Pharmacy Prior Authorization Criteria

Retinal Vascular Disease Agents

Indications for Prior Authorization

Beovu (brolucizumab)

• For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration
  Indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD).

• For diagnosis of Diabetic Macular Edema (DME)
  Indicated for the treatment of diabetic macular edema (DME).

Eylea (aflibercept)

• For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration
  Indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD).

• For diagnosis of Macular Edema Following Retinal Vein Occlusion
  Indicated for the treatment of patients with macular edema following retinal vein occlusion (RVO).

• For diagnosis of Diabetic Macular Edema
  Indicated for the treatment of patients with diabetic macular edema (DME).

• For diagnosis of Diabetic Retinopathy
  Indicated for the treatment of diabetic retinopathy (DR).

• For diagnosis of Retinopathy of Prematurity (ROP)
  Indicated for the treatment of retinopathy of prematurity (ROP).

Eylea HD (aflibercept)

• For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration
  Indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD).

• For diagnosis of Diabetic Macular Edema
  Indicated for the treatment of patients with diabetic macular edema (DME).

• For diagnosis of Diabetic Retinopathy
  Indicated for the treatment of diabetic retinopathy (DR).

Lucentis 0.5mg (ranibizumab), Byooviz (ranibizumab-nuna), Cimerli 0.5mg (ranibizumab-eqrn)

• For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration
  Indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD).

• For diagnosis of Macular Edema Following Retinal Vein Occlusion
  Indicated for the treatment of patients with macular edema following retinal vein occlusion (RVO).

• For diagnosis of Myopic Choroidal Neovascularization
  Indicated for the treatment of patients with myopic choroidal neovascularization (mCNV).

Lucentis 0.3 mg (ranibizumab), Cimerli 0.3mg (ranibizumab-eqrn)

• For diagnosis of Diabetic Macular Edema
  Indicated for the treatment of patients with diabetic macular edema (DME).

• For diagnosis of Diabetic Retinopathy
  Indicated for the treatment of diabetic retinopathy (DR).

Susvimo (ranibizumab)

• For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration
  Indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) who have previously responded to at least two intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor.

Vabysmo (faricimab-svoa)

• For diagnosis of Diabetic Macular Edema
  Indicated for the treatment of patients with diabetic macular edema (DME).

• For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration
  Indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD).

• For diagnosis of Macular Edema Following Retinal Vein Occlusion
  Indicated for the treatment of patients with macular edema following retinal vein occlusion.

Pavblu (aflibercept-ayyh)

• For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration
  Indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD).

• For diagnosis of Macular Edema Following Retinal Vein Occlusion
  Indicated for the treatment of patients with macular edema following retinal vein occlusion (RVO).

• For diagnosis of Diabetic Macular Edema
  Indicated for the treatment of patients with diabetic macular edema (DME).

• For diagnosis of Diabetic Retinopathy
  Indicated for the treatment of diabetic retinopathy (DR).

Criteria

Beovu, Vabysmo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Diabetic Macular Edema (DME), Neovascular (wet) age-related macular degeneration (nAMD)

• One of the following diagnoses:
• Neovascular (wet) age-related macular degeneration (nAMD) [A]
• Diabetic macular edema (DME)
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Vabysmo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Macular Edema following Retinal Vein Occlusion

• Diagnosis of macular edema following retinal vein occlusion
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Lucentis 0.3mg

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• One of the following diagnoses:
• Diabetic macular edema (DME)
• Diabetic retinopathy (DR)
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Byooviz, Lucentis 0.5mg

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• One of the following diagnoses:
• Neovascular (wet) age-related macular degeneration (nAMD) [A]
• Macular edema following retinal vein occlusion (RVO)
• Myopic choroidal neovascularization (mCNV)
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Cimerli 0.3mg

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• One of the following diagnoses:
• Diabetic macular edema (DME)
• Diabetic retinopathy (DR)
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Cimerli 0.5mg

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• One of the following diagnoses:
• Neovascular (wet) age-related macular degeneration (nAMD) [A]
• Macular edema following retinal vein occlusion (RVO)
• Myopic choroidal neovascularization (mCNV)
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Eylea, Pavblu

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy

• One of the following diagnoses:
• Neovascular (wet) age-related macular degeneration (nAMD) [A]
• Macular edema following retinal vein occlusion (RVO)
• Diabetic macular edema (DME)
• Diabetic retinopathy (DR)
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Eylea, Pavblu

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy

• Patient demonstrates positive clinical response to therapy (e.g., Improvement in Best Corrected Visual Acuity (BCVA) compared to baseline, stable vision)

Eylea Injectable Vial

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Retinopathy of Prematurity (ROP) [2, C]

• Diagnosis of retinopathy of prematurity (ROP)
AND
• ONE of the following: [2]
• Patient gestational age at birth less than or equal to 32 weeks [D]
• Patient birth weight less than or equal to 1500 grams
AND
• Patient weight greater than 800 grams on day of treatment [2]
AND
• Retinopathy of prematurity (ROP) is present in at least one eye with one of the following classifications: [2, E-H]
• ROP zone 1, stage 1 plus, 2 plus, 3, or 3 plus
• ROP zone 2, stage 2 plus or 3 plus
• AP - ROP (aggressive posterior ROP)
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases [I, 13 -14]

Eylea Injectable Vial

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Retinopathy of Prematurity (ROP) [2, C]

• Patient demonstrates positive clinical response to therapy as evidenced by the absence of active ROP and unfavorable structural outcomes (e.g., retinal detachment, macular dragging, macular fold, retrolental opacity) [2]
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases [I, 13 -14]

Eylea HD

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy

• One of the following diagnoses:
• Neovascular (wet) age-related macular degeneration (nAMD) [A]
• Diabetic macular edema (DME)
• Diabetic retinopathy (DR)
AND
• Trial and failure, or intolerance to Eylea
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Eylea HD

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Neovascular (Wet) Age-Related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy

• Patient demonstrates positive clinical response to therapy (e.g., Improvement in Best Corrected Visual Acuity (BCVA) compared to baseline, stable vision)
AND
• Trial and failure, or intolerance to Eylea

Susvimo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of neovascular (wet) age-related macular degeneration (nAMD) [A]
AND
• Prescribed by or in consultation with an ophthalmologist experienced in the treatment of retinal diseases

Beovu, Byooviz, Cimerli, Lucentis, Susvimo, Vabysmo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., Improvement in Best Corrected Visual Acuity (BCVA) compared to baseline, stable vision)

P & T Revisions

2024-12-07, 2024-12-05, 2024-10-31, 2024-10-09, 2024-05-02, 2024-03-13, 2023-11-17, 2023-10-20, 2023-10-08, 2023-03-28, 2023-01-31, 2022-11-02, 2022-08-04, 2022-07-21, 2022-07-06, 2022-04-05, 2021-12-03, 2021-04-07, 2020-08-24, 2020-07-02

References

1. Beovu Prescribing information. Novartis Pharmaceuticals Corporation. East Hanover, New Jersey. May 2022.
2. Eylea Prescribing Information. Regeneron Pharmaceuticals, Inc. Tarrytown, NY. February 2023.
3. Lucentis Prescribing information. Genentech, Inc. South San Francisco, CA. October 2020.
4. FDA Final Guidance on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Guidance for Industry. January 2018. Available at: https://www.fda.gov/media/90986/download. Accessed April 7,2021.
5. Compounding-American Academy of Ophthalmology - AAO.org. Available at: https://www.aao.org/headline/compounding. Accessed April 7, 2021.
6. Susvimo Prescribing information. Genentech, Inc. South San Francisco, CA. April 2022.
7. Vabysmo Prescribing information. Genentech, Inc. South San Francisco, CA. October 2023.
8. Byooviz Prescribing Information. Biogen, Inc. Cambridge, MA. April 2022.
9. Cimerli Prescribing Information. Coherus BioSciences, Inc. Redwood City, CA. August 2022.
10. Johnston, S. Retinopathy of Prematuity (ROP). Available at: https://www.childrenshospital.org/conditions/retinopathy-prematurity-rop. Accessed Feb 28, 2023.
11. Hartnett, M. Managing Retinopathy of Prematurity. Available at: https://www.aao.org/eyenet/article/managing-retinopathy-of-prematurity. Accessed February 28, 2023.
12. Coats, D. Retinopathy of prematurity: Treatment and prognosis. Available at: https://www.uptodate.com/contents/retinopathy-of-prematurity-treatment-and-prognosis. Accessed February 27, 2023.
13. Fierson W., et al. Screening Examination of Premature Infants for Retinopathy of Prematurity. American Academy of Pediatrics. Vol 142, Issue 6, Dec 2018. Available at https://publications.aap.org/pediatrics/article/142/6/e20183061/37478/Screening-Examination-of-Premature-Infants-for?autologincheck=redirected. Accessed March 14, 2023.
14. Wong, R., Ventura, C. et al. Training fellows for retinopathy of prematurity care: A Web-based survey. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3338950/. Accessed March 14, 2023.
15. Eylea HD Prescribing Information. Regeneron Pharmaceuticals, Inc. Tarrytown, NY. August 2023.
16. Eylea Healthcare Professionals website. Available at: https://eyleahcp.us/s/. Accessed September 26, 2023.
17. Pavblu Prescribing information. Amgen, Inc. Thousand Oaks, CA. August 2024.

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End Notes

1. Neovascular Age-Related Macular Degeneration (nAMD) may also be referred to as wet or exudative AMD. [1]
2. Congress established the 503(B) facilities to provide compounded pharmaceuticals for office use without a prescription. 503(B) Outsourcing Facilities are compounding pharmacies that must meet higher federal safety, sterility, and quality control standards. [4,5]
3. Each sterile vial should only be used for the treatment of a single eye. Do not use the EYLEA pre-filled syringe for the treatment of ROP. [2]
4. Gestational age: The length of time between a baby's conception and birth. [10]
5. How serious the ROP is depends on what part of the eye is affected (the zone); how far the disease has progressed (the stage); and whether the blood vessels themselves are markedly abnormal (plus disease). Stages 1 and 2 are considered mild; Stages 3-5 are increasingly serious. [10]
6. Zone 1: This represents the least amount of retinal vascular development and includes retinal vascularization limited to a circular area centered around the optic nerve. Zone I ROP is a strong predictor for severe ROP. Zone 2: Vascularization limited to the circular area outside zone I with the optic nerve as the center. Zone 3: Vascularization within the remaining temporal, crescent-shaped area. Once vascularization extends to the nasal ora serrata and into zone III, there is little risk of a poor visual outcome from ROP. [11]
7. Plus disease. Defined as two quadrants of dilated and tortuous vessels and is a strong predictor of severe ROP. [11]
8. Stage 1. A demarcation line between vascularized and avascular retina. Stage 2. A ridge with volume in the region of the demarcation line. Stage 3. Neovascularization growing into the vitreous at the ridge. Stage 3 is a strong predictor of severe ROP and a poor outcome. Stage 4. A partial retinal detachment. Treatment of progressive stage 4 ROP can preserve and improve visual outcomes by preventing stage 5 ROP. Stage 4 is further classified by whether the macula is involved (4A without macular involvement and 4B with macular involvement) and by whether it is predominantly exudative or tractional. Exudative ROP that occurs after treatment with laser or cryotherapy may resolve spontaneously. Stage 5. Total retinal detachment. [11]
9. Examinations for ROP should be performed by an ophthalmologist who is experienced in the examination of preterm infants for ROP using a binocular indirect ophthalmoscope. Pediatric ophthalmology and retina fellows are less adept than experienced attending ophthalmologists at identifying clinically significant ROP when examining digital images. [13, 14]
10. Eylea HD contains a higher molar dose of aflibercept designed to allow for longer dosing intervals between treatments. [16]

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Revision History

• 2024-12-07: update guideline
• 2024-12-05: This requirement (Trial and failure, contraindication, or intolerance to compounded Avastin* prepared by a 503(B) Outsourcing Facility) was removed temporarily due to communication of a drug supply issues with repackaged Avastin. Requirement will be added back when we have communication that drug supply is stable. IR team is aware.
• 2024-10-31: update guideline
• 2024-10-09: Add new strength to existing Vabysmo guideline.
• 2024-05-02: update guideline
• 2024-03-13: 2024 Annual Review
• 2023-11-17: update guideline
• 2023-10-20: Reauth standard verbiage update
• 2023-10-08: New UM PA Program for Eylea HD
• 2023-03-28: 2023 Annual Review
• 2023-01-31: Removed Macugen (discontinued). Updated T/F requirement for Byooviz, Cimerli, Eylea, Susvimo, Vabysmo, Lucentis, and Beovu. Added NF criteria for Byooviz. Updated background.
• 2022-11-02: Added criteria for Cimerli. Updated background and references.
• 2022-08-04: Added Byooviz with ST through compounded Avastin. Updated background and references.
• 2022-07-21: Separated Macugen from Beovu section given indications now differ. Formatting change only.
• 2022-07-06: Added new formulation for Beovu and criteria for new indication DME.
• 2022-04-05: Addition of new FDA product, Vabysmo. 2022 Annual Review, no other changes made.
• 2021-12-03: Include Non Formulary criteria for Beovu & new PA criteria for Susvimo
• 2021-04-07: 2021 Annual Review, no changes to criteria.
• 2020-08-24: Removed unneeded informational notes from Lucentis sections
• 2020-07-02: New Program

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