Download White Paper: Intensity-Modulated Radiation Therapy (IMRT): When

White Paper: Intensity-Modulated Radiation Therapy (IMRT): When is
IMRT Medically Necessary?
For Health Plans, Medical Management Organizations and TPAs
IMRT: An Overview
IMRT utilizes computer-controlled linear accelerators to deliver precise doses of radiation to a malignant tumor or speci c areas within the tumor. Controlling the intensity of the radiation beam in multiple small volumes allows the radiation dose to conform more precisely to the three-dimensional (3D) shape of the tumor. IMRT allows higher radiation
doses to be focused to the regions within the tumor while miniThe complexity and accuracy of radiation
mizing the dose to surrounding critical structures.
therapy have increased signi cantly due to
Treatment planning involves using 3D computed tomography rapid advances in radiation oncology. This
(CT) images of the patient in combination with computerized
has resulted in specialization in the types of
dose calculations to determine the dose-intensity pattern that will
best conform to the tumor shape. The multileaf collimators used technology used for di erent cancer sites, comto shape and focus the radiation beams can be adjusted during plicating the process of establishing evidencethe treatment session, allowing the radiation beam to be divided based criteria for practice guidelines and
in real time into several individual beams, each of which may be reimbursement for new procescedures.
individually turned on or o during the treatment. Combinations
of several intensity-modulated elds coming from di erent beam directions produce a custom-tailored radiation dose
that maximizes the dose to the tumor while minimizing the dose to adjacent normal tissues. The increased accuracy of
the radiation beam makes it possible to use higher radiation doses, which may be more e ective at killing cancer cells,
with fewer side e ects compared to conventional radiotherapies.
IMRT is used most extensively to treat cancers of the prostate, head and neck, and central nervous system. It has also
been used in limited situations to treat breast, thyroid, lung, gastrointestinal, and gynecologic malignances, and certain
types of sarcomas.
Clinical Applications of IMRT
IMRT is not a replacement therapy for conventional radiation therapy methods. However, it may be clinically indicated
when certain conditions are documented. For example, IMRT may be used when an immediately adjacent area has been
previously irradiated and abutting portals must be established with high precision. Other conditions that may call for
IMRT include the following: dose escalation is planned to deliver radiation doses in excess of those commonly utilized for
similar tumors with conventional treatment; the target volume is concave or convex, and the critical normal tissues are
within or around that convexity or concavity; the target volume is in close proximity to critical structures that must be
protected; or the volume of interest must be covered with narrow margins to adequately protect immediately adjacent
structures.
Common sites for IMRT include the following: carcinoma of the prostate; primary, metastatic, or benign tumors of the
central venous system; primary metastatic tumors of the spine where spinal cord tolerance may be exceeded by conventional treatment; and primary, metastatic, or benign lesions to the head and neck area. In addition, IMRT can be used for
re-irradiation that meets requirements for medical necessity, selected cases of thoracic and abdominal malignancies, and
other pelvic and retroperitoneal tumors that meet requirements for medical necessity.
There are a number of additional clinical uses for IMRT. IMRT may be necessary in lung cancer cases involving bilateral
mediastinal involvement, extension to the midline of the mediastinum, cardiac involvement, or tumor abutting or involving vertebrae or brachial plexus, or great vessels. Although not routinely indicated in breast cancer, IMRT may be necessary when more than two gantry angles are required to meet dose constraints or when internal mammary nodes must
be treated. IMRT is also indicated in pancreatic cancer and anal cancer, and for postoperative use in endometrial, cervical,
and advanced rectal cancer.
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Intensity-Modulated Radiation Therapy (IMRT): When is IMRT Medically Necesassary?
Potential Complications Associated With IMRT
IMRT is generally associated with fewer side e ects than conventional radiation therapy. Side e ects vary from person to person, depending on the type of radiation and dosage, and the location of the cancer. Some patients may not
experience side e ects at all. General side e ects of radiation therapy, which are usually temporary, include fatigue, skin
changes, hair loss, and loss of appetite, as well as speci c side e ects associated with the area of the body being treated.
Long-term side e ects, which occur months or years following treatment and are often permanent, can include infertility, joint changes, lymphedema, and secondary cancer.
Guidelines for the Use of IMRT
The 2014 National Comprehensive Cancer Network (NCCN) guidelines on prostate cancer include the following statements regarding treatment with IMRT:
•
For initial therapy, daily image-guided radiation therapy with IMRT/3D-conformal radiation therapy
•
Moderately hypofractionated image-guided IMRT regimens (2.4-4 Gy per fraction over four to six weeks) have been
tested in randomized controlled trials reporting similar e cacy and toxicity to conventionally fractionated IMRT
(they can be considered as an alternative to conventionally fractionated regimens when clinically indicated)
•
Extremely hypofractionated image-guided IMRT/stereotactic body radiation therapy regimens (6.5 Gy per fraction
or greater) are an emerging treatment modality with single institutional and pooled reports of similar e cacy and
toxicity to conventionally fractionated regimens (they can be considered as a cautious alternative to conventionally
fractionated regimens at clinics with appropriate technology, physics, and clinical expertise)
With regard to breast cancer and IMRT, the following recommendations were made by the NCCN in 2008:
•
When breast-conserving therapy with lumpectomy and radiation therapy is performed, the panel nds the data
inadequate to support the use of partial breast irradiation outside the con nes of a high quality, prospective clinical
trial
•
The panel recommends whole breast irradiation to include the majority of the breast tissue
•
Breast irradiation should be performed following CT-based treatment planning as to limit irradiation exposure to
the heart and lungs, and to ensure adequate coverage of the primary tumor and surgical site
•
Tissue wedging, forward planning with segments (step and shoot) or IMRT is recommended
The use of IMRT in other cancers has also been addressed by the NCCN guidelines:
•
Rectal cancer: IMRT should only be used in the context of a clinical trial or in unique situations including re-irradiation of recurrent disease after previous radiotherapy
•
Cervical cancer: IMRT is becoming more widely available, but issues regarding target de nition, patient and target
immobilization, tissue deformation, and reproducibility remain to be validated
•
Pancreatic adenocarcinoma: IMRT is increasingly being applied for therapy of pancreatic adenocarcinoma in the
adjuvant setting with the aim of increasing radiation dose to the gross tumor/tumor bed while minimizing toxicity
to surrounding tissues
•
Gastric cancer: IMRT in gastric cancer remains investigational and the impact of new conformal radiotherapy technologies needs to be assessed in randomized clinical trials
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Intensity-Modulated Radiation Therapy (IMRT): When is IMRT Medically Necesassary?
Determining Medical Necessity of IMRT
The complexity and accuracy of radiation therapy have increased signi cantly due to rapid advances in radiation
oncology. This has resulted in specialization in the types of technology used for di erent cancer sites, complicating the
process of establishing evidence-based criteria for practice guidelines and reimbursement for new procedures. Oftentimes, clinicians may try to justify using a new technology by citing studies that are too small and lack statistical power.
Education on clinical guidelines and new technologies and applications may play a key role in reducing overutilization.
Many health plans cover IMRT when very speci c conditions are met. For example, IMRT may be considered medically
necessary for the following indications:
•
Prostate cancer for dose escalation >75 Gy of the prostate and for postoperative radiation of the prostate to a dose
of at least 6300 cGy
•
Head and neck cancer, with the exception of patients with early stage larynx cancer (stage I and II)
•
Cancer involving the central nervous system
•
Carcinoma of the anus or vulva
•
Anaplastic thyroid cancer
•
Carcinoma of the cervix
•
Whole pelvic radiotherapy for gynecologic malignancies
•
Pediatric tumors (such as Ewing Sarcoma, Wilms’ Tumor)
•
Breast cancer, when at least one of the following is met:
1. Heart—3D results in 25 % of heart receiving 30Gy; or
2. Lung—3D results in 30% of ipsilateral lung receiving 20 Gy, or 3D results in 20% of combined lung volume
receiving 20Gy; or
3. Skin/Soft Tissue—3D results in 5% of intended breast receiving 7% of prescribed dose or medial lesion where
3D results in 10% of contralateral breast receiving 10Gy
An independent medical review, which is normally used by healthcare payers, looks at whether or not a speci c procedure was medically necessary, in an unbiased and timely manner. It allows ready access to a range of board-certi ed
specialists, which healthcare plans may lack internally, and facilitates e ective treatment of patients through the use of
specialists who keep up-to-date with the latest medical research literature and standard of care. This is especially important in oncology, which utilizes continually evolving technology. Board-certi ed oncologists understand the emerging
data on the radiation treatment planning process, remain current on available technologies as they are studied more
extensively and potentially accepted into clinical guidelines, and make proactive decisions based on the true needs of
the patient. Independent medical review also avoids con icts of interest, which can relate to economics, lack of specialists to review cases, or having the same doctor who denied a case review an appeal.
Conclusions
Advances in imaging techniques and computer software have led to signi cant improvements in the accuracy of radiation therapy, allowing more accurate targeting of tumors. These advances have improved outcomes and quality of life
for patients with cancer, but they have also led to the overutilization of new technologies.
Ongoing innovations in radiation therapy present the challenge for healthcare policy-makers and providers to develop
the most e ective, e cient, and safe treatments for patients, as well as to integrate these innovations into routine practice, guidelines, and coverage. Keeping up-to-date on clinical guidelines and new technologies and applications may
play a key role in reducing overutilization.
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Intensity-Modulated Radiation Therapy (IMRT): When is IMRT Medically Necesassary?
Bibliography
National Comprehensive Cancer Network. Breast Cancer. 2008.
National Comprehensive Cancer Network. Cervical Cancer. 2013.
National Comprehensive Cancer Network. Gastric Cancer. 2013.
National Comprehensive Cancer Network. Pancreatic Adenocarcinoma. 2013.
National Comprehensive Cancer Network. Prostate Cancer. Version 1.2014.
National Comprehensive Cancer Network. Rectal Cancer. 2013.
About AllMed
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