Intravitreal Inhibitors

Number: OTH903.020, OTH903.027

Effective Date: 02-15-2019

Coverage:

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Medical policies are a set of written guidelines that support current standards of practice. They are based on current peer-reviewed scientific literature. A requested therapy must be proven effective for the relevant diagnosis or procedure. For drug therapy, the proposed dose, frequency and duration of therapy must be consistent with recommendations in at least one authoritative source. This medical policy is supported by FDA- approved labeling and nationally recognized authoritative references. These references include, but are not limited to: MCG care guidelines, DrugDex (IIb strength of recommendation or higher), NCCN Guidelines (IIb level of evidence or higher), NCCN Compendia (IIb level of evidence or higher), professional society guidelines, and CMS coverage policy.

Intravitreal injection of anti-VEGF therapies, i.e., pegaptanib (Macugen®), ranibizumab (Lucentis™), bevacizumab (Avastin™), or aflibercept (Eylea™), may be considered medically necessary for the treatment of neovascular (wet) age-related (AMD).

Intravitreal injection of anti-VEGF therapies may be considered medically necessary for the treatment of choroidal (CNV; includes myopic CNV or mCNV) due to:

• Angioid streaks, • Central serous chorioretinopathy, • Choroidal retinal neovascularization, secondary to pathologic , • Choroidal retinal neovascularization, degenerative progressive high myopia, • Choroidal rupture or trauma, • Idiopathic choroidal neovascularization, • Multifocal choroiditis, • Pathologic myopia, • Presumed ocular histoplasmosis syndrome, and • .

Intravitreal injections of anti-VEGF therapies are considered experimental, investigational and/or unproven for all other choroidal vascular conditions, including but not limited to the treatment of chorioretinal scars.

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© Copyright Prime Therapeutics LLC. 01/2021 All Rights Reserved Effective 1/1/2021 Intravitreal injection of ranibizumab (Lucentis™) may be considered medically necessary for the treatment of the following retinal vascular conditions:

• Diabetic (DME);

• Diabetic (DR);

• Macular edema following central retinal vein occlusion (CRVO);

• Macular edema following branch retinal vein occlusion (BRVO);

• Neovascular ; or

• Rubeosis (neovascularization of the ).

Intravitreal injection of bevacizumab (Avastin™) may be considered medically necessary for the treatment of the following conditions:

• Choroidal (subretinal) neovascularization (i.e., secondary to neovascular age-related macular degeneration (AMD), myopic degeneration, angioid streaks, idiopathic, secondary to toxoplasmosis, trauma, etc.);

• Diabetic macular edema (DME);

• (DR);

• Retinal neovascularization (i.e., secondary to , secondary to central retinal vein occlusion, etc.);

• Macular retinal edema due to diabetes mellitus, central retinal vein occlusion and/or branch retinal vein occlusion;

• Neovascular glaucoma;

• Proliferative diabetic retinopathy as an adjunctive treatment to vitrectomy or photocoagulation;

• Other neovascular conditions of the (e.g., rubeosis iridis, trabecular angle neovascularization, etc.);

• Retinopathy of prematurity (ROP); or

• Rubeosis (neovascularization of the iris).

Intravitreal injection of pegaptanib (Macugen®) may be considered medically necessary for the treatment of the following conditions:

• Diabetic macular edema (DME), or

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© Copyright Prime Therapeutics LLC. 01/2021 All Rights Reserved Effective 1/1/2021 • Diabetic retinopathy (DR).

Intravitreal injection of aflibercept (EYLEA™) may be considered medically necessary for the treatment of the following conditions:

• Macular edema following retinal vein occlusion (RVO) (central retinal vein occlusion [CRVO] and branch retinal vein occlusion [BRVO]);

• Diabetic macular edema (DME); or

• Diabetic retinopathy (DR).

Intravitreal injection of ranibizumab (Lucentis™), bevacizumab (Avastin™), pegaptanib (Macugen®) or aflibercept (EYLEA™) is considered experimental, investigational and/or unproven for the treatment of all other retinal vascular disorders.

Length of Approval: 12 months

TARGET AGENTS Brand (generic) GPI HCPCS Code Multisource Code Eylea (aflibercept) 2mg/0.05 mL 86655010002020 Single dose vial 86655010002070 8665501000E520 J0178 M, N, O, or Y 8665501000E530 8665501000E542 2 mg/0.05 mL 8665501000E520 J0178 M, N, O, or Y Prefilled syringe Lucentis (ranibizumab) 0.5mg/0.05 mL 8665506000E520 J2778 M, N, O, or Y Prefilled syringe 0.3mg/0.05 mL 8665506000E510 J2778 M, N, O, or Y Prefilled syringe 0.3mg/0.05 mL 86655060002012 J2778 M, N, O, or Y Single dose vial 0.5mg/0.05 mL 86655060002020 J2778 M, N, O, or Y Single dose vial Macugen (pegaptanib) 0.3 mg/0.09 mL 86655050302020 J2503 M, N, O, or Y Prefilled syringe

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© Copyright Prime Therapeutics LLC. 01/2021 All Rights Reserved Effective 1/1/2021