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会議資料 (89 ページ)
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| 出典情報 | 医薬・生活衛生局が実施する検討会 医療上の必要性の高い未承認薬・適応外薬検討会議（第68回 7／4）《厚生労働省》 |
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（公知申請への該当性に係る企業見解の様式）
要望番号；IV-168
5)
Randen U, Trøen G, Tierens A, et al. Primary cold agglutinin-associated lymphoproliferative
disease: a B-cell lymphoma of the bone marrow distinct from lymphoplasmacytic lymphoma.
Haematologica 2014; 99(3): 497-504.
6)
Alaggio R, Amador C, Anagnostopoulos I, et al. The 5th edition of the World Health Organization
Classification of Haematolymphoid Tumours: Lymphoid Neoplasms. Leukemia 2022; 36(7):
1720-1748.
7)
Berentsen S, Barcellini W, D'Sa S, et al. Cold agglutinin disease revisited: a multinational,
observational study of 232 patients. Blood 2020; 136(4): 480-488.
8)
Barcellini W, Fattizzo B, Zaninoni A, et al. Clinical heterogeneity and predictors of outcome in
primary autoimmune hemolytic anemia: a GIMEMA study of 308 patients. Blood 2014; 124(19):
2930-2936.
9)
Lecouffe-Desprets M, Néel A, Graveleau J, et al. Venous thromboembolism related to warm
autoimmune hemolytic anemia: a case-control study. Autoimmun Rev 2015; 14(11): 1023-1028.
10) Yusuf HR, Hooper WC, Grosse SD, et al. Risk of venous thromboembolism occurrence among
adults with selected autoimmune diseases: a study among a U.S. cohort of commercial insurance
enrollees. Thromb Res 2015; 135(1): 50-57.
11) Barcellini W, Zaninoni A, Fattizzo B, et al. Predictors of refractoriness to therapy and healthcare
resource utilization in 378 patients with primary autoimmune hemolytic anemia from eight Italian
reference centers. Am J Hematol 2018; 93(9): E243-E246.
12) Audia S, Bach B, Samson M, et al. Venous thromboembolic events during warm autoimmune
hemolytic anemia. PLoS One 2018; 13: e0207218.
13) Broome CM, Cunningham JM, Mullins M, et al. Increased risk of thrombotic events in cold
agglutinin disease: a 10-year retrospective analysis. Res Pract Thromb Haemost 2020; 4(4):
628-635.
14) Hendrick AM. Auto-immune haemolytic anaemia--a high-risk disorder for thromboembolism?
Hematology 2003; 8(1): 53-56.
15) Hill QA, Stamps R, Masseyet E, et al. The diagnosis and management of primary autoimmune
haemolytic anaemia. Br J Haematol 2017; 176(3): 395-411.
16) Koppel A, Lim S, Osby M, et al: Rituximab as successful therapy in a patient with refractory
paroxysmal cold hemoglobinuria. Transfusion 2007; 47(10):1902-1904.
17) 米国添付文書 Rituxan®（2021 年 12 月改訂版）
18) 欧州製品情報 Mabthera®（2024 年 10 月改訂版）
19) 加国製品情報 Rituxan®（2023 年 6 月改訂版）
20) Local Coverage Determination (LCD): Off-label Use of Rituximab and Rituximab Biosimilars
(L38920). Medicare Coverage Database. Available from: https://www.cms.gov/medicarecoverage-database/view/lcd.aspx?lcdid=38920&ver=11&keyword=rituximab&keywordType=sta
rts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all
60
89 / 359
要望番号；IV-168
5)
Randen U, Trøen G, Tierens A, et al. Primary cold agglutinin-associated lymphoproliferative
disease: a B-cell lymphoma of the bone marrow distinct from lymphoplasmacytic lymphoma.
Haematologica 2014; 99(3): 497-504.
6)
Alaggio R, Amador C, Anagnostopoulos I, et al. The 5th edition of the World Health Organization
Classification of Haematolymphoid Tumours: Lymphoid Neoplasms. Leukemia 2022; 36(7):
1720-1748.
7)
Berentsen S, Barcellini W, D'Sa S, et al. Cold agglutinin disease revisited: a multinational,
observational study of 232 patients. Blood 2020; 136(4): 480-488.
8)
Barcellini W, Fattizzo B, Zaninoni A, et al. Clinical heterogeneity and predictors of outcome in
primary autoimmune hemolytic anemia: a GIMEMA study of 308 patients. Blood 2014; 124(19):
2930-2936.
9)
Lecouffe-Desprets M, Néel A, Graveleau J, et al. Venous thromboembolism related to warm
autoimmune hemolytic anemia: a case-control study. Autoimmun Rev 2015; 14(11): 1023-1028.
10) Yusuf HR, Hooper WC, Grosse SD, et al. Risk of venous thromboembolism occurrence among
adults with selected autoimmune diseases: a study among a U.S. cohort of commercial insurance
enrollees. Thromb Res 2015; 135(1): 50-57.
11) Barcellini W, Zaninoni A, Fattizzo B, et al. Predictors of refractoriness to therapy and healthcare
resource utilization in 378 patients with primary autoimmune hemolytic anemia from eight Italian
reference centers. Am J Hematol 2018; 93(9): E243-E246.
12) Audia S, Bach B, Samson M, et al. Venous thromboembolic events during warm autoimmune
hemolytic anemia. PLoS One 2018; 13: e0207218.
13) Broome CM, Cunningham JM, Mullins M, et al. Increased risk of thrombotic events in cold
agglutinin disease: a 10-year retrospective analysis. Res Pract Thromb Haemost 2020; 4(4):
628-635.
14) Hendrick AM. Auto-immune haemolytic anaemia--a high-risk disorder for thromboembolism?
Hematology 2003; 8(1): 53-56.
15) Hill QA, Stamps R, Masseyet E, et al. The diagnosis and management of primary autoimmune
haemolytic anaemia. Br J Haematol 2017; 176(3): 395-411.
16) Koppel A, Lim S, Osby M, et al: Rituximab as successful therapy in a patient with refractory
paroxysmal cold hemoglobinuria. Transfusion 2007; 47(10):1902-1904.
17) 米国添付文書 Rituxan®（2021 年 12 月改訂版）
18) 欧州製品情報 Mabthera®（2024 年 10 月改訂版）
19) 加国製品情報 Rituxan®（2023 年 6 月改訂版）
20) Local Coverage Determination (LCD): Off-label Use of Rituximab and Rituximab Biosimilars
(L38920). Medicare Coverage Database. Available from: https://www.cms.gov/medicarecoverage-database/view/lcd.aspx?lcdid=38920&ver=11&keyword=rituximab&keywordType=sta
rts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all
60
89 / 359