|00187-5600-XX Visudyne 15 MG SOLR (VALEANT)|
Verteporfin, a synthetic benzoporphyrin derivative, is cytotoxic photosensitizing agent used in photodynamic therapy. After intravenous infusion, treatment by nonthermal red light is required for treatment in the presence of oxygen. Treatment with verteporfin will leave an individual temporarily photosensitive and exposure to bright light should be avoided for a minimum of five days after treatment.
Verteporfin for the treatment of subfoveal choroidal neovascularization (CNV) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Verteporfin for the treatment of other conditions/diseases is considered investigational.
Verteporfin is considered medically appropriate if ALL of the following:
Photoactivation is accomplished with light from a nonthermal diode laser
Treatment of predominantly classic subfoveal choroidal neovascularization associated with ANY ONE of the following:
Age related macular degeneration (AMD)
Presumed ocular histoplasmosis
Must NOT be used in combination with any anti-angiogenic agents (e.g., pegaptanib, ranibizumab, bevacizumab, aflibercept)
Verteporfin is considered medically appropriate for renewal if ALL of the following:
Individual continues to meet initial approval criteria
Disease response is indicated by improvement in lines of visual acuity from baseline
Absence of unacceptable toxicity from the agent, including severe injection site reactions and severe visual disturbances
|INDICATION(S)||DOSAGE & ADMINISTRATION|
Infuse 6 mg/m2 IV over 10 minutes at a rate of 3 mL/minute per eye. One week after the first course, if no significant toxicity occurs, the second eye can be treated, if necessary.Approximately 3 months later, the eye(s) can be evaluated for re-treatment
LENGTH OF AUTHORIZATION
Coverage will be provided for a period of 3 months and may be renewed
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
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, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2018). Photodynamic therapy for choroidal neovascularization (9.03.08). Retrieved September 12, 2018 from BlueWeb.
Lexi-Comp Online. (2018). AHFS Dl. Verteporfin (EENT). Retrieved September 12, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, February). Verteporfin. Retrieved September 11, 2018 from MICROMEDEX Healthcare Series.
U.S. Food and Drug Administration. (2016, May). Center for Drug Evaluation and Research. Visudyne® (verteporfin for injection), for intravenous use. Retrieved September 11, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021119s027lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 10/9/2018
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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Maximum billable units per dose and over time by indication as a Medical Benefit