본문 바로가기
KERD
논문KCI 등재

신세포암에 사용되는 전신 항암요법의 요양급여기준에 관한 고찰

Assessment of Appropriateness of Criteria for Insurance Coverage on Systemic Therapy used in Renal Cell Carcinoma

윤정현|박은지|김정연|배민경
한국임상약학회 (Korean College Of Clinical Pharmacy)|2011.12|한국임상약학회지 (Korean Journal of Clinical Pharmacy)|제21권 제4호|pp. 319-331

2

조회

0

다운로드

0

인용

0

참고문헌

키워드

chemotherapyimmunotherapytargeted therapyrenal cell carcinoma
주제분류약학

초록

Purpose: The purpose of this study is to evaluate current criteria for insurance coverage by Health Insurance Review &Assessment Service (HIRA) on the systemic therapy used in the treatment of advanced or metastatic renal cell carcinoma (RCC), by reviewing all available clinical evidences including a variety of clinical practice guidelines. Methods:We searched clinical databases and collected data from published phase 1 through 3 randomized clinical trials on all systemic therapies used in RCC, including novel targeted therapies. Additionally, current clinical practice guidelines on the management of kidney cancer or RCC were reviewed. Based on the collected data we evaluated the appropriateness of the HIRA criteria for insurance coverage on the systemic therapy of RCC whether they are evidence-based and up to date. Results: On the basis of the collected data we concluded that there was a need for a revision in HIRA criteria for systemic therapy of RCC. Despite recent emerging therapeutic advances and changes in therapeutic strategies of management of RCC, some of anticancer regimens were inappropriately listed even though they were not proven to provide efficacy or safety superior to those of other therapies. We thus proposed an updated recommendation based on current clinical evidences. Conclusion: Systemic therapy of RCC is being rapidly changed with the advancement of understanding of the molecular biology of cancer. Consequently newly developed targeted therapies are becoming the standard therapy in the management of medically or surgically unresectable advanced or metastatic RCC. To provide effective and safe therapy to patients with RCC, the criteria for insurance coverage should be made carefully taking into consideration of most up-todate and high-quality clinical evidences, and should be continuously reviewed so as to reflect evidence-based clinical practice.

Abstract

Purpose: The purpose of this study is to evaluate current criteria for insurance coverage by Health Insurance Review &Assessment Service (HIRA) on the systemic therapy used in the treatment of advanced or metastatic renal cell carcinoma (RCC), by reviewing all available clinical evidences including a variety of clinical practice guidelines. Methods:We searched clinical databases and collected data from published phase 1 through 3 randomized clinical trials on all systemic therapies used in RCC, including novel targeted therapies. Additionally, current clinical practice guidelines on the management of kidney cancer or RCC were reviewed. Based on the collected data we evaluated the appropriateness of the HIRA criteria for insurance coverage on the systemic therapy of RCC whether they are evidence-based and up to date. Results: On the basis of the collected data we concluded that there was a need for a revision in HIRA criteria for systemic therapy of RCC. Despite recent emerging therapeutic advances and changes in therapeutic strategies of management of RCC, some of anticancer regimens were inappropriately listed even though they were not proven to provide efficacy or safety superior to those of other therapies. We thus proposed an updated recommendation based on current clinical evidences. Conclusion: Systemic therapy of RCC is being rapidly changed with the advancement of understanding of the molecular biology of cancer. Consequently newly developed targeted therapies are becoming the standard therapy in the management of medically or surgically unresectable advanced or metastatic RCC. To provide effective and safe therapy to patients with RCC, the criteria for insurance coverage should be made carefully taking into consideration of most up-todate and high-quality clinical evidences, and should be continuously reviewed so as to reflect evidence-based clinical practice.

참고문헌 (66)

  2. Storkel S, "Classification of renal cell carcinoma: Workgroup No. 1. Union Internationale Contre le Cancer (UICC) and the American Joint Committee on Cancer (AJCC)", Cancer, 80, pp.987~989 (1997)
  3. "European Association of Urology Guidelines on Renal Cell Carcinoma. 2010" (2010)[URL]
  5. Escudier B, "ESMO Guidelines Working Group. Renal cell carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up", Ann Oncol, 21, pp.137~139 (2010)
  6. Gore ME, "Interferon alfa-2a versus combination therapy with interferon alfa-2a, interleukin- 2, and fluorouracil in patients with untreated metastatic renal cell carcinoma (MRC RE04", EORTC GU 30012): an open-label randomized trial, 2010, pp.375, 641~648
  7. Corgna E, "Renal cancer", Crit Rev Oncol Hematol, 64, pp.247~262 (2007)
  8. Board RE, "Anti-angiogenic therapy in the treatment of advanced renal cell cancer", Cancer Treat Rev, 33, pp.1~8 (2007)
  9. Yagoda A, "Chemotherapy for advanced renal-cell carcinoma: 1983-1993", Semin Oncol, 22, pp.42~60 (1993)
  10. Yagoda A, "Cytotoxic chemotherapy for advanced renal cell carcinoma", Urol Clin North Am, 20, pp.303~321 (1993)
  11. Hartmann JT, "Chemotherapy for renal cell carcinoma", Anticancer Res, 19, pp.1541~1543 (1999)
  12. Motzer RJ, "Renal-cell carcinoma", N Engl J Med, 335, pp.865~875 (1996)
  13. Milowsky MI, "Chemotherapeutic strategies for renal cell carcinoma", Urol Clin North Am, 30, pp.601~609 (2003)
  14. Kroog GS, "Systemic Therapy for Metastatic renal cell carcinoma", Urol Clin North Am, 35, pp.687~701 (2008)
  15. Chouhan JD, "Sunitinib (Sutent®): A novel agent for the treatment of metastatic renal cell carcinoma", J Oncol Pharm Practice, 13, pp.5~16 (2007)
  16. "항암화학요 법 등 공고내용 전문"[URL]
  17. Motzer RJ, "Targeted therapy for metastatic renal cell carcinoma", J Clin Oncol, 24, pp.5601~5608 (2006)
  18. Motzer RJ, "Sunitinib versus inteferon alfa in metastatic renal-cell carcinoma", N Engl J Med, 356(2), pp.115~124 (2007)
  19. Negrier S, "Recombinant human interleukin-2, recombinant human interferon alfa- 2a, or both in metastatic renal-cell carcinoma", N Engl J Med, 338, pp.1272~1278 (1998)
  20. Motzer RJ, "Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma", J Clin Oncol, 20, pp.289~296 (2002)
  21. Johannsen M, "The role of cytokine therapy in metastatic renal cell cancer", Eur Urology, (suppl 6), pp.658~664 (2007)
  22. Coppin C, "Immunotherapy for advanced renal cell cancer", Cochrane Database Syst Rev, 1, pp.CD001425~ (2005)
  23. McDermott DF, "Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma", J Clin Oncol, 23, pp.133~141 (2005)
  24. Yang JC, "Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cell cancer", J Clin Oncol, 21, pp.3127~3132 (2003)
  25. Rosenberg SA, "Durability of complete responses in patients with metatstatic cancer treated with high-dose interleukin-2", Ann Surg, 228, pp.307~319 (1998)
  26. McDermott DF, "Immunotherapy of metastatic renal cell carcinoma", Cancer, 115(10), pp.2298~2305 (2009)
  27. Negrier S, "Medroxyprogesterone, interferon alfa-2a, interleukin-2, or combination of both cytokines in patients with metastatic renal carcinoma of intermediate prognosis: results from a randomized controlled trial", Cancer, 110, pp.2468~2477 (2007)
  28. Motzer RJ, "Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor, in patients with metastatic renal cell carcinoma", J Clin Oncol, 24, pp.16~24 (2006)
  29. Motzer RJ, "Sunitinib in patients with metastatic renal cell carcinoma", JAMA, 295, pp.2516~2524 (2006)
  30. Motzer RJ, "Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma", J Clin Oncol, 27, pp.3584~3590 (2009)
  31. 황유진, "Efficacy and Safety of Sunitinib on Metastatic Renal Cell Carcinoma: A Single-Institution Experience", Korean Journal of Urology, 51(7), pp.450~455 (2010), 대한비뇨기과학회
  32. 홍민희, "Treatment Outcomes of Sunitinib Treatment in Advanced Renal Cell Carcinoma Patients: A Single Cancer Center Experience in Korea", Cancer Research and Treatment, 41(2), pp.67~72 (2009), 대한암학회
  33. Yoo C, "The Efficacy and Safety of Sunitinib in Korean Patients with Advanced Renal Cell Carcinoma: High Incidence of Toxicity Leads to Frequent Dose Reduction", JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 40(10), pp.980~985 (2010), OXFORD UNIV PRESS
  34. Choueiri TK, "Risk of arterial thromboembolic events with sunitinib and sorafenib: A systematic review and meta-analysis of clinical trials", Clin Oncol, 28, pp.2280~2285 (2010)
  35. Flaherty KT, "Sorafenib in renal cell carcinoma", Clin Cancer Res, 13, pp.747~752 (2007)
  36. Escudier B, "Sorafenib in advanced clear-cell renal-cell carcinoma", N Engl J Med, 356, pp.125~134 (2007)
  37. Escudier B, "Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial", J Clin Oncol, 27, pp.3312~3318 (2009)
  38. Escudier B, "Randomized phase II trial of first-line treatment with sorafenib versus interferon alfa-2a in patients with metastatic renal cell carcinoma", J Clin Oncol, 27, pp.1280~1289 (2009)
  39. Escudier B, "Bevacizumab plus interfereon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial", Lancet, 370, pp.2103~2111 (2007)
  40. Rini B, "Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206", J Clin Oncol, 28, pp.2137~2143 (2010)
  41. Herrmann E, "Update on systemic therapies of metastatic renal cell carcinoma", World J Urol, 28, pp.303~309 (2010)
  42. Sternberg CN, "Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial", J Clin Oncol, 28, pp.1061~1068 (2010)
  43. "Pazopanib versus sunitinib in the treatment of locally advanced and/or metastatic renal cell carcinoma (COMPARZ). July 22, 2008" (2008)[URL]
  44. "Patient preference study of pazopanib versus sunitinib in advanced or metastatic kidney cancer (PISCES). February 4, 2010. July 22, 2008" (2008)[URL]
  45. Hudes G, "Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma", N Engl J Med, 356, pp.2271~2281 (2007)
  46. Parasuraman S, "Comparison of quality-adjusted survival in patients with advanced renal cell carcinoma receiving first-line treatment with temsirolimus (TEMSR) or interferon-a (IFN) or the combination of IFN+TEMSR", J Clin Oncol (Meeting Abstracts), 25(18S) (2007)
  47. Motzer RJ, "Efficacy of everolimus in advanced renal cell carcinoma: a doubleblind, randomised, placebo-controlled phase III trial", Lancet, 372, pp.449~456 (2008)
  48. Motzer RJ, "Phase 3 trial of everolimus for metastatic renal cell carcinoma: Final results and analysis of prognostic factors", Cancer, 116, pp.4256~4265 (2010)
  49. Motzer RJ, "Treatment outcome and survival associated with metastatic renal cell carcinoma of non-clear-cell histology", J Clin Oncol, 20, pp.2376~2381 (2002)
  50. Murphy BR, "A phase II trial of interferon-alpha 2A plus fluorouracil in advanced renal cell carcinoma. A Hoosier Oncology Group study", Invest New Drugs, 10, pp.225~230 (1992)
  51. Elias L, "A phase II trial of interferon-alpha and 5-fluorouracil in patients with advanced renal cell carcinoma. A Southwest Oncology Group Study", Cancer, 78, pp.1085~1088 (1996)
  52. Igarashi T, "Interferon-alpha and 5-fluorouracil therapy in patients with metastatic renal cell carcinoma: an open multicenter trial. The Japanese Study Group Against Renal Cancer", Urology, 53, pp.53~59 (1999)
  53. Fossa S, "Recombinant interferon alfa-2α with or without vinblastine in metastatic renal cell carcinoma: Results of a European multicentre phase III study", Ann Oncol, 3, pp.301~305 (1992)
  54. hart JA, "Vinblastine fails to improve response of renal cancer to interferon alfan1: high response rate in patients with pulmonary metastases", J Clin Oncol, 9, pp.832~836 (1991)
  55. Kriegmari M, "Interferon α and vinblastine versus medroxyprogesterone acetate in the treatment of metastatic renal cell carcinoma", Urology, 45, pp.758~762 (1995)
  56. Sella A, "Phase II study of interferon-alpha and chemotherapy (5-fluorouracil and mitomycin C) in metastatic renal cell cancer", J Urol, 147, pp.573~577 (1992)
  57. Vasquez-Lopez E, "The reaction of the pituitary gland and related hypothalamic centers in the hamster to prolonged treatment with estrogens", J Path Bact, 56, pp.1~3 (1944)
  58. Bloom JH, "Medroxyprogesterone acetate (Provea) in the treatment of metastatic renal cancer", Br J Cancer, 25, pp.250~265 (1971)
  59. Harris DT, "Hormonal therapy and chemotherapy of RCC", Semin Oncol, 10, pp.422~430 (1983)
  60. Kjaer M, "The role of medroxyprogesterone acetate (MPA) in the treatment of renal adenocarcinoma", Cancer Treat Rev, 15, pp.195~209 (1988)
  61. Motzer RJ, "Systemic therapy for renal cell carcinoma", J Urol, 163, pp.408~417 (2000)
  62. Kakehi Y, "Measurement of multidrug-resistance messenger RNA in urogenital cancers; elevated expression in renal cell carcinoma is associated with intrinsic drug resistance", J Urol, 139, pp.862~865 (1988)
  63. Yagoda A, "Phase II cytotoxic chemotherapy trials in RCC: 1983-1988", Prog Clin Biol Res, 350, pp.227~241 (1990)
  64. Motzer RJ, "Treatment outcome and survival associated with metastatic renal cell carcinoma of non-clear-cell histology", J Clin Oncol, 20, pp.2376~2381 (2002)
  65. Choueiri TK, "Efficacy of sunitinib and sorafenib in metastatic papillary and chromophobe renal cell carcinoma", J Clin Oncol, 26, pp.127~131 (2008)
  66. Benedict Á, "Economic evaluation of new targeted therapies for the first-line treatment of patients with metastatic renal cell carcinoma", BJU Int, 108, pp.665~672 (2011)

관련 논문AI추천

비소세포폐암에 사용되는 항암화학요법의 요양급여기준 적절성 평가김정연, 박은지, 배민경, 윤정현한국임상약학회 · 한국임상약학회지2011 · 제21권 제3호Systemic Treatments for Metastatic Renal Cell Carcinoma: 10-Year Experience of Immunotherapy and Targeted Therapy김선호, 김성한, 박원서, 서호경, 이강현, 정재영, 정진수대한암학회 · Cancer Research and Treatment2016 · 제48권 제3호Novel Sunitinib Strategy in Metastatic Renal Cell Carcinoma on Hemodialysis: Intermittent Dose of Sunitinib after Hemodialysis김건민, 김기향, 김주훈, 김효송, 라선영, 박영년, 윤상현, 최준정대한암학회 · Cancer Research and Treatment2010 · 제42권 제3호Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study강정훈, 김호영, 라선영, 박세훈, 이경희, 이세훈, 이수진, 이재련, 임재윤, 임호영, 정기선, Suee Lee대한암학회 · Cancer Research and Treatment2018 · 제50권 제2호Treatment Outcomes of Sunitinib Treatment in Advanced Renal Cell Carcinoma Patients: A Single Cancer Center Experience in Korea김찬, 김효송, 라선영, 신상준, 안정련, 안중배, 전홍재, 정현철, 홍민희대한암학회 · Cancer Research and Treatment2009 · 제41권 제2호Application of the International Metastatic Renal Cell Carcinoma Database Consortium and Memorial Sloan Kettering Cancer Center Risk Models in Patients with Metastatic Non-clear Cell Renal Cell Carcinoma: A Multi-institutional Retrospective Study Using the Korean Metastatic Renal Cell Carcinoma Registry곽철, 김성한, 김정권, 박재영, 서성일, 서일영, 송미경, 송채린, 이학민, 정진수, 정창욱, 주정남, 홍성후, 황의창대한암학회 · Cancer Research and Treatment2019 · 제51권 제2호

이 간행물의 다른 논문 (12건)

Effects of Polycan on bone Metabolism in healthy Perimenopausal Women: a 12-week Randomized, Double-blind, Placebo-controlled study채수완, 김달식, 조형래, 백향임, 김민걸, 김기영, 김주완, 채한정, 김선영, 하기찬pp. 297-304Alterations of Cyclosporine Concentrations by Antibiotics in Patients with Hematopoietic Stem Cell Transplantation최유리, 방준석, 나현오, 송헌정, 유옥리pp. 305-310소비자의 의약품안전성 인식정도 및 관련정보 획득경로지은희, 이숙향, 오정미, 김수경pp. 311-318의약분업 이후 의원 및 약국에서의 항생제 사용 실태이현경, 지은희, 오정미, 송윤경pp. 332-338효율적인 의약품 평가를 위한 약물계량학 분석법 도입의 전략 방안윤휘열, 전다혜, 김명규, 김영훈, 하지혜, 오정미, 한나영, 이상민, 최보윤, 강원구, 지은희, 신완균pp. 339-346
원문 보기