68782-0001-XX MACUGEN 0.3MG/0.09ML Solution (BAUSCH HEALTH)
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.
Pegaptanib sodium for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Diabetic macular edema
Neovascular (wet) age-related macular degeneration
Pegaptanib sodium for the treatment of other conditions/diseases is considered investigational.
Pegaptanib sodium is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Free from ocular and/or periocular infections
Therapy will not be used with other ophthalmic VEGF inhibitors (i.e., aflibercept, ranibizumab, brolucizumab-dbll, bevacizumab, etc.)
Definitive diagnosis of ANY ONE of the following
Diabetic macular edema
Neovascular (wet) age-related macular degeneration (AMD) and BCBST requirement: Documentation of prior trial and failure of ANY ONE of the following:
Pegaptanib sodium is considered medically appropriate for renewal if ALL of the following criteria are met:
DOSAGE & ADMINISTRATION
0.3 mg intravitreally once every 6 weeks into the eye to be treated**
**NOTE: The safety and efficacy of administration to both eyes concurrently have not been established
LENGTH OF AUTHORIZATION
Coverage will be provided annually and may be renewed.
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).
No controlled studies were found in the published literature that validate the use of pegaptanib sodium for the treatment of other conditions or diseases.
Lexi-Comp Online. (2020, March). AHFS DI. Pegaptanib sodium. Retrieved November 3, 2020 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2020, August). Pegaptanib sodium. Retrieved November 3, 2020 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2011, July). Center for Drug Evaluation and Research. Macugen® (pegaptanib sodium injection) intravitreal injection. Retrieved November 4, 2020 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021756s018lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 4/2/2021
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