Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Transcatheter Arterial Chemoembolization (TACE) of Hepatic Malignancies

Policy #:07.05.06f

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

When all eligibility criteria listed below are met, transcatheter arterial chemoembolization (TACE) is considered medically necessary and, therefore, covered for any of the following conditions:
  • Treatment of unresectable hepatocellular carcinoma (HCC) in individuals without any extrahepatic metastases
  • Palliative treatment of unresectable cholangiocarcinoma
  • Reduction of tumor bulk to treat symptoms associated with unresectable hepatic metastases of neuroendocrine tumors (e.g., carcinoid and pancreatic islet cell tumors)
  • Treatment of carcinoid syndrome that has failed systemic octreotide therapy
  • As a bridge to transplantation for individuals with HCC who are already on an orthotopic liver transplantation (OLT) waiting list, to retard tumor progression and accommodate waiting list times
  • Treatment of liver metastases from ocular (uveal) melanoma

ELIGIBILITY CRITERIA

TACE is considered medically necessary and, therefore, covered for any of the above conditions when all of the following criteria are met:
  • The individual has a patent portal vein on superior mesenteric arterial portovenography.
  • Either one of the following is met:
    • The individual has a tumor burden less than 50 percent of liver volume.
    • The individual is receiving TACE as a bridge to transplantation and has one tumor of less than 5 cm or three tumors of less than 3 cm each.
  • The individual has adequate liver function as determined by a Child-Pugh score of A or B (see classification table below). For individuals with unresectable cholangiocarcinoma a Child-Pugh score of C may be acceptable.
  • The individual does not have any contraindications to angiography.

CHILD-PUGH CLASSIFICATION TABLE

This score employs five clinical measures of chronic liver disease. Each measure is scored 1-3 points, with 3 indicating most severe derangement. Child-Pugh Scoring: A=5-6, B=7-9, C=10-15. It should be noted that different textbooks and publications use different measures. Some older reference works substitute prothrombin time (PT) prolongation for international normalized ratio (INR).
Measure
1 point
2 points
3 points
Hepatic encephalopathy
None
Moderate
Severe
Ascites
None
Moderate
Severe
Serum albumin (g/dL)
Greater than 3.5
2.8-3.5
Less than 2.8
INR
Less than 1.7
1.7-2.20
Greater than 2.20
Serum bilirubin (mg/dL)
Less than 2
2-3
Greater than 3


EXPERIMENTAL/INVESTIGATIONAL

TACE is considered experimental/investigational and, therefore, not covered when it is used for any of the following conditions because the safety and/or effectiveness of these uses cannot be established by review of the available published peer-reviewed literature:
  • As a neoadjuvant or adjuvant therapy pre- or post-curative resection
  • For recurrent HCC after curative resection
  • For other types of liver metastases, including, but not limited to, those from colorectal carcinoma, soft-tissue sarcoma, and breast carcinoma

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agency, other health care professionals, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation must be made available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, transcatheter arterial chemoembolization (TACE) of hepatic malignancies is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in the medical policy are met. However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

Description

Hepatic tumors are classified as primary or metastatic. Primary hepatic tumors are either hepatocellular carcinoma (HCC) or cholangiocarcinoma. Cholangiocarcinoma may be further subdivided into intrahepatic or extrahepatic disease. The most common primary liver cancer is HCC. Hepatic tumors are difficult to treat due to the frequently advanced stage of the tumor at the time of diagnosis, with untreated survival usually in the three- to six-month range. Liver transplantation or resection are the only curative options, but they are often not feasible due to the size or location of the tumor. Additionally, because HCC usually develops in individuals with cirrhosis or chronic hepatitis, poor liver function or comorbid conditions further complicate treatment. Consequently, there is no universally accepted treatment for unresectable hepatic tumors. Alternative treatments, including ablation (thermal or chemical) and systemic chemotherapy, yield response rates of only 10 percent to 20 percent.

Transcatheter arterial chemoembolization (TACE) is a regional therapy being used as an alternative to systemic chemotherapy, intra-arterial chemotherapy, and various ablative procedures used in the treatment of resectable and nonresectable hepatic tumors. TACE involves the administration of a chemotherapeutic agent (usually doxorubicin, mitomycin C, or cisplatin) into the hepatic artery, followed by arterial embolization. A poppy seed oil (lipiodol), which concentrates within HCC and carcinoid tumors, is commonly used as a suspension medium and embolic agent for the chemotherapeutic agent(s); however, other frequently used embolizing agents include polyvinyl alcohol, collagen, and gelatin sponge powder and pledgets. Embolization provides a longer dwell time and greater concentration of the chemotherapeutic drug in the tumor, while sparing functional liver tissue. With embolization, the concentration of anticancer agents within the tumor can be up to 100 percent higher than with systemic chemotherapy. This typically results in tumor necrosis with a reduction of tumor bulk between 60 percent and 100 percent. The procedure is also known as hepatic artery chemoembolization (HACE), but it should not be confused with intrahepatic arterial chemotherapy, in which high-dose chemotherapy is infused into the hepatic artery without embolization.

TACE has been investigated to treat resectable, unresectable, and recurrent hepatocellular carcinoma, cholangiocarcinoma, liver metastases, and in the liver transplant setting. Inclusion criteria for TACE vary among studies, but portal vein patency and adequate liver function are critical (i.e., Child Pugh score of A or B). TACE candidates should have no contraindications to angiography (i.e., normal coagulation and renal function), absence of main portal vein thrombosis (unless segmental injections can be performed), absence of extrahepatic metastases (primarily for individuals with unresectable HCC or candidates for liver transplantation), and serum bilirubin level less than 3 mg/dL. Repeat procedures can be provided every two to three months for unresectable HCC, when new or residual disease is detected, depending on individual tolerance to the procedure.

A frequent side effect of TACE is postembolization syndrome (fever, abdominal pain, nausea, and vomiting), which occurs in 80 percent to 90 percent of patients. Additional side effects may include cholecystitis, pancreatitis, liver abscesses, and gastric erosions or ulcers. Liver failure is a risk in those with pretreatment borderline liver function.

TACE is commonly performed by interventional radiologists and usually requires overnight hospitalization.

TACE FOR TREATMENT OF HCC

TACE has been established as a treatment option for unresectable HCC. Although no commonly acceptable protocol is in place, its effectiveness has been shown in select individuals. Although the procedure is considered palliative, recent studies report increased survival if strict patient selection is followed to enhance benefit and reduce risks.

TACE AS A BRIDGE TO LIVER TRANSPLANTATION

Because of long waiting lists for orthotopic liver transplants (OLT), as many as 20 percent of eligible transplantation candidates drop out due to disease progression. TACE is used as a bridge to OLT to slow tumor progression and accommodate waiting list times, and experts endorse this approach. Non-randomized studies describe good survival results, and a recent intent-to-treat study reported no disease progression and no waiting list dropouts over a mean period of six months. Study candidates met all of the following OLT inclusion criteria: one lesion of less than 5 cm in size or three lesions (each less than 3 cm in size); absence of extrahepatic disease or vascular invasion; and Child-Pugh score of either A or B. The procedure was repeated every six to eight weeks until a complete response was achieved or a donor organ became available. It should be noted that this study was specific to preventing tumor progression and accommodating OLT waiting list times, not as neoadjuvant therapy to downstage tumors or prevent tumor shedding prior to curative resection, a procedure that has not shown a survival benefit.

TACE FOR TREATMENT OF LIVER METASTASES FROM NEUROENDOCRINE TUMORS

Neuroendocrine tumors (e.g., pancreatic islet cell and carcinoid tumors) frequently metastasize to the liver. Because these tumors are hypervascular (deriving more than 80 percent of their blood supply from the hepatic artery) and infrequently result in extrahepatic metastases, they are good candidates for localized chemoembolization. In addition, morbidity risk is lower than in HCC because cirrhosis or hepatitis is not usually associated with neuroendocrine metastases. However, by the time these tumors are discovered, they may be large and cause debilitating symptoms related to tumor bulk and carcinoid syndrome (severe flushing, diarrhea, wheezing, facial edema, and abdominal pain). When initial treatment with somatostatin agents is not effective, TACE is a palliative approach that can be of clinical benefit in instances when the tumors are growing and control of symptoms is failing. The procedure can be repeated if initial treatment does not result in improvement or if symptoms reappear.

TACE FOR TREATMENT OF LIVER METASTASES FROM OCULAR (UVEAL) MELANOMA

Uveal melanoma (also called ocular melanoma) is the most common primary ocular malignancy in adults, with an incidence of 3500-4000 cases per year. Up to 40 percent of individuals have metastases at diagnosis; of those who develop metastases, the liver is the sole or dominant site in more than 80 percent of cases. The median survival of individuals after diagnosis of liver metastases is two-to-nine months; one-year survival rate is estimated at 10 percent.

Uveal melanoma with liver metastases is a difficult condition to manage. Systemic therapies and immunotherapy have little effect, and surgery is rarely an option. Hepatic artery chemotherapy is an alternative, but in a retrospective review, TACE was found to be superior to this modality. Although response rates achieved with TACE are high compared with those achieved with systemic or other regional therapy, there are no prospective randomized controlled trials that compare TACE with other treatment modalities. Also, because of the poor prognosis for this disorder, additional comparative studies are unlikely. TACE may be considered a palliative or symptomatic approach for individuals with advanced disease, a poor prognosis, and limited treatment options.

TACE AS NEOADJUVANT/ADJUVANT TREATMENT BEFORE OR AFTER CURATIVE LIVER RESECTION

The objective of neoadjuvant therapy is to prevent tumor shedding or to reduce tumor mass to make surgical resection easier. Adjuvant treatment is provided after surgery in an effort to suppress tumor recurrences. Use of TACE as neoadjuvant or adjuvant therapy pre- or post-surgery has been proposed, but there is no definitive evidence that these approaches prolong survival, and most experts agree that more study is required. In addition, there is insufficient evidence to support TACE use for recurrent HCC after curative liver resection.

TACE FOR TREATMENT OF CHOLANGIOCARCINOMA

The only curative approaches for the treatment of cholangiocarcinoma are surgery or transplantation, and individuals with cholangiocarcinoma may have poor prognosis even after surgery. Additionally, by the time the diagnosis for this disease is made, the majority of patients have unresectable cholangiocarcinoma. There is a lack of standardized treatment regimens for unresectable cholangiocarcinoma. The choices of treatment in those with unresectable cholangiocarcinoma include systemic chemotherapy that may have partial efficacy, palliative biliary drainage and stenting (in extrahepatic cholangiocarcinoma), or locoregional therapies such as TACE. Participation in a clinical trial is also another option that is available to explore an unproven therapy.

Evidence regarding safety and efficacy of treatment modalities such as TACE is limited when this therapy is employed for unresectable cholangiocarcinoma. Unresectable intrahepatic cholangiocarcinoma may have slightly better outcomes than unresectable extrahepatic disease when TACE is administered; however, evidence and clinical consensus suggest that this therapy may be offered only as a palliative option for unresectable cholangiocarcinoma.

TACE FOR TREATMENT OF LIVER METASTASES FROM COLORECTAL CANCER

For patients with liver metastases from CRC who do not qualify for surgical resection, traditionally,
systemic chemotherapy is first-line treatment. However, in more than 60% of cases, the treatment fails and disease progresses. For the large proportion of patients in whom second- and third-line medical treatment has failed, other palliative therapies to control disease progression and symptoms have been studied, including TACE.

The literature has reported a median survival in patients with liver-dominant colorectal metastases treated with chemoembolization from 7 to 25 months. However, studies are difficult to compare, as some patients who were treated were still eligible for systemic chemotherapy, and survival was sometimes calculated and reported as a mean time from the date of diagnosis of liver metastases rather than from the first treatment with TACE.

Vogl et al evaluated tumor control and survival in 463 patients with unresectable liver metastases of colorectal origin that did not respond to systemic chemotherapy and were treated with TACE. Of the 463 patients, 67% had 5 or more metastases, 8% had 1 metastasis, 10% had 2, and 14% had 3 or 4. Patients were treated at 4-week intervals, with a total of 2441 chemoembolization procedures performed (mean, 5.3 sessions per patient), using one of 3 local chemotherapy protocols. Local tumor control was PR in 68 patients (14.7%), stable disease in 223 patients (48.2%), and progressive disease in 172 patients (37.1%). Median survival from the start of TACE treatments was 14 months (compared with the results from a previous study by the same author, in which untreated patients had a survival rate of 7 to 8 months).48 One-year survival rate after TACE was 62% and 28%, respectively, at 2 years. No difference in survival was observed between the 3 different local chemotherapy protocols.

Hong et al compared salvage therapy for liver-dominant colorectal metastatic adenocarcinoma using TACE or 90-yttrium radioembolization. Mean dominant lesion sizes were 9.3 cm and 8.2 cm in the chemoembolization and radioembolization groups, respectively. Multilobar disease was present in 67% and 87% of the respective groups, and extrahepatic metastases were present in 43% and 33%, respectively. Of 36 patients, 21 underwent TACE, with a median survival of 7.7 months (survival measured from the date of the first TACE treatment to the date of death or to April 2007, if still living). Survival results were comparable with other studies addressing CRC and TACE, which ranged from 7 to 10 months. Median survival was 6.9 months for the radioembolization group (p=0.27). The 1-, 2-, and 5- year survival rates for the 2 groups were 43%, 10%, and 0%, respectively, for the chemoembolization group and 34%, 18%, and 0%, respectively, for the radioembolization group.

Richardson et al reported on a systematic review of 1 RCT and 5 observational studies on TACE with irinotecan-eluting beads for unresectable colorectal liver metastasis. Survival times ranged from a median of 15.2 months to 25 months. The most common AE was postembolization syndrome (abdominal pain, nausea, vomiting) followed by hypertension. In the RCT included in the Richardson systematic review, Fiorentini et al reported on 74 patients randomly allocated to TACE with irinotecan-eluting beads (n=36) or systemic irinotecan, fluorouracil and leucovorin (n=38).49 With irinotecan-eluting beads, OS was significantly longer with a median OS of 22 months (95% CI, 21 to 23 months) versus 15 months (95% CI, 12 to 18) for the systemic chemotherapy group (p=0.031). PFS was significantly longer at 7 months (95% CI, 3 to 11) in the irinotecan-eluting beads group compared with 4 months (95% CI, 3 to 5) months in the systemic chemotherapy group (p=0.006). However, larger studies are needed to confirm these findings.

A majority of the studies that have investigated TACE for treatment of liver metastases from colorectal cancer have consisted of small numbers of patients or they have suffered from other limitations and biases due to study designs. The results have been variable across studies due to variation in patient selection criteria and regimens used between different studies. For instance, studies are difficult to compare because some patients who were treated were still eligible for systemic chemotherapy, and survival was sometimes calculated and reported as a mean time from the date of diagnosis of liver metastases rather than from the first treatment with TACE.

TACE FOR HEPATIC METASTASES FROM BREAST CANCER AND OTHER METASTASES

Vogl et al (2010) reported the efficacy of repeated treatments with TACE in 208 patients with unresectable hepatic metastases from breast cancer. A total of 1068 chemoembolizations were performed (mean, 5.1 sessions per patient; range, 3-25). Mean patient age was 56.4 years (range, 29-81). Patients received either 1 of 2 chemotherapeutic agents alone (mitomycin-C or gemcitabine) or in combination. Tumor response was evaluated by magnetic resonance imaging according to RECIST criteria. For all chemotherapy protocols, local tumor control was PF 13% (27/208), stable disease 50.5% (105/208), and progressive disease 36.5% (76/208). The 1-, 2-, and 3-year survival rates after TACE were 69%, 40%, and 33%. Median and mean survival times from the beginning of the TACE sessions were 18.5 and 30.7 months. Treatment with mitomycin-C only showed median and mean survival times of 13.3 and 24 months, and with gemcitabine only 11 and 22.3 months. With a combination of mitomycin-C and gemcitabine, median and mean survival times were 24.8 and 35.5 months (all results are respectively).

Studies investigating TACE for Hepatic Metastases From Breast Cancer and Other Metastases have consisted of small numbers of patients, and the results have been variable across studies due to variation in patient selection criteria and regimens used between different studies. At this time, the data do not support the use of TACE in these settings.

NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN) GUIDELINES
  • Hepatocellular carcinoma (v.2.2014): chemoembolization is listed as an option for patients with unresectable HCC with tumors not amenable to ablation therapy only and in the absence of large-volume extrahepatic disease (category 2A_, with the additional recommendation that tumor lesions larger than 5 cm should be treated using arterial embolic approaches, whereas those tumors 3 to 5 cm can be considered for combination therapy with ablation and arterial embolization. Additionally, TACE is relatively contraindicated in patients with portal vein thrombosis and bilirubin levels greater than 3 mg/dL and absolutely contraindicated with Child-Pugh class C liver function.
  • Intrahepatic cholangiocarcinoma (v.2.2014): does not address the use of TACE in intrahepatic cholangiocarcinoma.
  • Neuroendocrine tumors, carcinoid, and islet cell tumors (v.2.2014): chemoembolization is recommended for patients with unresectable liver metastases (category 2B).
  • Colon cancer (v1.2015): the use of arterially-directed embolic therapy for metastatic colon cancer to the liver has a category 3 recommendation (based on any level of evidence, there is major National Comprehensive Cancer Network [NCCN] disagreement about whether the intervention is appropriate).
  • No NCCN guidelines were identified for ocular malignancies.
  • Breast cancer (v3.2014): TACE is not addressed as a treatment option for breast cancer metastatic to the liver.

References


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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

37243, 75894


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C22.0 Liver cell carcinoma

C22.8 Malignant neoplasm of liver, primary, unspecified as to type

C22.1 Intrahepatic bile duct carcinoma

C22.9 Malignant neoplasm of liver, not specified as primary or secondary

C24.0 Malignant neoplasm of extrahepatic bile duct

C24.8 Malignant neoplasm of overlapping sites of biliary tract

C24.9 Malignant neoplasm of biliary tract, unspecified

C25.4 Malignant neoplasm of endocrine pancreas

C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct

C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct

C78.89 Secondary malignant neoplasm of other digestive organs

C7B.02 Secondary carcinoid tumors of liver

D01.5 Carcinoma in situ of liver, gallbladder and bile ducts

E34.0 Carcinoid syndrome




HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 07.05.06f
09/12/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Transcatheter Arterial Chemoembolization (TACE) of Hepatic Malignancies.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 10/02/2015
Version Issued Date: 10/02/2015
Version Reissued Date: 09/12/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.