Research Article
BibTex RIS Cite

ALTERNATİF BİR GERİ ÖDEME MODELİ OLARAK KONTROLLÜ GİRİŞ ANLAŞMALARI

Year 2019, Issue: 16, 165 - 194, 21.01.2020
https://doi.org/10.21441/sosyalguvence.677288

Abstract

Sağlık teknolojilerinin son birkaç on yıldaki baş döndürücü gelişimi ve artan sağlık harcamalarının finansmanı sorunu değer bazlı ödeme, performansa dayalı ödeme, risk paylaşımı gibi kavramları ön plana çıkarmış, geleneksel geri ödeme yöntemlerinden ziyade alternatif geri ödeme modellerine olan ilgiyi artırmıştır. Bu çalışma kontrollü giriş anlaşmalarını ve türlerini betimleyerek bilgi edinme ve alternatif geri ödeme modeli olarak kontrollü giriş anlaşmalarının değerlendirilmesi amacını taşımaktadır. Bu çalışmada kontrollü giriş anlaşmalarının ortak özelliklerinin altı çizilerek tanımlandığı ve sınıflandırılmasının yapıldığı, sıkça atıfta bulunulan ve son yıllarda yayınlanan makalelerden yola çıkılarak, kontrollü giriş anlaşmalarının tanımı ve sınıflandırılması yapılmıştır. Daha sonra güncel yayınlardan tespit edilen; kontrollü giriş anlaşmalarının çeşitli ülkelerde görülme sıklığı, türlerinin dağılımı, uygulandığı alanlar hakkında bilgi verilmektedir. Ayrıca kontrollü giriş anlaşmaları hakkında geniş bir deneyime sahip Amerika Birleşik Devletleri, Birleşik Krallık ve İtalya ile kontrollü giriş anlaşmaları politikalarına etkisi sebebiyle de Fransa’da kontrollü giriş anlaşmalarının gelişme süreci özellikle kamu uygulamaları ve düzenlemeleri göz önünde bulundurularak incelenmiştir. Son olarak kontrollü giriş anlaşmalarının avantajları ve dezavantajları tartışıldıktan sonra kontrollü giriş anlaşmalarının ne tür koşullar karşılandığında en verimli şekilde faydalanılabileceğine ilişkin sonuçlar çıkarılmıştır. Bu konuda yayınlaşmış çok fazla Türkçe çalışma olmadığı da göz önünde bulundurulduğunda, çalışmanın ülkemizde konu ile ilgili ortak bir terminoloji oluşturulmasına katkı sağlayacağı düşünülmektedir.

References

  • ABPI-the Association of the British Pharmaceutical Industry. (2014). Essential Medicines and Health Products Information Portal. (World Health Organization, Dü.) Ocak 20, 2019 tarihinde Understanding the 2014 Pharmaceutical Price Regulation Scheme: http://apps.who.int/medicinedocs/en/m/abstract/Js23395en/ adresinden alındı
  • Brügger, U. (2014). A review of Coverage with Evidence Development (CED) in different countries: What works and what doesn't. Manchester. Nisan 10, 2019 tarihinde https://htai.org/wp-content/uploads/2018/02/CED_Report_Bruegger_Final_Version.pdf adresinden alındı
  • Carbonneil, C. (2017). Correspondence:New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues. Value in Health, 20, s. 178-179. Nisan 08, 2019 tarihinde alındı
  • Carlson, J. J., Chen, S., & Garrison Jr., L. P. (2017, Temmuz 10). Performance-Based Risk-Sharing Arrangements: An Updated International Review. PharmacoEconomics, s. 1063-1072.
  • Carlson, J. J., Sullivana, S. D., Garrison, L. P., Neumann, P. J., & Veenstra, D. L. (2010). Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. Health Policy, 12-25.
  • Centers for Medicare & Medicaid. (2005, Temmuz 12). Fact Sheet: CMS Responds to Stakeholder Feedback Regarding Coverage with Evidence Development. Mart 04, 2019 tarihinde Coverage with Evidence Development: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Downloads/guidfactsheet.pdf adresinden alındı
  • Centers for Medicare & Medicaid Services. (2014, Kasım 20). Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development. Nisan 02, 2019 tarihinde Coverage with Evidence Development: https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27 adresinden alındı
  • Centers for Medicare & Medicaid Services. Coverage with Evidence Development. Şubat 22, 2019 tarihinde https://www.cms.gov/medicare/coverage/coverage-with-evidence-development/ adresinden alındı
  • CMS, Coverage and Analysis Group. (2006, Temmuz 12). National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development. Şubat 15, 2019 tarihinde National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development: https://www.cms.gov/medicare/coverage/determinationprocess/downloads/ced.pdf adresinden alındı
  • Department of Health. (2002, Şubat 04). Health Service Circular HSC2002/004. Ocak 05, 2019 tarihinde Cost effective Provision of Disease Modifying Therapies for people With Multiple Sclerosis: https://webarchive.nationalarchives.gov.uk/20120514191805/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4012214.pdf adresinden alındı
  • Drummond, M. (2015). When do performance-based risk-sharing arrangements make sense? Eur J Health Econ(16), 569–571.
  • Duke Margolis Center for Health Policy. (2017). Developing a Path to Value-Based Payment for medical Products. Background Paper, Washington DC. Aralık 18, 2018 tarihinde https://healthpolicy.duke.edu/sites/default/files/atoms/files/value_based_payment_background_paper_-_october_2017_final.pdf adresinden alındı
  • Garrison Jr., L. P., Towse, A., Briggs, A., de Pouvourville, G., Grueger, J., Mohr, P. E., . . . Sleeper, M. (2013). Performance-Based Risk Sharing Arrangements-Good Practices for design, Implementation, and Evaluation: Report of the ISPOR Good Practices for Performance-Based Risk-Sharing Arrangements Task Force. Value in Health(16), s. 703-719. ISPOR TASK FORCE REPORTS. adresinden alındı
  • Gonçalves, F. R., Santos, S., Silva, C., & Sousa, G. (2018). Risk-sharing agreements, present and future. ecancermedicalscience(12), 823.
  • Hutton, J., Trueman, P., & Henshall, C. (2007). Coverage with evidence development: an examination of conceptual and policy issues. Int J Technol Assess Health Care(23), 425–432.
  • Hutton, J., Trueman, P., & Henshall, C. (2007). Coverage with Evidence Development: An examination of conceptual and policy issues. International Journal of Technology Assessment in Health Care, s. 425–435.
  • Kanavos , P., Ferrario, A., Tafuri, G., & Siviero, P. (2017). Managing Risk and Uncertainty in Health Technology Introduction: The Role of Managed Entry Agreements. Global Policy, 8(2), 84-92.
  • Klemp, M., Frønsdal, K. B., & Facey, K. (2011). What principles should govern the use of managed entry agreements? International Journal of Technology Assessment in Health Care, 27(1), 77–83.
  • Le Service Public de la Diffusion du Droit. (2015, 2 16). Décret n° 2015-179 du 16 février 2015 fixant les procédures applicables au titre de la prise en charge prévue à l'article L. 165-1-1 du code de la sécurité sociale. DÉCRET n°2015-179 du 16 février 2015 : https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000030252103&categorieLien=id adresinden alındı
  • Martelli, N., van den Brink, H., & Borget, I. (2016). New French Coverage with Evidence Development for Innovative Medical DEvices: Improvements and Unresolved Issues. Value in Health, 19, s. 17-19. Nisan 08, 2019 tarihinde https://www.valueinhealthjournal.com/article/S1098-3015(15)05079-2/pdf adresinden alındı
  • Mohr, P. E., & Tunis, S. R. (2010). Access with Evidence Development The US Experience. Pharmacoeconomics. 28 (2), s. 153-162. Maryland: Center for Medical Technology Policy. Mart 26, 2019 tarihinde alındı
  • NICE. (2007, Ekim 23). Technology Appraisal Guidance. Şubat 05, 2019 tarihinde Bortezomib monotheraphy for relapsed multiple myeloma: https://www.nice.org.uk/guidance/ta129/resources/bortezomib-monotherapy-for-relapsed-multiple-myeloma-pdf-82598141743045 adresinden alındı
  • NICE. (2009a, Ekim). Guide to the Multiple Technology Appraisal. Mart 01, 2019 tarihinde Guide to the Multiple Technology Appraisal: https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/Guide-to-the-multiple-technology-appraisal-process.pdf adresinden alındı
  • NICE. (2009b, Ekim). Guideline to the Single Technology Appraisal Process. Mart 01, 2019 tarihinde Guideline to the Single Technology Appraisal Process: https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/Guide-to-the-single-technology-appraisal-process.pdf adresinden alındı
  • NICE. (2019, Aralık 6). Patient Access Schemes Liaison Unit. NICE: https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison-unit adresinden alındı
  • Patient Access Schemes Liaison Unit (PASLU). (2019, Ocak). Patient Access Scheme Proposal Template (Complex Scheme). Patient access schemes liaison unit. Londra, Birleşik Krallık. Şubat 01, 2019 tarihinde https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison-unit adresinden alındı
  • Piatkiewicz, T. J., Traulsen, J. M., & Holm-Larsen, T. (2018). Risk-Sharing Agreements in the EU: A Systematic Review of Major Trends. PharmacoEconomics(2), 109-123. doi:https://doi.org/10.1007/s41669-017-0044-1
  • Spoors, J. (2012, Temmuz 16). Patient Access Scheme in the New NHS. British Journal of Halthcare Management, Vol 8(No 8), 412-418.
  • Tunis, S. R., & Pearson, S. D. (2006, Eylül/Ekim). Coverage Options For Promising Technologies: Medicare's 'Coverage With Evidence Development'. 25, 5. doi:10.1377/hltaff.25.5.1218
  • Walker, S., Sculpher, M., Claxton, K., & Palmer, S. (2012). Coverage with Evidence Development, Only in Research, Risk Sharing, or Patient Access Scheme? A Framework for Coverage Decisions. V A L U E I N H E A L T H, 15, 5 7 0 – 5 7 9.
  • Wetering,, E., Exel, J., & Brouwer, W. (2017). The Challenge of Conditional Reimbursement: Stopping Reimbursement Can Be More Difficult Than Not Starting in the First Place! VALUE IN HEALTH(20), 118-125.
Year 2019, Issue: 16, 165 - 194, 21.01.2020
https://doi.org/10.21441/sosyalguvence.677288

Abstract

References

  • ABPI-the Association of the British Pharmaceutical Industry. (2014). Essential Medicines and Health Products Information Portal. (World Health Organization, Dü.) Ocak 20, 2019 tarihinde Understanding the 2014 Pharmaceutical Price Regulation Scheme: http://apps.who.int/medicinedocs/en/m/abstract/Js23395en/ adresinden alındı
  • Brügger, U. (2014). A review of Coverage with Evidence Development (CED) in different countries: What works and what doesn't. Manchester. Nisan 10, 2019 tarihinde https://htai.org/wp-content/uploads/2018/02/CED_Report_Bruegger_Final_Version.pdf adresinden alındı
  • Carbonneil, C. (2017). Correspondence:New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues. Value in Health, 20, s. 178-179. Nisan 08, 2019 tarihinde alındı
  • Carlson, J. J., Chen, S., & Garrison Jr., L. P. (2017, Temmuz 10). Performance-Based Risk-Sharing Arrangements: An Updated International Review. PharmacoEconomics, s. 1063-1072.
  • Carlson, J. J., Sullivana, S. D., Garrison, L. P., Neumann, P. J., & Veenstra, D. L. (2010). Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. Health Policy, 12-25.
  • Centers for Medicare & Medicaid. (2005, Temmuz 12). Fact Sheet: CMS Responds to Stakeholder Feedback Regarding Coverage with Evidence Development. Mart 04, 2019 tarihinde Coverage with Evidence Development: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Downloads/guidfactsheet.pdf adresinden alındı
  • Centers for Medicare & Medicaid Services. (2014, Kasım 20). Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development. Nisan 02, 2019 tarihinde Coverage with Evidence Development: https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=27 adresinden alındı
  • Centers for Medicare & Medicaid Services. Coverage with Evidence Development. Şubat 22, 2019 tarihinde https://www.cms.gov/medicare/coverage/coverage-with-evidence-development/ adresinden alındı
  • CMS, Coverage and Analysis Group. (2006, Temmuz 12). National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development. Şubat 15, 2019 tarihinde National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development: https://www.cms.gov/medicare/coverage/determinationprocess/downloads/ced.pdf adresinden alındı
  • Department of Health. (2002, Şubat 04). Health Service Circular HSC2002/004. Ocak 05, 2019 tarihinde Cost effective Provision of Disease Modifying Therapies for people With Multiple Sclerosis: https://webarchive.nationalarchives.gov.uk/20120514191805/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4012214.pdf adresinden alındı
  • Drummond, M. (2015). When do performance-based risk-sharing arrangements make sense? Eur J Health Econ(16), 569–571.
  • Duke Margolis Center for Health Policy. (2017). Developing a Path to Value-Based Payment for medical Products. Background Paper, Washington DC. Aralık 18, 2018 tarihinde https://healthpolicy.duke.edu/sites/default/files/atoms/files/value_based_payment_background_paper_-_october_2017_final.pdf adresinden alındı
  • Garrison Jr., L. P., Towse, A., Briggs, A., de Pouvourville, G., Grueger, J., Mohr, P. E., . . . Sleeper, M. (2013). Performance-Based Risk Sharing Arrangements-Good Practices for design, Implementation, and Evaluation: Report of the ISPOR Good Practices for Performance-Based Risk-Sharing Arrangements Task Force. Value in Health(16), s. 703-719. ISPOR TASK FORCE REPORTS. adresinden alındı
  • Gonçalves, F. R., Santos, S., Silva, C., & Sousa, G. (2018). Risk-sharing agreements, present and future. ecancermedicalscience(12), 823.
  • Hutton, J., Trueman, P., & Henshall, C. (2007). Coverage with evidence development: an examination of conceptual and policy issues. Int J Technol Assess Health Care(23), 425–432.
  • Hutton, J., Trueman, P., & Henshall, C. (2007). Coverage with Evidence Development: An examination of conceptual and policy issues. International Journal of Technology Assessment in Health Care, s. 425–435.
  • Kanavos , P., Ferrario, A., Tafuri, G., & Siviero, P. (2017). Managing Risk and Uncertainty in Health Technology Introduction: The Role of Managed Entry Agreements. Global Policy, 8(2), 84-92.
  • Klemp, M., Frønsdal, K. B., & Facey, K. (2011). What principles should govern the use of managed entry agreements? International Journal of Technology Assessment in Health Care, 27(1), 77–83.
  • Le Service Public de la Diffusion du Droit. (2015, 2 16). Décret n° 2015-179 du 16 février 2015 fixant les procédures applicables au titre de la prise en charge prévue à l'article L. 165-1-1 du code de la sécurité sociale. DÉCRET n°2015-179 du 16 février 2015 : https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000030252103&categorieLien=id adresinden alındı
  • Martelli, N., van den Brink, H., & Borget, I. (2016). New French Coverage with Evidence Development for Innovative Medical DEvices: Improvements and Unresolved Issues. Value in Health, 19, s. 17-19. Nisan 08, 2019 tarihinde https://www.valueinhealthjournal.com/article/S1098-3015(15)05079-2/pdf adresinden alındı
  • Mohr, P. E., & Tunis, S. R. (2010). Access with Evidence Development The US Experience. Pharmacoeconomics. 28 (2), s. 153-162. Maryland: Center for Medical Technology Policy. Mart 26, 2019 tarihinde alındı
  • NICE. (2007, Ekim 23). Technology Appraisal Guidance. Şubat 05, 2019 tarihinde Bortezomib monotheraphy for relapsed multiple myeloma: https://www.nice.org.uk/guidance/ta129/resources/bortezomib-monotherapy-for-relapsed-multiple-myeloma-pdf-82598141743045 adresinden alındı
  • NICE. (2009a, Ekim). Guide to the Multiple Technology Appraisal. Mart 01, 2019 tarihinde Guide to the Multiple Technology Appraisal: https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/Guide-to-the-multiple-technology-appraisal-process.pdf adresinden alındı
  • NICE. (2009b, Ekim). Guideline to the Single Technology Appraisal Process. Mart 01, 2019 tarihinde Guideline to the Single Technology Appraisal Process: https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/Guide-to-the-single-technology-appraisal-process.pdf adresinden alındı
  • NICE. (2019, Aralık 6). Patient Access Schemes Liaison Unit. NICE: https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison-unit adresinden alındı
  • Patient Access Schemes Liaison Unit (PASLU). (2019, Ocak). Patient Access Scheme Proposal Template (Complex Scheme). Patient access schemes liaison unit. Londra, Birleşik Krallık. Şubat 01, 2019 tarihinde https://www.nice.org.uk/about/what-we-do/patient-access-schemes-liaison-unit adresinden alındı
  • Piatkiewicz, T. J., Traulsen, J. M., & Holm-Larsen, T. (2018). Risk-Sharing Agreements in the EU: A Systematic Review of Major Trends. PharmacoEconomics(2), 109-123. doi:https://doi.org/10.1007/s41669-017-0044-1
  • Spoors, J. (2012, Temmuz 16). Patient Access Scheme in the New NHS. British Journal of Halthcare Management, Vol 8(No 8), 412-418.
  • Tunis, S. R., & Pearson, S. D. (2006, Eylül/Ekim). Coverage Options For Promising Technologies: Medicare's 'Coverage With Evidence Development'. 25, 5. doi:10.1377/hltaff.25.5.1218
  • Walker, S., Sculpher, M., Claxton, K., & Palmer, S. (2012). Coverage with Evidence Development, Only in Research, Risk Sharing, or Patient Access Scheme? A Framework for Coverage Decisions. V A L U E I N H E A L T H, 15, 5 7 0 – 5 7 9.
  • Wetering,, E., Exel, J., & Brouwer, W. (2017). The Challenge of Conditional Reimbursement: Stopping Reimbursement Can Be More Difficult Than Not Starting in the First Place! VALUE IN HEALTH(20), 118-125.
There are 31 citations in total.

Details

Primary Language Turkish
Subjects Health Policy
Journal Section Makaleler
Authors

Tuğba Yıldız This is me 0000-0001-6510-6509

Aygen Bayazıt Uzun This is me 0000-0002-8320-3801

Publication Date January 21, 2020
Published in Issue Year 2019 Issue: 16

Cite

APA Yıldız, T., & Bayazıt Uzun, A. (2020). ALTERNATİF BİR GERİ ÖDEME MODELİ OLARAK KONTROLLÜ GİRİŞ ANLAŞMALARI. Sosyal Güvence(16), 165-194. https://doi.org/10.21441/sosyalguvence.677288