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, or photochemotherapy.
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: Photodynamic Therapy (PDT) for Dermatologic Conditions
MEDICAL APPROPRIATENESS
Photodynamic therapy is considered medically appropriate if ANY ONE of the following criteria are met:
Obstructing aerodigestive cancer, for palliation when treatment cannot 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
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
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
Badreddine, R. J., Prasad, G. A., Wang, K. K., Song, L. M., Buttar, N. S., Dunagan, K. T., et al. (2010). Prevalence and predictors of recurrent neoplasia after ablation of Barrett's esophagus. Gastrointestinal Endoscopy, 71 (4), 697-703. (Level 2 Evidence - Independent study)
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2010). Oncologic applications of photodynamic therapy, including Barrett's esophagus (8.01.06). Retrieved March 10, 2011 from BlueWeb. (38 articles and/or guidelines reviewed)
Blume, J. E., & Oseroff, A. R. (2007). Aminolevulinic acid photodynamic therapy for skin cancers. Dermatologic Clinics, 25 (1), 5-14.
Chennat, J., & Waxman, I. (2010). Endoscopic treatment of Barrett's esophagus: From metaplasia to intramucosal carcinoma. World Journal of Gastroenterology, 16 (30), 3780-3785.
Fayter, D., Corbett, M., Heirs, M., Fox, D., & Eastwood, A. (2010). A systematic review of photodynamic therapy in the treatment of pre-cancerous skin conditions, Barrett's oesophagus and cancers of the biliary tract, brain, head and neck, lung, oesophagus and skin. Health Technology Assessment, 14 (37), 1-288.
Menon, D., Stafinski, T., Wu, H., Lau, D., & Wong, C. (2010). Endoscopic treatments for Barrett's esophagus: a systematic review of safety and effectiveness compared to esophagectomy. BMC Gastroenterology, 10, 111.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010). Porfimer. Retrieved March 14, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011, January). NCCN clinical practice guidelines in oncology™. Esophageal and esophagogastric junction cancers - V.1.2011. Retrieved March 11, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf.
National Comprehensive Cancer Network. (2011, March). NCCN clinical practice guidelines in oncology™. Non-small cell lung cancer - V.3.2011. Retrieved March 11, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.
National Guideline Clearinghouse. (2009, June). The Society of Thoracic Surgeons practice guideline series: Guidelines for the management of Barrett's esophagus with high-grade dysplasia. Retrieved March 10, 2011 from http://www.guidelines.gov.
National Institute for Health and Clinical Excellence (NICE). (2009, March). Photodynamic therapy for brain tumours. Retrieved March 10, 2011 from http://www.nice.org.uk/nicemedia/pdf/IPG290Guidance.pdf.
National Institute for Health and Clinical Excellence (NICE). (2008, April). Interstitial photodynamic therapy for malignant parotid tumours. Retrieved March 10, 2011 from http://www.nice.org.uk/nicemedia/pdf/IPG259Guidance.pdf.
National Institute for Health and Clinical Excellence (NICE). (2007, January). Palliative photodynamic therapy for advanced oesophageal cancer. Retrieved March 10, 2011 from http://www.nice.org.uk/nicemedia/pdf/IPG206guidance.pdf.
Overholt, B. F., Wang, K. K., Burdick, J. S., Lightdale, C. J., Kimmey, M., Nava, H. R., et al. (2007). Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia. Gastrointestinal Endoscopy, 66 (3), 460-468. (Level 1 Evidence - Industry sponsored)
Prasad, G. A., Wang, K. K., Buttar, N. S., Wongkeesong, L. M., Krishnadath, K. K., Nichols, F. C., et al. (2007). Long-term survival following endoscopic and surgical treatment of high-grade dysplasia in Barrett's esophagus. Gastroenterology, 132 (4), 1226-1233.
U. S. Food and Drug Administration. (2000, June). Center for Devices and Radiological Health. Medical devices. Diomed 630 PDT Laser - P990021. Retrieved March 11, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P990021b.pdf.
U. S. Food and Drug Administration. (2003, August). Center for Devices and Radiological Health. Medical devices. Wizard X-cell photodynamic therapy balloon with fiber optic diffuser - P020021. Retrieved March 11, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020021b.pdf.
U. S. Food and Drug Administration. (2008, August). Center for Drug Evaluation and Research. Photofrin® (porfimer sodium) label. Retrieved March 14, 2010 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020451s019lbl.pdf.
ORIGINAL EFFECTIVE DATE: 3/1985
MOST RECENT REVIEW DATE: 4/14/2011
ID_BT
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