Photodynamic Therapy (PDT) for Conditions of the Eye
Photodynamic therapy (PDT) is a two-stage process in which a photosensitive pharmaceutical agent is administered followed by exposure to the particular light source which activates the agent. Ocular conditions treated with PDT are characterized by choroidal neovascularization (CNV), the inappropriate growth of vessels and cellular infiltrate. CNV usually originates in the choroid and can extend under the retina to cause detachment and scarring that diminishes visual acuity.
The most common ocular condition marked by CNV is neovascular or wet age-related macular degeneration (AMD) which can progress rapidly in visual deterioration. Wet AMD is classified as classic or occult, based on the appearance of lesions on fluorescein angiography. Classic lesions are clearly defined and leak fluorescein uniformly. Occult lesions are often hidden or difficult to determine growth extent, as the leak of fluorescein is patchy. Some lesions may exhibit both classic and occult components.
Two other conditions that present with CNV have shown response to PDT: pathologic myopia, a rare condition of abnormal elongation of the eye, and presumed ocular histoplasmosis, a condition that is asymptomatic unless CNV lesions affect the macula.
The photosensitizing agent used in PDT for conditions of the eye is verteporfin. Administered intravenously, it appears to accumulate in areas of CNV. The light required for activation of verteporfin is a nonthermal red light from a 689 nm wavelength laser. Upon activation, verteporfin emits free radicals that destroy the neovascular endothelium and occlude the new vessels.
An example of a preparation of verteporfin is VisudyneŽ.
REFER TO DECISION SUPPORT TREE
POLICY
Photodynamic therapy for the treatment of certain conditions of the eye is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Photodynamic therapy (PDT) for the treatment of other ophthalmic conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Photodynamic therapy for the treatment of certain conditions of the eye is considered medically appropriate if ANY ONE of the following criteria are met:
Diagnosis of neovascular (wet) age-related macular degeneration with ANY ONE of the following:
Classic choroidal neovascularization (CNV) when the area of CNV is greater than 50% of the lesion
Occult lesions with no classic choroidal neovascularization (CNV)
Diagnosis of pathologic myopia of greater than 6 diopters
Diagnosis of presumed ocular histoplasmosis
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of photodynamic therapy for any conditions/diseases of the eye other than those listed above.
Any light source used with the agent verteporfin must have specific FDA approval for use in photodynamic therapy for conditions of the eye.
SOURCES
American Academy of Ophthalmology. (2005). Preferred Practice PatternŽ. Age-related macular degeneration. Retrieved March 27, 2009 from http://one.aao.org/asset.axd?id=29a3f5f4-afa1-41ea-bbc5-0bb01ff1fc9c.
BlueCross and BlueShield Association. Medical Policy Reference Manual. (6:2008). Photodynamic therapy for subfoveal choroidal neovascularization (9.03.08). Retrieved March 26, 2009 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer Software]. (2008, July). Ocular photodynamic therapy (NCS 80.2.1, pp. 2-40 - 41). Ingenix.
Complete Guide to Medicare Coverage Issues [Computer Software]. (2008, July). Verteporfin. (NCS 80.3.1, p. 2-42). Ingenix.
Lexi-Comp Online. (2009). AHFS DI. Verteporfin (EENT). Retrieved March 26, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Verteporfin. Retrieved March 26, 2009 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2008, June). VisudyneŽ (Verteporfin for injection) approval letter. Retrieved March 26, 2008 from http://www.fda.gov/cder/foi/appletter/2008/021119se8-013ltr.pdf.
U. S. Food and Drug Administration. (2008, June). VisudyneŽ (Verteporfin for injection) label. Retrieved March 26, 2008 from http://www.fda.gov/cder/foi/label/2008/021119s013lbl.pdf.
Wormald, R., Evans, J. R., Smeeth, L. L., Henshaw, K. S. Photodynamic therapy for neovascular age-related macular degeneration. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD002030. DOI:10.1002/14651858.CD002030.pub3.
ORIGINAL EFFECTIVE DATE: 3/1985
MOST RECENT REVIEW DATE: 6/11/2009
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.
Pharmaceutical Decision Support Tree
Photodynamic Therapy (PDT) for Conditions of the Eye
Does the individual have a diagnosis of neovascular or wet age-related macular degeneration (AMD)?
If yes, go to question #2
If no, go to question #4
Does the individual show evidence of classic AMD with choroidal neovascularization in more than 50% of the area of the lesion?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Does the individual show evidence of occult AMD with no classic lesions?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have a diagnosis of pathologic myopia greater than 6 diopters?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #5
Does the individual have a diagnosis of presumed ocular histoplasmosis?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.