mp-337 - Medical Policies - Alabama
Oncologic Applications of Photodynamic Therapy, Including Barrett Esophagus
Policy Number: MP-337
Latest Review Date: July 2021
Policy Grade: A
Effective for dates of service on or after August 28, 2017:
One or more courses of photodynamic therapy may be considered medically necessary for any of the following oncologic applications:
- Palliative treatment of obstructing esophageal cancer; OR
- Palliative treatment of obstructing endobronchial lesions; OR
- Treatment of early-stage non-small cell lung cancer in patients who are ineligible for surgery and radiation therapy; OR
- Treatment of high-grade dysplasia in Barrett esophagus; OR
- Palliative treatment of unresectable cholangiocarcinoma when used with stenting
Other oncologic applications of photodynamic therapy including, but not limited to, other malignancies and Barrett's esophagus without associated high-grade dysplasia are considered investigational.
*Refer also to medical policy 596- Focal Treatments for Prostate Cancer
DESCRIPTION OF PROCEDURE OR SERVICE:
Photodynamic therapy (PDT; also called phototherapy, photo-radiotherapy, photosensitizing therapy, or photo-chemotherapy) is an ablative treatment that uses a photosensitizing agent to expose tumor cells to a light source of a specific wavelength for the purpose of damaging the cells. After administration of the photosensitizing agent, the target tissue is exposed to light using a variety of laser techniques. For example, a laser fiber may be placed through the channel of the endoscope, or a specialized modified diffuser may be placed via fluoroscopic guidance. Treatment for tumor cells occurs through selective retention of the photosensitizing agent and the selective delivery of light.
Photodynamic therapy (PDT) has been investigated for use in a wide variety of tumors, including esophageal, lung, cholangiocarcinoma, prostate, bladder, breast, brain (administered intraoperatively), skin, and head and neck cancers. Barrett esophagus also has been treated with PDT. PDT for focal treatment of prostate cancer is discussed in Policy 596 Focal Treatment for Prostate Cancer.
Several photosensitizing agents have been used in PDT: porfimer sodium (Photofrin®), administered intravenously 48 hours before light exposure, and 5-aminolevulinic acid (5-ALA), administered orally 4 to 6 hours before the procedure. Aminolevulinic acid is metabolized to protoporphyrin IX, which is preferentially taken up by the mucosa. Clearance of porfimer occurs in a variety of normal tissues over 40 to 72 hours, but tumor cells retain porfimer for a longer period. Laser treatment of Barrett esophagus may be enhanced by the use of balloons containing a cylindrical diffusing fiber. The balloon compresses the mucosal folds of the esophagus, thus increasing the likelihood that the entire Barrett mucosa is exposed to light. All patients who receive porfimer become photosensitive and must avoid exposure of skin and eyes to direct sunlight or bright indoor light for 30 days.
The most recent update with literature review covered the period through May 25, 2021. Most studies from outside the U.S. use photosensitizing agents that have not been cleared for use in the U.S.
Summary of Evidence
For individuals who have obstructing esophageal cancer who receive PDT as palliation, the evidence includes systematic reviews, randomized controlled trials (RCTs), and uncontrolled single-arm studies. Relevant outcomes are change in disease status, symptoms, quality of life, and treatment-related morbidity. A meta-analysis comparing PDT with neodymium-doped yttrium aluminum garnet laser suggested that improvements in dysphagia are similar, although estimates are imprecise. Compared with the neodymium-doped yttrium aluminum garnet laser, PDT is associated with a lower risk of perforation and a higher risk of adverse reactions to the light (e.g. photosensitivity). PDT plus argon plasma coagulation appears to prolong the time to recurrence of dysphagia as opposed to argon plasma coagulation alone. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have obstructing endobronchial lesions who receive PDT as palliation, the evidence includes (RCTs) and uncontrolled single-arm studies. Relevant outcomes are change in disease status, symptoms, quality of life, and treatment-related morbidity. Evidence from RCTs comparing PDT with neodymium-doped yttrium aluminum garnet laser has generally supported reductions in symptoms using PDT similar to those using a laser. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have early-stage non-small-cell lung cancer who are not candidates for surgery or radiotherapy who receive PDT, the evidence includes uncontrolled single-arm studies. Relevant outcomes are overall survival (OS), disease-specific survival, change in disease status, quality of life, and treatment-related morbidity. There are few patients with early-stage non-small-cell lung cancer who are not candidates for surgery or radiotherapy. While several treatment methods (eg, laser, electrocautery, cryotherapy, brachytherapy) are available for this population, studies comparing the treatment methods are not available. Case series of PDT include between 21 and 95 patients and have reported complete response rates ranging from 72% to 100%. Given the small size of this potential population and the ineligibility for standard surgical treatment or radiotherapy, it is unlikely that stronger evidence will become available. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with Barrett esophagus with high-grade dysplasia who receive PDT, the evidence includes 2 systematic reviews and 2 RCTs. Relevant outcomes are OS, disease-specific survival, change in disease status, quality of life, and treatment-related morbidity. One RCT compared PDT plus a proton pump inhibitor with a proton pump inhibitor alone and demonstrated higher response rates and lower risk of progression with cancer persisting during 5 years of follow-up for patients in the PDT plus proton pump inhibitor group. The results of the RCT also revealed that patients treated with PDT had significantly more complications, including a high rate of strictures. Another RCT compared PDT performed with different photosensitizers; results revealed that neither were valuable long-term treatments for dysplastic Barrett esophagus. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have unresectable cholangiocarcinoma who receive PDT plus stenting as palliation, the evidence includes systematic reviews, RCTs, and observational studies. Relevant outcomes are change in disease status, symptoms, quality of life, and treatment-related morbidity. Two small RCTs and several observational studies have found that PDT plus stenting is associated with the greater elimination of bile duct stenosis and improved survival benefit compared with stenting alone. One RCT comparing stenting plus chemotherapy and PDT with stenting plus chemotherapy without PDT reported longer progression-free survival, but not OS, with similar adverse event rates. Case series have suggested an improvement in the quality of life with PDT. The main complication of PDT in cholangiocarcinoma is cholangitis. Given the small size of this potential population, it is unlikely that stronger evidence will become available. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have other malignancies (eg, gynecologic, bladder, head and neck, brain, soft tissue) who receive PDT, the evidence includes controlled observational studies and uncontrolled single-arm studies. Relevant outcomes are OS, disease-specific survival, change in disease status, quality of life, and treatment-related morbidity. The published literature on PDT for these malignancies is generally comprised of small case series without comparator groups. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
PRACTICE GUIDELINES AND POSITION STATEMENTS
American College of Chest Physicians
In 2013, ACCP updated its evidence-based practice guidelines on the diagnosis and treatment of bronchial intraepithelial neoplasia and early lung cancer of the central airways. The College recommended PDT and other endobronchial treatments (brachytherapy, cryotherapy, electrocautery) “for patients with superficial limited mucosal lung cancer in the central airway who are not candidates for surgical resection.” (Grade 1C: strong recommendation based on low-quality evidence) The guidelines summarized the evidence for PDT in early lung cancer as follows:
“PDT appears to be an effective therapeutic modality for small early-stage centrally located lung cancers, the majority of which are squamous cell carcinomas. Complete response (CR) rates have been achieved in 32% to 100% of cancers, with the longitudinal length of the cancer being an important predictor of response. However, some patients experience local recurrences, and long-term outcomes remain suboptimal. Talaporfin sodium (NPe6), a newer-generation photosensitizer, appears to be as effective but better tolerated than older agents. However, these data have only been reported by one group and need to be validated in larger numbers of patients.”
American Gastroenterological Association
The 2011 American Gastroenterological Association’s position statement on Barrett esophagus management recommended photodynamic therapy as an option for treatment of confirmed high-grade dysplasia with Barrett esophagus.
American College of Gastroenterology
The 2016 American College of Gastroenterology guidelines on diagnosis and management of Barrett esophagus stated that there is Level I evidence for prevention of cancer for PDT and radiofrequency ablation in Barrett esophagus with high grade dysplasia. The guidelines also stated: “Given the costs and side-effect profile of photodynamic therapy, as well as the large body of data supporting the safety and efficacy of radiofrequency ablation, this modality appears to be the preferred therapy for most patients.”
National Comprehensive Cancer Network
Esophageal Cancer and Barrett Esophagus
The National Comprehensive Cancer Network (NCCN) guidelines (v.2.2021) for esophageal cancer state that RFA has become the preferred treatment while photodynamic therapy is an alternative strategy for patients who have Barrett esophagus with high-grade dysplasia. The guidelines also state that PDT can effectively treat esophageal obstruction but “is less commonly performed due to photosensitivity and costs” compared with radiation and brachytherapy.
NCCN guidelines on hepatobiliary cancers (v.2.2021) describe PDT as a relatively new therapy for local treatment of unresectable cholangiocarcinoma, stating that the combination of PDT and biliary stenting “was reported to be associated with prolonged overall survival in patients with unresectable cholangiocarcinoma based on 2 small randomized clinical trials [Ortner et al (2003) and Zoepf et al (2005)].”
Non-Small Cell Lung Cancer
NCCN guideline (v.4.2021) on non-small cell lung cancer (NSCLC) state that PDT is a treatment option in patients with locoregional recurrence of non-small cell lung cancer with endobronchial obstruction or severe hemoptysis.
National Institute for Health and Care Excellence
- Guidance for palliative treatment of advanced esophageal cancer, treatment of localized inoperable endobronchial cancer, and treatment of advanced bronchial carcinoma has indicated that current evidence on safety and efficacy is sufficient to support the use of PDT for these indications.
- NICE guidance has indicated that PDT should not be used for the following 3 indications due to poor quality evidence: interstitial photodynamic therapy for malignant parotid tumors, early-stage esophageal cancer, and bile duct cancer.
- NICE guidance has indicated that PDT may be considered for Barrett esophagus with flat HGD, taking into account the evidence of their long-term efficacy, cost, and complication rates. The guidance notes that current evidence on the use of PDT for Barrett esophagus with either low-grade dysplasia or no dysplasia is inadequate so that the balance of risk and benefit is unclear.
- NICE guidance on PDT for brain tumors has indicated that current evidence is limited in quality and quantity, and the procedure should only be used in context of RCTs with well-defined inclusion criteria and treatment protocols, and collection of both survival and quality of life outcomes.
U.S. Preventive Services Task Force Recommendations
Hematoporphyrin, Photodynamic Therapy; photochemotherapy, phototherapy, photoradiotherapy, Oncologic Applications, Photofrin®, Photoradiation Therapy, Photosensitizing Therapy, PDT, NPc6, Foscan, meta-tetrahydroxyphenylchorin, Barrett Esophagus
APPROVED BY GOVERNING BODIES:
Labeled indications for porfimer sodium (Photofrin®; Pinnacle Biologics), as approved by the U.S. Food and Drug Administration (FDA) are as follows:
- Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy
- Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small cell lung cancer (NSCLC).
- Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated.
High-Grade Dysplasia in Barrett Esophagus
- Treatment of high-grade dysplasia in Barrett esophagus who do not undergo esophagectomy
As of June 2018, oral 5-aminolevulinic acid (5-ALA) has not received FDA approval as a photosensitizing agent for PDT. Topical 5-ALA used for treatment of actinic keratoses is addressed separately.
This policy only addresses the non-dermatologic oncologic applications of photodynamic therapy and does not address its use in dermatologic applications, such as actinic keratosis (see policy #050 Dermatologic Applications of Photodynamic Therapy), and superficial basal cell cancer or age-related macular degeneration (see policy #047 Photodynamic Therapy, Ocular; Visudyne). In addition, photodynamic therapy should not be confused with extracorporeal photopheresis, which involves withdrawing blood from the patient, irradiating it with ultraviolet light, and then returning the blood to the patient. Extracorporeal photopheresis is addressed separately, (see policy #028 Extracorporeal Photopheresis).
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
|31641||Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with destruction of tumor or relief of stenosis by any method other than excision (e.g., laser therapy, cryotherapy)|
|43229||Esophagoscopy, Flexible, Transoral; With Ablation of Tumor(s), Polyp(s) or Other Lesion(s), (Includes Pre and Post-dilation and Guide Wire Passage, When Performed)|
|96570||Photodynamic therapy by endoscopic application of light to ablate abnormal tissue via application of photosensitive drug(s); first 30 minutes (list separately in addition to code for endoscopy or bronchoscopy procedures of lung and gastrointestinal tract)|
|96571||Photodynamic therapy by endoscopic application of light to ablate abnormal tissue via application of photosensitive drug(s); each additional 15 minutes (list separately in addition to code for endoscopy or bronchoscopy procedures of lung and gastrointestinal tract)|
Porfimer Sodium, 75 mg
- 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. Apr 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. Sep 2014; 11 (3):259-264.
- 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):766-74.
- Babjuk M, Böhle A, Burger M et al. European Association of Urology. Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1 and CIS). Uroweb 2014. www.uroweb.org/guidelines/online-guidelines/.
- 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):1178-83.
- Bahng S, Yoo BC, Paik SW et al. Photodynamic therapy for bile duct invasion of hepatocellular carcinoma. Photochem Photobiol Sci 2013; 12(3):439-45.
- 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):618-22.
- 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. Sep 2014; 11(3):420-425.
- 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.
- Dunn JM, Mackenzie GD, Banks MR et al. A randomized controlled trial of ALA vs. Photofrin photodynamic therapy for high-grade dysplasia arising in Barrett’s oesophagus. Lasers Med Sci 2013; 28(3):707-15.
- 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):1433-9.
- 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):547-52.
- FNCLCC. The Free Dictionary by Farlex. https://acronyms.thefreedictionary.com/FNCLCC. Accessed May 21, 2019.
- 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. Mar 2017; 103(3):912-919.
- FV MCD, Al-Kheraif AA, Qadri T, et al. Efficacy of photodynamic therapy in the management of oral premalignant lesions. A systematic review. Photodiagnosis Photodyn Ther. Oct 11 2014.
- Godoy H, Vaddadi P, Cooper M et al. Photodynamic therapy effectively palliates gynecologic malignancies. Eur J Gynaecol Oncol 2013; 34(4):300-2.
- 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.
- 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. Mar 2016; 13:330-333.
- 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.
- https://www.nccn.org/professionals/physicians_gls/PDF/esophageal.pdf.Accessed May 20, 2019.
- https://www.nccn.org/professionals/physicians_gls/PDF/hepatobiliary.pdf.Accessed May 20, 2019.
- Huggett MT, Jermyn M, Gillams A, et al. Phase I/II study of verteporfin photodynamic therapy in locally advanced pancreatic cancer. Br J Cancer. Apr 2 2014; 110(7):1698-1704.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Kasivisvanathan V, Emberton M, Ahmed HU. Focal therapy for prostate cancer: rationale and treatment opportunities. Clin Oncol (R Coll Radiol) 2013; 25(8):461-73.
- Kohoutova D, Haidry R, Banks M, et al. Long-term outcomes of the randomized controlled trial comparing 5-aminolaevulinic acid and Photofrin photodynamic therapy for Barrett's oesophagus related neoplasia. Scand J Gastroenterol. 2018 May;53(5):527-532.
- Konda VJ, Waxman I. Endotherapy for Barrett's esophagus. Am J Gastroenterol 2012; 107(6):827- 33.
- Lambert A, Nees L, Nuyts S, et al. Photodynamic Therapy as an Alternative Therapeutic Tool in Functionally Inoperable Oral and Oropharyngeal Carcinoma: A Single Tertiary Center Retrospective Cohort Analysis. Front Oncol. 2021; 11: 626394.
- 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):1192-9.
- 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- 43.
- Lu Y, Liu L, Wu JC, et al. Efficacy and safety of photodynamic therapy for unresectable cholangiocarcinoma: A meta-analysis. Clin Res Hepatol Gastroenterol. Dec 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.
- 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.
- 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):845-52.
- Nakamura T, Kusuzaki K, Matsubara T, et al. Long-term clinical outcome in patients with high-grade soft tissue sarcoma who were treated with surgical adjuvant therapy using acridine orange after intra-lesional or marginal resection. Photodiagnosis Photodyn Ther. 2018 Sep;23:165-170.
- National Comprehensive Cancer Network (NCCN). Esophageal and esophagogastric junction cancer (V.2.2018). Available online at www.nccn.org/professionals/physician_gls/PDF/esophageal.pdf. Accessed June 7, 2018.
- National Comprehensive Cancer Network (NCCN). Hepatobiliary cancers (V.1.2018). Available online at www.nccn.org/professionals/physician_gls/PDF/hepatobiliary.pdf. Accessed June 7, 2018.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Esophageal and esophagogastric junction cancer. Version 2.2021. https://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf. Accessed May 27, 2021.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hepatobiliary cancers. Version 2.2021. https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed May 27, 2021.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer. Version 4.2021. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed May 27, 2021.
- National Comprehensive Cancer Network (NCCN). Non-small cell lung cancer (V.4.2018). Available online at www.nccn.org/professionals/physician_gls/PDF/nscl.pdf. Accessed June 23, 2017.
- National Comprehensive Cancer Network. https://www.nccn.org/professionals/physician_gls/PDF/esophageal.pdf. Accessed May 20, 2019.
- National Comprehensive Cancer Network. https://www.nccn.org/professionals/physician_gls/PDF/hepatobiliary.pdf. Accessed May 20, 2019.
- National Institute for Health and Care Excellence. Interstitial photodynamic therapy for malignant parotid tumours [IPG259]. 2008; http://www.nice.org.uk/nicemedia/pdf/IPG259Guidance.pdf. Accessed May 26, 2021.
- National Institute for Health and Care Excellence. Palliative photodynamic therapy for advanced oesophageal cancer [IPG206]. 2007; http://www.nice.org.uk/nicemedia/pdf/IPG206guidance.pdf. Accessed June 7, 2018.
- National Institute for Health and Care Excellence. Photodynamic therapy for localised inoperable endobronchial cancer [IPG137]. 2005; http://www.nice.org.uk/guidance/ipg137. Accessed June 7, 2018.
- National Institute for Health and Care Excellence. Photodynamic therapy for advanced bronchial carcinoma [IPG87]. 2004; http://guidance.nice.org.uk/IPG87/Guidance/pdf/English. Accessed June 7, 2018.
- National Institute for Health and Care Excellence. Photodynamic therapy for bile duct cancer [IPG134]. 2005; http://www.nice.org.uk/guidance/IPG134/Guidance/pdf. Accessed June 7, 2018.
- National Institute for Health and Care Excellence. Photodynamic therapy for Barrett's oesophagus [IPG350]. 2010; http://www.nice.org.uk/guidance/ipg350. Accessed June 7, 2018.
- National Institute for Health and Care Excellence. Photodynamic therapy for brain tumours [IPG290]. 2009; http://www.nice.org.uk/nicemedia/pdf/IPG290Guidance.pdf. Accessed June 7, 2018.
- National Institute for Health and Care Excellence. Photodynamic therapy for bile duct cancer [IPG134]. 2005; http://www.nice.org.uk/guidance/IPG134/Guidance/pdf. Accessed May 27, 2021.
- National Institute for Health and Care Excellence. Photodynamic therapy for localised inoperable endobronchial cancer [IPG137]. 2005; http://www.nice.org.uk/guidance/ipg137. Accessed May 27, 2021.
- National Institute for Health and Care Excellence. Photodynamic therapy for advanced bronchial carcinoma [IPG87]. 2004; http://guidance.nice.org.uk/IPG87/Guidance/pdf/English. Accessed May 27, 2021.
- National Institute for Health and Care Excellence. Photodynamic therapy for Barrett's oesophagus [IPG350]. 2010; http://www.nice.org.uk/guidance/ipg350. Accessed May 27, 2021.
- National Institute for Health and Care Excellence. Photodynamic therapy for brain tumours [IPG290]. 2009; http://www.nice.org.uk/nicemedia/pdf/IPG290Guidance.pdf. Accessed May 30, 2021.
- National Institute for Health and Clinical Excellence. IPG259 Interstitial photodynamic therapy for malignant parotid tumors-guidance. 2008. Available online at www.nice.org.uk/nicemedia/pdf/IPG259Guidance.pdf. Last accessed February, 2014.
- Nomura T, Mimata H. Focal therapy in the management of prostate cancer: an emerging approach for localized prostate cancer. Adv Urol 2012; 2012:391437.
- 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. Dec 2012;9(4):287-292.
- Pinnacle Biologics. Photofrin® (porfimer sodium injection) prescribing information, June 2011. Available online at: www.pinnaclebiologics.com/our-products/photofrinreg-prescribing-information. Last accessed February, 2014.
- Product insert, Photofrin (Sanofi Pharmaceuticals) www.sanofi-synthelabous.com.
- 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):706-11.
- 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):1612-20.
- Shaheen NJ, Falk GW, Iyer PG, et al. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. Jan 2016; 111(1):30-50; quiz 51.
- 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):762-4.
- 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):468-74.
- 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):1084-91.
- 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):475-91.
- Tao XH, Guan Y, Shao D, et al. Efficacy and safety of photodynamic therapy for cervical intraepithelial neoplasia: a systemic review. Photodiagnosis Photodyn Ther. Jun 2014; 11(2):104-112.
- Tomizawa Y, Tian J. Photodynamic therapy for unresectable cholangiocarcinoma. Dig Dis Sci 2012; 57(2):274-83.
- 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. Mar 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.
- 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. May 2013;143(5 Suppl):e263S277S.
- 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.
- Zhang R, Wang L. Photodynamic therapy for treatment of usual-type vulvar intraepithelial neoplasia: a case report and literature review. J Int Med Res. Aug 2019; 47(8): 4019-4026.
- 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). May 2018; 97(21):e10864.
- Zoepf T, Jakobs R, Arnold JC et al. Palliation of nonresectable bile duct cancer: improved survival after photodynamic therapy. Am J Gastroenterol 2005; 100(11):2426-30.
Medical Policy Group, January 2009 (4)
Medical Policy Administration Committee, February 2009
Available for comment February 6-March 23, 2009
Medical Policy Group, March 2010 (3)
Medical Policy Group, June 2011; Updates to Key Points & References
Medical Policy Group, March 2012 (3): Updated Key Points & References
Medical Policy Panel, March 2013
Medical Policy Group, April 2013 (3): Updated Key Points & References; no change in policy statement
Medical Policy Panel, March 2014
Medical Policy Group, March 2014 (3): 2014 Updates to Description, Key Points, Governing Bodies & References; no change in policy statement
Medical Policy Group, June 2014 (3): Updated policy with link to CareCore National© medical policies effective August 1, 2014
Medical Policy Administration Committee, June 2014
Available for comment June 16 through July 31, 2014
Medical Policy Group, July 2014: Removed CareCore link. Transfer to CareCore is on hold until further notice. The policy has been returned to FINAL.
Medical Policy Panel, March 2015
Medical Policy Group, March 2015 (3): 2015 Updates to Key Points, Code, and References; no change to policy statement.
Medical Policy Group, April 2015(4): Added statement under policy section to refer to medical policy 596 for focal treatments for prostate cancer.
Medical Policy Panel, August 2017
Medical Policy Group, August 2017 (3): 2017 Updates to Title, Description, Policy, Key Points, Approved by Governing Bodies & References; Policy statement updated to reflect adding coverage criteria for palliative treatment of unresectable cholangiocarcinoma when used with stenting.
Medical Policy Administration Committee, September 2017
Available for comment August 30 through October 13, 2007
Medical Policy Panel, July 2018
Medical Policy Group, August 2018 (2): Updates to Description, Key Points, and References. No change in policy statement. Added Key Words (phototherapy, photoradiotherapy, Barrett esophagus). Removed previous coding section prior to 12/31/13.
Medical Policy Panel, July 2019
Medical Policy Group, July 2019 (2): Updates to Description, Key Points, and References. No change in Policy Statement.
Medical Policy Panel, July 2020
Medical Policy Group, July 2020 (5): Updates to Key Points and References. No change to Policy Statement.
Medical Policy Panel, July 2021
Medical Policy Group, July 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.