Subject:
Radiation Therapy for Hodgkin Lymphoma
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 Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
I. Definitive radiation therapy
A. Definitive radiation therapy as sole therapy is medically necessary for selected cases of stage I-IIA lymphocyte predominant Hodgkin lymphoma
1. Doses ranging from 30 to 36 Gy in a single phase may be required
2. Complex, three dimensional (3D) Conformal Radiation Therapy (3DCRT) or Intensity-Modulated Radiation Therapy (IMRT) techniques may be used
II. Adjuvant radiation therapy (combined modality treatment) after chemotherapy
A. Radiation treatment regimens following chemotherapy depend on clinical stage, presence or absence of bulky disease, the chemotherapy regimen used (ABVD or Stanford V), as well as the response to treatment (Positron Emission Tomography [PET] scan Deauville 3-4)
1. Doses ranging from 20 to 45 Gy with conventional fractionation may be required
2. Complex, 3DCRT or IMRT techniques are medically necessary
B. Combined modality treatment after chemotherapy is medically necessary in some cases of individuals with stage III-IV disease, to areas of initial bulky involvement or to areas of less than a complete response (CR)
1. Doses ranging from 20 to 45 Gy with conventional fractionation may be required
2. Complex, 3DCRT or IMRT techniques are medically necessary, directed at up to 4 separate sites, in up to 2 phases apiece
C. Concurrent chemotherapy carries a high toxicity burden, requires substantial supportive care, and the expertise of an experienced multidisciplinary team
III. Salvage radiation therapy
A. Salvage radiation therapy is medically necessary after chemotherapy to areas of relapsed bulky involvement
1. Doses ranging from 20 to 45 Gy with conventional fractionation may be required
2. Complex, 3DCRT or IMRT techniques are medically necessary, directed at up to 4 separate sites, in up to 2 phases apiece
B. Salvage radiation therapy is medically necessary in an individual who relapses after solo chemotherapy for initial stage I/IIA disease
1. Definitive radiation doses ranging from 30 to 45 Gy using conventional fractionation may be required
2. Depending on the extent of the disease, Complex, 3DCRT or IMRT techniques may be necessary
a. Treatment of up to 3 sites may be required with up to 2 phases per site
b. Complex, 3DCRT, or IMRT techniques may be used
IV. Palliative radiation therapy
A. In an individual with advanced or recurrent disease that is felt not to be curative and who has symptomatic local disease, photon and/or electron techniques are indicated for symptom control
1. Up to 10 fractions are medically necessary in 1 phase
2. Complex, 3DCRT, or IMRT techniques may be used
V. Radiation therapy, photon and/or electron techniques:
A. Complex, 3DCRT, and IMRT techniques are medically necessary
B. Respiratory gating techniques and image guidance techniques may be appropriate to minimize the amount of critical tissue (such as lung) that is exposed to the full dose of radiation. IGRT may be approved for 3D treatment in the thorax or for small volume fields elsewhere
C. The use of photon beam and/or electron beam radiation therapy may be medically necessary.
Medicare Coverage:
There is no National Coverage Determination (NCD) for Radiation Treatment for Hodgkin's Lymphoma. In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for complex, three-dimensional conformal radiation therapy (3DCRT) or photon and/or electron beam radiation therapy for Hodgkin's Lymphoma. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for complex, three-dimensional conformal radiation therapy (3DCRT) and photon and/or electron beam radiation therapy for Hodgkin's Lymphoma.
Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has issued a determination for Intensity-Modulated Radiation Therapy (IMRT). Medicare Advantage Products follow LCD L36711 for Intensity Modulated Radiation Therapy (IMRT). For additional information and eligibility, refer to Local Coverage Determination (LCD): Intensity Modulated Radiation Therapy (IMRT) (L36711). 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&.
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: Based upon established criteria, assessment of peer-reviewed literature, and consensus present in established guidelines (American College of Radiology [ACR]/American Society for Radiation Oncology [ASTRO], National Comprehensive Cancer Network [NCCN]), radiation therapy is considered an integral component in the multi-disciplinary management of Hodgkin lymphoma (HD). Proper management of the disease requires the cooperation of a complex multi-disciplinary team that includes experts in diagnostic imaging, pathology, radiation oncology and medical oncology. HD treatment is based on initial stage of disease as well as the medical condition of the individual, and treatment is dynamically modified based on the speed and extent of response to initial therapy. At diagnosis, areas of involvement may be supra-diaphragmatic only, sub-diaphragmatic only, or a combination of the two in the more advanced stages. The stage determines decisions made about the proper extent of radiation. The varied pathologic subtypes, for the most part at present, do not materially affect the dose or field decisions to be made in this disease.
Treatment decisions are preceded by workup and staging and planned in conjunction with the appropriate members of the multi-disciplinary team.
Initial management will usually require chemotherapy (in a variety of different acceptable regimens), followed by assessment of response, leading to an appropriate choice of doses and fields of radiation therapy. Chemotherapy alone may be appropriate for early stage non-bulky disease, with radiation therapy reserved for relapse. As mentioned in the Policy section, treatment is individualized depending on the initial clinical stage, presence or absence of bulky disease, chemotherapy regimen used, and response to chemotherapy as evaluated by repeat staging including a PET scan with results incorporating the Deauville criteria.]
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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 Hodgkin Lymphoma
Radiation Treatment for Hodgkin Lymphoma
Hodgkin Lymphoma, Radiation Treatment for
References:
1. Abuzetun JY, Loberiza F, Vose J, et al. The Stanford V regimen is effective in patients with good risk Hodgkin lymphoma but radiotherapy is a necessary component. Br J Haematol. 2009 Feb;144(4):531- 537.
2. Aleman BMP, Raemaekers JMM, Tirelli U, et al. Involved-field radiotherapy for advanced Hodgkin’s lymphoma. N Engl J Med. 2003 Jun 12; 348(24):2396-2406.
3. Aleman BM, Raemaekers JMM, Tomiŝiĉ R, et al. Involved-field radiotherapy for patients in partial remission after chemotherapy for advanced Hodgkin’s lymphoma. Int J Radiat Oncol Biol Phys. 2007 Jan 1; 67(1):19-30.
4. Aversa SM, Salvagno L, Soraru M, et al. Stanford V regimen plus consolidative radiotherapy is an effective therapeutic program for bulky or advanced-stage Hodgkin’s disease. Acta Haematol. 2004 August; 112(3):141-147.
5. Behar RA, Horning SJ, Hoppe RT. Hodgkin’s disease with bulky mediastinal involvement: Effective management with combined modality therapy. Int J Radiat Oncol Biol Phys. 1993 Apr 2; 25(5):771-776.
6. Bonadonna G, Bonfante V, Viviani S, et al. ABVD plus subtotal nodal versus involved-field radiotherapy in early-stage Hodgkin’s disease: Long-term results. J Clin Oncol. 2004 Jul 15; 22(14):2835-2841.
7. Canellos GP, Abramson JS, Fisher DC, et al. Treatment of favorable, limited-stage Hodgkin’s lymphoma with chemotherapy without consolidation by radiation therapy. J Clin Oncol. 2010 Mar 20; 28(9):1611-1615.
8. Cella L, Liuzzi R, Conson M, et al. Multivariate normal tissue complication probability modeling of heart valve dysfunction in Hodgkin lymphoma survivors. Int J Radiat Oncol Biol Phys. 2013 Oct 1; 87(2):304-310.
9. de Vathaire F, El-Fayech C, Ayed FFB, et al. Radiation dose to the pancreas and risk of diabetes mellitus in childhood cancer survivors: a retrospective cohort study. Lancet Oncol. 2012 Oct; 13(10):1002-1010.
10. Domínguez AR, Marquez A, Gumá J, et al. Treatment of stage I and II Hodgkin’s lymphoma with ABVD chemotherapy: results after 7 years of a prospective study. Ann Oncol. 2004 Dec; 15(12):1798-1804.
11. Edwards-Bennett SM, Jacks LM, Moskowitz CH, et al. Stanford V program for locally extensive and advanced Hodgkin lymphoma: the Memorial Sloan-Kettering Cancer Center experience. Ann Oncol. 2010 Mar; 21(3):574-581.
12. Engert A, Franklin J, Eich HT, et al. Two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine plus extended-field radiotherapy is superior to radiotherapy alone in early favorable Hodgkin’s lymphoma: Final results of the GHSG HD7 trial. J Clin Oncol. 2007 Aug 10; 25(23):3495-3502.
13. Engert A, Schiller P, Josting A, et al. Involved-field radiotherapy is equally effective and less toxic compared with extended-field radiotherapy after four cycles of chemotherapy in patients with early-stage unfavorable Hodgkin’s lymphoma: Results of the HD8 trial of the German Hodgkin’s Lymphoma Study Group. J Clin Oncol. 2003 Oct 1; 21(19):3601-3608.
14. Fabian CJ, Mansfield CM, Dahlberg S, et al. Low-dose involved field radiation after chemotherapy in advanced Hodgkin disease. A Southwest Oncology Group randomized study. Ann Intern Med. 1994 Jun 1; 120(11):903-912.
15. Fermé C, Eghbali H, Meerwaldt JH, et al. Chemotherapy plus involved-field radiation in early-stage Hodgkin’s disease. N Engl J Med. 2007 Nov 8;357(19):1916-1927.
16. Fox AM, Dosoretz AP, Mauch PM, et al, Predictive factors for radiation pneumonitis in Hodgkin lymphoma patients receiving combined-modality therapy. Int J Radiat Oncol Biol Phys. 2012 May 1; 83(1):277-282.
17. Gobbi PG, Levis A, Chisesi T, et al. ABVD versus modified Stanford V versus MOPPEBVCAD with optional and limited radiotherapy in intermediate- and advanced-stage Hodgkin’s lymphoma: Final results of a multicenter randomized trial by the Intergruppo Italiano Linfomi. J Clin Oncol. 2005 Dec 20; 23(38):9198-9207.
18. Hoppe RT. Hodgkin’s lymphoma: The role of radiation in the modern combined strategies of treatment. Hematol Oncology Clin North Am. 2007; 21(5):915-927.
19. Horning SJ, Hoppe RT, Breslin S, et al. Stanford V and radiotherapy for locally extensive and advanced Hodgkin’s disease: Mature results of a prospective clinical trial. J Clin Oncol. 2002 Feb 1; 20(3):630-637.
20. Hoskin PJ, Lowry L, Horwich A, et al. Randomized comparison of the Stanford V regimen and ABVD in the treatment of advanced Hodgkn’s lymphoma: United Kingdom National Cancer Research Institute Lymphoma Group Study ISRCTN 64141244. J Clin Oncol. 2009 Nov 10; 27(32):5390-5396.
21. Jacobson CA, Longo DL. Management of early-stage Hodgkin’s lymphoma. PPO Updates. Principles & Practice of Oncology. 2011. 25(2).
22. Johnson PWM, Sydes MR, Hancock BW, et al. Consolidation radiotherapy in patients with advanced Hodgkin’s lymphoma: Survival data from the UKLG LY09 Randomized Controlled Trial (ISRCTN97144519). J Clin Oncol. 2010 Jul 10; 28(20):3352-3359.
23. Laskar S, Gupta T, Vimal S, et al. Consolidation radiation after complete remission in Hodgkin’s disease following six cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine chemotherapy: Is there a need? J Clin Oncol. 2004 Jan 1; 22(1):62-68.
24. Longo D, Glatstein E, Duffey P, et al. Radiation therapy versus combination chemotherapy in the treatment of early-stage Hodgkin’s disease: seven-year results of a prospective randomized trial. J Clin Oncol. 1991 Jun 1; 9(6):906-917.
25. Longo DL, Russo A, Duffey PL, et al. Treatment of advanced- stage massive mediastinal Hodgkin’s disease: the case for combined modality treatment. J Clin Oncol. 1991; 9(2):227-235.
26. Macdonald DA, Connors JM. New strategies for the treatment of early stages of Hodgkin’s lymphoma. Hematol Oncol Clin North Am. 2007; 21(5):871-880.
27. Meyer RM, Gospodarowicz MK, Connors JM, et al. Randomized comparison of ABVD chemotherapy with a strategy that includes radiation therapy in patients with limited-stage Hodgkin’s lymphoma: National Cancer Institute of Canada Clinical Trials Group and the Eastern Cooperative Oncology Group. J Clin Oncol. 2005 Jul 20; 23(21):4634-4642.
28. National Comprehensive Cancer Network (NCCN) Guidelines®. Version 2.2019 – July 15, 2019. Hodgkin Lymphoma. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hodgkin Lymphoma Version 2.2019. 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.
29. Press OW, LeBlanc M, Lichter AS, et al. Phase III randomized intergroup trial of subtotal lymphoid irradiation versus doxorubicin, vinblastine, and subtotal lymphoid irradiation for stage IA to IIA Hodgkin’s disease. J Clin Oncol. 2001 Nov 15; 19(22):4238-4244.
30. Santoro A, Bonadonna G, Valagussa P, et al. Long-term results of combined chemotherapy-radiotherapy approach in Hodgkin's disease: superiority of ABVD plus radiotherapy versus MOPP plus radiotherapy. J Clin Oncol. 1987 Jan; 5(1):27-37.
31. Solanki AA, LeMieux, MH, Chiu BC-H, et al. Long-term outcomes in patients with early stage nodular lymphocyte-predominant Hodgkin’s lymphoma treated with radiotherapy. PLOS|ONE. 2013 Sep; 8(9):1-6.
32. Specht L, Yahalom J, Illidge T, et al. Modern radiation therapy for Hodgkin lymphoma: Field and dose guidelines from the International Lymphoma Radiation Oncology Group (ILROG). Int J Radiat Oncol Biol Phys. 2014 Jul 15; 89(4):854-862.
33. Straus DJ, Portlock CS, Qin J, et al. Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease. Blood. 2004 Dec 1; 104(12):3483-3489.
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.
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