Photodynamic Therapy (PDT) for the Treatment of Cancer, including Barrett's Esophagus
DESCRIPTION
Photodynamic therapy (PDT) for the treatment of cancer, including Barrett’s esophagus utilizes a photosynthesizing drug given intravenously that preferentially accumulates in cancerous tissues. After a period of time ranging from a few minutes to 48 hours, the treated cancer cells are exposed to a low-energy single wavelength laser light that activates the drug. A light source (e.g., fiberoptic endoscope, quartz fiberoptic cable with a modified tip) delivers the laser light to the tumor. Light-activation of the drug produces a toxic form of oxygen that causes destruction of the cancer cells.
Photodynamic therapy may also be called phototherapy, photoradiation therapy, photosensitizing therapy, photochemotherapy, or porfimer sodium (Photofrin®) therapy.
POLICY
Photodynamic therapy for the treatment of cancer, including Barrett’s esophagus, is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Photodynamic therapy for the treatment of other conditions / diseases, including, but not limited to, the following: Barrett's esophagus without associated high-grade dysplasia, other head and neck cancers, and all other malignancies is considered investigational.
Any drug or device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Policies with similar titles:
MEDICAL APPROPRIATENESS
Photodynamic therapy is considered medically appropriate if ANY ONE of the following criteria are met:
Obstructing aerodigestive cancer, for palliation when treatment can not be performed satisfactorily with Nd:YAG (neodymium: Yttrium-aluminum-garnet) laser therapy
Early-stage microinvasive endobronchial non-small cell lung cancer (NSCLC), as curative treatment when surgery and radiotherapy are not indicated
Advanced-stage obstructing endobronchial non-small lung cancer (NSCLC), for the reduction of obstruction and palliation of symptoms
Barrett's esophagus with associated high-grade dysplasia
ADDITIONAL INFORMATION
The American College of Gastroenterology recommends that an expert gastrointestinal pathologist confirm the diagnosis of dysplasia in Barrett's esophagus.
Individuals who received the photosensitizing agent must avoid exposure of skin and eyes to direct sunlight or bright indoor light for 30 days.
No well-designed studies were found in published literature that validate the application of photodynamic therapy for other oncologic applications, other malignancies and Barrett's esophagus without associated high-grade dysplasia or provide comparisons to other techniques. Studies are not available that can predict clinical events for these conditions and, thus, be used to alter the treatment for individuals.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2008). Oncologic applications of photodynamic therapy, including Barrett's esophagus (8.01.06). Retrieved August 10, 2009 from BlueWeb. (20 articles and/or guidelines reviewed)
Institute for Clinical Systems Improvement. Technology Assessment Report. (2002, October). Photodynamic therapy for head and neck, tracheobronchial, and esophageal cancer. Retrieved December 5, 2002 from http://www.icsi.org/guidelines_and_more/technology_assessment_reports/technology_assessment_reports_-_active/photodynamic_therapy_for_head_and_neck__tracheobronchial__and_esophageal_cancer.html.
Overholt, B. F., Lightdale, C. J., Wang, K. K., Canto, M. I., Burdick, S., Haggitt, R. C., et al. (2005). Photodynamic therapy with porfimer sodium for ablation of high-grad dysplasia in Barrett's esophagus: International, partially blinded, randomized phase III trial. Gastrointestinal Endoscopy, 62 (4), 488-98. Abstract retrieved September 28, 2005 from PubMed database.
U. S. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). (2000, June). Package Insert: Photofrin. Retrieved December 5, 2002 from http://www.fda.gov/cdrh/pdf/p990021c.pdf.
U. S. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). (2003, August). FDA approves Photofrin for treatment of pre-cancerous lesions in Barrett's esophagus. Retrieved September 28, 2005 from http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01246.html.
U. S. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). (2000, June). Premarket Approval Letter: Diomed 630 PDT Laser, Model T2USA. Retrieved September 28, 2005 from http://www.fda.gov/cdrh/pdf/P990021a.pdf.
ORIGINAL EFFECTIVE DATE: 3/1985
MOST RECENT REVIEW DATE: 9/10/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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