DESCRIPTION
Transpupillary thermotherapy (TTT) is a technique in which low-level heat is delivered through the pupil to the choroid and retinal pigment epithelium using a modified diode laser. TTT is proposed as a treatment option for retinoblastoma and choroidal melanoma by delivering heat directly to the tumor surface via infrared wavelengths of light resulting in tumor necrosis. This technology may be used alone for small tumors and in conjunction with chemotherapy or radiation for larger tumors. TTT is also proposed as a treatment for classic and occult choroidal neovascularization to prevent growth and leakage of new blood vessels.
POLICY
Transpupillary thermotherapy is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Transpupillary thermotherapy for the treatment of other ophthalmologic conditions/diseases, including, but not limited to, the following: choroidal neovascularization and age-related macular degeneration is considered investigational.
MEDICAL APPROPRIATENESS
Transpupillary thermotherapy is considered medically appropriate for ANY ONE of the following conditions:
Choroidal melanoma when ALL of the following are met:
Intraocular recurrence
No orbital involvement
Retinoblastoma
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g., statement.
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Evidence remains insufficient to determine whether transpupillary thermotherapy is as beneficial as the established alternatives to treat choroidal neovascularization and age-related macular degeneration. Well-designed studies are needed to validate safety and efficacy.
SOURCES
American Academy of Ophthalmology. (2019). Preferred practice pattern: age-related macular degeneration. Retrieved May 10, 2021 from www.aao.org/ppp.
American Academy of Ophthalmology. (2020). Retinoblastoma. Retrieved July 14, 2020 from https://www.aao.org/eye-health/diseases/retinoblastoma-treatment.
American Cancer Society. (2020). Laser therapy (photocoagulation or thermotherapy) for retinoblastoma. Retrieved July 14, 2020 from https://www.cancer.org/.
Giudice, G., de Belvis, V., Tavolato, M., Galan, A. (2011). Large-spot subthreshold transpupillary thermotherapy for chronic serous macular detachment. Clinical Ophthalmology, (5), 355-360. (Level 3 evidence)
Hasanreisoglu, M., Saktanasate, J., Schwendeman, R., Shields, J. A., & Shields, C. L. (2015). Indocyanine green-enhanced transpupillary thermotherapy for retinoblastoma: analysis of 42 tumors. Journal of Pediatric Ophthalmology and Strabismus, 52 (6), 348-354. Abstract retrieved November 23, 2016 from PubMed database.
Manayath, G.J., Karandikar, S.S., Narendran, S, Kumarswamy, K.A., Saravanan, V.R., Morris, R.J., & Venkatapathy, N. (2017). Low fluence photodynamic therapy versus graded subthreshold transpupillary thermotherapy for chronic central serous chorioretinopathy: results from a prospective study. Ophthalmic Surgery, Lasers and Imaging Retina, 48 (4), 334-338. Abstract retrieved August 24, 2018 from PubMed database.
Mashayekhi, A., Shields, C. L., Rishi, P., Atalay, H. T., Pellegrini, M., McLaughlin, J. P., et al. (2015). Primary transpupillary thermotherapy for choroidal melanoma in 391 cases: importance of risk factors in tumor control. Ophthalmology, 122 (3), 600-609. Abstract retrieved November 23, 2016 from PubMed database.
National Cancer Institute. (2023). Intraocular (Uveal) Melanoma Treatment. Retrieved September 27, 2023 from https://www.nih.gov/institutes-nih.
National Cancer Institute. (2023). Retinoblastoma treatment. Retrieved September 27, 2023 from https://www.nih.gov/institutes-nih.
National Comprehensive Cancer Network. (2023, May). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Uveal melanoma V.1.2023. Retrieved September 27, 2023 from the National Comprehensive Cancer Network.
National Institute for Health and Care Excellence. (2004). Transpupillary thermotherapy for age-related macular degeneration. Retrieved August 24, 2018 from http://www.nice.org.uk.
Nowak, M., Jurowski, P., Grzybowski, A., Goś, R., Pastuszka, M., Kapica, A., et al. (2012). A prospective study on different methods for the treatment of choroidal neovascularization. The efficacy of verteporfin photodynamic therapy, intravitreal bevacizumab and transpupillary thermotherapy in patients with neovascular age-related macular degeneration. Medical Science Monitor, 18 (6), CR374-380. (Level 2 evidence)
Russo, I., Levy-Gabriel, C., Dupont, A., Rouic, L, Cassoux, N., Desjardins, L., et al. (2020). Prospective phase II study of children affected by bilateral intraocular retinoblastoma with macular involvement of both eyes or in the only preserved eye. Macular tumor control, eye preservation rate, and visual outcome. Pediatric Blood & Cancer, 68 (1), e28721. doi: 10.1002/pbc.28721. Abstract retrieved May 10, 2021 from PubMed database.
Shah, P., Narendran, V., & Kalpana, N. (2011). Large spot transpupillary thermotherapy: A quicker laser for treatment of high risk prethreshold retinopathy of prematurity - a randomized study. Indian Journal of Ophthalmology, 59 (2), 155-158. (Level 2 evidence)
Shields, C.L., Santos, M.C., Diniz, W., Gündüz, K., Mercado, G., Cater, J.R., & Shields, J.A. (1999). Thermotherapy for retinoblastoma. Archives Ophthalmology, 117 (7), 885-893. Abstract retrieved July 14, 2020 from PubMed database.
Turcotte, S., Bergeron, D., Rousseau, A., & Mouriaux, F. (2014). Primary transpupillary thermotherapy for choroidal indeterminate melanocytic lesions. Canadian Journal of Ophthalmology, 49 (5), 464-467. Abstract retrieved October 5, 2017 from PubMed database.
ORIGINAL EFFECTIVE DATE: 5/1/2002
MOST RECENT REVIEW DATE: 11/9/2023
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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