Ana Sayfa İlaç Amerika Birleşik Devletleri ve Diğer Seçilmiş Ülkelerde Yeni Onkoloji İlaçlarının Onay ve...

Amerika Birleşik Devletleri ve Diğer Seçilmiş Ülkelerde Yeni Onkoloji İlaçlarının Onay ve Kapsama Kararlarının Karşılaştırılması

ARKA PLAN: Antikanser ilaçları için küresel ilaç satışları 74.4 $ (2014),
terapötik sınıfa göre tutar bazlı ilk sıradaki ilaç grubudur (ülkeye göre farklılık olabilir)

AMAÇ: Yeni antikanser ilaçları için onay ve kapsama kararlarını karşılaştırmak;
Amerika Birleşik Devletleri ve AB, İngiltere, Avustralya ve Kanada.

YÖNTEMLER: Onaylanan tüm yeni antikanser ilaç endikasyonlarını belirledik
(FDA tarafından 1 Ocak 2009 ve 31 Aralık 2013 arasında).
Her bir için ülke, organizasyonları, süreçleri, kriterleri ve özel değerlendirmeleri gözden geçirdik; ilaç için onay ve kapsama kararları vermek için kullanılan faktörler
göstergeler onaylandı.

SONUÇLAR: Onay ve geri ödeme kararları önemli ölçüde ülkeye göre değişmektedir;
Amerika’nın en az erişim kısıtlaması vardı.
Avustralya, incelenen 5 ülkenin en kısıtlayıcı olanıydı.

TABLE 1 List of New Oncology Drugs Approved by the FDA, January 1, 2009-December 31, 2013

Brand Name Active Ingredient Indication Route of Administration Approval Dates Coverage
FDA EMA Canada Australia United Kingdom France Canada Australia
Abraxane Paclitaxel protein-bound particles Non-small cell lung cancer Injectable October 2012 Not Approved Not Approved Not Approved NA NA NA NA
Adcetris Brentuximab vedotin Hodgkin lymphoma and anaplastic large cell lymphoma Injectable August 2011 October 2012 February 2013 December 2013 Yes Yes Yes No
Afinitor Everolimus Renal cell carcinoma Oral March 2009 August 2009 Not Approved August 2009 Yes Yes NA Yes
Afinitor Everolimus Advanced pancreatic neuroendocrine tumors Oral May 2011 September 2011 August 2011 July 2012 Yes Yes Yes Yes
Afinitor Everolimus Hormone receptor-positive, HER2-negative breast cancer Oral July 2012 July 2012 January 2013 February 2013 Yes Yes Yes Yes
Arzerra Ofatumumab Chronic lymphocytic leukemia Injectable October 2009 April 2010 August 2012 Not Approved Yes No No NA
Avastin Bevacizumab Renal cell carcinoma Injectable July 2009 January 2008 Not Approved Not Approved Yes No NA NA
Bosulif Bosutinib Ph+ chronic myelogenous leukemia Oral September 2012 March 2013 Not Approved Not Approved Ye s Ye s NA NA
Cometriq Cabozantinib Metastatic medullary thyroid cancer Oral November 2012 Not Approved Not Approved Not Approved NA NA NA NA
Erivedge Vismodegib Basal cell carcinoma Oral January 2012 July 2013 August 2013 May 2013 Ye s Ye s Ye s No
Erwinaze Asparaginase Erwinia chrysanthemi Acute lymphoblastic leukemia Injectable November 2011 Not Approved Not Approved Not Approved NA NA NA NA
Folotyn Pralatrexate Peripheral T-cell lymphoma Injectable September 2009 Not Approved Not Approved Not Approved NA NA NA NA
Gazyva Obinutuzumab Previously untreated chronic lymphocytic leukemia Injectable October 2013 Not Approved Not Approved Not Approved NA NA NA NA
Gilotrif Afatinib Metastatic non-small cell lung cancer with EGFR mutations Oral July 2013 September 2013 Not Approved November 2013 No Ye s NA No
Halaven Eribulin mesylate Metastatic breast cancer Injectable November 2010 March 2011 March 2012 August 2012 Ye s Ye s Ye s No
He re eptin Trastuzumab Gastric cancer Injectable October 2010 January 2010 August 2010 September 2010 Yes Yes No Yes
Iclusig Ponatinib Chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia Oral December 2012 July 2013 Not Approved Not Approved Yes No NA NA
Imbruvica Ibrutinib Mantle cell lymphoma Oral November 2013 Not Approved Not Approved Not Approved NA NA NA NA
Inlyta Axitinib Advanced renal cell carcinoma Oral January 2012 September 2012 August 2012 July 2012 Yes Yes Yes No
Istodax Romidepsin Cutaneous T-cell lymphoma Injectable November 2009 Not Approved Not Approved August 2013 NA NA NA No
Jevtana Cabazitaxel Prostate cancer Injectable June 2010 March 2011 August 2011 December 2011 Yes Yes No Yes
Kadcyla Ado-trastuzumab HER2-positive metastatic breast cancer Injectable February 2013 November 2013 October 2013 September 2013 No Yes Yes No
Kyprolis Carfilzomib Multiple myeloma Injectable July 2012 Not Approved Not Approved Not Approved NA NA NA NA
Marchqibo Vincristine Ph-acute lymphoblastic leukemia Injectable August 2012 Not Approved Not Approved Not Approved NA NA NA NA
Mekinist Trametinib Unresectable or metastatic melanoma with BRAF V600E or V600K mutations Oral May 2013 Not Approved August 2013 Not Approved NA NA No NA
Perjeta Pertuzumab HER2+ metastatic breast cancer Injectable June 2012 March 2013 May 2013 May 2013 Ye s Ye s Ye s No
Pomalyst Pomalidomide Relapsed and refractory multiple myeloma Oral February 2013 August 2013 Not Approved Not Approved Ye s No NA NA
Provenge Sipuleucel-T Hormone refractory prostate cancer Injectable May 2010 September 2013 Not Approved Not Approved No No NA NA
Revlimid Lenalidomide Mantle cell lymphoma Oral June 2013 Not Approved Not Approved Not Approved NA NA NA NA
Stivarga Regorafenib Metastatic colorectal cancer Oral September 2012 September 2013 April 2013 November 2013 Ye s No No No
Stivarga Regorafenib Gastrointestinal stromal tumor Oral February 2013 Not Approved April 2013 Not Approved NA NA No NA
Sutent Sunitinib Pancreatic neuroendocrine tumors Oral May 2011 December 2010 Not Approved March 2011 Ye s Ye s NA Yes
Sylatron Peginterferon alfa-2b Melanoma Injectable April 2011 Not Approved Not Approved Not Approved NA NA NA NA
Synribo Omacetaxine Chronic or accelerated phase chronic myeloid leukemia Injectable October 2012 Not Approved Not Approved Not Approved NA NA NA NA
Tafinlar Dabrafenib Unresectable or metastatic melanoma with BRAF V600E mutation Oral May 2013 September 2013 August 2013 August 2013 No No No Yes
Vandetanib Vandetanib Thyroid cancer Oral April 2011 February 2012 February 2012 January 2013 Ye s Ye s No No
Votrient Pazopanib Renal cell carcinoma Oral October 2009 June 2010 August 2010 June 2010 Yes No Yes Yes
Votrient Pazopanib Soft tissue sarcoma Oral April 2012 August 2012 August 2010 May 2011 Ye s No No Yes
Xalkori Crizotinib ALK+ non-small cell lung cancer Oral August 2011 October 2012 May 2012 September 2013 Ye s Ye s No No
Xgeva Denosumab Giant cell tumor of bone Injectable June 2013 Not Approved June 2011 Not Approved NA NA No NA
Xtandi Enzalutamide Metastatic castration-resistant prostate cancer Oral August 2012 June 2013 June 2013 Not Approved Yes No Yes NA
Yervoy Ipilimumab Metastatic melanoma Injectable March 2011 July 2011 March 2012 June 2011 Yes No Yes Yes
Zaltrap Ziv-aflibercept Metastatic colorectal cancer Injectable August 2012 February 2013 Not Approved April 2013 Yes Yes NA No
Zelboraf Vemurafenib BRAFm+ melanoma Oral August 2011 February 2012 March 2012 May 2012 Yes Yes Yes No
Zytiga Abiraterone Prostate cancer Oral May 2011 September 2011 July 2011 March 2012 Yes Yes Yes Yes

Sources: The FDA and CenterWatch websites were used to identify drugs approved by the FDA for the treatment of any cancer between the dates shown above (http://www.fda.gov/http://www.centerwatch.com/).

Notes: The date December 31, 2013, was used as the end point for approval decisions, and June 30, 2014, was used as the end point for coverage decisions in non-U.S. countries. NA denotes not applicable because these drugs were not approved in other countries, so they were not covered.

EMA = European Medicines Agency; FDA =U.S. Food and Drug Administration.