Subject:
Radiation Therapy for Hepatobiliary Cancer
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Over the past several decades, methods to plan and deliver radiation therapy have evolved in ways that permit more precise targeting of tumors with complex geometries. Earlier methods involved two-dimensional treatment planning based on flat images, and radiation beams with cross-sections of uniform intensity that were sequentially aimed at the tumor along 2 or 3 intersecting axes. These methods were collectively termed conventional external beam radiation therapy (EBRT).
Subsequent enhancement evolved using 3-dimensional images, usually from computed tomography (CT) scans, to delineate the tumor, its boundaries with adjacent normal tissue, and organs at risk for radiation damage. Radiation oncologists used these images, displayed from a "beam's-eye-view", to shape each of several beams (e.g., with compensators, blocks, or wedges) to conform to the patient's tumor geometry perpendicular to the beam's axis. Computer algorithms were developed to estimate cumulative radiation dose delivered to each volume of interest by summing the contribution from each shaped beam. Methods also were developed to position the patient and the radiation portal reproducibly for each fraction, and immobilize the patient, thus maintaining consistent beam axes across treatment sessions. However, "forward" planning used a trial and error process to select treatment parameters (the number of beams and the intensity, shape, and incident axis of each beam). The planner/radiotherapist modified one or more parameters and recalculated dose distributions, if analysis predicted underdosing for part of the tumor or overdosing of nearby normal tissue. Furthermore, since beams had uniform cross-sectional intensity wherever they bypassed shaping devices, it was difficult to match certain geometries (e.g., concave surfaces). Collectively, these methods are termed 3-dimensional conformal radiation therapy (3D-CRT).
Other methods were subsequently developed to permit beam delivery with non-uniform cross-sectional intensity. This often relies on a device (multi-leaf collimator, MLC) situated between the beam source and patient that moves along an arc around the patient. As it moves, a computer varies aperture size independently and continuously for each leaf. Thus, MLCs divide beams into narrow "beamlets", with intensities that range from zero to 100% of the incident beam. Beams may remain on as MLCs move around the patient (dynamic MLC), or they may be off during movement and turned on once the MLC reaches prespecified positions ("step and shoot" technique). Another method of delivering radiation beam uses a small radiation portal emitting a single narrow beam that moves spirally around the patient, with intensity varying as it moved. This method, also known as tomotherapy or helical tomotherapy, is described as the use of a linear accelerator inside a large "donut" that spirals around the body while the patient laid on the table during treatment. Each method (MLC-based or tomotherapy) is coupled to a computer algorithm for "inverse" treatment planning. The planner/radiotherapist delineates the target on each slice of a CT scan, and specifies that target's prescribed radiation dose, acceptable limits of dose heterogeneity within the target volume, adjacent normal tissue volumes to avoid, and acceptable dose limits within the normal tissues. Based on these parameters and a digitally-reconstructed radiographic image of the tumor and surrounding tissues and organs at risk, computer software optimizes the location and shape of beam ports, and beam and beamlet intensities, to achieve the treatment plan's goals. Collectively, these methods are termed intensity-modulated radiation therapy (IMRT).
According to ECRI Institute, there are two different approaches to image-guided radiation therapy that are in current use: pre-treatment imaging and real-time guidance. IMRT is an example of a method that uses pre-treatment imaging to prepare a treatment plan. In contrast, real-time guidance utilizes real-time imaging (at the time of treatment) to guide treatment. It provides real-time, online images of the radiation target area from a computed tomography (CT) scanner before, during, and after therapy. Patient positioning, radiation field alignment, and collimator positioning can be verified and adjusted before and during irradiation. This approach should, in theory, provide more accurate radiation delivery than conventional IMRT. Organ motion, day-to-day variations in tumor position, and differences in patient positioning in each treatment session could be taken into account with real-time imaging.
Policy:
(NOTE: This policy only applies to adult members. It does not apply to pediatric members.
For treatment using proton beam therapy, please refer to a separate policy on 'Proton Beam Radiation Therapy' - Policy #011 in the Radiology Section.
For treatment using selective internal radiation therapy (SIRT), please refer to the policy on 'Radiation Therapy with Yttrium-90 Microspheres' - Policy #054 in the Treatment Section.
For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
I. Primary Hepatocellular Carcinoma (HCC)
A. Definitive treatment
1. In the treatment of medically or technically unresectable localized HCC in an individual with adequate hepatic reserve
a. The use of 25 to 39 fractions of three-dimensional conformal radiation therapy (3DCRT) or intensity-modulated radiation therapy (IMRT) is considered medically necessary.
b. The use of 3 to 5 fractions of stereotactic body radiation therapy (SBRT) is considered medically necessary to treat concurrently one or more tumors when there is evidence of the ability to protect an adequate volume of uninvolved liver.
B. Palliative treatment
1. In an individual with localized disease or local disease with minimal extrahepatic disease, up to 20 fractions of 3DCRT is considered medically necessary.
II. Intrahepatic Bile Duct Cancer (Cholangiocarcinoma)
A. Definitive treatment
1. In the management of unresectable localized intrahepatic bile duct cancer
a. The use of 25 to 33 fractions of 3DCRT or IMRT is considered medically necessary.
b. The use of up to 5 fractions of SBRT is considered medically necessary.
B. Adjuvant (postoperative) treatment
1. In the management of resected intrahepatic bile duct cancer with positive margins and/or positive regional lymph nodes
a. The use of 25 to 33 fractions of 3DCRT or IMRT is considered medically necessary.
C. Palliative treatment
1. In an individual with unresectable localized intrahepatic bile duct cancer, up to 20 fractions of 3DCRT is considered medically necessary.
III. Extrahepatic Bile Duct Cancer (Cholangiocarcinoma)
A. Definitive treatment
1. In the management of unresectable localized extrahepatic bile duct cancer
a. The use of 25 to 33 fractions of 3DCRT is considered medically necessary.
b. The use of SBRT is not considered medically necessary.
B. Adjuvant (postoperative) treatment
1. In the management of resected extrahepatic bile duct cancer
a. The use of 25 to 33 fractions of 3DCRT is considered medically necessary.
b. The use of SBRT is not considered medically necessary.
C. Palliative Treatment
1. In an individual with unresectable localized extrahepatic bile duct cancer, up to 20 fractions of 3DCRT is considered medically necessary.
IV. Gallbladder Cancer
A. Definitive treatment
1. In the management of unresectable localized gallbladder cancer
a. The use of 25 to 33 fractions of 3DCRT is considered medically necessary.
b. The use of SBRT is not considered medically necessary.
B. Adjuvant (postoperative) treatment
1. In the management of resected gallbladder cancer with positive margins and/or positive regional lymph nodes
a. The use of 25 to 33 fractions of 3DCRT is considered medically necessary.
b. The use of SBRT is not considered medically necessary.
C. Palliative treatment
1. In an individual with unresectable localized gallbladder cancer, up to 20 fractions of 3DCRT is considered medically necessary.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for External beam photon radiation therapy (EBRT), stereotactic body radiation therapy (SBRT) or 3DCRT. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for Radiation Therapy for Hepatobiliary Cancer for External beam photon radiation therapy (EBRT), stereotactic body radiation therapy (SBRT) or 3DCRT.
Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has issued a determination for Intensity-Modulated Radiation Therapy (IMRT). Per LCD L36711 and Local Coverage Article: Billing and Coding: Intensity Modulated Radiation Therapy (IMRT) (A56725), IMRT is covered for limited indications when LCD L36711 and A56725 criteria is met.
For additional information and eligibility, refer to Local Coverage Determination (LCD): Intensity Modulated Radiation Therapy (IMRT) (L36711) and Local Coverage Article: Billing and Coding: Intensity Modulated Radiation Therapy (IMRT) (A56725). Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36711&ver=18&name=314*1&UpdatePeriod=749&bc=AAAAEAAAAAAAAA%3d%3d&.
[INFORMATIONAL NOTE: Key Clinical Points
I. Primary Liver Cancer (HCC)
The incidence of HCC is increasing in the United States, most notably in the population infected with hepatitis C virus that have developed cirrhosis. Cirrhosis from other causes, such as genetic hemochromatosis, also carries a high risk of developing HCC. Because of the underlying cirrhosis, the healthy liver reserve is often decreased. Screening of populations known to be at high risk for HCC has led to an increased rate of detection of HCC and often at an earlier stage amenable to local treatment.
Prior to treatment, an assessment of liver health is necessary and is traditionally quantitated using the Child-Pugh classification system. The Child-Pugh score is based on laboratory and clinical measures and assigns a patient with cirrhosis into compensated (class A) or uncompensated (class B or C) status. Additional measures of liver health include factors of portal hypertension and the presence of varices. The Model for End-stage Liver Disease (MELD) includes a numerical scale that often is applied when there is consideration of liver transplantation.
There are three types of HCC based on morphology: nodular (most commonly associated with cirrhosis), massive (most commonly in a non-cirrhotic liver), and diffuse (numerous nodules throughout the liver).
Numerous staging systems have been devised for HCC; each often having its own specific applicability, such as prognosis, suitability for a given intervention, or based on HCC etiology. National Comprehensive Cancer Network (NCCN®) categories include potentially resectable or transplantable based on performance status or comorbidities, unresectable, inoperable based on performance status or comorbidities with local disease only, and metastatic disease.
Management of HCC depends on etiology and the underlying health of uninvolved liver. Partial hepatectomy, liver transplantation, bridge therapy while awaiting transplantation, downstaging strategies, and locoregional therapies are potentially available. Locoregional therapies include ablation (chemical, thermal, cryo) with criteria regarding tumor number, size, location, and general liver health often dictating the ideal approach. Locoregional therapy may be performed by laparoscopic, percutaneous, or open approach. Arterially directed therapy involves the selective catheter-based infusion of material that causes embolization of tumors using bland, chemotherapy-impregnated, or radioactive products.
External Beam Radiation Therapy (EBRT) is a treatment option for certain cases of HCC not amenable to resection for technical or medical reasons, and can be delivered using one of several available highly-conformal techniques such as 3DCRT, IMRT and SBRT. Proton Beam Therapy (PBT) generally is not medically necessary but may be considered in unique clinical settings. (See Proton Beam Therapy guideline) For each technique, there must be sufficient uninvolved liver such that the technique is capable of respecting the tolerance of normal liver tissue. Several radiation schedules are available, including hypofractionation, SBRT (1 to 5 fractions), and conventional fractionation. Safety data are limited for treating other than Child-Pugh class A cases. A dose modification is needed when treating Child-Pugh class B. Radiation therapy is generally not given for class C cases. Combinations of several locoregional therapies may be required. Locoregional management may serve as a bridge to liver transplant.
For the many cases of HCC that are advanced at the time of presentation and not amenable to locoregional therapies with intent to cure, systemic therapy has been employed. Systemic therapies include cytotoxic chemotherapy drugs and the multikinase angiogenesis inhibitor sorafenib. These are most commonly utilized in Child-Pugh class A patients, where data demonstrating a benefit in overall survival and better tolerance have been reported. While the intent of locoregional therapy is local control, EBRT may also play a role of palliation of symptoms in the liver, or distantly in cases of metastatic disease.
II. Intrahepatic Bile Duct Cancer (Cholangiocarcinoma)
The junction of the right and left hepatic ducts serves as the dividing location. Cholangiocarcinomas that occur on the hepatic side of the junction of the right and left hepatic ducts within the hepatic parenchyma are also known as intrahepatic bile duct cancers, or "peripheral cholangiocarcinomas". Those cancers that occur at or near the junction of the right and left hepatic ducts are known as Klatskin tumors and are considered extrahepatic. Early stage cancers in this location are less likely to present with biliary obstruction than their extrahepatic counterparts. Symptoms may be nonspecific, and detection may be incidental. They are typically adenocarcinomas. Surgical resection has the highest potential for cure, though surgery is often not possible due to local extent of disease or metastases. Highest surgical cure rates are seen if there is only one lesion, vascular invasion is not present, and lymph nodes are not involved.
The role of adjuvant radiation therapy after resection is not firmly established, but is considered an option for adjuvant management in the post-resection R1 and R2 situations, and/or when nodes are positive, for definitive management of unresectable tumors, and for palliation. Numerous other methods of locoregional treatment, such as radiofrequency ablation, transarterial chemoembolization and photodynamic therapy are available. The use of intraluminal brachytherapy (low dose rate [LDR] or high dose rate [HDR]) has been described and may be useful in unique situations. Data are limited; the optimal approach is not established.
The selection of radiation technique and the use of concurrent chemotherapy are best made in the context of a multidisciplinary approach. When radiation therapy is used, the preservation of normal liver function and respect for constraints of nearby other normal organs must be maintained. When SBRT has been employed for larger lesions, doses >80.5 Gy biologically equivalent dose (BED) have been found to be effective. When SBRT type technique is used for more than 5 fractions, it is to be reported as 3DCRT or IMRT.
III. Extrahepatic Bile Duct Cancer (Cholangiocarcinoma)
The junction of the right and left hepatic ducts serves as the dividing location of intra- and extrahepatic bile duct cancers. Those extrahepatic cholangiocarcinomas that arise near the right and left hepatic duct junction are known as hilar or Klatskin tumors. Those more distal may occur anywhere along the common bile duct down to near the ampulla of Vater. They are typically adenocarcinomas, and are more likely to present with bile duct obstruction than their intrahepatic counterpart. Surgical resection is the only potentially curative treatment.
As the incidence is low, there is no firmly established role of radiation therapy, though its use is an accepted option in postoperative cases of R0, R1, R2 margins and/or positive nodes. When radiation therapy is used, the preservation of normal liver function and respect for constraints of nearby other normal organs must be maintained, especially the small bowel, stomach, and kidneys. Data to support specific regimens are limited.
The selection of radiation technique and the use of concurrent chemotherapy are best made in the context of a multidisciplinary approach. Because of the proximity to hollow viscus structures, daily doses in excess of 2.2 Gy are avoided.
IV. Gallbladder Cancer
Gallbladder cancers are the most common of the biliary tract cancers, tend to be very aggressive, and most commonly are adenocarcinomas. They tend to invade locally and cause both nodal and distant metastases. A common presentation of gallbladder cancer is to be diagnosed at the time of cholecystectomy for what was preoperatively thought to be cholecystitis. Complete resection provides the only realistic chance for cure, the likelihood of which decreases as the extent of surgery needs to increase to achieve clear margins.
The use of adjuvant radiation therapy after resection appears to be most beneficial in patients with T2 and higher primary tumor status, or if nodes are positive, and is most commonly given concurrent with capecitabine or gemcitabine. T1a and T1b, N0 cases have not been shown to benefit from adjuvant radiation, which may be omitted. Because of the proximity to hollow viscus structures, daily doses in excess of 2.2 Gy are avoided, unless the target is within the hepatic parenchyma.
Definitive radiation therapy along with fluoropyrimidine-based chemotherapy is as an option for patients with unresectable gallbladder cancer that has not spread beyond a locoregional state. Such an approach often becomes a palliative exercise, and should be weighed against other means of palliation that includes biliary decompression followed by chemotherapy.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Radiation Therapy for Hepatobiliary Cancer
Radiation Treatment of Hepatobiliary Cancer
Hepatobiliary Cancer, Radiation Treatment of
Radiation Treatment of Primary Liver Cancer
Liver Cancer, Primary, Radiation Treatment of
Radiation Treatment of Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), Radiation Treatment of
HCC (Hepatocellular Carcinoma), Radiation Treatment of
Radiation Treatment of Intrahepatic Bile Duct Cancer
Intrahepatic Bile Duct Cancer, Radiation Treatment of
Radiation Treatment of Extrahepatic Bile Duct Cancer
Extrahepatic Bile Duct Cancer, Radiation Treatment of
Radiation Treatment of Bile Duct Cancer
Bile Duct Cancer, Radiation Treatment of
Radiation Treatment of Gallbladder Cancer
Galbladder Cancer, Radiation Treatment of
References:
1. Ben-Josef E, Guthrie KA, El-Khoueiry AB, et al. SWOG S0809: A phase II intergroup trial of adjuvant capecitabine and gemcitabine followed by radiotherapy and concurrent capecitabine in extrahepatic cholangiocarcinoma and gallbladder carcinoma. Journal of Clinical Oncology. 2015 Aug 20; (33)24: 2617-2622. doi:10.1200/JCO.2014.60.2219.
2. Carr, BI (editor). Introduction: Hepatocellular carcinoma. Seminars in Oncology. 2012 Aug; 39(4):p367-522, e9-e22.
3. Mazloom A, Hezel AF, Katz AW. Stereotactic body radiation therapy as a bridge to transplantation and for recurrent disease in transplanted liver of a patient with hepatocellular carcinoma. Case Rep Oncol. 2014 Jan-Apr; 7(1):18-22.
4. National Comprehensive Cancer Network (NCCN) Guidelines® Version 4.2019 – December 20, 2019. Hepatobiliary Cancers. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers 4.2019. 2019 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN®. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org.
5. National Comprehensive Cancer Network (NCCN) Radiation Therapy Compendium™. https://www.nccn.org/professionals/radiation/content/.
6. O’Connor JK, Trotter, J, Davis GL, et al. Long-term outcomes of stereotactic body radiation therapy in the treatment of hepatocellular cancer as a bridge to transplantation. Liver Transpl. 2012 Aug; 18(8):949-954.
7. Radiation Therapy Oncology Group (RTOG) Protocol 1112: Randomized Phase III Study of Sorafenib versus Stereotactic Body radiation Therapy followed by Sorafenib in Hepatocellular Carcinoma.
8. Tao, R, Krishnan S, Bhosale PR, et al. Ablative radiotherapy doses lead to a substantial prolongation of survival in patients with inoperable intrahepatic cholangiocarcinoma: A retrospective dose response analysis. J Clin Oncol. 2016 Jan 20; 34(3):219-226.
9. Wahl DR, Stenmark MH, Tao Y. Outcomes after stereotactic body radiotherapy or radiofrequency ablation for hepatocellular carcinoma. J Clin Oncol. 2016 Feb 10; 34(5):42-459.
10. Wang SJ, Fuller CD, Jong-Sung K, et al. Prediction model for estimating the survival benefit of adjuvant radiotherapy for gallbladder cancer. J Clin Oncol. 2008 May 1; 26(13):2112-2117.
11. Wang SJ, Lemieux A, Kalpathy-Cramer J, et al. Nomogram for predicting the benefit of adjuvant chemoradiotherapy for resected gallbladder cancer. J Clin Oncol. 2011 Dec 10; 29(35):4627-4632.
12. Welling TH, Feng M, Wan S, et al. Neoadjuvant stereotactic body radiation therapy, capecitabine, and liver transplantation for unresectable hilar cholangiocarcinoma. Liver Transpl. 2014 Jan; 20(1)81-88.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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