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Printer Friendly Version Macugen® (pegaptanib sodium injection), Lucentis® (ranibizumab injection), Eylea® (aflibercept injection)

Macugen® (pegaptanib sodium injection), Lucentis® (ranibizumab injection), Eylea® (aflibercept injection)

DESCRIPTION

Macugen® (pegaptanib sodium), and Lucentis® (ranibizumab), and Eylea® (aflibercept) are selective vascular endothelial growth factor (VEGF) antagonists. VEGF is a secreted protein that selectively binds and activates its receptors located primarily on the surface of vascular endothelial cells. VEGF induces angiogenesis and increases vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD, a leading cause of blindness. VEGF has been implicated in blood-retinal barrier breakdown and pathological ocular neovascularization.

FDA APPROVED INDICATIONS

Macugen® is FDA approved for the treatment of neovascular (wet) age-related macular degeneration.

Lucentis® is FDA approved for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema.

Eylea® is FDA approved for the treatment of Neovascular (wet) age-related macular degeneration and macular edema following central retinal vein occlusion.

IDENTIFICATION

Generic Name: Pegaptanib sodium
Brand Name: Macugen®

Generic Name: Ranibizumab
Brand Name: Lucentis®

Generic Name: Aflibercept
Brand Name: Eylea®

POLICY

Prior authorization is required.

Macugen is considered medically necessary for the treatment of neovascular (wet) age-related macular degeneration.

Lucentis is considered medically necessary for the treatment of neovascular (wet) age-related macular degeneration and macular edema following retinal vein occlusion.

Effective 08/10/12, Lucentis is considered medically necessary for the treatment of diabetic macular edema.

Eylea is considered medically necessary for the treatment of neovascular (wet) age-related macular degeneration.

Effective 09/21/12, Eylea is considered medically necessary for the treatment of macular edema following central retinal vein occlusion.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

POLICY HISTORY

3/31/2005: Approved by Medical Policy Advisory Committee (MPAC)

6/6/2005: Code Reference section completed

12/20/2005: Specific HCPCS code for 1/1/2006 added

7/10/2006: Added Lucentis to the policy and changed CuraScript fax number

7/18/2007: Code Reference section updated; HCPCS J3490 added

10/17/2007: CuraScript is a preferred provider for Macugen® or Lucentis®. Accredo is a preferred provider for Lucentis®

12/18/2007: Coding updated per 2008 CPT/HCPCS revisions

01/01/2009: Accredo amd CuraScript preferred provider information removed. BCBSMS information added.

02/23/2011: Policy statement and description updated to add macular edema following retinal vein occlusion as an approved indication for Lucentis.

07/26/2012: Added coverage guidelines for Eylea® (aflibercept).

11/27/2012: Policy description and statement updated regarding Lucentis and Eylea. Policy statement revised to state the following: Effective 08/10/12, Lucentis is considered medically necessary for the treatment of diabetic macular edema. Effective 09/21/12, Eylea is considered medically necessary for the treatment of macular edema following central retinal vein occlusion. Added ICD-9 codes 362.07 and 362.83 to the Covered Codes table.

01/07/2013: Added the following new 2013 CPT code to the Code Reference section: J0178.

SOURCE(S)

www.fda.gov/

www.efactsonline.com

Evangelos S. Gragoudas, M.D. et al. Pegaptanib for Neovascular Age-Related Macular Degeneration. The New EnglandJournal of Medicine. December 30, 2004, Vol. 351, No. 27, 2805-2816.

Hayes Alert, Volume VIII, Number 1 – January 2005

Macugen® Prescribing Information

Facts and Comparisons, May 2006

Lucentis® Prescribing Information

Eylea® Prescribing Information

CODE REFERENCE

This is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Code Number	Description
CPT-4

ICD-9 Procedure

ICD-9 Diagnosis
362.07	Diabetic macular edema (Added 11-27-2012)
362.52	Exudative senile macular degeneration (wet)
362.83	Retinal edema (Added 11-27-2012)
HCPCS
J0178	Injection, aflibercept, 1 mg (New 01-01-2013)
J2503	Injection, pegaptanib sodium, 0.3 mg (effective 1-1-2006)
J2778	Injection, ranibizumab, 0.1 mg (new 1-1-2008)
J3490	Unclassified drugs (Lucentis®, ranibizumab) (added 7-18-2007)
Q2046	Injection, aflibercept, 1 mg (Added 07-26-2012) (Deleted 12-31-2012)
S0198	Injection, pegaptanib sodium, 0.3 mg (effective 7-1-2005)

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