BlueCross BlueShield of Tennessee Medical Policy Manual

Verteporfin  

NDC CODE(S)

00187-5600-xx Visudyne 15 MG SOLR (VALEANT)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All Indications 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.

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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® or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of verteporfin for the treatment of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2016). Photodynamic therapy for choroidal neovascularization (9.03.08). Retrieved July 6, 2016 from BlueWeb.

Lexi-Comp Online. (2016, March). AHFS Dl. Verteporfin. Retrieved July 6, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, June). Verteporfin. Retrieved July 6, 2016 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 July 6, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021119s027lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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

Verteporfin (Visudyne®)

  1. Is this the initial request for this agent for this individual?

If yes, go to question #2

If no, go to question #7

  1. Does the individual have a diagnosis of predominantly classic subfoveal choroidal neovascularization associated with ANY ONE of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Will photoactivation be accomplished with light from a nonthermal diode laser?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the agent to be used in combination with any anti-angiogenic agents (e.g., Pegaptanib [Macugen®], Ranibizumab [Lucentis®], Bevacizumab [Avastin®], Aflibercept [Eylea™])?

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

If no, go to question #5

  1. Is the request for 150 billable units every 7 days or less (1 billable unit = 0.1 mg) for an authorization of three months or less?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the requested dosage 6 mg/m2 IV over 10 minutes at a rate of 3 ml/minute per eye, then one week after the first course, if no significant toxicity occurs, the second eye can be treated, if necessary?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the criteria in questions 2 through 6?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has the individual begun treatment with ANY ONE of the following?

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

If no, go to question #9

  1. Is disease response is indicated by improvement in lines of visual acuity from baseline?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent?

If yes, this satisfies medical necessity and medical appropriateness criteria for renewal

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.