and medium businesses are the main components of gene and cell therapy research. The inclusion of gene and cell therapies in guidelines and legislation may improve the market access of these therapies

Kaynakça

  • Allied Market Research. (2019). Gene Therapy Market Overview [Fact Sheet]. https://www.alliedmarketresearch.com/gene-therapy- market.
  • American Society of Gene & Cell Therapy. (2018). Gene and Cell Therapy [Fact Sheet]. https://www.asgct.org/education/gene-and-cell-therapy- defined.
  • APM Health Europe. (2019). https://www.apmhealtheurope.com/index.php
  • Blasimme, A., & Rial-Sebbag, E. (2013). “Regulation of cell-based therapies in Europe: current challenges and emerging issues”. Stem cells and development, 22(S1), 14-19.
  • Bouslouk, M. (2016). “G-BA benefit assessment of new orphan drugs in Germany: the first five years”. Expert Opin Orphan Drugs, 4(5), 453-455.
  • Busse, R., & Blümel, M. (2014). “Germany: health system review”. Health Systems in Transition. https://apps.who.int/iris/bitstream/handle/10665/130246/HiT- 16-2-2014-eng.pdf?sequence=5&isAllowed=y
  • Chamova, J., & Stellalliance, A. B. (2017). “Mapping of HTA national organisations, programmes and processes in EU and Norway”. Brussels: European Commission.
  • de Wilde, S., Guchelaar, H. J., Herberts, C., Lowdell, M., Hildebrandt, M., Zandvliet, M., & Meij, P. (2016).
  • “Development of cell therapy medicinal products by academic institutes”. Drug Discovery Today, 21(8), 1206-1212.
  • de Wilde, S., Guchelaar, H. J., Zandvliet, M. L., & Meij, P. (2016). “Clinical development of gene-and cell-based therapies: overview of the European landscape”. Molecular Therapy-Methods & Clinical Development, 3, 16073.
  • Die Spreu Vom Weizen Trennen. Das Arzneimittelmarkt- neuordnungsgesetz (AMNOG). (2018).
  • Bundersministerium für Gesundheit (2020). Die Spreu vom Weizen trennen. https://www.bundesgesundheitsministerium.de/fileadmi n/Dateien/5_Publikationen/Gesundheit/Broschueren/Br oschuere_Die_Spreu_vom_Weizen_trennen_- _Das_Arzneimittelmarktneuordnungsgesetz.pdf.
  • Eldem, T., & Eldem, B. (2018). “Ocular Drug, Gene and Cellular Delivery Systems and Advanced Therapy Medicinal Products”. Turkish Journal of Ophthalmology, 48(3), 132.
  • European Medicines Agency. (2014). Guideline on good
  • pharmacovigilance practices (GVP). Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1), 90. EMA/873138/2011.
  • Halioua-Haubold, C. L., Peyer, J. G., Smith, J. A., Arshad, Z., Scholz, M., Brindley, D. A., & MacLaren, R. E. (2017). “Focus: Genome Editing: Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan”. The Yale journal of biology and medicine, 90(4), 683.
  • Hanna, E., Rémuzat, C., Auquier, P., & Toumi, M. (2016). “Advanced therapy medicinal products: current and future perspectives”. Journal of market access & health policy, 4(1), 31036.
  • Hanna, E., Rémuzat, C., Auquier, P., & Toumi, M. (2017). “Gene therapies development: slow progress and promising prospect”. Journal of market access & health policy, 5(1), 1265293.
  • Institute for Quality and Efficiency in Health Care. (2019). HTA reports. https://www.iqwig.de/en/methods/results/hta- reports.7459.html
  • Institute for Quality and Efficiency in Health Care. (2019). Negative pressure wound therapy for wounds healing by primary intention. https://www.iqwig.de/en/projects-results/projects/non- drug-interventions/n-projekte/n17-01b-negative- pressure-wound-therapy-for-wounds-healing-by- primary-intention.9666.html
  • Italian Medicines Agency. (2018). Ministero della Salute. http://www.agenziafarmaco.gov.it/en.
  • Ji, W., Bolander, J., Chai, Y. C., Katagiri, H., Marechal, M., & Luyten, F. P. (2017). “Toward advanced therapy medicinal products (ATMPs) Combining Bone Morphogenetic Proteins (BMP) and cells for bone regeneration”. In Bone Morphogenetic Proteins: Systems Biology Regulators, (127-169).
  • Jørgensen, J., & Kefalas, P. (2015). “Reimbursement of licensed cell and gene therapies across the major European healthcare markets”. Journal of market access & health policy, 3(1), 29321.
  • Kahveci, R., Koç, E. M., & Küçük, E. Ö. (2017). “Health technology assessment in Turkey”. International Journal of Technology Assessment in Health Care, 33(3), 402.
  • Karagöz, U., Kotmakçı, M., Akbaba, H., Çetintaş, V. B., & Kantarcı, G. (2018). “Preparation and characterization of non-viral gene delivery systems with pEGFP-C1 Plasmid DNA”. Brazilian Journal of Pharmaceutical Sciences, 54(1).
  • Klug, B., Celis, P., Carr, M., & Reinhardt, J. (2012). “Regulatory structures for gene therapy medicinal products in the European Union”. In Methods in enzymology, Academic Press, 507, 337-354..
  • Laires, P., Inês, M., Gouveia, M., Mateus, C., Miguel, L. S., & Pinto, C. G. (2016). “The Challenges of Health Technology Assessment in Portugal”. Revista Portuguesa de Farmacoterapia, 8(3), 24-34.
  • Maciulaitis, R., D'apote, L., Buchanan, A., Pioppo, L., & Schneider, C. K. (2012). “Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive”. Molecular Therapy, 20(3), 479-482.
  • Mahla, R. S. (2016). “Stem cells applications in regenerative medicine and disease therapeutics”. International journal of cell biology.
  • Mao, A. S., & Mooney, D. J. (2015). “Regenerative medicine: current therapies and future directions”. Proceedings of the National Academy of Sciences, 112(47), 14452-14459.
  • Massetti, M., Aballéa, S., Videau, Y., Rémuzat, C., Roïz, J., & Toumi, M. (2015). “A comparison of HAS & NICE guidelines for the economic evaluation of health technologies in the context of their respective national health care systems and cultural environments”. Journal of market access & health policy, 3(1), 24966.
  • Migliaccio, G., & Pintus, C. (2012). “Role of the EU framework in regulation of stem cell-based products”. In Mesenchymal Stem Cells-Basics and Clinical Application II (287-299).
  • Ministry of Health (Portugal). (2019). Health Technology Assessment Report. https://www.dgs.pt/ National Authority for Health. (2014). Pricing & Reimbursement of Drugs and HTA Policies in France [Fact Sheet]. France. https://www.has sante.fr/portail/upload/docs/application/pdf/2014- 03/pricing_reimbursement_of_drugs_and_hta_policies_ in_france.pdf.
  • National Institute for Health and Care Excellence. (2013). Guide to the Methods of Technology Appr Appraisal 2013. https://www.nice.org.uk/process/pmg9/resources/guide- to-the-methods-of-technology-appraisal-2013-pdf- 2007975843781.
  • National Institute for Health and Clinical Excellence. (2010). Guidance on Cancer Services Improving Outcomes for People with Skin Tumours Including Melanoma (Update). https://www.nice.org.uk/guidance/csg8/resources/impro ving-outcomes-for-people-with-skin-tumours-including- melanoma-2010-partial-update-pdf-773380189.
  • Papadaki, M. (2017). “Adaptation through collaboration: developing novel platforms to advance the delivery of advanced therapies to patients”. Frontiers in Medicine, 4, 56.
  • Paul Ehrlich Institut. (2018). Regulation. https://www.pei.de/EN/regulation/regulation- node.html;jsessionid=74951A6DF52E57B9F202A8B2 D5D94F36.intranet242
  • Petricciani, J., Hayakawa, T., Stacey, G., Trouvin, J. H., & Knezevic, I. (2017). “Scientific considerations for the regulatory evaluation of cell therapy products”. Biologicals, 50, 20-26.
  • Pimpinella, G., & Tartaglia, L. (2013). “Pharmacovigilance and the Italian medicines agency”. Journal of pharmacology & pharmacotherapeutics, 4(1), 4.
  • Pogue, R. E., Cavalcanti, D. P., Shanker, S., Andrade, R. V., Aguiar, L. R., de Carvalho, J. L., & Costa, F. F. (2018). “Rare genetic diseases: update on diagnosis, treatment and online resources”. Drug discovery today, 23(1), 187-195.
  • Smith, M., Zakrzewski, J., James, S., & Sadelain, M. (2018). “Posttransplant chimeric antigen receptor therapy”. Blood, 131(10), 1045-1052.
  • Templeton, N. S. (Ed.). (2008). “Gene And Cell Therapy: Therapeutic Mechanisms And Strategies”. Boca Raton: Crc Press.
  • Terzic, A., Pfenning, M. A., Gores, G. J., & Harper Jr, C. M. (2015). “Regenerative medicine build‐out”. Stem cells translational medicine, 4(12), 1373-1379.
  • Theidel, U., & von der Schulenburg, J. M. G. (2016). “Benefit assessment in Germany: implications for price discounts”. Health economics review, 6(1), 33.
  • Touchot, N., & Flume, M. (2017). “Early insights from commercialization of gene therapies in Europe”. Genes, 8(2), 78.
  • Valton, J., Guyot, V., Boldajipour, B., Sommer, C., Pertel, T., Juillerat, A., ... & Poirot, L. (2018). “A versatile safeguard for chimeric antigen receptor T-cell immunotherapies”. Scientific reports, 8(1), 1-8.
  • Zylberberg, C., Charo, A., Haddock, R., Lin-Gibson, S., Lumelsky, N., & Petersen, T. (2017). “Manufacturing cell therapies: the paradigm shift in healthcare of this century”. NAM Perspect, 1-13.

HEALTH POLICIES ABOUT GENE & CELL THERAPIES IN FRANCE, GERMANY, ITALY, UNITED KINGDOM, SPAIN, PORTUGAL AND TURKEY

Yıl 2020, Cilt 4, Sayı 2, 49 - 67, 31.12.2020

Öz

Objective: Genetic diseases constitute the majority of rare diseases. The Orphanet portal for rare diseases lists more than 5800 diseases in its database. Rare diseases of genetic origin are less common than other diseases. The current treatment costs of these diseases cause a high budget impact on health systems. Gene and cell therapies are targeting the innovating treatment methods to cure the underlying diseases rather than the symptoms. Researchers, health care industries, small and medium-sized enterprises companies, as well as major pharmaceutical companies, are paying more attention to gene and cell therapies. European countries are highly invested in gene and cell therapy research. This study aims to provide information on trends and health policies in Europe.
Methods: The study followed an inductive research approach with secondary data search which was collected from different online sources to perform areviow on the regulatory process, reimbursement, pricing decisions, and regenerative therapy market.
Results: The United Kingdom, Germany, Italy, Portugal, Spain, and France follow the European Medicines Agency regulatory process for market approval. Turkey does not follow the European Medicines Agency and does not have any defined regulation authority for gene and cell therapy. France, Germany, and the United Kingdom have recently published updated health technology assessment reports. Portugal and Spain do not have nationally approved gene and cell therapy practices, however, have initiated research resource on cellular and gene therapies. The United Kingdom and Germany are the most advanced in the commercialization and legalization of gene and cellular therapies in selected countries.
Conclusion: European countries have variable pricing, reimbursement, and market access regulations apart from the common European Medicines Agency regulations. Improved gene and cell therapy regulations have proven the clinical effectiveness of new treatments. Academic research centers, small and medium businesses are the main components of gene and cell therapy research. The inclusion of gene and cell therapies in guidelines and legislation may improve the market access of these therapies

Kaynakça

  • Allied Market Research. (2019). Gene Therapy Market Overview [Fact Sheet]. https://www.alliedmarketresearch.com/gene-therapy- market.
  • American Society of Gene & Cell Therapy. (2018). Gene and Cell Therapy [Fact Sheet]. https://www.asgct.org/education/gene-and-cell-therapy- defined.
  • APM Health Europe. (2019). https://www.apmhealtheurope.com/index.php
  • Blasimme, A., & Rial-Sebbag, E. (2013). “Regulation of cell-based therapies in Europe: current challenges and emerging issues”. Stem cells and development, 22(S1), 14-19.
  • Bouslouk, M. (2016). “G-BA benefit assessment of new orphan drugs in Germany: the first five years”. Expert Opin Orphan Drugs, 4(5), 453-455.
  • Busse, R., & Blümel, M. (2014). “Germany: health system review”. Health Systems in Transition. https://apps.who.int/iris/bitstream/handle/10665/130246/HiT- 16-2-2014-eng.pdf?sequence=5&isAllowed=y
  • Chamova, J., & Stellalliance, A. B. (2017). “Mapping of HTA national organisations, programmes and processes in EU and Norway”. Brussels: European Commission.
  • de Wilde, S., Guchelaar, H. J., Herberts, C., Lowdell, M., Hildebrandt, M., Zandvliet, M., & Meij, P. (2016).
  • “Development of cell therapy medicinal products by academic institutes”. Drug Discovery Today, 21(8), 1206-1212.
  • de Wilde, S., Guchelaar, H. J., Zandvliet, M. L., & Meij, P. (2016). “Clinical development of gene-and cell-based therapies: overview of the European landscape”. Molecular Therapy-Methods & Clinical Development, 3, 16073.
  • Die Spreu Vom Weizen Trennen. Das Arzneimittelmarkt- neuordnungsgesetz (AMNOG). (2018).
  • Bundersministerium für Gesundheit (2020). Die Spreu vom Weizen trennen. https://www.bundesgesundheitsministerium.de/fileadmi n/Dateien/5_Publikationen/Gesundheit/Broschueren/Br oschuere_Die_Spreu_vom_Weizen_trennen_- _Das_Arzneimittelmarktneuordnungsgesetz.pdf.
  • Eldem, T., & Eldem, B. (2018). “Ocular Drug, Gene and Cellular Delivery Systems and Advanced Therapy Medicinal Products”. Turkish Journal of Ophthalmology, 48(3), 132.
  • European Medicines Agency. (2014). Guideline on good
  • pharmacovigilance practices (GVP). Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1), 90. EMA/873138/2011.
  • Halioua-Haubold, C. L., Peyer, J. G., Smith, J. A., Arshad, Z., Scholz, M., Brindley, D. A., & MacLaren, R. E. (2017). “Focus: Genome Editing: Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan”. The Yale journal of biology and medicine, 90(4), 683.
  • Hanna, E., Rémuzat, C., Auquier, P., & Toumi, M. (2016). “Advanced therapy medicinal products: current and future perspectives”. Journal of market access & health policy, 4(1), 31036.
  • Hanna, E., Rémuzat, C., Auquier, P., & Toumi, M. (2017). “Gene therapies development: slow progress and promising prospect”. Journal of market access & health policy, 5(1), 1265293.
  • Institute for Quality and Efficiency in Health Care. (2019). HTA reports. https://www.iqwig.de/en/methods/results/hta- reports.7459.html
  • Institute for Quality and Efficiency in Health Care. (2019). Negative pressure wound therapy for wounds healing by primary intention. https://www.iqwig.de/en/projects-results/projects/non- drug-interventions/n-projekte/n17-01b-negative- pressure-wound-therapy-for-wounds-healing-by- primary-intention.9666.html
  • Italian Medicines Agency. (2018). Ministero della Salute. http://www.agenziafarmaco.gov.it/en.
  • Ji, W., Bolander, J., Chai, Y. C., Katagiri, H., Marechal, M., & Luyten, F. P. (2017). “Toward advanced therapy medicinal products (ATMPs) Combining Bone Morphogenetic Proteins (BMP) and cells for bone regeneration”. In Bone Morphogenetic Proteins: Systems Biology Regulators, (127-169).
  • Jørgensen, J., & Kefalas, P. (2015). “Reimbursement of licensed cell and gene therapies across the major European healthcare markets”. Journal of market access & health policy, 3(1), 29321.
  • Kahveci, R., Koç, E. M., & Küçük, E. Ö. (2017). “Health technology assessment in Turkey”. International Journal of Technology Assessment in Health Care, 33(3), 402.
  • Karagöz, U., Kotmakçı, M., Akbaba, H., Çetintaş, V. B., & Kantarcı, G. (2018). “Preparation and characterization of non-viral gene delivery systems with pEGFP-C1 Plasmid DNA”. Brazilian Journal of Pharmaceutical Sciences, 54(1).
  • Klug, B., Celis, P., Carr, M., & Reinhardt, J. (2012). “Regulatory structures for gene therapy medicinal products in the European Union”. In Methods in enzymology, Academic Press, 507, 337-354..
  • Laires, P., Inês, M., Gouveia, M., Mateus, C., Miguel, L. S., & Pinto, C. G. (2016). “The Challenges of Health Technology Assessment in Portugal”. Revista Portuguesa de Farmacoterapia, 8(3), 24-34.
  • Maciulaitis, R., D'apote, L., Buchanan, A., Pioppo, L., & Schneider, C. K. (2012). “Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive”. Molecular Therapy, 20(3), 479-482.
  • Mahla, R. S. (2016). “Stem cells applications in regenerative medicine and disease therapeutics”. International journal of cell biology.
  • Mao, A. S., & Mooney, D. J. (2015). “Regenerative medicine: current therapies and future directions”. Proceedings of the National Academy of Sciences, 112(47), 14452-14459.
  • Massetti, M., Aballéa, S., Videau, Y., Rémuzat, C., Roïz, J., & Toumi, M. (2015). “A comparison of HAS & NICE guidelines for the economic evaluation of health technologies in the context of their respective national health care systems and cultural environments”. Journal of market access & health policy, 3(1), 24966.
  • Migliaccio, G., & Pintus, C. (2012). “Role of the EU framework in regulation of stem cell-based products”. In Mesenchymal Stem Cells-Basics and Clinical Application II (287-299).
  • Ministry of Health (Portugal). (2019). Health Technology Assessment Report. https://www.dgs.pt/ National Authority for Health. (2014). Pricing & Reimbursement of Drugs and HTA Policies in France [Fact Sheet]. France. https://www.has sante.fr/portail/upload/docs/application/pdf/2014- 03/pricing_reimbursement_of_drugs_and_hta_policies_ in_france.pdf.
  • National Institute for Health and Care Excellence. (2013). Guide to the Methods of Technology Appr Appraisal 2013. https://www.nice.org.uk/process/pmg9/resources/guide- to-the-methods-of-technology-appraisal-2013-pdf- 2007975843781.
  • National Institute for Health and Clinical Excellence. (2010). Guidance on Cancer Services Improving Outcomes for People with Skin Tumours Including Melanoma (Update). https://www.nice.org.uk/guidance/csg8/resources/impro ving-outcomes-for-people-with-skin-tumours-including- melanoma-2010-partial-update-pdf-773380189.
  • Papadaki, M. (2017). “Adaptation through collaboration: developing novel platforms to advance the delivery of advanced therapies to patients”. Frontiers in Medicine, 4, 56.
  • Paul Ehrlich Institut. (2018). Regulation. https://www.pei.de/EN/regulation/regulation- node.html;jsessionid=74951A6DF52E57B9F202A8B2 D5D94F36.intranet242
  • Petricciani, J., Hayakawa, T., Stacey, G., Trouvin, J. H., & Knezevic, I. (2017). “Scientific considerations for the regulatory evaluation of cell therapy products”. Biologicals, 50, 20-26.
  • Pimpinella, G., & Tartaglia, L. (2013). “Pharmacovigilance and the Italian medicines agency”. Journal of pharmacology & pharmacotherapeutics, 4(1), 4.
  • Pogue, R. E., Cavalcanti, D. P., Shanker, S., Andrade, R. V., Aguiar, L. R., de Carvalho, J. L., & Costa, F. F. (2018). “Rare genetic diseases: update on diagnosis, treatment and online resources”. Drug discovery today, 23(1), 187-195.
  • Smith, M., Zakrzewski, J., James, S., & Sadelain, M. (2018). “Posttransplant chimeric antigen receptor therapy”. Blood, 131(10), 1045-1052.
  • Templeton, N. S. (Ed.). (2008). “Gene And Cell Therapy: Therapeutic Mechanisms And Strategies”. Boca Raton: Crc Press.
  • Terzic, A., Pfenning, M. A., Gores, G. J., & Harper Jr, C. M. (2015). “Regenerative medicine build‐out”. Stem cells translational medicine, 4(12), 1373-1379.
  • Theidel, U., & von der Schulenburg, J. M. G. (2016). “Benefit assessment in Germany: implications for price discounts”. Health economics review, 6(1), 33.
  • Touchot, N., & Flume, M. (2017). “Early insights from commercialization of gene therapies in Europe”. Genes, 8(2), 78.
  • Valton, J., Guyot, V., Boldajipour, B., Sommer, C., Pertel, T., Juillerat, A., ... & Poirot, L. (2018). “A versatile safeguard for chimeric antigen receptor T-cell immunotherapies”. Scientific reports, 8(1), 1-8.
  • Zylberberg, C., Charo, A., Haddock, R., Lin-Gibson, S., Lumelsky, N., & Petersen, T. (2017). “Manufacturing cell therapies: the paradigm shift in healthcare of this century”. NAM Perspect, 1-13.

Ayrıntılar

Birincil Dil İngilizce
Konular Sağlık Bilimleri ve Hizmetleri
Bölüm Makaleler
Yazarlar

Güvenç KOÇKAYA (Sorumlu Yazar)
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.
Türkiye


Gulpembe OGUZHAN
ONDOKUZ MAYIS ÜNİVERSİTESİ
Türkiye


Furkan Muhammed ÜLGER Bu kişi benim
HACETTEPE ÜNİVERSİTESİ
Türkiye


Kardelen ÇAM
ECONiX Araştırma Analiz ve Danışmanlık A.Ş.
0000-0001-5613-0160
Türkiye

Yayımlanma Tarihi 31 Aralık 2020
Yayınlandığı Sayı Yıl 2020, Cilt 4, Sayı 2

Kaynak Göster

APA Koçkaya, G. , Oguzhan, G. , Ülger, F. M. & Çam, K. (2020). HEALTH POLICIES ABOUT GENE & CELL THERAPIES IN FRANCE, GERMANY, ITALY, UNITED KINGDOM, SPAIN, PORTUGAL AND TURKEY . Eurasian Journal of Health Technology Assessment , 4 (2) , 49-67 . Retrieved from https://dergipark.org.tr/tr/pub/ehta/issue/59458/828008

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