EYLEA/EYLEA HD

I.  Eylea (aflibercept) may be considered medically necessary when the following criteria are met:

A.  Prescribed by an ophthalmologist,

AND

B.  Diagnosis of neovascular (wet) age related macular degeneration (AMD),

OR

C.  Diagnosis of macular edema due to retinal vein occlusion (RVO)

OR

D.  Diagnosis of diabetic macular edema (DME)

OR

E.  Diabetic retinopathy (DR) in patient with DME

AND

Treatment with bevacizumab has been ineffective, not tolerated or contraindicated.

Initial Approval:  1 year

Dosing of Eylea

Neovascular (wet) age related macular degeneration:  2 mg administered via intravitreal injection every 4 weeks for the first 12 weeks, followed by 2 mg every 8 weeks.

Macular edema due to retinal occulsion:  2 mg monthly

Diabetic macular edema & diabetic retinopathy:  2 mg administered via intravitreal injection every 4 weeks for the first 5 injections, followed by 2 mg every 8 weeks.   **Authorization will be reviewed annually to confirm maintenance or improvement of visual acuity (e.g., stabilization or gain of Snellen and/or ETDRS letters, stabilization or gain of ETDRS-DRSS score).

Dosing of Eylea HD

Neovascular (wet) age related macular degeneration: 8mg every 4 weeks for first three doses, followed by 8mg via intravitreal injection once every 8-16 weeks, +/- 1 week.

Diabetic macular edema & diabetic retinopathy: 8mg every 4 weeks for ther first three doses, then 8mg via intravitreal injection once every 8-16 weeks, +/- 1 week.

LUCENTIS

I.  Lucentis (ranibizumab) may be considered medically necessary if the following criteria are met:

A.  Prescribed by an ophthalmologist,

AND

B.  Diagnosis of neovascular (wet) age related macular degeneration (AMD),

OR

C.  Diagnosis of macular edema due to retinal vein occlusion (RVO)

OR

D.  Diagnosis of diabetic macular edema (DME)

OR

E.  Diabetic retinopathy (DR) in patient with DME

OR

F.  Myopic choroidal neovascularization (mCNV)

AND

G.  Treatment with bevacizumab has been ineffective, not tolerated or contraindicated.

Initial Approval:  1 year

Dosing of Lucentis

Neovascular (wet) age related macular degeneration & macular edema due to retinal vein occulsion: 0.5mg administered via intravitreal injection every 4 weeks

Diabetic macular edema & diabetic retinopathy:  0.3mg administered via intravitreal injection every 4 weeks

Myopic choroidal neovascularization 0.5mg administered via intravitreal injection every 4 weeks for up to three months.

** Authorization will be reviewed annually to confirm maintenance or improvement of visual acuity (e.g., stabilization or gain of Snellen and/or ETDRS letters; stabilization or gain of ETDRS-DRSS score).

BEOVU

I. Beovu (brolucizumab) may be considered medically necessary if the following criteria are met:

A.  Prescribed by an ophthalmologist

AND

B.  Diagnosis of neovascular (wet) age related macular degeneration (AMD)

AND

C.  Treatment with bevacizumab has been ineffective, not tolerated or contraindicated.

Initial Approval: 1 year

Dosing of Beovu:

Macular edema due to AMD:  6 mg (per eye) every 4 weeks for the first 3 doses; 6 mg (per eye) every 8-12 weeks thereafter.

** Authorization will be reviewed annually to confirm maintenance or improvement of visual acuity (e.g., stabilization or gain of Snellen and/or ETDRS letters; stabilization or gain of ETDRS-DRSS score).

MACUGEN

I.  Macugen (pegaptanib) may be considered medically necessary if the following criteria is met:

A.  Prescribed by an ophthalmologist

AND

B.  Diagnosis of neovascular (wet) age related macular degeneration (AMD)

AND

C.  Treatment with bevacizumab has been ineffective, not tolerated or contraindicated.

Initial Approval: 1 year

Dosing of Macugen:

Wet AMD:  0.3mg administered via intravitreal injection once every 6 weeks

**Authorization will be reviewed annually to confirm maintenance or improvement of visual acuity (e.g., stabilization or gain of Snellen and/or ETDRS letters, stabilization or gain of EDRS-DRSS score).

VABYSMO

I.  Vabysmo (faricimab-svoa) may be considered medically necessary when the following criteria are met:

A.  Prescribed by an opthalmologist,

AND

B.  Diagnosis of neovascular (wet) age related macular degeneration (AMD)

OR

C.  Diagnosis of diabetic macular edema (DME)

OR

D.  Diabetic retinopathy (DR) in patients with DME

AND

E.  Treatment with bevacizumab has been ineffective, not tolerated or contraindicated.

Initial Approval: 4 months 

Dosing of Vabysmo

• Neovascular (wet) age related macular degeneration: 6 mg administered via intravitreal injection every 4 weeks for 4 doses,
• Diabetic macular edema and diabetic retinopathy: 6 mg administered via intravitreal injection every 4 weeks for the first 4 doses.  

Vabysmo renewal:

I. Vabysmo (faricimab-svoa) may be considered medically necessary when the following criteria are met:

1. The patient has been approved for the requested agent through the plan's prior authorization process AND
2. The patient has had clinical benefit with the requested agent AND
3. The patient does NOT have any FDA labeled contraindications to the requested agent AND
4. ONE of the following
   1. The dose requested is within the FDA approved dosage guidelines OR
   2. The prescriber has provided information in support of therapy outside FDA approved dosage

Renewal dosing of Vabysmo

• Neovascular (wet) age related macular degeneration: One of three regimens

1. 6mg at weeks 28 and 44

2. 6mg at weeks 24, 36, and 48

3. 6mg at weeks 20, 28, 36, and 44

• Diabetic macular edema and diabetic retinopathy: One of three regimens

1. If resolution of edema (based on central subfield thickness (CST) of the macula)as measured by optical coherence tomography is achieved, then dose of 6mg may be modified by extensions of up to 4wk interval increments OR reductions of up to every 8wk injections

2. 6mg every 4 weeks for 2 addtional doses, then every 8 weeks over the next 28 weeks

3. The patient's central subfield thickness (CST) of the macula as measured by optical coherence tomography has been assessed and documentation has been provided that chronic 6mg every 4 weeks is appropriate.

**Authorization will be reviewed annually to confirm maintenance or improvement of visual acuity (e.g., stabilization or gain of Snellen and/or ETDRS letters, stabilization or gain of EDRS-DRSS score).

Syfovre

I. Syfovre (pegcetacoplan) may be considered medically necessary if the following criteria are met:

A.  Prescribed by an ophthalmologist

AND

B.  Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)

Initial Approval: 1 year

Dosing of Syfovre

15mg intravitreal injection into each affected eye once every 25-60 days

The use of intravitreal injections technique has been widely used by ophthalmologists to treat various ocular disease; the diseases include but are not limited to: neovascular age related macular degeneration, diabetic macular edema, and macular edema due to retinal vein occlusions. This procedure, which consists of injecting the drug directly into the center of the eye, can be done in the outpatient setting with the use of local anesthetics; hospitalization is not necessary.  The current intravitreal anti-VEGFs on the market include: aflibercept, bevacizumab, brolucizumab, pegaptinib, and ranibizumab.  These drugs work by binding to the growth factors to suppress the formation of irregular blood vessels.

Avastin

Avastin (bevacizumab) is a recombinant humanized monoclonal IgF1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF).  Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells.  The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation.

Beovu

Beovu (brolucizumab) is a human VEGF inhibitors.  Brolucizumab binds to the three major isoforms of VEGF-A (e.g. VEGF110), VEGF121, and VEGF165), thereby preventing interaction with receptors VEGFR-1 and VEGFR-2.  By inhibiting VEGF-A, brolucizumab suppresses endothelial cell proliferation, neovascularization, and vascular permeability.

Eylea

Eylea (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1.  Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PIGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells.  VEGF acts via two receptors tyrosine kinase, VEGFR-1, which is also present on the surface of leucocytes.  Activation of these receptors by VEGF-A can results in neovascularization and vascular permeability.

Lucentis

Lucentis (ranibizumab) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for infraocular use.  Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A).  The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.