1 Clinical Policy Title: Radioembolization and chemoembolization for liver cancer and other indications Clinical Policy Number: 05.02.09 Effective Date: February 1, 2016 Initial Review Date: November 18, 2015 Most Recent Review Date: February 15, 2017 Next Review Date: February 2018 Related policies: None. ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Keystone First when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Keystone First’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First’s clinical policies are not guarantees of payment. Coverage policy Keystone First considers the use of radioembolization to be clinically proven and, therefore, medically necessary to treat cancer in the liver in the following instances: Inoperable or unresectable primary hepatic cancer (i.e., hepatocellular carcinoma [HCC]). Colorectal cancer with exclusively liver metastases. Neuroendocrine tumors, such as octreotide-resistant carcinoid tumors or refractory pancreatic neuroendocrine tumors (PNETs), which have spread to the liver. Ocular melanoma that has spread to the liver when rendered in the context of an investigational review board (IRB)-approved clinical trial protocol. Cholangiocarcinoma (i.e., cholangiocellular carcinoma [CCC]) that has spread to the liver when rendered in the context of an IRB-approved clinical trial protocol. Liver tumors too large for surgery to shrink them to allow surgical removal. Policy contains: Transarterial embolization. Radioembolization. Chemoembolization. Hepatocellular carcinoma.
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Radioembolization and chemoembolization for … definition of “medically necessary,” and the specific facts of the ... called “microspheres” ... Radioembolization and chemoembolization
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Clinical Policy Title: Radioembolization and chemoembolization for liver cancer
and other indications
Clinical Policy Number: 05.02.09
Effective Date: February 1, 2016
Initial Review Date: November 18, 2015
Most Recent Review Date: February 15, 2017
Next Review Date: February 2018
Related policies:
None.
ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Keystone First when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Keystone First’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First’s clinical policies are not guarantees of payment.
Coverage policy
Keystone First considers the use of radioembolization to be clinically proven and, therefore, medically
necessary to treat cancer in the liver in the following instances:
Inoperable or unresectable primary hepatic cancer (i.e., hepatocellular carcinoma [HCC]).
Colorectal cancer with exclusively liver metastases.
Neuroendocrine tumors, such as octreotide-resistant carcinoid tumors or refractory
pancreatic neuroendocrine tumors (PNETs), which have spread to the liver.
Ocular melanoma that has spread to the liver when rendered in the context of an
in tumor size) with significantly longer overall survival.
Salem (2010)
Radioembolization for
Hepatocellular Carcinoma Using
Key points:
RCT of 291 patients administered HCC radioembolization treatment.
Response rates of 42% – 57% and overall time to progression of 7.9
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Yttrium-90 Microspheres: A
Comprehensive Report of Long-
term Outcomes.
months.
Ibrahim (2008)
Treatment of unresectable
cholangiocarcinoma using
yttrium-90 microspheres: results
from a pilot study.
Key points:
Pilot study of Y-90 in 24 patients with ICC.
Partial response in 27%, stable disease in 68% and progression in 5%.
Median overall survival was 14.9 months.
Coldwell (2007)
Use of yttrium-90 microspheres in
the treatment of unresectable
hepatic metastases from breast
cancer.
Key points:
Study of radioembolization for breast cancer metastases to liver.
Diminished tumor volume was demonstrated in 47%, stable disease or
minor improvement in 47% and 5% showed no response.
Among responders the survival at 14 months was 86%.
Van Hazel (2004)
Randomized phase 2 trial of SIR-
Spheres plus
fluorouracil/leucovorin
chemotherapy versus
fluorouracil/leucovorin
chemotherapy alone in advanced
colorectal cancer.
Key points:
Study of hepatic colorectal metastases treated by radioembolization.
Y-90 resulted in higher response and longer time to progression (18.6
months versus 3.6 months) than chemotherapy with systemic 5-FUand
leucovorin.
Gupta (2003)
Hepatic artery embolization and
chemoembolization for treatment
of patients with metastatic
carcinoid tumors: the M.D.
Anderson experience.
Key points:
Retrospectively studied the outcomes of 81 patients with systemic
chemotherapy-resistant carcinoid metastases to liver when treated with
hepatic artery embolization or chemoembolization.
Partial response was observed in 46 patients (67%), minimal response in
six patients (8.7%), stable disease in 11 patients (16%), and progressive
disease in six patients (8.7%).
Median progression-free survival was 19 months.
The median overall survival time was 31 months.
References Professional society guidelines/other: American Cancer Society. Cancer Facts & Figures 2015. Atlanta, Ga: American Cancer Society; 2015. American Joint Committee on Cancer. Liver. In: AJCC Cancer Staging Manual. 7th ed. New York, NY: Springer; 2010:191 – 195. Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2013. National Cancer Institute. Bethesda, MD, 2016.
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National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Hepatobiliary Cancers. V.2.2014. Web site. www.nccn.org. Accessed December 26, 2016. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN / SRTR 2012 Annual Data Report: liver. Rockville, MD: Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation; 2012. Website. http://srtr.transplant.hrsa.gov/annual_reports/2012/pdf/03_liver_13.pdf. Accessed December 26, 2016. United States Department of Health and Human Services. The Health Consequences of Smoking — 50 Years of Progress. A Report of the Surgeon General. Website. http://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf Accessed December 26, 2016. Peer-reviewed references: Akahori T, Sho M, Tanaka T, et al. Significant efficacy of new transcatheter arterial chemoembolization technique for hepatic metastases of pancreatic neuroendocrine tumors. Anticancer Res. 2013 Aug;33(8):3355 – 8. Asnacios A, Fartoux L, Romano O, et al. Gemcitabine plus oxaliplatin (GEMOX) combined with cetuximab in patients with progressive advanced stage hepatocellular carcinoma: Results of a multicenter phase 2 study. Cancer. 2008;112:2733 – 2739. Bartlett DL, DiBisceglie AM, Dawson LA. Cancer of the liver. In: DeVita VT, Lawrence TS, Rosenberg SA, eds. DeVita, Hellman, and Rosenberg's Cancer: Principles and Practice of Oncology. 9th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2011:997 – 1018. Bester L, Meteling B, Pocock N, Pavlakis N, Chua TC, Saxena A, et al. Radioembolization versus standard care of hepatic metastases: comparative retrospective cohort study of survival outcomes and adverse events in salvage patients. J Vasc Interv Radiol 2012;23:96 – 105. Biolato M, Marrone G, Racco S, et al. Transarterial chemoembolization (TACE) for unresectable HCC: A new life begins? Eur Rev Med Pharmacol Sci. 2010;14(4):356 – 362. Brandi G, de Rosa F, Agostini V, et al. Metronomic capecitabine in advanced hepatocellular carcinoma patients: a phase II study. Oncologist. 2013;18(12):1256 – 7. Bruix J, Tak WY, Gasbarrini A, et al. Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study. Eur J Cancer. 2013;49(16):3412 – 9. Bruix J, Sherman M. Management of hepatocellular carcinoma. Hepatology. 2005;42:1208 – 1230. Cannon RM, Urbano J, Kralj I, et al. Management of diffuse hepatocellular carcinoma (≧ 10 Lesions) with doxorubicin-loaded DC beads is a safe and effective treatment option. Onkologie. 2012;35(4):184 – 188.
Cao G, Li J, Shen L, Zhu X. Transcatheter arterial chemoembolization for gastrointestinal stromal tumors with liver metastases. World J Gastroenterol. 2012 Nov 14;18(42):6134 – 40. Cohen SJ, Konski AA, Putnam S, et al. Phase I study of capecitabine combined with radioembolization using yttrium-90 resin microspheres (SIR-Spheres) in patients with advanced cancer. Br J Cancer. 2014;111(2):265 – 271. Coldwell DM, Kennedy AS, Nutting CW.Use of yttrium-90 microspheres in the treatment of unresectable hepatic metastases from breast cancer. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):800 – 4. Coldwell D Sangro B, Salem R, Wasan H, Kennedy A. Radioembolization in the treatment of unresectable liver tumors: experience across a range of primary cancers. Am J Clin Oncol. 2012;35(2):167 – 77. El-Serag HB. Hepatocellular carcinoma. N Engl J Med. 2011;365:1118 – 1127. Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012;379:1245 – 1255. Glantzounis GK, Tokidis E, Basourakos SP, Ntzani EE, Lianos GD, Pentheroudakis G. The role of portal vein embolization in the surgical management of primary hepatobiliary cancers. A systematic review. Eur J Surg Oncol. 2016;0748-7983(16):30177-9. Graf H, Jüngst C, Straub G, et al. Chemoembolization combined with pravastatin improves survival in patients with hepatocellular carcinoma. Digestion. 2008;78:34 – 38. Gulec SA , Pennington K, Wheeler J, et al. Yttrium-90 microsphere-selective internal radiation therapy with chemotherapy (chemo-SIRT) for colorectal cancer liver metastases: an in vivo double-arm-controlled phase II trial. Am J Clin Oncol. 2013 Oct;36(5):455 – 60. Gupta S, Yao JC, Ahrar K, et al. Hepatic artery embolization and chemoembolization for treatment of patients with metastatic carcinoid tumors: the M.D. Anderson experience. Cancer J. 2003;9(4):261 – 7. Hassan MM, Spitz MR, Thomas MB, et al. Effect of different types of smoking and synergism with hepatitis C virus on risk of hepatocellular carcinoma in American men and women: Case-control study. Int J Cancer. 2008;123:1883 – 1891. Heo J, Reid T, Ruo L, et al. Randomized dose-finding clinical trial of oncolytic immunotherapeutic vaccinia JX-594 in liver cancer. Nat Med. 2013 Mar;19(3):329 – 336. Hoshida Y, Villanueva A, Kobayashi M, et al. Gene expression in fixed tissues and outcome in hepatocellular carcinoma. N Engl J Med. 2008;359:1995 – 2004. Ibrahim S, Mulcahy M, Lewndowski R, et al. Treatment of unresectable cholangiocarcinoma using yttrium-90 microspheres: results from a pilot study. Cancer 2008:113:2119 – 28. Ishizuka M, Kubota K, Shimoda M, Kita J, Kato M, Park KH, Shiraki T. Effect of menatetrenone, a vitamin k2 analog, on recurrence of hepatocellular carcinoma after surgical resection: a prospective randomized controlled trial. Anticancer Res. 2012;32(12):5415 – 5420.
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Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Canc J Clin. 2011;61:69 – 90. Lau W, Kennedy A, Kim Y, et al. Patient Selection and Activity Planning Guide for Selective Internal Radiotherapy With Yttrium-90 Resin Microspheres. Int J Rad Onc Biol Phys 2012;82(1):401 – 407 Kosmider S, Tan TH, Yip D, Dowling R, Lichtenstein M, Gibbs P.Radioembolization in combination with systemic chemotherapy as first-line therapy for liver metastases from colorectal cancer. J Vasc Interv Radiol. 2011;22(6):780 – 6. Lencioni R, Chen XP, Dagher L, Venook AP. Treatment of intermediate/advanced hepatocellular carcinoma in the clinic: How can outcomes be improved? Oncologist. 2010;15(suppl 4):42 – 52. Lencioni R, Crocetti L. Local-regional treatment of hepatocellular carcinoma. Radiology. 2012;262:43 – 58. Lencioni R, Petruzzi P, Crocetti L. Chemoembolization of hepatocellular carcinoma. Semin Intervent Radiol. 2013;30(1):3 – 11. Lewandowski RJ, Geschwind JF, Liapi E, Salem R. Transcatheter intraarterial therapies: Rationale and overview. Radiology. 2011;259:641 – 657. Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359:378 –390. Maheshwari S, Sarraj A, Kramer J, El-Serag HB. Oral contraception and the risk of hepatocellular carcinoma. J Hepatol. 2007;47:506 – 513. Maluccio M, Covey AM, Gandhi R, et al. Comparison of survival rates after bland arterial embolization and ablation versus surgical resection for treating solitary hepatocellular carcinoma up to 7 cm. J Vasc Interv Radiol 2005;16:955 – 961. Marrero JA, Fontana RJ, Fu S, et al. Alcohol, tobacco and obesity are synergistic risk factors for hepatocellular carcinoma. J Hepatol. 2005;42:218 – 224. Memon K, Lewandowski RJ, Riaz A, Salem R. Yttrium 90 microspheres for the treatment of hepatocellular carcinoma. Recent Results Cancer Res. 2013;190:207 – 24. Miyake Y, Kobashi H, Yamamoto K. Meta-analysis: The effect of interferon on development of hepatocellular carcinoma in patients with chronic hepatitis B virus infection. J Gastroenterol. 2009;44:470 – 475. Onaca N, Davis GL, Jennings LW, Goldstein RM, Klintmalm GB. Improved results of transplantation for hepatocellular carcinoma: a report from the International Registry of Hepatic Tumors in Liver Transplantation. Liver Transpl. 2009;15(6):574 – 80.
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Rathmann N, Diehl SJ, Dinter D, et al. Radioembolization in patients with progressive gastrointestinal stromal tumor liver metastases undergoing treatment with tyrosine kinase inhibitors. J Vasc Interv Radiol. 2015;26(2):231 – 8. Salem R, Lewandowski R, Mulcahy M, et al. Radioembolization for Hepatocellular Carcinoma Using Yttrium-90 Microspheres: A Comprehensive Report of Long-term Outcomes. Imaging and Advanced Technology. 2010;138(1), 52 – 64. Samuel M, Chow PK, Chan Shih-Yen E, Machin D, Soo KC. Neoadjuvant and adjuvant therapy for surgical resection of hepatocellular carcinoma. Cochrane Database Syst Rev. 2009;(1):CD001199. Sangro B, Carpanese L, Cianni R, et al. European Network on Radioembolization with Yttrium-90 Resin Microspheres (ENRY) (2011), Survival after yttrium-90 resin microsphere radioembolization of hepatocellular carcinoma across Barcelona clinic liver cancer stages: A European evaluation. Hepatology, 54: 868 – 878. Santoro A, Rimassa L, Borbath I, et al. Tivantinib for second-line treatment of advanced hepatocellular carcinoma: a randomised, placebo-controlled phase 2 study. Lancet Oncol. 2013;14(1):55 – 63. Shen Q, Fan J, Yang XR, et al. Serum DKK1 as a protein biomarker for the diagnosis of hepatocellular carcinoma: a large-scale, multicentre study. Lancet Oncol. 2012;13(8):817 – 826. Siegel AB, Cohen EI, Ocean A, et al. Phase II trial evaluating the clinical and biologic effects of bevacizumab in unresectable hepatocellular carcinoma. J Clin Oncol. 2008;26:2992 – 2998. Spreafico C, Cascella T, Facciorusso A, et al. Transarterial chemoembolization for hepatocellular carcinoma with a new generation of beads: Clinical-radiological outcomes and safety profile. Cardiovasc Intervent Radiol. 2015;38(1):129 – 134. Thomas MB, Morris JS, Chadha R, et al. Phase II trial of the combination of bevacizumab and erlotinib in patients who have advanced hepatocellular carcinoma. J Clin Oncol. 2009;27:843 – 850. Toh HC, Chen PJ, Carr BI, et al. Phase 2 trial of linifanib (ABT-869) in patients with unresectable or metastatic hepatocellular carcinoma. Cancer. 2013;119(2):380 – 387. Uhm JE, Park JO, Lee J, et al. A phase II study of oxaliplatin in combination with doxorubicin as first-line systemic chemotherapy in patients with inoperable hepatocellular carcinoma. Cancer Chemother Pharmacol. 2009;63:929 – 935. Van Hazel G, Blackwell A, Anderson J, et al. Randomised phase 2 trial of SIR-Spheres plus fluorouracil/leucovorin chemotherapy versus fluorouracil/leucovorin chemotherapy alone in advanced colorectal cancer. J Surg Oncol. 2004,1;88(2):78 – 85. Weber S, Jarnagin W, Duffy A, et al. Liver and bile duct cancer. In: Abeloff MD, Armitage JO, Lichter AS, Niederhuber JE. Kastan MB, McKenna WG, eds. Clinical Oncology. 4th ed. Philadelphia, Pa: Elsevier; 2008:1569 – 1579.
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Yamakado K, Nakatsuka A, Takaki H, et al. Early-stage hepatocellular carcinoma: radiofrequency ablation combined with chemoembolization versus hepatectomy. Radiology 2008;247:260-266. Yang TX, Chua TC, Morris DL. Radioembolization and chemoembolization for unresectable neuroendocrine liver metastases - a systematic review. Surg Oncol. 2012;21(4):299 – 308. Ye SL, Takayama T, Geschwind J, et al. Current approaches to the treatment of early hepatocellular carcinoma. Oncologist. 2010;15(suppl 4):34 – 41. Yeo W, Chung HC, Chan SL, et al. Epigenetic therapy using belinostat for patients with unresectable hepatocellular carcinoma: a multicenter phase I/II study with biomarker and pharmacokinetic analysis of tumors from patients in the Mayo Phase II Consortium and the Cancer Therapeutics Research Group. J Clin Oncol. 2012;30(27):3361 – 3367. Zhang CH, Xu GL, Jia WD, Ge YS. Effects of interferon alpha treatment on recurrence and survival after complete resection or ablation of hepatocellular carcinoma: A meta-analysis of randomized controlled trials. Int J Cancer. 2009;124:2982 – 2988. Zhong C, Guo RP, Li JQ, et al. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage IIIA hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009;135:1437 – 1445. Zhou B, Shan H, Zhu KS, et al. Chemoembolization with lobaplatin mixed with iodized oil for unresectable recurrent hepatocellular carcinoma after orthotopic liver transplantation. J Vasc Interv Radiol. 2010;21(3):333 – 8. CMS National Coverage Determination (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly Submitted Codes Below are the most commonly submitted codes for the services and items subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in accordance with those manuals.
CPT Code Description Comment
37243 Vascular embolization for tumors
75894 Transcatheter therapy, embolization, any method, radiologic supervision and interpretation
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ICD-10 Code Description Comment
C22.0 Liver cell carcinoma
C22.1 Intrahepatic bile duct carcinoma
C22.8 Malignant neoplasm, liver, unspecified as to type
C25.4 Malignant neoplasm of the endocrine pancreas
C69.90 Malignant neoplasm of unspecified site, unspecified eye
C69.91 Malignant neoplasm of unspecified site, right eye
C69.92 Malignant neoplasm of unspecified site, left eye
C78.7 Metastatic neoplasm, liver
Z09 Encounter for f/u exam after completed treatment for conditions other than malignant neoplasm