よむ、つかう、まなぶ。
会議資料 (90 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000198856_00042.html |
| 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》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
（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
&sortBy=relevance&bc=1 [Cited 2025 Mar 27]
21) Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars (A58582). Medicare
Coverage Database. Available from: https://www.cms.gov/medicare-coverage-database/
view/article.aspx?articleid=58582&ver=14&keyword=rituximab&keywordType=starts&areaId=a
ll&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C
1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1 [Cited 2025 Mar 27]
22) Local Coverage Determination (LCD): Off-label Use of Rituximab and Rituximab Biosimilars
(L35026). Medicare Coverage Database. Available from: https://www.cms.gov/medicarecoverage-database/view/lcd.aspx?lcdid=35026&ver=75&keyword=rituximab&keywordType=sta
rts&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C
3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1 [Cited 2025 Mar 27]
23) Billing and Coding: Rituximab (A56380). Medicare Coverage Database. Available from:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=56380&ver=54
[Cited 2025 Mar 27]
24) Birgens H, Frederiksen H, Hasselbalch HC, et al. A phase III randomized trial comparing
glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune
haemolytic anaemia. Br J Haematol 2013; 163(3): 393-399.
25) Bussone G, Ribeiro E, Dechartres A, et al. Efficacy and safety of rituximab in adults' warm
antibody autoimmune haemolytic anemia: retrospective analysis of 27 cases. Am J Hematol
2009; 84(3): 153-157.
26) D'Arena G, Califano C, Annunziata M, et al. Rituximab for warm-type idiopathic autoimmune
hemolytic anemia: a retrospective study of 11 adult patients. Eur J Haematol 2007; 79(1): 53-58.
27) Barcellini W, Zaja F, Zaninoni A, et al. Low-dose rituximab in adult patients with idiopathic
autoimmune hemolytic anemia: clinical efficacy and biologic studies. Blood 2012; 119(16):
3691-3697.
28) Maung SW, Leahy M, O'Leary HM, et al. A multi-centre retrospective study of rituximab use in
the treatment of relapsed or resistant warm autoimmune haemolytic anaemia. Br J Haematol
2013; 163(1): 118-122.
29) Provan D, Butler T, Evangelista ML, Amadori S, Newland AC, Stasi R. Activity and safety
profile of low-dose rituximab for the treatment of autoimmune cytopenias in adults.
Haematologica 2007; 92(12): 1695-1698.
30) Berentsen S, Tjønnfjord GE, Brudevold R, et al. Favourable response to therapy with the
anti-CD20 monoclonal antibody rituximab in primary chronic cold agglutinin disease. Br J
Haematol 2001; 115(1): 79-83.
31) Berentsen S, Ulvestad E, Gjertsen BT, et al. Rituximab for primary chronic cold agglutinin
disease: a prospective study of 37 courses of therapy in 27 patients. Blood 2004; 103(8):
2925-2928.
61
90 / 359
要望番号；IV-168
&sortBy=relevance&bc=1 [Cited 2025 Mar 27]
21) Billing and Coding: Off-label Use of Rituximab and Rituximab Biosimilars (A58582). Medicare
Coverage Database. Available from: https://www.cms.gov/medicare-coverage-database/
view/article.aspx?articleid=58582&ver=14&keyword=rituximab&keywordType=starts&areaId=a
ll&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C
1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1 [Cited 2025 Mar 27]
22) Local Coverage Determination (LCD): Off-label Use of Rituximab and Rituximab Biosimilars
(L35026). Medicare Coverage Database. Available from: https://www.cms.gov/medicarecoverage-database/view/lcd.aspx?lcdid=35026&ver=75&keyword=rituximab&keywordType=sta
rts&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C
3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1 [Cited 2025 Mar 27]
23) Billing and Coding: Rituximab (A56380). Medicare Coverage Database. Available from:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=56380&ver=54
[Cited 2025 Mar 27]
24) Birgens H, Frederiksen H, Hasselbalch HC, et al. A phase III randomized trial comparing
glucocorticoid monotherapy versus glucocorticoid and rituximab in patients with autoimmune
haemolytic anaemia. Br J Haematol 2013; 163(3): 393-399.
25) Bussone G, Ribeiro E, Dechartres A, et al. Efficacy and safety of rituximab in adults' warm
antibody autoimmune haemolytic anemia: retrospective analysis of 27 cases. Am J Hematol
2009; 84(3): 153-157.
26) D'Arena G, Califano C, Annunziata M, et al. Rituximab for warm-type idiopathic autoimmune
hemolytic anemia: a retrospective study of 11 adult patients. Eur J Haematol 2007; 79(1): 53-58.
27) Barcellini W, Zaja F, Zaninoni A, et al. Low-dose rituximab in adult patients with idiopathic
autoimmune hemolytic anemia: clinical efficacy and biologic studies. Blood 2012; 119(16):
3691-3697.
28) Maung SW, Leahy M, O'Leary HM, et al. A multi-centre retrospective study of rituximab use in
the treatment of relapsed or resistant warm autoimmune haemolytic anaemia. Br J Haematol
2013; 163(1): 118-122.
29) Provan D, Butler T, Evangelista ML, Amadori S, Newland AC, Stasi R. Activity and safety
profile of low-dose rituximab for the treatment of autoimmune cytopenias in adults.
Haematologica 2007; 92(12): 1695-1698.
30) Berentsen S, Tjønnfjord GE, Brudevold R, et al. Favourable response to therapy with the
anti-CD20 monoclonal antibody rituximab in primary chronic cold agglutinin disease. Br J
Haematol 2001; 115(1): 79-83.
31) Berentsen S, Ulvestad E, Gjertsen BT, et al. Rituximab for primary chronic cold agglutinin
disease: a prospective study of 37 courses of therapy in 27 patients. Blood 2004; 103(8):
2925-2928.
61
90 / 359