Subject:
Radiation Therapy for Small Cell Lung Cancer
Description:
_______________________________________________________________________________________
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.
__________________________________________________________________________________________________________________________
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: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
I. For limited stage disease, definitive external beam radiation therapy to a dose of 60-70 Gy in 30-35 nfractions or 45 Gy delivered twice daily is considered medically necessary.
II. For stage III, definitive external beam radiation therapy to a dose of 60-70 Gy in 30-35 fractions or 45 Gy delivered twice daily using 3D conformal technqiue or intensity-modulated radiation therapy (IMRT) is considered medically necessary.
III. For extensive stage disease in which all systemic disease (metastases) has complete or near-complete resolution with chemotherapy, definitive external beam radiation therapy to a dose of 60 Gy in 30 fractions using a 3D conformal technique is considered medically necessary.
IV. Prophylactic cranial irradiation (PCI) using a dose of 25 Gy in 10 fractions is medically necessary in a responding individual (local disease and extensive disease) with good performance status.
V. Palliative treatment
A. The use of up to 10 fractions of a 3D conformal technique is 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). Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for Radiation Therapy for Small Cell Lung Cancer.
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). Per LCD L36711, IMRT for Small Cell Lung Cancer may be covered when L36711 criteria is met. 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&
Medicaid Coverage: For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP: For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE:
There is little role for surgery in the management of an individual with SCLC. In the few cases of clinical stage T1-T2N0 disease, surgery establishes the diagnosis and effectively removes the primary tumor. Such individuals should also be staged with mediastinoscopy, and if mediastinal lymph nodes are negative, chemotherapy alone can be entertained. External beam photon radiation therapy improves survival of an individual with limited stage SCLC. Concurrent chemoradiotherapy leads to improved survival as compared with sequential therapy. Standard external beam photon radiation therapy fractionation consists of either 45 Gy given at 1.5 Gy twice daily (hyperfractionation/accelerated) or at 1.8 to 2 Gy per day to 54 to 70 Gy. Local thoracic external beam photon radiation therapy for individuals with extensive stage disease is not an established approach, however, in selected individuals it may be considered, such as those with clinically apparent disease only at the primary site and complete response elsewhere.
More than 50% of individuals with SCLC will experience brain metastases during the course of disease. Prophylactic cranial radiotherapy reduces this risk by approximately 50% in relative terms, and improves overall survival in an individual with chemo-responsive limited stage SCLC and extensive stage SCLC. Concerns regarding neurocognitive defects are obviated by avoiding high dose per fraction treatment and concurrent chemotherapy. At the 2019 annual congress of the European Society for Radiotherapy & Oncology (ESTRO 38), Belderbos et al. (2019) presented the results of NCT01780675 which is a phase III trial of prophylactic cranial irradiation with or without hippocampus avoidance in SCLC. In this prospective, multicenter randomized phase III trial, 168 patients with limited stage (70% of patients) or extensive stage (30% of patients) SCLC were randomized to standard PCI or hippocampus avoidance PCI (HA-PCI) using IMRT or VMAT. All patients received 25 Gy in 10 fractions. The authors evaluated neurocognitive functioning at 4 months and 8 months using the Hopkins Verbal Learning Test- Revised (HVLT-R). The study demonstrated that there was a decline in neurocognitive functioning (total recall score of the HVLT-R) by at least 5 points compared to baseline in 28% of all study participants. There was no significant difference in neurocognitive function between those who received standard PCI compared to those who received hippocampal avoidance PCI (Belderbos et al., 2019). PCI is not appropriate for an individual with severe co-morbidities, one who is bedridden most of the time, or one with severely impaired cognitive functioning. The recommended regimen for PCI is 25 Gy in 10 daily fractions. In selected individuals with extensive disease, a shorter course, such as 20 Gy in 5 fractions may be appropriate. Higher doses have not proved beneficial and are associated with more neurocognitive deficits.]
________________________________________________________________________________________
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.
___________________________________________________________________________________________________________________________
Index:
Radiation Therapy for Small Cell Lung Cancer
Radiation Treatment of Small Cell Lung Cancer
Radiotherapy for Small Cell Lung Carcinoma
Stereotactic Radiotherapy, Small Cell Lung Cancer
Small Cell Lung Cancer, Stereotactic Radiotherapy
SBRT, Small Cell Lung Cancer
Small Cell Lung Cancer, Radiation Therapy
References:
1. Aupérin A, Arriagada R, Pignon JP, et al. for the Prophylactic Cranial Irradiation Overview Collaborative Group. Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. N Engl J Med. 1999 Aug 12; 341(7):476-484.
2. Belderbos J, Phd M, Ruysscher DD, Jaeger KD, et al. OC-0503 Phase III trial of Prophylactic Cranial Irradiation with or without Hippocampus Avoidance in SCLC. Radiotherapy and Oncology. 2019; 133(Supplement 1):S259. doi:10.1016/s0167-8140(19)30923-5.
3. Bogart JA, Herndon II JE, Lyss AP, et al. 70 Gy thoracic radiotherapy is feasible concurrent with chemotherapy for limited-stage small cell lung cancer: analysis of Cancer and Leukemia Group B study 39808. Int J Radiat Oncol Biol Phys. 2004 Jun 1; 59(2): 460-468.
4. Fried DB, Morris DE, Poole C, et al. Systematic review evaluating the timing of thoracic radiation therapy in combined modality therapy for limited-stage small cell lung cancer. J Clin Oncol. 2004 Dec 1; 22(23):4837-4845. Erratum in J Clin Oncol. 2005 Jan 1; 23(1):248.
5. Gregor A, Cull A, Stephens RJ, et al. United Kingdom Coordinating Committee for Cancer Research (UKCCCR) and the European Organization for Research and Treatment of Cancer (EORTC). Prophylactic cranial irradiation is indicated following complete response to induction therapy in small cell lung cancer: results of a multicentre randomised trial. Eur J Cancer. 1997 Oct; 33(11):1752–1758.
6. Kong FM, Wang S. Nondosimetric risk factors for radiation-induced lung toxicity. Semin Radiat Oncol. 2015 Apr; 25(2):100-109.
7. Le Péchoux C, Hatton M, Halton M, Kobierska A, et al. Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212) . J Clin Oncol. 26(15S); 2008 May 20 (suppl; abstr LBA7514).
8. Le Péchoux C, Laplanche A, Faivre-Finn C, et al. on behalf of the Prophylactic Cranial Irradiation (PCI) Collaborative Group. Clinical neurological outcome and quality of life among patients with limited small-cell cancer treated with two different doses of prophylactic cranial irradiation in the intergroup phase III trial (PCI99-01, EORTC 22003-08004, RTOG 0212 and IFCT 99-01). Ann Oncol. 2011 May; 22(5):1154-1163.
9. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2020 - February 5, 2020. Small Cell Lung Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Small Cell Lung Cancer 2.2020 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.
10. Pignon JP, Arriagada R, Ihde DC, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3; 327(23):1618-1624.
11. Rodrigues G, Videtic GMM, Sur R, et al. Palliative thoracic radiotherapy in lung cancer: An American Society for Radiation Oncology evidence-based clinical practice guideline. Pract Radiat Oncol. 2011 Apr-Jun; 1(2):60-71.
12. Simpson JR, Francis ME, Perez-Tamayo R, et al. Palliative radiotherapy for inoperable carcinoma of the lung: final report of a RTOG multi-institutional trial. Int J Radiat Oncol Biol Phys. 1985 Apr; 11(4): 751-758.
13. Slotman B, Faivre-Finn C, Kramer G, et al. for the EORTC Radiation Oncology Group and Lung Cancer Group. Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med. 2007 Aug 16; 357(7):664-672.
14. Turrisi AT, Kim K, Blum R, et al. Twice daily compared to once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28; 340(4): 265-271.
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.
_________________________________________________________________________________________
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
____________________________________________________________________________________________________________________________ |