BlueCross BlueShield of Tennessee Medical Policy Manual

Pegaptanib Sodium

NDC CODE(S)

68782-0001 -  Macugen 0.3mg Solution for Injection (Valeant Pharmaceuticals)

DESCRIPTION

Pegaptanib sodium is a selective vascular endothelial growth factor (VEGF) antagonist.  VEGF is a secreted protein that selectively binds and activates its receptors located primarily on the surface of vascular endothelial cells. It induces angiogenesis, and increases vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of age-related macular degeneration (AMD), a leading cause of blindness.

Pegaptanib is an aptamer, a pegylated modified oligonucleotide.  It adopts a three-dimensional conformation that enables it to bind to extracellular VEGF and is effective at suppressing pathological neovascularization.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

0.3 mg once every 6 weeks by intravitreous injection into the eye to be treated

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®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

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

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Pegaptanib sodium. Retrieved November 28 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, November). Pegaptinib sodium. Retrieved November 28, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2011, October). Center for Drug Evaluation and Research. Macugen® (pegaptanib sodium injection) intravitreal injection. Retrieved November 28, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021756s018lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  2/27/2018

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

Pegaptanib Sodium (Macugen®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #5

  1. Does the individual have a definitive diagnosis of 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. Is the individual free from ocular and/or periocular infections?

If yes, go to question #4

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

  1. Is the request for 1 billable unit every 42 days per eye for dosage of 0.3 mg once every 6 weeks by intravitreous injection into the eye to be treated for an authorization period of one year with possible renewal?

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 approval criteria in questions 2 through 4?

If yes, go to question #6

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, go to question #7

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

  1. Is continued administration necessary for the maintenance treatment of the condition?

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.