Vascular endothelial growth factor (VEGF) has been implicated in the pathogenesis of a variety of ocular vascular conditions. The macula, with the fovea at its center, has the highest photoreceptor concentration and is where visual detail is discerned. The anti-VEGF agent’s brolucizumab-dbll (Beovu®), ranibizumab (Lucentis™), ranibizumab-nuna (Byooviz^TM) – biosimilar to Lucentis, ranibizumab injection ocular implant (Susvimo^TM), bevacizumab (Avastin®), pegaptanib (Macugen®) andaflibercept (Eylea ™), and faricimab-svoa (Vabysmo^TM) are used to treat certain ocular disorders and are given by intravitreal injection.

Symptomatic vitreomacular adhesion (VMA) occurs when the vitreous (jelly-like substance inside the eye) has persistent adhesion to the macula. Symptomatic VMA symptoms such as distorted or decreased vision are a result of this persistent adhesion. If the disease progresses, the symptoms can worsen and may result in central vision defect and loss of vision. Ocriplasmin (Jetrea®), a proteolytic enzyme, is a single intravitreal injection indicated for the treatment of symptomatic VMA. It breaks down proteins in the eye responsible for VMA.

Aflibercept (Eylea) may be considered medically necessary for the treatment of individuals with ANY ONE of the following conditions:

• Diabetic macular edema (DME); or
• Diabetic retinopathy in patients with r without DME; or
• Macular edema following retinal vein occlusion (RVO); or
• Neovascular (wet) age-related macular degeneration (AMD) when treatment with bevacizumab (Avastin) has been ineffective, not tolerated, or is contraindicated; and
• Initial authorization will be for a period of 12 months.

Reauthorization Criteria

• Continuation of aflibercept (Eylea) may be considered medically necessary when there is positive clinical response (e.g. improvement in visual acuity); and
• Reauthorization will be for a period of 12 months.

The use of aflibercept (Eylea) for any other indication is considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Bevacizumab (Avastin) may be considered medically necessary for the treatment of individuals with ANY ONE of the following conditions:

• Choroidal neovascularization secondary to ANY ONE of the following:
  • Angioid streaks; or
  • Central serous chorioretinopathy; or
  • Choroidal rupture or trauma; or
  • Pathologic myopia; or
  • Presumed ocular histoplasmosis syndrome; or
• DME; or
• Idiopathic choroidal neovascularization; or
• Macular edema following RVO; or
• Neovascular (wet) AMD; or
• Neovascular glaucoma; or
• Non-proliferative diabetic retinopathy with macular edema; or
• Proliferative diabetic retinopathy; or
• Retinopathy of prematurity; or
• Rubeosis (neovascularization of the iris); or
• Traction retinal detachment as an adjunct to surgery.

The use of bevacizumab (Avastin) for any other indication is considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Brolucizumab-dbll (Beovu) may be considered medically necessary for the treatment of individuals with:

• Neovascular (wet) AMD when treatment with bevacizumab (Avastin) has been ineffective, not tolerated, or is contraindicated; and
• Initial authorization will be for a period of 12 months

Reauthorization Criteria

• Continuation of brolucizumab-dbll (Beovu) may be considered medically necessary when there is positive clinical response (e.g. improvement in visual acuity); and
• Reauthorization will be for a period of 12 months.

The use of brolucizumab-dbll (Beovu) for any other indication is considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

A single intravitreal injection of ocriplasmin (Jetrea) may be considered medically necessary for treatment of an eye* with symptomatic VMA when ALL of the following criteria are met:  

• Individual is greater than or equal to 18 years of age; and
• Optical coherence tomography (OCT) demonstrates ALL of the following:
  • There is vitreous adhesion within 6-mm of the fovea (center of macula); and
  • There is elevation of the posterior vitreous cortex (outer layer of the vitreous); and
  • Individual has best-corrected visual acuity of 20/25 or less in the eye to be treated with ocriplasmin (Jetrea); and
• Individual does not have ANY of the following:
  • Proliferative diabetic retinopathy; or  
  • Neovascular (wet) AMD; or
  • Retinal vascular occlusion; or
  • Aphakia; or
  • High myopia (more than -8 diopters);
  • Uncontrolled glaucoma; or
  • Macular hole greater than 400 µm in diameter; or
  • Vitreous opacification; or
  • Lenticular or zonular instability; or
  • History of retinal detachment in either eye; or
  • Prior vitrectomy in the affected eye; or
  • Prior laser photocoagulation of the macula in the affected eye; or
  • Prior treatment with ocular surgery, intravitreal injection or retinal laser photocoagulation in the previous 3 months.

*NOTE: For treatment of bilateral VMA, a waiting period of at least 7 days is recommended before treatment of the contralateral eye.

Repeat intravitreal injection of ocriplasmin (Jetrea) in the affected eye is considered experimental/investigational.

The use of ocriplasmin (Jetrea) for any other indication is considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Pegaptanib (Macugen) may be considered medically necessary for the treatment of individuals with:

• Neovascular (wet) AMD when treatment with bevacizumab (Avastin) has been ineffective, not tolerated, or is contraindicated; and
• Initial authorization will be for a period of 12 months.

Reauthorization Criteria

The use of pegaptanib (Macugen) for any other indication is considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Ranibizumab (Lucentis) may be considered medically necessary for the treatment of individuals with ANY ONE of the following conditions:

• Diabetic macular edema (DME); or
• Diabetic retinopathy in patients with or without DME; or
• Macular edema following RVO; or
• Myopic Choroidal Neovascularization (mCNV); or
• Neovascular (wet) AMD when treatment with bevacizumab (Avastin) has been ineffective, not tolerated, or is contraindicated; and
• Initial authorization will be for a period of 12 months.

Reauthorization Criteria

• Continuation of ranibizumab (Lucentis) may be considered medically necessary when there is positive clinical response (e.g. improvement in visual acuity); and
• Reauthorization will be for a period of 12 months.

The use of ranibizumab (Lucentis) for any other indication is considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Ranibizumab-nuna (Byooviz) may be considered medically necessary for the treatment of individuals with ANY ONE of the following conditions:

• Macular Edema Following Retinal Vein Occlusion (RVO); or
• Myopic Choroidal Neovascularization; or 
• Neovascular (Wet) Age-Related Macular Degeneration when treatment with bevacizumab (Avastin) has been ineffective, not tolerated, or is contraindicated; and
• Initial authorization will be for a period of 12 months.
  

Reauthorization Criteria

• Continuation of ranibizumab-nuna (Byooviz) may be considered medically necessary when there is positive clinical response (e.g. improvement in visual acuity); and
• Reauthorization will be for a period of 12 months.

The use of ranibizumab-nuna (Byooviz) for any other indication is considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Ranibizumab (Susvimo) intravitreal injection via ocular implant may be considered medically necessary for the treatment of individuals with:

• Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two (2) intravitreal injections of a VEGF inhibitor medication within the past six (6) months; and
• Treatment with bevacizumab (Avastin) has been ineffective, not tolerated, or is contraindicated; and
• Initial authorization will be for a period of 12 months.

Reauthorization Criteria

• Continuation of ranibizumab (Susvimo) may be considered medically necessary when there is positive clinical response (e.g. improvement in visual acuity); and
• Reauthorization will be for a period of 12 months.

The use of ranibizumab (Susvimo) for any other indication is considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Faricimab-svoa (Vabysmo) may be considered medically necessary for the treatment of individuals with ANY ONE of the following conditions:

• Neovascular (Wet) (AMD) when treatment with bevacizumab (Avastin) has been ineffective, not tolerated, or is contraindicated; or
• Diabetic Macular Edema (DME); and
• Initial authorization will be for a 12 month period

Reauthorization Criteria

• Continuation of faricimab-svoa (Vabysmo) may be considered medically necessary when there is positive clinical response (e.g. improvement in visual acuity); and
• Reauthorization will be for a period of 12 months.

The use of faricimab-svoa (Vabysmo) for any other indication is considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.