Araştırma Makalesi
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İLAÇ ERİŞİMİNDE ÖNCELİKLENDİRME VE KISITLAMA KARARLARINA İLİŞKİN TÜRKİYE ÖRNEĞİ: İKİ YENİLİKÇİ İLACA DAYALI DEĞERLENDİRME

Yıl 2024, Cilt: 48 Sayı: 3, 1135 - 1141, 10.09.2024
https://doi.org/10.33483/jfpau.1525060

Öz

Amaç: İlaca erişimde ilaç ruhsatlandırması, fiyatlandırması ve geri ödenmesi kritik öneme sahiptir. Bu çalışmadaki amaç; Amerika Birleşik Devletleri, Avrupa Birliği ve Türkiye arasında seçilmiş yenilikçi ürünlerin geri ödeme koşullarını karşılaştırmak ve Türkiye’nin son yıllardaki ruhsat ve geri ödeme kararlarını değerlendirmektir.
Gereç ve Yöntem: Bu çalışmada onkoloji ve hiperlipidemi tedavileri çalışma alanı olarak belirlendi. Onkoloji alanında birden fazla endikasyonu olan Nivolumab ve hiperlipidemi alanında kullanılan Evolokumab çalışma ilaçları olarak seçildi. Seçilen ilaçların onaylı endikasyonları ve endikasyon onay tarihleri web tabanlı taranan FDA, EMA ve TİTCK resmi internet sitelerinden elde edildi
Sonuç ve Tartışma: Nivolumabın FDA tarafından 11, EMA tarafından 10 endikasyonu onaylıyken, Türkiye'de 8 endikasyonu onaylıdır. Evolokumabın FDA tarafından 3, EMA tarafından 3 endikasyonu onaylıyken, Türkiye'de 2 endikasyonu onaylıdır. Nivolumabın, Türkiye’de ruhsat alması, ortalama FDA’den 24.0 ve EMA’dan 20.4 ay sonra gerçekleşmiştir. Bu ilacın endikasyonlarının Türkiye'de geri ödenmesi de sırasıyla 27.6 ve 25.2 ay sonra gerçekleşmiştir. Evolokumab'ın Türkiye'deki endikasyonları FDA ve EMA'dan sırasıyla 10 ay ve 13.2 ay sonra onaylanmıştır. Evolokumab'ın Türkiye'de geri ödenen tek endikasyonu, FDA ve EMA tarafından onaylandıktan sonra sırasıyla 72.0 ve 74.4 ay sonra ödemeye girmiştir.
Çalışmamızda incelenen ilaçlar üzerinden bütçe beklentisi yüksek olan ilaçlara yapılan kısıtlamalarla belirli hasta gruplarına öncelik verilmiş olduğu ve bu önceliklendirme kararları ile hastaların tedaviye erişimi sağlanmaya çalışıldığı görülmektedir.

Kaynakça

  • 1. Gonçalves, F.R, Santos S., Silva C., Sousa G. (2018). Risk-sharing agreements, present and future. Ecancermedicalscience, 10, 12, 823. [CrossRef]
  • 2. Piatkiewicz, T.J, Traulsen, J.M., Holm-Larsen T. (2018). Risk-sharing agreements in the EU: A systematic review of major trends. PharmacoEconomics-Open, 2(2), 109-123. [CrossRef]
  • 3. Pauwels, K., Huys, I., Casteels, M., De Nys, K., Simoens, S. (2014). Market access of cancer drugs in European countries: Improving resource allocation. Targeted Oncology, 9(2), 95-110. [CrossRef]
  • 4. Noorani, H.Z., Husereau, D.R., Boudreau, R., Skidmore, B. (2007). Priority setting for health technology assessments: A systematic review of current practical approaches. International Journal of Technology Assessment in Health Care, 23(3), 310-315. [CrossRef]
  • 5. Oral, M., Özçelikay, G. Ethical Overview of Pharmaceutical Industry Policies in Türkiye from Various Perspectives. (2017) Turkish Journal of Pharmaceutical Sciences, 14(3), 264-273. [CrossRef]
  • 6. Beşerî Tıbbi Ürünlerin Fiyatlandırılması Hakkında Tebliğ. Türkiye Cumhuriyeti Mevzuatı. Türkiye Cumhuriyeti Resmî Gazete 11.12.2015; 29559.
  • 7. Gürsoy K. (2015) An overview of Turkish healthcare system after health transformation program: Main successes, performance assessment, further challenges, and policy options. Sosyal Güvence Dergisi, 7, 83-112. [CrossRef]
  • 8. Sosyal Güvenlik Kurumu Sağlık Uygulama Tebliği 2013, 24/03/2013 tarihli ve 28597 sayılı Resmî Gazete.
  • 9. Sosyal Güvenlik Kurumu Genel Sağlık Sigortası Alternatif Geri Ödeme Yönetmeliği. Türkiye Cumhuriyeti mevzuatı. Türkiye Cumhuriyeti Resmî Gazete 10.02.2016; 29620.
  • 10. Vanderpuye-Orgle, J., Erim, D., Qian, Y., Boyne, D.J., Cheung, W.Y., Bebb, G., Shah, A., Pericleous, L., Maruszczak, M., Brenner, D.R. (2022). Estimating the impact of delayed access to oncology drugs on patient outcomes in Canada. Oncology and Therapy, 10(1), 195-210. [CrossRef]
  • 11. Kim, H., Liew, D., Goodall, S. (2020). Cost-effectiveness and financial risks associated with immune checkpoint inhibitor therapy. British Journal of Clinical Pharmacology, 86(9), 1703-1710. [CrossRef]
  • 12. Opdivo® Kısa Ürün Bilgisi web site. Retrieved from https://titck.gov.tr/storage/Archive/2022/kubKtAttachments/TTCKOnaylKBOPDIVO40MG_d3b2004d-15f5-4052-a983-9c83bf3f0ce2.pdf. Accessed date: 15.03.2024.
  • 13. Repatha ®, Kısa Ürün Bilgisi. Retrieved from https://titck.gov.tr/storage/kubKtAttachments/FhEGXmOrwNoUV.pdf. Accessed date: 16.03.2024.
  • 14. Brunetti, N.D., De Gennaro, L., Tricarico, L., Caldarola, P. (2019). Budget impact analysis of PCSK9 inhibitors costs from a community payers' perspective in Apulia, Italy. Open heart, 6(2), e001018. [CrossRef]
  • 15. IQVIA web site (2021). Retrieved from https://www.iqvia.com/newsroom/2021/12/global-medicine-spending-to-reach-18-trillion-in-2026-including-spending-on-covid-19-vaccines-accord. Accessed date: 10.03.2024.
  • 16. Opdivo® Summary of Product Characteristics web site. Retrieved from https://ec.europa.eu/health/documents/community-register/2015/20150619132099/anx_132099_en.pdf. Accessed date: 15.03.2024.
  • 17. Repatha ® Summary of Product Characteristics. Retrieved from https://ec.europa.eu/health/documents/community-register/2015/20150717132330/anx_132330_en.pdf. Accessed date: 16.03.2024.
  • 18. FDA web site. Retrieved from Drugs@FDA: FDA-Approved Drugs https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554 Accessed date: 17.03.2024.
  • 19. EMA web site. Retrieved from Opdivo Overview https://www.ema.europa.eu/en/medicines/human/EPAR/opdivo#overview Accessed date: 17.03.2024.
  • 20. EMA web site. Retrieved from Opdivo Procedural steps taken and scientific information after the authorisation opdivo-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf (europa.eu). Accessed date: 18.03.2024.
  • 21. EMA web site. Accessed address: Repatha Overview, https://www.ema.europa.eu/en/medicines/human/EPAR/repatha#product-details. Accessed date: 18.03.2024.
  • 22. Repatha FDA approval history. Retrieved from https://www.drugs.com/history/repatha.html. Accessed date: 17.03.2024.
  • 23. Titck - Türkiye İlaç ve Tıbbi Cihaz Kurumu Küb/Kt listesi web site. Retrieved from https://titck.gov.tr/kubkt. Accessed date: 16.03.024.
  • 24. Sağlık Uygulama Tebliği. Retrieved from https://www.sgk.gov.tr/Download/DownloadFile?f=59b7ba1a-3d67-41d3-81ef-79558b72cf22.zip&d=d8fb2272-85b7-40e4-868e-10927caba080. Accessed date: 18.05.2024.
  • 25. Seixas, B.V., Dionne, F., Mitton, C. (2021). Practices of decision making in priority setting and resource allocation: A scoping review and narrative synthesis of existing frameworks. Health Economics Review, 11(1), 2. [CrossRef]
  • 26. Husereau, D., Boucher, M., Noorani, H. (2010). Priority setting for health technology assessment at CADTH. International Journal of Technology Assessment in Health Care, 26(3), 341-347. [CrossRef]
  • 27. Beşeri İlaçların Fiyatlandırılmasına Dair Karar. Türkiye Cumhuriyeti mevzuatı. Türkiye Cumhuriyeti Resmî Gazete 14.02.2004, 25373.
  • 28. Remuzat, C., Urbinati, D., Mzoughi, O., El Hammi, E., Belgaied, W., and Toumi, M. (2015). Overview of external reference pricing systems in Europe. Journal of Market Access & Health Policy, 3, 27675. [CrossRef]
  • 29. Voehler, D., Koethe, B.C., Synnott, P.G., Ollendorf, D.A. (2023). The impact of external reference pricing on pharmaceutical costs and market dynamics. Health Policy Open, 4, 100093. [CrossRef]
  • 30. Barrios, C., de Lima Lopes, G., Yusof, M.M., Rubagumya, F., Rutkowski, P., and Sengar, M. (2023). Barriers in access to oncology drugs-A global crisis. Nature Reviews Clinical Oncology, 20(1), 7-15. [CrossRef]
  • 31. Vural E.H., Kaskati T., Vural I.M., Özalp M.A., Gümüşel B. (2024). Are Turkish pharmaceutical pricing strategies an access barrier to oncology medicines for Türkiye? Frontiers in Pharmacology, 15, 1364341. [CrossRef]
  • 32. Atikeler, E.K., Leufkens, H.G.M.B., Goettsch, W. (2020). Access to medicines in Türkiye: Evaluation of the process of medicines brought from abroad. International Journal of Technology Assessment in Health Care, 36(6), 585-591. [CrossRef]

TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS

Yıl 2024, Cilt: 48 Sayı: 3, 1135 - 1141, 10.09.2024
https://doi.org/10.33483/jfpau.1525060

Öz

Objective: Drug licensing, price, and reimbursement are essential for medical access. This study examines US, EU, and Turkish reimbursement for innovative medicines and evaluates Türkiye's recent licensing and reimbursement decisions.
Material and Method: Nivolumab, an anticancer medicine, and Evolocumab, a hyperlipidemia treatment, were studied. Web-based searches of FDA, EMA, and TİTCK offical websites revealed authorized indications and approval dates for chosen medications.
Result and Discussion: Nivolumab has been authorized for 11 indications by the FDA and 10 by the EMA, although it is only approved for 8 in Türkiye. Evolocumab has been authorized for three indications by the FDA, three by the EMA, and two in Türkiye. Nivolumab was approved in Türkiye an average of 24.0 months after the FDA and 20.4 months after the EMA. In Türkiye, the indications for this medicine were reimbursed 27.6 and 25.2 months later, respectively. The FDA and EMA authorized the indications for evolocumab in Türkiye 10 months and 13.2 months later, respectively. The FDA and EMA authorized evolocumab's single reimbursement indication in Türkiye after 72.0 and 74.4 months, respectively. Our investigation found that some patient groups were given priority by limiting pharmaceuticals with high budget expectations, and these prioritizing decisions were made to secure patients' access to therapy.

Etik Beyan

The authors declare that the ethics committee approval is not required for this study.

Kaynakça

  • 1. Gonçalves, F.R, Santos S., Silva C., Sousa G. (2018). Risk-sharing agreements, present and future. Ecancermedicalscience, 10, 12, 823. [CrossRef]
  • 2. Piatkiewicz, T.J, Traulsen, J.M., Holm-Larsen T. (2018). Risk-sharing agreements in the EU: A systematic review of major trends. PharmacoEconomics-Open, 2(2), 109-123. [CrossRef]
  • 3. Pauwels, K., Huys, I., Casteels, M., De Nys, K., Simoens, S. (2014). Market access of cancer drugs in European countries: Improving resource allocation. Targeted Oncology, 9(2), 95-110. [CrossRef]
  • 4. Noorani, H.Z., Husereau, D.R., Boudreau, R., Skidmore, B. (2007). Priority setting for health technology assessments: A systematic review of current practical approaches. International Journal of Technology Assessment in Health Care, 23(3), 310-315. [CrossRef]
  • 5. Oral, M., Özçelikay, G. Ethical Overview of Pharmaceutical Industry Policies in Türkiye from Various Perspectives. (2017) Turkish Journal of Pharmaceutical Sciences, 14(3), 264-273. [CrossRef]
  • 6. Beşerî Tıbbi Ürünlerin Fiyatlandırılması Hakkında Tebliğ. Türkiye Cumhuriyeti Mevzuatı. Türkiye Cumhuriyeti Resmî Gazete 11.12.2015; 29559.
  • 7. Gürsoy K. (2015) An overview of Turkish healthcare system after health transformation program: Main successes, performance assessment, further challenges, and policy options. Sosyal Güvence Dergisi, 7, 83-112. [CrossRef]
  • 8. Sosyal Güvenlik Kurumu Sağlık Uygulama Tebliği 2013, 24/03/2013 tarihli ve 28597 sayılı Resmî Gazete.
  • 9. Sosyal Güvenlik Kurumu Genel Sağlık Sigortası Alternatif Geri Ödeme Yönetmeliği. Türkiye Cumhuriyeti mevzuatı. Türkiye Cumhuriyeti Resmî Gazete 10.02.2016; 29620.
  • 10. Vanderpuye-Orgle, J., Erim, D., Qian, Y., Boyne, D.J., Cheung, W.Y., Bebb, G., Shah, A., Pericleous, L., Maruszczak, M., Brenner, D.R. (2022). Estimating the impact of delayed access to oncology drugs on patient outcomes in Canada. Oncology and Therapy, 10(1), 195-210. [CrossRef]
  • 11. Kim, H., Liew, D., Goodall, S. (2020). Cost-effectiveness and financial risks associated with immune checkpoint inhibitor therapy. British Journal of Clinical Pharmacology, 86(9), 1703-1710. [CrossRef]
  • 12. Opdivo® Kısa Ürün Bilgisi web site. Retrieved from https://titck.gov.tr/storage/Archive/2022/kubKtAttachments/TTCKOnaylKBOPDIVO40MG_d3b2004d-15f5-4052-a983-9c83bf3f0ce2.pdf. Accessed date: 15.03.2024.
  • 13. Repatha ®, Kısa Ürün Bilgisi. Retrieved from https://titck.gov.tr/storage/kubKtAttachments/FhEGXmOrwNoUV.pdf. Accessed date: 16.03.2024.
  • 14. Brunetti, N.D., De Gennaro, L., Tricarico, L., Caldarola, P. (2019). Budget impact analysis of PCSK9 inhibitors costs from a community payers' perspective in Apulia, Italy. Open heart, 6(2), e001018. [CrossRef]
  • 15. IQVIA web site (2021). Retrieved from https://www.iqvia.com/newsroom/2021/12/global-medicine-spending-to-reach-18-trillion-in-2026-including-spending-on-covid-19-vaccines-accord. Accessed date: 10.03.2024.
  • 16. Opdivo® Summary of Product Characteristics web site. Retrieved from https://ec.europa.eu/health/documents/community-register/2015/20150619132099/anx_132099_en.pdf. Accessed date: 15.03.2024.
  • 17. Repatha ® Summary of Product Characteristics. Retrieved from https://ec.europa.eu/health/documents/community-register/2015/20150717132330/anx_132330_en.pdf. Accessed date: 16.03.2024.
  • 18. FDA web site. Retrieved from Drugs@FDA: FDA-Approved Drugs https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125554 Accessed date: 17.03.2024.
  • 19. EMA web site. Retrieved from Opdivo Overview https://www.ema.europa.eu/en/medicines/human/EPAR/opdivo#overview Accessed date: 17.03.2024.
  • 20. EMA web site. Retrieved from Opdivo Procedural steps taken and scientific information after the authorisation opdivo-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf (europa.eu). Accessed date: 18.03.2024.
  • 21. EMA web site. Accessed address: Repatha Overview, https://www.ema.europa.eu/en/medicines/human/EPAR/repatha#product-details. Accessed date: 18.03.2024.
  • 22. Repatha FDA approval history. Retrieved from https://www.drugs.com/history/repatha.html. Accessed date: 17.03.2024.
  • 23. Titck - Türkiye İlaç ve Tıbbi Cihaz Kurumu Küb/Kt listesi web site. Retrieved from https://titck.gov.tr/kubkt. Accessed date: 16.03.024.
  • 24. Sağlık Uygulama Tebliği. Retrieved from https://www.sgk.gov.tr/Download/DownloadFile?f=59b7ba1a-3d67-41d3-81ef-79558b72cf22.zip&d=d8fb2272-85b7-40e4-868e-10927caba080. Accessed date: 18.05.2024.
  • 25. Seixas, B.V., Dionne, F., Mitton, C. (2021). Practices of decision making in priority setting and resource allocation: A scoping review and narrative synthesis of existing frameworks. Health Economics Review, 11(1), 2. [CrossRef]
  • 26. Husereau, D., Boucher, M., Noorani, H. (2010). Priority setting for health technology assessment at CADTH. International Journal of Technology Assessment in Health Care, 26(3), 341-347. [CrossRef]
  • 27. Beşeri İlaçların Fiyatlandırılmasına Dair Karar. Türkiye Cumhuriyeti mevzuatı. Türkiye Cumhuriyeti Resmî Gazete 14.02.2004, 25373.
  • 28. Remuzat, C., Urbinati, D., Mzoughi, O., El Hammi, E., Belgaied, W., and Toumi, M. (2015). Overview of external reference pricing systems in Europe. Journal of Market Access & Health Policy, 3, 27675. [CrossRef]
  • 29. Voehler, D., Koethe, B.C., Synnott, P.G., Ollendorf, D.A. (2023). The impact of external reference pricing on pharmaceutical costs and market dynamics. Health Policy Open, 4, 100093. [CrossRef]
  • 30. Barrios, C., de Lima Lopes, G., Yusof, M.M., Rubagumya, F., Rutkowski, P., and Sengar, M. (2023). Barriers in access to oncology drugs-A global crisis. Nature Reviews Clinical Oncology, 20(1), 7-15. [CrossRef]
  • 31. Vural E.H., Kaskati T., Vural I.M., Özalp M.A., Gümüşel B. (2024). Are Turkish pharmaceutical pricing strategies an access barrier to oncology medicines for Türkiye? Frontiers in Pharmacology, 15, 1364341. [CrossRef]
  • 32. Atikeler, E.K., Leufkens, H.G.M.B., Goettsch, W. (2020). Access to medicines in Türkiye: Evaluation of the process of medicines brought from abroad. International Journal of Technology Assessment in Health Care, 36(6), 585-591. [CrossRef]
Toplam 32 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Tıbbi Farmakoloji
Bölüm Araştırma Makalesi
Yazarlar

Elif Hilal Vural 0000-0003-1309-6606

Ensar Korkut Kılıc 0009-0000-5292-1686

Enver Kağan Atikeler Bu kişi benim 0000-0002-8655-4877

Bülent Gümüşel Bu kişi benim 0000-0002-7533-7949

Erken Görünüm Tarihi 17 Ağustos 2024
Yayımlanma Tarihi 10 Eylül 2024
Gönderilme Tarihi 30 Temmuz 2024
Kabul Tarihi 11 Ağustos 2024
Yayımlandığı Sayı Yıl 2024 Cilt: 48 Sayı: 3

Kaynak Göster

APA Vural, E. H., Kılıc, E. K., Atikeler, E. K., Gümüşel, B. (2024). TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS. Journal of Faculty of Pharmacy of Ankara University, 48(3), 1135-1141. https://doi.org/10.33483/jfpau.1525060
AMA Vural EH, Kılıc EK, Atikeler EK, Gümüşel B. TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS. Ankara Ecz. Fak. Derg. Eylül 2024;48(3):1135-1141. doi:10.33483/jfpau.1525060
Chicago Vural, Elif Hilal, Ensar Korkut Kılıc, Enver Kağan Atikeler, ve Bülent Gümüşel. “TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS”. Journal of Faculty of Pharmacy of Ankara University 48, sy. 3 (Eylül 2024): 1135-41. https://doi.org/10.33483/jfpau.1525060.
EndNote Vural EH, Kılıc EK, Atikeler EK, Gümüşel B (01 Eylül 2024) TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS. Journal of Faculty of Pharmacy of Ankara University 48 3 1135–1141.
IEEE E. H. Vural, E. K. Kılıc, E. K. Atikeler, ve B. Gümüşel, “TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS”, Ankara Ecz. Fak. Derg., c. 48, sy. 3, ss. 1135–1141, 2024, doi: 10.33483/jfpau.1525060.
ISNAD Vural, Elif Hilal vd. “TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS”. Journal of Faculty of Pharmacy of Ankara University 48/3 (Eylül 2024), 1135-1141. https://doi.org/10.33483/jfpau.1525060.
JAMA Vural EH, Kılıc EK, Atikeler EK, Gümüşel B. TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS. Ankara Ecz. Fak. Derg. 2024;48:1135–1141.
MLA Vural, Elif Hilal vd. “TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS”. Journal of Faculty of Pharmacy of Ankara University, c. 48, sy. 3, 2024, ss. 1135-41, doi:10.33483/jfpau.1525060.
Vancouver Vural EH, Kılıc EK, Atikeler EK, Gümüşel B. TURKISH EXAMPLE OF PRIORITIZATION AND RESTRICTION DECISIONS IN MEDICINE ACCESS: EVALUATION BASED ON TWO INNOVATIVE DRUGS. Ankara Ecz. Fak. Derg. 2024;48(3):1135-41.

Kapsam ve Amaç

Ankara Üniversitesi Eczacılık Fakültesi Dergisi, açık erişim, hakemli bir dergi olup Türkçe veya İngilizce olarak farmasötik bilimler alanındaki önemli gelişmeleri içeren orijinal araştırmalar, derlemeler ve kısa bildiriler için uluslararası bir yayım ortamıdır. Bilimsel toplantılarda sunulan bildiriler supleman özel sayısı olarak dergide yayımlanabilir. Ayrıca, tüm farmasötik alandaki gelecek ve önceki ulusal ve uluslararası bilimsel toplantılar ile sosyal aktiviteleri içerir.