Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Photodynamic Therapy (PDT) Using Porfimer Sodium (Photofrin®)

Policy #:07.00.10i

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Photodynamic therapy (PDT) using porfimer sodium (Photofrin®) is considered medically necessary and, therefore, covered for any of the following conditions:
  • Ablation of high-grade dysplasia (HGD) in individuals with Barrett’s esophagus (BE) who do not undergo esophagectomy (surgery to remove the esophagus)
  • Palliation in individuals with completely obstructing esophageal cancer, or in individuals with partially obstructing esophageal cancer when, in the opinion of the physician, the disease cannot be satisfactorily treated with Nd:YAG laser therapy
  • Palliation in individuals with unresectable cholangiocarcinoma, when used as an adjunct to biliary stenting
  • Palliation in individuals with completely or partially obstructing endobronchial non-small-cell lung cancer (NSCLC), including relief of symptoms and reduction of obstruction
  • Treatment of microinvasive endobronchial NSCLC in individuals for whom surgery and radiotherapy are not indicated
  • Treatment of low-risk superficial basal cell carcinoma in individuals where surgery or radiation therapy is contraindicated or impractical
  • Treatment of actinic keratoses and low-risk squamous cell carcinoma in situ (Bowen's disease)

All other uses for photodynamic therapy with porfimer sodium (Photofrin®) are considered experimental/investigational and, therefore, not covered because their safety and/or efficacy cannot be established by review of the available published literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, photodynamic therapy (PDT) using porfimer sodium (Photofrin®) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Photodynamic therapy (PDT) using porfimer sodium (Photofrin®) was approved by the FDA on December 22, 1998.

Description

Photodynamic therapy (PDT) involves the use of a photosensitizing agent and subsequent exposure of tumor cells to a laser light source to induce cellular damage. Porfimer sodium (Photofrin®) is a photosensitizing agent that has been approved by the US Food and Drug Administration (FDA) for the PDT of esophageal and endobronchial tumors and high-grade dysplasia (HGD) in individuals with Barrett’s esophagus (BE). It is chemically designed to have a unique affinity for the neoplastic tissue to be treated. Once introduced into the body, porfimer sodium (Photofrin®) accumulates and is retained in the neoplastic tissue to a greater degree than in normal tissue. The cytotoxic and antitumor actions of porfimer sodium (Photofrin®) depend on light and oxygen. The cancer cells are destroyed once the porfimer sodium (Photofrin®) accumulates in the tumor cells, and those cells are exposed to a nonthermal laser light.

PDT with porfimer sodium (Photofrin®) is a two-stage process. The first stage involves the intravenous injection of porfimer sodium (Photofrin®). llumination with 630nm wavelength laser light constitutes the second stage of therapy. This stage begins 40 to 50 hours following the injection. The targeted irradiation of the tissue is calibrated to emit light at a wavelength that corresponds to the drug's absorption peak. This activates the drug, enabling it to locally treat the neoplastic tissue without affecting surrounding normal tissue. A second laser light application may be performed 96 to 120 hours after the porfimer sodium (Photofrin®) injection, preceded by gentle debridement of the residual tumor.

Per the US Food and Drug Administration (FDA) labeling for porfimer sodium (Photofrin®), the treatment of esophageal and endobronchial cancer may warrant a second course of PDT a minimum of 30 days after the initial therapy; up to three courses of PDT (each separated by a minimum of 30 days) can be given. For the ablation of HGD in BE, individuals may receive an additional course of PDT a minimum of 90 days after the initial therapy. Up to three courses of PDT (each injection separated by a minimum of 90 days) can be given to a previously treated segment that still shows HGD, low-grade dysplasia or Barrett’s metaplasia, or to a new segment if the initial Barrett’s segment was more than 7 cm in length.

In addition to the use of porfimer sodium (Photofrin®) in the PDT of esophageal and endobronchial tumors and HGD in individuals with BE, professional literature suggests that as a palliative strategy for inoperable, unresectable cholangiocarcinoma, biliary stenting in combination with PDT using porfimer sodium (Photofrin®) as an adjunct therapy leads to prolongation of survival when compared to stenting alone. Generally, PDT is administered via endoscopy to the tumor mass in the bile ducts. Further treatment with PDT using porfimer sodium (Photofrin®) may be performed in cases of residual tumor in the bile ducts. Further studies of PDT with other treatment combinations are warranted to determine optimal palliation therapy. Currently, adjuvant therapy is not usually recommended outside of clinical trials.

Clinical research on the use of photodynamic therapy using porfimer sodium (Photofrin®) in the treatment of other cancers is ongoing, including its use in the treatment of cancers of the brain, prostate, breast, and bladder. Whether photodynamic therapy using porfimer sodium (Photofrin®) has an effect on health outcomes for individuals with those types of cancer has yet to be determined.
References


Ahn PH, Quon H, O'Malley BW, et al. Toxicities and early outcomes in a phase 1 trial of photodynamic therapy for premalignant and early stage head and neck tumors. Oral Oncol. 2016;55:37-42.

Akopov A, Rusanov A, Gerasin A, et al. Preoperative endobronchial photodynamic therapy improves resectability in initially irresectable (inoperable) locally advanced non small cell lung cancer. Photodiagnosis Photodyn Ther. 2014;11(3):259-264.

Aziz F, Telara S, Moseley H, et al. Photodynamic therapy adjuvant to surgery in metastatic carcinoma in brain. Photodiagnosis Photodyn Ther.2009;6(3-4):227-230.

Azzouzi AR, Barret E, Moore CM, et al. TOOKAD((R)) Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer. BJU Int. 2013;112(6):766-774.

Bader MJ, Stepp H, Beyer W, et al. Photodynamic therapy of bladder cancer - a phase I study using hexaminolevulinate (HAL). Urol Oncol. 2013;31(7):1178-1183.

Badreddine RJ, Prasad GA, Wang KK, et al. Prevalence and predictors of recurrent neoplasia after ablation of Barrett's esophagus. Gastrointest Endosc.2010;71(4):697-703.

Bahng S, Yoo BC, Paik SW, et al. Photodynamic therapy for bile duct invasion of hepatocellular carcinoma. Photochem Photobiol Sci. 2013;12(3):439-445.

Baron TH. Photodynamic therapy: standard of care for palliation of cholangiocarcinoma? Clin Gastroenterol Hepatol.2008;6(3):266-267.

Barret E, Ahallal Y, Sanchez-Salas R, et al. Morbidity of focal therapy in the treatment of localized prostate cancer. Eur Urol. 2013;63(4):618-622.

Baumann P, Nyman J, Hoyer M, et al. Outcome in a prospective phase II trial of medically inoperable stage I non-small-cell lung cancer patients treated with stereotactic body radiotherapy. J Clin Oncol. 2009;27(20):3290-3296.

Berr F. Photodynamic therapy for cholangiocarcinoma. Semin Liver Dis. 2004;24(2):177-187.

Biel A. Photodynamic therapy treatment of early oral and laryngeal cancers. Photochem Photobiol. 2007;83(5):1063-68.

Chahal P, Baron TH. Endoscopic palliation of cholangiocarcinoma. Curr Opin Gastroenterol. 2006;22(5):551-560.

Choi MC, Jung SG, Park H, et al. Fertility preservation via photodynamic therapy in young patients with early-stage uterine endometrial cancer: a long-term follow-up study. Int J Gynecol Cancer. 2013;23(4):698-704.

Choi MC, Jung SG, Park H, et al. Fertility preservation by photodynamic therapy combined with conization in young patients with early stage cervical cancer: a pilot study. Photodiagnosis Photodyn Ther. 2014;11(3):420-425.

Cortese DA, Edell ES, Kinsey JH. Photodynamic therapy for early stage squamous cell carcinoma of the lung. Mayo Clin Proc. 1997;72(7):595-602.

Corti L, Toniolo L, Boso C, et al. Long-term survival of patients treated with photodynamic therapy for carcinoma in situ and early non-small-cell lung carcinoma. Lasers Surg Med. 2007;39(5):394-402.

Dai Y, Li C, Xie Y, et al. Interventions for dysphagia in oesophageal cancer. Cochrane Database Syst Rev. 2014;10:CD005048.

de Visscher SA, Dijkstra PU, Tan IB, et al. mTHPC mediated photodynamic therapy (PDT) of squamous cell carcinoma in the head and neck: a systematic review. Oral Oncol. 2013;49(3):192-210.

Diaz-Jiménez JP, Martínez-Ballarín JE, Llunell A, et al. Efficacy and safety of photodynamic therapy versus Nd-YAG laser resection in NSCLC with airway obstruction. Eur Respir J. 1999;14(4):800-805.

Dunn JM, Mackenzie GD, Banks MR, et al. A randomised controlled trial of ALA vs. Photofrin photodynamic therapy for high-grade dysplasia arising in Barrett’s oesophagus. Lasers Med Sci. 2013;28(3):707-715.

Durbec M, Cosmidis A, Fuchsmann C, et al. Efficacy and safety of photodynamic therapy with temoporfin in curative treatment of recurrent carcinoma of the oral cavity and oropharynx. Eur Arch Otorhinolaryngol. 2013;270(4):1433-1439.

Eckel F, Jelic S. Biliary cancer: ESMO Clinical Recommendation for diagnosis, treatment, and follow-up. Ann Oncol. 2009;20(Supplement 4):iv46-iv48.

Eljamel S. Photodynamic applications in brain tumors: a comprehensive review of the literature. Photodiagnosis Photodyn Ther.2010;7(2):76-85.

Endo C, Miyamoto A, Sakurada A, et al. Results of long-term follow-up of photodynamic therapy for roentgenographically occult bronchogenic squamous cell carcinoma. Chest. 2009;136(2):369-375.

Eymerit-Morin C, Zidane M, Lebdai S, et al. Histopathology of prostate tissue after vascular-targeted photodynamic therapy for localized prostate cancer. Virchows Arch. 2013;463(4):547-552.

Fayter D, Corbett M, Heirs M, et al. 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 Technol Assess.2010;14(37):1-288.

Fernando HC, Murthy SC, Hofstetter W, et al. The Society of Thoracic Surgeons practice guideline series: guidelines for the management of Barrett's esophagus with high-grade dysplasia. Ann Thorac Surg.2009;87(6):1993-2002.

Friedberg JS, Simone CB, 2nd, Culligan MJ, et al. Extended pleurectomy-decortication-based treatment for advanced stage epithelial mesothelioma yielding a median survival of nearly three years. Ann Thorac Surg. 2017;103(3):912-919.

Furukawa K, Kato H, Konaka C, et al. Locally recurrent central-type early stage lung cancer < 1.0 cm in diameter after complete remission by photodynamic therapy. Chest. 2005;128(5):3269-3275.

Gao F, Bai Y, Ma SR, et al. Systematic review: photodynamic therapy for unresectable cholangiocarcinoma. J Hepatobiliary Pancreat Surg.2010;17(2):125-131.

Godoy H, Vaddadi P, Cooper M, et al. Photodynamic therapy effectively palliates gynecologic malignancies. Eur J Gynaecol Oncol. 2013;34(4):300-302.

Gondivkar SM, Gadbail AR, Choudhary MG, et al. Photodynamic treatment outcomes of potentially-malignant lesions and malignancies of the head and neck region: A systematic review. J Investig Clin Dent. May 08 2017.

Harewood GC, Baron TH, Rumalla A, et al. Pilot study to assess patient outcomes following endoscopic application of photodynamic therapy for advanced cholangiocarcinoma. J Gastroenterol Hepatol. 2005;20(3):415-420.

Hauge T, Hauge PW, Warloe T, et al. Randomised controlled trial of temoporfin photodynamic therapy plus chemotherapy in nonresectable biliary carcinoma--PCS Nordic study. Photodiagnosis Photodyn Ther. 2016;13:330-333.

Heier SK, Rothman KA, Heier LM, et al. Photodynamic therapy for obstructing esophageal cancer: light dosimetry and randomized comparison with Nd:YAG laser therapy. Gastroenterology. 1995;109(1):63-72.

Hillemanns P, Garcia F, Petry KU, et al. A randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia 1/2. Am J Obstet Gynecol. 2015;212(4):465.e461-467.

Hillemanns P, Petry KU, Soergel P, et al. Efficacy and safety of hexaminolevulinate photodynamic therapy in patients with low-grade cervical intraepithelial neoplasia. Lasers Surg Med. Aug 2014;46(6):456-461.

Huggett MT, Jermyn M, Gillams A, et al. Phase I/II study of verteporfin photodynamic therapy in locally advanced pancreatic cancer. Br J Cancer. 2014;110(7):1698-1704.

Istomin YP, Lapzevich TP, Chalau VN, et al. Photodynamic therapy of cervical intraepithelial neoplasia grades II and III with Photolon. Photodiagnosis Photodyn Ther.2010;7(3):144-151.

Kahaleh M, Mishra R, Shami VM, et al. Unresectable cholangiocarcinoma: comparison of survival in biliary stenting along versus stenting with photodynamic therapy. Clin Gastroenterol Hepatol.2008;6(3):290-297.

Karakullukcu B, Stoker SD, Wildeman AP, et al. A matched cohort comparison of mTHPC-mediated photodynamic therapy and trans-oral surgery of early stage oral cavity squamous cell cancer. Eur Arch Otorhinolaryngol. 2013;270(3):1093-1097.

Kasivisvanathan V, Emberton M, Ahmed HU. Focal therapy for prostate cancer: rationale and treatment opportunities. Clin Oncol (R Coll Radiol). 2013;25(8):461-473.

Kato H, Okunaka T, Shimatani H. Photodynamic therapy for early stage bronchogenic carcinoma. J Clin Laser Med Surg. 1996;14(5):235-238.

Konda VJ, Waxman I. Endotherapy for Barrett's esophagus. Am J Gastroenterol. 2012;107(6):827-833.

Kusuzaki K, Murata H, Matsubara T, et al. Clinical trial of photodynamic therapy using acridine orange with/without low dose radiation as new limb salvage modality in musculoskeletal sarcomas. Anticancer Res. 2005;25(2B):1225-1235.

Lee JY, Diaz RR, Cho KS, et al. Efficacy and safety of photodynamic therapy for recurrent, high grade nonmuscle invasive bladder cancer refractory or intolerant to bacille Calmette-Guerin immunotherapy. J Urol. 2013;190(4):1192-1199.

Li LB, Xie JM, Zhang XN, et al. Retrospective study of photodynamic therapy vs photodynamic therapy combined with chemotherapy and chemotherapy alone on advanced esophageal cancer. Photodiagnosis Photodyn Ther.2010;7(3):139-143.

Lightdale CJ, Heier SK, Marcon NE, et al. Photodynamic therapy with porfimer sodium versus thermal ablation therapy with Nd:YAG laser for palliation of esophageal cancer: a multicenter randomized trial. Gastrointest Endosc. 1995;42(6):507-512.

Lindenmann J, Matzi V, Neuboeck N, et al. Multimodal therapy of malignant pleural mesothelioma: is the replacement of radical surgery imminent? Interact Cardiovasc Thorac Surg. 2013;16(3):237-243.

Lu Y, Liu L, Wu JC, et al. Efficacy and safety of photodynamic therapy for unresectable cholangiocarcinoma: A meta-analysis. Clin Res Hepatol Gastroenterol. 2015;39(6):718-724.

Matsubara T, Kusuzaki K, Matsumine A, et al. Can a less radical surgery using photodynamic therapy with acridine orange be equal to a wide-margin resection? Clin Orthop Relat Res. 2013;471(3):792-802.

Matzi V, Maier A, Woltsche M, et al. Polyhematoporphyrin-mediated photodynamic therapy and decortication in palliation of malignant pleural mesothelioma: a clinical pilot study. Interact Cardiovasc Thorac Surg.2004;3(1):52-56.

McCann P, Stafinski T, Wong C, et al. The safety and effectiveness of endoscopic and non-endoscopic approaches to the management of early esophageal cancer: a systematic review. Cancer Treat Rev. 2011;37(1):11-62.

Moghissi K, Dixon K, Stringer M, et al. The place of bronchoscopic therapy in advanced unresectable lung cancer: experience of 100 cases. Eur J Cardiothorac Surg. 1999;15(1):1-6.

Moghissi K, Dixon K, Thorpe JA, et al. Photodynamic therapy (PDT) in early central lung cancer: a treatment option for patients ineligible for surgical resection. Thorax. 2007;62(5):391-395.

Muragaki Y, Akimoto J, Maruyama T, et al. Phase II clinical study on intraoperative photodynamic therapy with talaporfin sodium and semiconductor laser in patients with malignant brain tumors. J Neurosurg. 2013;119(4):845-852.

National Cancer Institute (NCI). Photodynamic Therapy for Cancer. [NCI Web site]. September 6, 2011. Available at: http://www.cancer.gov/about-cancer/treatment/types/surgery/photodynamic-fact-sheet. Accessed August 29, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Basal cell skin cancer. v.1.2018. [NCCN Web site]. 09/18/2017. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf.
Accessed August 29, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Esophageal and esophagogastric junction cancers. v.2.2018. [NCCN Web site]. 05/22/2018. Available at: http://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf. Accessed August 29, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Hepatobiliary cancers. v.3.2018. [NCCN Web site]. 08/29/2018. Available at: http://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed August 29, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Non-small cell lung cancer. v.6.2018. [NCCN Web site]. 08/17/2018. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed August 29, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Squamous cell skin cancer. v.2.2018. [NCCN Web site]. 10/05/2017. Available at: http://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf.
Accessed August 29, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium™.Porfimer sodium. [NCCN Web site]. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed August 29, 2018.

National Institute for Health and Clinical Excellence (NICE). Interstitial photodynamic therapy for malignant parotid tumours. [NICE Web site]. April 2008. Available at: http://www.nice.org.uk/guidance/IPG259. Accessed August 29, 2018.

National Institute for Health and Clinical Excellence (NICE). Palliative photodynamic therapy for advanced oesophageal cancer. [NICE Web site]. January 2007. Available at: http://www.nice.org.uk/guidance/IPG206. Accessed August 29, 2018.

National Institute for Health and Clinical Excellence (NICE). Photodynamic therapy for advanced bronchial carcinoma. [NICE Web site]. August 2004. Available at: http://www.nice.org.uk/guidance/ipg87. Accessed August 29, 2018.

National Institute for Health and Clinical Excellence (NICE). Photodynamic therapy for bile duct cancer. [NICE Web site]. July 2005. Available at: http://www.nice.org.uk/guidance/ipg134. Accessed August 29, 2018.

National Institute for Health and Clinical Excellence (NICE). Photodynamic therapy for brain tumours. [NICE Web site]. March 2009. Available at: http://www.nice.org.uk/guidance/IPG290. Accessed August 29, 2018.

National Institute for Health and Clinical Excellence (NICE). Photodynamic therapy for early-stage oesophageal cancer. [NICE Web site]. December 2006. Available at: http://www.nice.org.uk/guidance/IPG200. Accessed August 29, 2018.

National Institute for Health and Clinical Excellence (NICE). Photodynamic therapy for Barrett's oesophagus. [NICE Web site]. June 2010. Available at: http://www.nice.org.uk/guidance/ipg350. Accessed August 29, 2018.

National Institute for Health and Clinical Excellence (NICE). Photodynamic therapy for localized inoperable endobronchial cancer. [NICE Web site]. November 2005. Available at: http://www.nice.org.uk/guidance/ipg137. Accessed August 29, 2018.

Nomura T, Mimata H. Focal therapy in the management of prostate cancer: an emerging approach for localized prostate cancer. Adv Urol. 2012:391-437.

Ortner ME, Caca K, Berr F, et al. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003;125(5):1355-1363.

Overholt BF, Wang KK, Burdick JS, et al. Five-year efficacy and safety of photodynamic therapy with photofrin in Barrett's high-grade dysplasia. Gastrointest Endosc.2007;66(3):460-468.

Pech O, Behrens A, May A, et al. Long-term results and risk factor analysis for recurrence after curative and endoscopic therapy in 349 patients with high-grade intraepithelial neoplasia and mucosal adenocarcinoma in Barrett's oesophagus. Gut.2008;57(9):1200-1206.

Pereira S. Photodynamic therapy for pancreatic and biliary tract cancer: the United Kingdom experience. J Natl Compr Canc Netw. 2012;10 Suppl 2:S48-51.

Pereira SP, Aithal GP, Ragunath K, et al. Safety and long term efficacy of porfimer sodium photodynamic therapy in locally advanced biliary tract carcinoma. Photodiagnosis Photodyn Ther. 2012;9(4):287-292.

Prasad GA, Wang KK, Buttar NS, et al. Long-term survival following endoscopic and surgical treatment of high-grade dysplasia in Barrett's esophagus. Gastroentrology. 2007;132(4):1226-1233.

Prasad GA, Wang KK, Buttar NS, et al. Predictors of stricture formation after photodynamic therapy for high-grade dysplasia in Barrett's esophagus. Gastrointest Endosc. 2007;65(1):60-66.

Rigual NR, Shafirstein G, Frustino J, et al. Adjuvant intraoperative photodynamic therapy in head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2013;139(7):706-711.

Rigual NR, Thankappan K, Cooper M, et al. Photodynamic therapy for head and neck dysplasia and cancer. Arch Otolaryngol Head Neck.2009;135(8):784-788.

Rupinski M, Zagorowicz E, Regula J, et al. Randomized comparison of three palliative regimens including brachytherapy, photodynamic therapy, and APC in patients with malignant dysphagia (CONSORT 1a) (Revised II). Am J Gastroenterol. 2011;106(9):1612-1620.

Schweitzer VG, Somers ML. PHOTOFRIN-mediated photodynamic therapy for treatment of early stage (TisT2N0M0) SqCCa of oral cavity and oropharynx. Lasers Surg Med.2010;42(1):1-8.

Shaheen NJ, Falk GW, Iyer PG, et al. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016;111(1):30-50; quiz 51.

Shim CS, Cheon YK, Cha SW, et al. Prospective study of the effectiveness of percutaneous transhepatic photodynamic therapy for advanced bile duct cancer and the role of intraductal ultrasonography in response assessment. Endoscopy. 2005;37(5):425-433.

Silbergleit AK, Somers ML, Schweitzer VG, et al. Vocal fold vibration after photofrin-mediated photodynamic therapy for treatment of early-stage laryngeal malignancies. J Voice. 2013;27(6):762-764.

Soergel P, Dahl GF, Onsrud M, et al. Photodynamic therapy of cervical intraepithelial neoplasia 1-3 and human papilloma virus (HMV) infection with methylaminolevulinate and hexaminolevulinate--a double-blind, dose-finding study. Lasers Surg Med. 2012;44(6):468-474.

Spechler SJ, Sharma P, Souza RF, et al. American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Gastroenterology. 2011;140(3):1084-1091.

Stoker SD, van Diessen JN, de Boer JP, et al. Current treatment options for local residual nasopharyngeal carcinoma. Curr Treat Options Oncol. 2013;14(4):475-491.

Tao XH, Guan Y, Shao D, et al. Efficacy and safety of photodynamic therapy for cervical intraepithelial neoplasia: a systemic review. Photodiagnosis Photodyn Ther. 2014;11(2):104-112.

Tomizawa Y, Tian J. Photodynamic therapy for unresectable cholangiocarcinoma. Dig Dis Sci. 2012;57(2):274-283.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Photofrin® (porfimer sodium) injection. Prescribing information. [FDA Web site]. 06/2011. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s023lbl.pdf. Accessed August 29, 2016.

Vohra F, Al-Kheraif AA, Qadri T, et al. Efficacy of photodynamic therapy in the management of oral premalignant lesions. A systematic review. Photodiagnosis Photodyn Ther. 2015;12(1):150-159.

Wildeman MA, Fles R, Herdini C, et al. Primary treatment results of Nasopharyngeal Carcinoma (NPC) in Yogyakarta, Indonesia. PLoS One. 2013;8(5):e63706.

Wildeman MA, Nyst HJ, Karakullukcu B, et al. Photodynamic therapy in the therapy for recurrent/persistent nasopharyngeal cancer. Head Neck Oncol.2009;1(1):40.

Winters U, Dayana S, Lear JT, et al. Clinical and Immunologic results of a phase II trial of sequential imiquimod and photodynamic therapy for vulval intraepithelial neoplasia. Clin Cancer Res. 2008;14(16):5292- 9.

Wisnivesky JP, Yung RC, Mathur PN, et al. Diagnosis and treatment of bronchial intraepithelial neoplasia and early lung cancer of the central airways: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 Suppl):e263S-277S.

Witzigmann H, Berr F, Ringel U, et al. Surgical and palliative management and oucome in 184 patients with hilar cholangiocarcinoma: palliative photodynamic therapy plus stenting is comparable to R1/R2 resection. Ann Surg.2006;244(2):230-239.

Wolff JM, Mason M. Drivers for change in the management of prostate cancer - guidelines and new treatment techniques. BJU Int. 2012;109 Suppl 6:33-41.

Yamaguchi S, Tsuda H, Takemori M, et al. Photodynamic therapy for cervical intraepithelial neoplasia. Oncology. 2005;69(2):110-116.

Zhang W, Zhang A, Sun W, et al. Efficacy and safety of photodynamic therapy for cervical intraepithelial neoplasia and human papilloma virus infection: A systematic review and meta-analysis of randomized clinical trials. Medicine (Baltimore). 2018;97(21):e10864.

Zoepf T, Jakobs R, Arnold JC, Apel D, Riemann JF. Palliation of nonresectable bile duct cancer: improved survival after photodynamic therapy. Am J Gastroenterol. 2005;100(11):2426-2430.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

31641, 43229, 43270, 43278, 96570, 96571


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C15.3 Malignant neoplasm of upper third of esophagus

C15.4 Malignant neoplasm of middle third of esophagus

C15.5 Malignant neoplasm of lower third of esophagus

C15.8 Malignant neoplasm of overlapping sites of esophagus

C15.9 Malignant neoplasm of esophagus, unspecified

C22.0 Liver cell carcinoma

C22.1 Intrahepatic bile duct carcinoma

C22.2 Hepatoblastoma

C22.3 Angiosarcoma of liver

C22.4 Other sarcomas of liver

C22.7 Other specified carcinomas of liver

C22.8 Malignant neoplasm of liver, primary, unspecified as to type

C22.9 Malignant neoplasm of liver, not specified as primary or secondary

C23 Malignant neoplasm of gallbladder

C24.0 Malignant neoplasm of extrahepatic bile duct

C24.1 Malignant neoplasm of ampulla of Vater

C24.8 Malignant neoplasm of overlapping sites of biliary tract

C24.9 Malignant neoplasm of biliary tract, unspecified

C34.00 Malignant neoplasm of unspecified main bronchus

C34.01 Malignant neoplasm of right main bronchus

C34.02 Malignant neoplasm of left main bronchus

C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11 Malignant neoplasm of upper lobe, right bronchus or lung

C34.12 Malignant neoplasm of upper lobe, left bronchus or lung

C34.2 Malignant neoplasm of middle lobe, bronchus or lung

C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31 Malignant neoplasm of lower lobe, right bronchus or lung

C34.32 Malignant neoplasm of lower lobe, left bronchus or lung

C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91 Malignant neoplasm of unspecified part of right bronchus or lung

C34.92 Malignant neoplasm of unspecified part of left bronchus or lung

C44.01 Basal cell carcinoma of skin of lip

C44.02 Squamous cell carcinoma of skin of lip

C44.111 Basal cell carcinoma of skin of unspecified eyelid, including canthus

C44.1121 Basal cell carcinoma of skin of right upper eyelid, including canthus

C44.1122 Basal cell carcinoma of skin of right lower eyelid, including canthus

C44.1191 Basal cell carcinoma of skin of left upper eyelid, including canthus

C44.1192 Basal cell carcinoma of skin of left lower eyelid, including canthus

C44.1221 Squamous cell carcinoma of skin of right upper eyelid, including canthus

C44.1222 Squamous cell carcinoma of skin of right lower eyelid, including canthus

C44.1291 Squamous cell carcinoma of skin of left upper eyelid, including canthus

C44.1292 Squamous cell carcinoma of skin of left lower eyelid, including canthus

C44.211 Basal cell carcinoma of skin of unspecified ear and external auricular canal

C44.212 Basal cell carcinoma of skin of right ear and external auricular canal

C44.219 Basal cell carcinoma of skin of left ear and external auricular canal

C44.221 Squamous cell carcinoma of skin of unspecified ear and external auricular canal

C44.222 Squamous cell carcinoma of skin of right ear and external auricular canal

C44.229 Squamous cell carcinoma of skin of left ear and external auricular canal

C44.310 Basal cell carcinoma of skin of unspecified parts of face

C44.311 Basal cell carcinoma of skin of nose

C44.319 Basal cell carcinoma of skin of other parts of face

C44.320 Squamous cell carcinoma of skin of unspecified parts of face

C44.321 Squamous cell carcinoma of skin of nose

C44.329 Squamous cell carcinoma of skin of other parts of face

C44.41 Basal cell carcinoma of skin of scalp and neck

C44.42 Squamous cell carcinoma of skin of scalp and neck

C44.510 Basal cell carcinoma of anal skin

C44.511 Basal cell carcinoma of skin of breast

C44.519 Basal cell carcinoma of skin of other part of trunk

C44.520 Squamous cell carcinoma of anal skin

C44.521 Squamous cell carcinoma of skin of breast

C44.529 Squamous cell carcinoma of skin of other part of trunk

C44.611 Basal cell carcinoma of skin of unspecified upper limb, including shoulder

C44.612 Basal cell carcinoma of skin of right upper limb, including shoulder

C44.619 Basal cell carcinoma of skin of left upper limb, including shoulder

C44.621 Squamous cell carcinoma of skin of unspecified upper limb, including shoulder

C44.622 Squamous cell carcinoma of skin of right upper limb, including shoulder

C44.629 Squamous cell carcinoma of skin of left upper limb, including shoulder

C44.711 Basal cell carcinoma of skin of unspecified lower limb, including hip

C44.712 Basal cell carcinoma of skin of right lower limb, including hip

C44.719 Basal cell carcinoma of skin of left lower limb, including hip

C44.721 Squamous cell carcinoma of skin of unspecified lower limb, including hip

C44.722 Squamous cell carcinoma of skin of right lower limb, including hip

C44.729 Squamous cell carcinoma of skin of left lower limb, including hip

C44.81 Basal cell carcinoma of overlapping sites of skin

C44.82 Squamous cell carcinoma of overlapping sites of skin

C44.91 Basal cell carcinoma of skin, unspecified

C44.92 Squamous cell carcinoma of skin, unspecified

C78.00 Secondary malignant neoplasm of unspecified lung

C78.01 Secondary malignant neoplasm of right lung

C78.02 Secondary malignant neoplasm of left lung

C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct

C78.80 Secondary malignant neoplasm of unspecified digestive organ

C78.89 Secondary malignant neoplasm of other digestive organs

C7A.090 Malignant carcinoid tumor of the bronchus and lung

D00.1 Carcinoma in situ of esophagus

D01.5 Carcinoma in situ of liver, gallbladder and bile ducts

D02.20 Carcinoma in situ of unspecified bronchus and lung

D02.21 Carcinoma in situ of right bronchus and lung

D02.22 Carcinoma in situ of left bronchus and lung

D04.0 Carcinoma in situ of skin of lip

D04.10 Carcinoma in situ of skin of unspecified eyelid, including canthus

D04.111 Carcinoma in situ of skin of right upper eyelid, including canthus

D04.112 Carcinoma in situ of skin of right lower eyelid, including canthus

D04.121 Carcinoma in situ of skin of left upper eyelid, including canthus

D04.122 Carcinoma in situ of skin of left lower eyelid, including canthus

D04.20 Carcinoma in situ of skin of unspecified ear and external auricular canal

D04.21 Carcinoma in situ of skin of right ear and external auricular canal

D04.22 Carcinoma in situ of skin of left ear and external auricular canal

D04.30 Carcinoma in situ of skin of unspecified part of face

D04.39 Carcinoma in situ of skin of other parts of face

D04.4 Carcinoma in situ of skin of scalp and neck

D04.5 Carcinoma in situ of skin of trunk

D04.60 Carcinoma in situ of skin of unspecified upper limb, including shoulder

D04.61 Carcinoma in situ of skin of right upper limb, including shoulder

D04.62 Carcinoma in situ of skin of left upper limb, including shoulder

D04.70 Carcinoma in situ of skin of unspecified lower limb, including hip

D04.71 Carcinoma in situ of skin of right lower limb, including hip

D04.72 Carcinoma in situ of skin of left lower limb, including hip

D04.8 Carcinoma in situ of skin of other sites

D04.9 Carcinoma in situ of skin, unspecified

D09.8 Carcinoma in situ of other specified sites

D09.9 Carcinoma in situ, unspecified

D13.0 Benign neoplasm of esophagus

D37.8 Neoplasm of uncertain behavior of other specified digestive organs

D37.9 Neoplasm of uncertain behavior of digestive organ, unspecified

K22.711 Barrett's esophagus with high grade dysplasia

L57.0 Actinic keratosis



HCPCS Level II Code Number(s)

J9600 Injection, porfimer sodium, 75 mg


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 07.00.10i:
12/17/2018The following conditions were added to the policy as Medically Necessary:
  • Treatment of low-risk superficial basal cell carcinoma in individuals where surgery or radiation therapy is contraindicated or impractical
  • Treatment of actinic keratoses and low-risk squamous cell carcinoma in situ (Bowen's disease)

The following ICD-10 Diagnosis Codes were added to the policy:
    C44.01, C44.02, C44.111, C44.1121, C44.1122, C44.1191, C44.1192,C44.1221, C44.1222, C44.1291, C44.1292, C44.211, C44.212, C44.219, C44.221, C44.222, C44.229, C44.310, C44.311, C44.319, C44.320, C44.321, C44.329, C44.41, C44.42, C44.510, C44.511, C44.519, C44.520, C44.521, C44.529, C44.611, C44.612, C44.619, C44.621, C44.622, C44.629, C44.711, C44.712, C44.719, C44.721, C44.722, C44.729, C44.81, C44.82, C44.91, C44.92, D04.0, D04.10, D04.111, D04.112, D04.121, D04.122, D04.20, D04.21, D04.22, D04.30, D04.39, D04.4, D04.5, D04.60, D04.61, D04.62, D04.70, D04.71, D04.72, D04.8, D04.9, D09.8, D09.9, L57.0


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 12/17/2018
Version Issued Date: 12/17/2018
Version Reissued Date: N/A

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