BlueCross BlueShield of Tennessee Medical Policy Manual

Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses

DESCRIPTION

Actinic keratoses (AKs) are the most common pre-malignant skin lesions. They are found predominantly on the scalp, face, dorsal hands and lower extremities. Typically caused by solar photodamage, actinic keratoses appear as rough, scaly patches ranging in normal skin tone to reddish brown.

Actinic keratoses are common precursors to squamous cell carcinoma (SCC) and basal cell carcinoma (BCC), which are collectively known as keratinocyte carcinoma (KC), the most common malignancy in the United States. Up to forty-four percent of potentially fatal metastatic squamous cell carcinomas originate from actinic keratoses.

Differential diagnosis of actinic keratoses as opposed to early SCC in-situ or Bowen’s disease is difficult as there are no sharp histological criteria that precisely define their limits. Some authorities consider them to be the same condition, a clinically significant implication, as poorly differentiated squamous cell carcinoma is the most likely to recur as invasive disease and metastasize. This indicates that actinic keratoses should receive prompt treatment: There is no way to determine which lesions will progress into invasive or metastatic carcinoma and removal of early lesions is relatively simple

Photodynamic therapy is a method of treating actinic keratoses which involves the application of an agent to each lesion where it is converted into photosensitive protoporphyrin. Upon exposure to a light source of a specific wave length, photoactivation causes the production of toxic singlet oxygen and other cytotoxic free radicals which lead to cell death and destruction of the lesion.

Examples of photodynamic therapy for the treatment of actinic keratoses (AKs) are aminolevulinic acid (e.g., Levulan® Kerastick®) used with a blue light source (e.g., Blu-U® Blue Light Photodynamic Therapy Illuminator) and methyl aminolevulinate hydrochloride (e.g., Metvixia®) used with an LED based narrow band (630 nm) red light technology device (e.g., Aktilite® CL128).

REFER TO DECISION SUPPORT TREE

POLICY

Photodynamic therapy with aminolevulinic acid and exposure to blue light for the treatment of actinic keratoses is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Photodynamic therapy with methyl aminolevulinate hydrochloride used with an LED-based narrow band (630 nm) red light technology device for the treatment of actinic keratoses (AKs) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Photodynamic therapy with aminolevulinic acid and exposure to blue light or methyl aminolevulinate hydrochloride used with an LED-based narrow band (630 nm) red light technology device for the treatment of other dermatologic conditions including, but not limited to squamous cell carcinoma, basal cell carcinoma or Bowen's disease is considered investigational.

See also:

MEDICAL APPROPRIATENESS

Photodynamic therapy with aminolevulinic acid and exposure to blue light for the treatment of actinic keratoses (AKs) is considered medically appropriate if ALL of the following criteria are met:

Lesions are ANY ONE of the following:

Thin or slightly palpable; better felt than seen
Moderately thick; easily seen and felt

Lesions are non-hyperkeratotic

Photodynamic therapy with methyl aminolevulinate hydrochloride used with an LED-based narrow band (630 nm) red light technology device for the treatment of actinic keratoses (AKs) is considered medically appropriate if ALL of the following criteria are met:

Lesions are ANY ONE of the following:

Thin or slightly palpable; better felt than seen
Moderately thick; easily seen and felt

Lesions are non-hyperkeratotic
Lesions are non-pigmented
The individual is immunocompetent
Lesion preparation is provided in the physician’s office

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 application of photodynamic therapy (PDT) for the treatment of other dermatologic conditions including, but not limited to squamous cell carcinoma, basal cell carcinoma or Bowen's disease.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2006). Dermatologic applications of photodynamic therapy (2.01.44). Retrieved August 11, 2008 from BlueWeb.

Braathen, L. R., Szeimies, R., Basset-Seguin, N., Bissonnette, R., Foley, P., Pariser, D., et al. (2007). Guidelines on the use of photodynamic therapy for nonmelanoma skin cancer: An international consensus. The Journal of the American Academy of Dermatology, 56 (1), 125-143. (Level 1 - Industry sponsored)

Jagdeo, J., Weinstock, M. A., Piepkorn, M., & Bingham, S. F. (2007). Reliability of the histopathologic diagnosis of keratinocyte carcinomas: The Department of Veteran Affairs topical tretinoin chemoprevention trial group. Journal of the American Academy of Dermatology, 57(2), 279-284.

Jancin, B. (2008, May 21). Actinic keratoses’ high risk of cancer progression revised sharply upward. MD Consult News. Retrieved August 10, 2008 from MD Consult.

Lexi-Comp Online. (2008). AHFS DI. Aminolevulinic acid hydrochloride (Topical). Retrieved August 11, 2008 from Lexi-Comp Online with AHFS.

McIntyre, W. J., Downs, M. R., & Bedwell, S. A. (2007). Treatment options for actinic keratoses. American Family Physician, 76(5), 667-671.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2008). Aminolevulinic Acid. Retrieved August 11, 2008 from MICROMEDEX Healthcare Series.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2008). Methyl Aminolevulinate. Retrieved August 19, 2008 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2003, June). Center for Drug Evaluation and Research. Levulan® Kerastick®: (aminolevulinic acid HCl) for topical solution, 20%. Retrieved August 11, 2008 from http://www.fda.gov/cder/foi/label/2003/20965slr003_levulan_lbl.pdf.

U. S. Food and Drug Administration. (2003, June). Center for Drug Evaluation and Research. Levulan® Kerastick®: Approval Letter. Retrieved August 11, 2008 from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory.

U. S. Food and Drug Administration. (2003, June). Center for Drug Evaluation and Research. Metvixia® (methyl aminolevulinate) cream: Approval letter. Retrieved August 19, 2008 from http://www.fda.gov/cder/foi/appletter/2008/021415s003ltr.pdf.

U. S. Food and Drug Administration. (2008, June). Center for Drug Evaluation and Research. Metvixia® (methyl aminolevulinate) cream, 16.8%. Retrieved August 19, 2008 from http://www.fda.gov/cder/foi/label/2008/021415s003lbl.pdf.

ORIGINAL EFFECTIVE DATE: 9/1/2002

MOST RECENT REVIEW DATE: 3/12/2009

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 for the Treatment of Actinic Keratoses

Is the requested medication being used to treat squamous cell carcinoma, basal cell carcinoma, Bowen's disease or any dermatologic condition other than actinic keratoses?

If yes, this does not meet medical necessity and/or medical appropriateness criteria

If no, go to question #2

Does the individual have a diagnosis of actinic keratoses?

If yes, go to question #3