`
`
`
`UnitedHealthcare® Commercial
`Medical Benefit Drug Policy
`Ophthalmologic Policy:
`Vascular Endothelial Growth Factor (VEGF) Inhibitors
`
`Policy Number: 2022D0042V
`Effective Date: January 1, 2022
`
`Page
`Table of Contents
`Coverage Rationale ....................................................................... 1
`Definitions ...................................................................................... 3
`Applicable Codes .......................................................................... 3
`Background.................................................................................. 24
`Benefit Considerations ................................................................ 24
`Clinical Evidence ......................................................................... 25
`U.S. Food and Drug Administration ........................................... 35
`References ................................................................................... 36
`Policy History/Revision Information ........................................... 39
`Instructions for Use ..................................................................... 39
`
`Coverage Rationale
`
`
` Instructions for Use
`
`
`
`Related Commercial Policies
` Macular Degeneration Treatment Procedures
`• Maximum Dosage Policy
`• Oncology Medication Clinical Coverage
`Community Plan Policy
`• Ophthalmologic Policy: Vascular Endothelial Growth
`Factor (VEGF) Inhibitors
`
`
`
`
`
`Related Medicare Advantage Policy
`• Medicare Part B Step Therapy Programs
`
` See Benefit Considerations
`
`
`This policy provides information about the use of certain specialty pharmacy medications administered by the intravitreal route
`for ophthalmologic conditions.
`
`This policy refers to the following drug products, all of which are vascular endothelial growth factor (VEGF) inhibitors:
` Avastin® (bevacizumab)
` Beovu® (brolucizumab-dbll)
` Eylea® (aflibercept)
` Lucentis® (ranibizumab)
` Macugen® (pegaptanib)
`
`
`The following information pertains to medical necessity review:
`
`General Requirements (applicable to all medical necessity requests)
` For initial therapy, both of the following:
`o Diagnosis; and
`o
`Intravitreal VEGF inhibitor administration is no more than 12 doses per year per eye, regardless of diagnosis.
`
` For continuation of therapy, both of the following:
`o Documentation of positive clinical response to anti-VEGF therapy; and
`o
`Intravitreal VEGF inhibitor administration is no more than 12 doses per year per eye, regardless of diagnosis.
`
`
`
`
`
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`Page 1 of 40
`Effective 01/01/2022
`
`
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 1
`
`

`

`Diagnosis-Specific Requirements
`The information below indicates the list of proven and medically necessary indications.
`
`Beovu (brolucizumab) is proven and medically necessary for the treatment of:
` Neovascular age-related macular degeneration (AMD)
`
`
`Avastin (bevacizumab) is proven and medically necessary for the treatment of:
` Choroidal neovascularization secondary to pathologic myopia, angioid streaks/pseudoxanthoma elasticum, or ocular
`histoplasmosis syndrome (OHS)
` Diabetic macular edema (DME)
` Macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
` Neovascular age-related macular degeneration (AMD)
` Neovascular glaucoma
` Neovascularization of the iris (NVI) (rubeosis iridis)
` Proliferative diabetic retinopathy
` Type I retinopathy of prematurity
`
`
`Eylea (aflibercept) is proven and medically necessary for the treatment of:
` Diabetic macular edema (DME)
` Diabetic retinopathy
` Macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
` Neovascular age-related macular degeneration (AMD)
`
`
`Lucentis (ranibizumab) is proven and medically necessary for the treatment of:
` Choroidal neovascularization secondary to pathologic myopia, angioid streaks/pseudoxanthoma elasticum, or ocular
`histoplasmosis syndrome (OHS)
` Diabetic macular edema (DME)
` Diabetic retinopathy
` Macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
` Neovascular age-related macular degeneration (AMD)
`
`
`Macugen (pegaptanib) is proven and medically necessary for the treatment of:
` Diabetic macular edema
` Neovascular age-related macular degeneration (AMD)
`
`
`Additional Information
`Avastin (bevacizumab) is supplied in sterile vials containing a solution of 25 mg/mL. Doses utilized in ophthalmic conditions
`generally range from 6.2 mcg to 2.5 mg. Therefore, bevacizumab in vials is often divided into single-dose, prefilled syringes for
`intravitreal use by compounding pharmacies. Compounding pharmacies must comply with United States Pharmacopeia (USP)
`Chapter 797, which sets standards for the compounding, transportation, and storage of compounded sterile products (CSP).1
`The Pharmacy Compounding Accreditation Board can verify that the pharmacy is adhering to these standards.2
`
`The American Society of Retinal Specialists (ASRS) is committed to ensuring that retina specialists have access to
`compounded drugs (such as Avastin) that are prepared with high-quality material following good quality controls and sound
`engineering design by appropriately trained personnel. Refer to their information page at https://www.asrs.org/advocacy-
`practice/access-to-safe-compounded-agents for resources pertaining to access of safe compounded agents.14
`
`Refer to the US Food and Drug Administration (FDA) Section of this policy for information related to contamination of
`compounded bevacizumab. In an effort to guard against contamination during the compounding process, the United States
`Veterans Health Administration (USVHA) requires that only USVHA pharmacies may dispense bevacizumab for intravitreal
`administration to Veterans Administration beneficiaries. The medication must be dispensed directly to the VA ophthalmologist,
`who will then be responsible for preparing and administering the bevacizumab dose for each patient. In addition to strict
`labeling and storage requirements, the ophthalmologist is required to prepare only one dose of medication from each vial; if
`both eyes are to be treated, a separate vial and syringe must be utilized.3
`
`
`
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`Page 2 of 40
`Effective 01/01/2022
`
`
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 2
`
`

`

`Definitions
`
`Type I Retinopathy of Prematurity (ROP), also known as “high-risk pre-threshold ROP”, is defined as any of the following:
` Any stage ROP with plus disease in zone I
` Stage 3 ROP without plus disease in zone I
` Stage 2 or 3 ROP with plus disease in zone II
`
`
`Applicable Codes
`
`The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive.
`Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service.
`Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may
`require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim
`payment. Other Policies and Guidelines may apply.
`
`
`HCPCS Code
`J0178
`J0179
`J2503
`J2778
`J9035
`
`Description
`Injection, aflibercept, 1 mg
`Injection, brolucizumab-dbll, 1 mg
`Injection, pegaptanib sodium, 0.3 mg
`Injection, ranibizumab, 0.1 mg
`Injection, bevacizumab, 10 mg
`
`
`
`Diagnosis Code
`
`Description
`
`B39.4
`B39.5
`B39.9
`E08.311
`
`E08.319
`
`E08.3211
`
`E08.3212
`
`E08.3213
`
`E08.3219
`
`E08.3291
`
`E08.3292
`
`Histoplasmosis capsulati, unspecified
`Histoplasmosis duboisii
`Histoplasmosis, unspecified
`Diabetes mellitus due to underlying condition with
`unspecified diabetic retinopathy with macular edema
`Diabetes mellitus due to underlying condition with
`unspecified diabetic retinopathy without macular
`edema
`Diabetes mellitus due to underlying condition with
`mild non-proliferative diabetic retinopathy with
`macular edema, right eye
`Diabetes mellitus due to underlying condition with
`mild non-proliferative diabetic retinopathy with
`macular edema, left eye
`Diabetes mellitus due to underlying condition with
`mild non-proliferative diabetic retinopathy with
`macular edema, bilateral
`Diabetes mellitus due to underlying condition with
`mild non-proliferative diabetic retinopathy with
`macular edema, unspecified eye
`Diabetes mellitus due to underlying condition with
`mild non-proliferative diabetic retinopathy without
`macular edema, right eye
`Diabetes mellitus due to underlying condition with
`mild non-proliferative diabetic retinopathy without
`
`Brand Name
`Eylea
`Beovu
`Macugen
`Lucentis
`Avastin
`
`Applies to HCPCS Code
`J0179
`J2503
`J2778
`
`
`x
`
`
`x
`
`
`x
`
`x
`x
`
`J9035
`x
`x
`x
`x
`
`J0178
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`Page 3 of 40
`Effective 01/01/2022
`
`
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 3
`
`

`

`Diagnosis Code
`
`Description
`
`Applies to HCPCS Code
`J0179
`J2503
`J2778
`
`J0178
`
`J9035
`
`E08.3293
`
`E08.3299
`
`E08.3311
`
`E08.3312
`
`E08.3313
`
`E08.3319
`
`E08.3391
`
`E08.3392
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`macular edema, left eye
`Diabetes mellitus due to underlying condition with
`mild non-proliferative diabetic retinopathy without
`macular edema, bilateral
`Diabetes mellitus due to underlying condition with
`mild non-proliferative diabetic retinopathy without
`macular edema, unspecified eye
`Diabetes mellitus due to underlying condition with
`moderate non-proliferative diabetic retinopathy with
`macular edema, right eye
`Diabetes mellitus due to underlying condition with
`moderate non-proliferative diabetic retinopathy with
`macular edema, left eye
`Diabetes mellitus due to underlying condition with
`moderate non-proliferative diabetic retinopathy with
`macular edema, bilateral
`Diabetes mellitus due to underlying condition with
`moderate non-proliferative diabetic retinopathy with
`macular edema, unspecified eye
`Diabetes mellitus due to underlying condition with
`moderate non-proliferative diabetic retinopathy
`without macular edema, right eye
`Diabetes mellitus due to underlying condition with
`moderate non-proliferative diabetic retinopathy
`without macular edema, left eye
`Diabetes mellitus due to underlying condition with
`moderate non-proliferative diabetic retinopathy
`without macular edema, bilateral
`Diabetes mellitus due to underlying condition with
`moderate non-proliferative diabetic retinopathy
`without macular edema, unspecified eye
`Diabetes mellitus due to underlying condition with
`severe non-proliferative diabetic retinopathy with
`macular edema, right eye
`Diabetes mellitus due to underlying condition with
`severe non-proliferative diabetic retinopathy with
`macular edema, left eye
`Diabetes mellitus due to underlying condition with
`severe non-proliferative diabetic retinopathy with
`macular edema, bilateral
`Diabetes mellitus due to underlying condition with
`severe non-proliferative diabetic retinopathy with
`macular edema, unspecified eye
`Diabetes mellitus due to underlying condition with
`severe non-proliferative diabetic retinopathy without
`macular edema, right eye
`Diabetes mellitus due to underlying condition with
`severe non-proliferative diabetic retinopathy without
`
`E08.3393
`
`E08.3399
`
`E08.3411
`
`E08.3412
`
`E08.3413
`
`E08.3419
`
`E08.3491
`
`E08.3492
`
`x
`
`x
`
`x
`
`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`Page 4 of 40
`Effective 01/01/2022
`
`
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 4
`
`

`

`Diagnosis Code
`
`Description
`
`Applies to HCPCS Code
`J0179
`J2503
`J2778
`
`J0178
`
`J9035
`
`E08.3493
`
`E08.3499
`
`E08.3511
`
`E08.3512
`
`E08.3513
`
`E08.3519
`
`E08.3521
`
`E08.3522
`
`E08.3523
`
`E08.3529
`
`E08.3531
`
`E08.3532
`
`E08.3533
`
`E08.3539
`
`E08.3541
`
`macular edema, left eye
`Diabetes mellitus due to underlying condition with
`severe non-proliferative diabetic retinopathy without
`macular edema, bilateral
`Diabetes mellitus due to underlying condition with
`severe non-proliferative diabetic retinopathy without
`macular edema, unspecified eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with macular
`edema, right eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with macular
`edema, left eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with macular
`edema, bilateral
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with macular
`edema, unspecified eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with traction retinal
`detachment involving the macula, right eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with traction retinal
`detachment involving the macula, left eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with traction retinal
`detachment involving the macula, bilateral
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with traction retinal
`detachment involving the macula, unspecified eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with traction retinal
`detachment not involving the macula, right eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with traction retinal
`detachment not involving the macula, left eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with traction retinal
`detachment not involving the macula, bilateral
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with traction retinal
`detachment not involving the macula, unspecified
`eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with combined
`traction retinal detachment and rhegmatogenous
`retinal detachment, right eye
`
`x
`
`x
`
`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`
`
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`Page 5 of 40
`Effective 01/01/2022
`
`
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 5
`
`

`

`Diagnosis Code
`
`E08.3542
`
`Description
`
`Applies to HCPCS Code
`J0179
`J2503
`J2778
`
`x
`x
`
`J0178
`x
`
`J9035
`x
`
`E08.3543
`
`E08.3549
`
`E08.3551
`
`E08.3552
`
`E08.3553
`
`E08.3559
`
`E08.3591
`
`E08.3592
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
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`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with combined
`traction retinal detachment and rhegmatogenous
`retinal detachment, left eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with combined
`traction retinal detachment and rhegmatogenous
`retinal detachment, bilateral
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy with combined
`traction retinal detachment and rhegmatogenous
`retinal detachment, unspecified eye
`Diabetes mellitus due to underlying condition with
`stable proliferative diabetic retinopathy, right eye
`Diabetes mellitus due to underlying condition with
`stable proliferative diabetic retinopathy, left eye
`Diabetes mellitus due to underlying condition with
`stable proliferative diabetic retinopathy, bilateral
`Diabetes mellitus due to underlying condition with
`stable proliferative diabetic retinopathy, unspecified
`eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy without macular
`edema, right eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy without macular
`edema, left eye
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy without macular
`edema, bilateral
`Diabetes mellitus due to underlying condition with
`proliferative diabetic retinopathy without macular
`edema, unspecified eye
`Diabetes mellitus due to underlying condition with
`diabetic macular edema, resolved following
`treatment, right eye
`Diabetes mellitus due to underlying condition with
`diabetic macular edema, resolved following
`treatment, left eye
`Diabetes mellitus due to underlying condition with
`diabetic macular edema, resolved following
`treatment, bilateral
`Diabetes mellitus due to underlying condition with
`diabetic macular edema, resolved following
`treatment, unspecified eye
`Drug or chemical induced diabetes mellitus with
`unspecified diabetic retinopathy with macular edema
`Drug or chemical induced diabetes mellitus with mild
`
`E08.3593
`
`E08.3599
`
`E08.37X1
`
`E08.37X2
`
`E08.37X3
`
`E08.37X9
`
`E09.311
`
`E09.3211
`
`x
`
`x
`
`
`
`
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`Page 6 of 40
`Effective 01/01/2022
`
`
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 6
`
`

`

`Diagnosis Code
`
`Description
`
`Applies to HCPCS Code
`J0179
`J2503
`J2778
`
`J0178
`
`J9035
`
`E09.3212
`
`E09.3213
`
`E09.3219
`
`E09.3291
`
`E09.3292
`
`E09.3293
`
`E09.3299
`
`E09.3311
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
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`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`non-proliferative diabetic retinopathy with macular
`edema, right eye
`Drug or chemical induced diabetes mellitus with mild
`non-proliferative diabetic retinopathy with macular
`edema, left eye
`Drug or chemical induced diabetes mellitus with mild
`non-proliferative diabetic retinopathy with macular
`edema, bilateral
`Drug or chemical induced diabetes mellitus with mild
`non-proliferative diabetic retinopathy with macular
`edema, unspecified eye
`Drug or chemical induced diabetes mellitus with mild
`non-proliferative diabetic retinopathy without macular
`edema, right eye
`Drug or chemical induced diabetes mellitus with mild
`non-proliferative diabetic retinopathy without macular
`edema, left eye
`Drug or chemical induced diabetes mellitus with mild
`non-proliferative diabetic retinopathy without macular
`edema, bilateral
`Drug or chemical induced diabetes mellitus with mild
`non-proliferative diabetic retinopathy without macular
`edema, unspecified eye
`Drug or chemical induced diabetes mellitus with
`moderate non-proliferative diabetic retinopathy with
`macular edema, right eye
`Drug or chemical induced diabetes mellitus with
`moderate non-proliferative diabetic retinopathy with
`macular edema, left eye
`Drug or chemical induced diabetes mellitus with
`moderate non-proliferative diabetic retinopathy with
`macular edema, bilateral
`Drug or chemical induced diabetes mellitus with
`moderate non-proliferative diabetic retinopathy with
`macular edema, unspecified eye
`Drug or chemical induced diabetes mellitus with
`moderate non-proliferative diabetic retinopathy
`without macular edema, right eye
`Drug or chemical induced diabetes mellitus with
`moderate non-proliferative diabetic retinopathy
`without macular edema, left eye
`Drug or chemical induced diabetes mellitus with
`moderate non-proliferative diabetic retinopathy
`without macular edema, bilateral
`Drug or chemical induced diabetes mellitus with
`moderate non-proliferative diabetic retinopathy
`without macular edema, unspecified eye
`Drug or chemical induced diabetes mellitus with
`
`E09.3312
`
`E09.3313
`
`E09.3319
`
`E09.3391
`
`E09.3392
`
`E09.3393
`
`E09.3399
`
`E09.3411
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`Page 7 of 40
`Effective 01/01/2022
`
`
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 7
`
`

`

`Diagnosis Code
`
`Description
`
`Applies to HCPCS Code
`J0179
`J2503
`J2778
`
`J0178
`
`J9035
`
`E09.3412
`
`E09.3413
`
`E09.3419
`
`E09.3491
`
`E09.3492
`
`E09.3493
`
`E09.3499
`
`E09.3511
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`severe non-proliferative diabetic retinopathy with
`macular edema, right eye
`Drug or chemical induced diabetes mellitus with
`severe non-proliferative diabetic retinopathy with
`macular edema, left eye
`Drug or chemical induced diabetes mellitus with
`severe non-proliferative diabetic retinopathy with
`macular edema, bilateral
`Drug or chemical induced diabetes mellitus with
`severe non-proliferative diabetic retinopathy with
`macular edema, unspecified eye
`Drug or chemical induced diabetes mellitus with
`severe non-proliferative diabetic retinopathy without
`macular edema, right eye
`Drug or chemical induced diabetes mellitus with
`severe non-proliferative diabetic retinopathy without
`macular edema, left eye
`Drug or chemical induced diabetes mellitus with
`severe non-proliferative diabetic retinopathy without
`macular edema, bilateral
`Drug or chemical induced diabetes mellitus with
`severe non-proliferative diabetic retinopathy without
`macular edema, unspecified eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with macular
`edema, right eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with macular
`edema, left eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with macular
`edema, bilateral
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with macular
`edema, unspecified eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with traction retinal
`detachment involving the macula, right eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with traction retinal
`detachment involving the macula, left eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with traction retinal
`detachment involving the macula, bilateral
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with traction retinal
`detachment involving the macula, unspecified eye
`Drug or chemical induced diabetes mellitus with
`
`E09.3512
`
`E09.3513
`
`E09.3519
`
`E09.3521
`
`E09.3522
`
`E09.3523
`
`E09.3529
`
`E09.3531
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`Page 8 of 40
`Effective 01/01/2022
`
`
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 8
`
`

`

`Diagnosis Code
`
`Description
`
`Applies to HCPCS Code
`J0179
`J2503
`J2778
`
`J0178
`
`J9035
`
`E09.3532
`
`E09.3533
`
`E09.3539
`
`E09.3541
`
`E09.3542
`
`E09.3543
`
`E09.3549
`
`E09.3551
`
`E09.3552
`
`E09.3553
`
`E09.3559
`
`E09.3591
`
`E09.3592
`
`E09.3593
`
`E09.3599
`
`proliferative diabetic retinopathy with traction retinal
`detachment not involving the macula, right eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with traction retinal
`detachment not involving the macula, left eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with traction retinal
`detachment not involving the macula, bilateral
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with traction retinal
`detachment not involving the macula, unspecified
`eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with combined
`traction retinal detachment and rhegmatogenous
`retinal detachment, right eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with combined
`traction retinal detachment and rhegmatogenous
`retinal detachment, left eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with combined
`traction retinal detachment and rhegmatogenous
`retinal detachment, bilateral
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy with combined
`traction retinal detachment and rhegmatogenous
`retinal detachment, unspecified eye
`Drug or chemical induced diabetes mellitus with
`stable proliferative diabetic retinopathy, right eye
`Drug or chemical induced diabetes mellitus with
`stable proliferative diabetic retinopathy, left eye
`Drug or chemical induced diabetes mellitus with
`stable proliferative diabetic retinopathy, bilateral
`Drug or chemical induced diabetes mellitus with
`stable proliferative diabetic retinopathy, unspecified
`eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy without macular
`edema, right eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy without macular
`edema, left eye
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy without macular
`edema, bilateral
`Drug or chemical induced diabetes mellitus with
`proliferative diabetic retinopathy without macular
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`x
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`x
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`x
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`x
`
`x
`
`x
`
`x
`
`x
`
`x
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`x
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`x
`
`
`
`
`
`
`
`
`
`x
`
`x
`
`x
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`x
`
`x
`
`x
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`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`Page 9 of 40
`Effective 01/01/2022
`
`
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 9
`
`

`

`Diagnosis Code
`
`Description
`
`Applies to HCPCS Code
`J0179
`J2503
`J2778
`
`J0178
`
`J9035
`
`E09.37X1
`
`E09.37X2
`
`E09.37X3
`
`E09.37X9
`
`E10.311
`
`E10.3211
`
`E10.3212
`
`E10.3213
`
`E10.3219
`
`
`
`
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`edema, unspecified eye
`Drug or chemical induced diabetes mellitus with
`diabetic macular edema, resolved following
`treatment, right eye
`Drug or chemical induced diabetes mellitus with
`diabetic macular edema, resolved following
`treatment, left eye
`Drug or chemical induced diabetes mellitus with
`diabetic macular edema, resolved following
`treatment, bilateral
`Drug or chemical induced diabetes mellitus with
`diabetic macular edema, resolved following
`treatment, unspecified eye
`Type 1 diabetes mellitus with unspecified diabetic
`retinopathy with macular edema
`Type 1 diabetes mellitus with mild non-proliferative
`diabetic retinopathy with macular edema, right eye
`Type 1 diabetes mellitus with mild non-proliferative
`diabetic retinopathy with macular edema, left eye
`Type 1 diabetes mellitus with mild non-proliferative
`diabetic retinopathy with macular edema, bilateral
`Type 1 diabetes mellitus with mild non-proliferative
`diabetic retinopathy with macular edema,
`unspecified eye
`Type 1 diabetes mellitus with mild non-proliferative
`diabetic retinopathy without macular edema, right
`eye
`Type 1 diabetes mellitus with mild non-proliferative
`diabetic retinopathy without macular edema, left eye
`Type 1 diabetes mellitus with mild non-proliferative
`diabetic retinopathy without macular edema, bilateral
`Type 1 diabetes mellitus with mild non-proliferative
`diabetic retinopathy without macular edema,
`unspecified eye
`Type 1 diabetes mellitus with moderate non-
`proliferative diabetic retinopathy with macular
`edema, right eye
`Type 1 diabetes mellitus with moderate non-
`proliferative diabetic retinopathy with macular
`edema, left eye
`Type 1 diabetes mellitus with moderate non-
`proliferative diabetic retinopathy with macular
`edema, bilateral
`Type 1 diabetes mellitus with moderate non-
`proliferative diabetic retinopathy with macular
`edema, unspecified eye
`Type 1 diabetes mellitus with moderate non-
`proliferative diabetic retinopathy without macular
`Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors
`UnitedHealthcare Commercial Medical Benefit Drug Policy
`Proprietary Information of UnitedHealthcare. Copyright 2022 United HealthCare Services, Inc.
`
`E10.3291
`
`E10.3292
`
`E10.3293
`
`E10.3299
`
`E10.3311
`
`E10.3312
`
`E10.3313
`
`E10.3319
`
`E10.3391
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`Page 10 of 40
`Effective 01/01/2022
`
`Mylan Exhibit 1167
`Mylan v. Regeneron, IPR2021-00881
`Page 10
`
`

`

`Diagnosis Code
`
`Description
`
`Applies to HCPCS Code
`J0179
`J2503
`J2778
`
`J0178
`
`J9035
`
`E10.3392
`
`E10.3393
`
`E10.3399
`
`E10.3411
`
`E10.3412
`
`E10.3413
`
`E10.3419
`
`E10.3491
`
`E10.3492
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`x
`
`edema, right eye
`Type 1 diabetes mellitus with moderate non-
`proliferative diabetic retinopathy without macular
`edema, left eye
`Type 1 diabetes mellitus with moderate non-
`proliferative diabetic retinopathy without macular
`edema, bilateral
`Type 1 diabetes mellitus with moderate non-
`proliferative diabetic retinopathy without macular
`edema, unspecified eye
`Type 1 diabetes mellitus with severe non-proliferative
`diabetic retinopathy with macular edema, right eye
`Type 1 diabetes mellitus with severe non-proliferative
`diabetic retinopathy with macular edema, left eye
`Type 1 diabetes mellitus with severe non-proliferative
`diabetic retinopathy with macular edema, bilateral
`Type 1 diabetes mellitus with severe non-proliferative
`diabetic retinopathy with macular edema,
`unspecified eye
`Type 1 diabetes mellitus with severe non-proliferative
`diabetic retinopathy without macular edema, right
`eye
`Type 1 diabetes mellitus with severe non-proliferative
`diabetic retinopathy without macular edema, left eye
`Type 1 diabetes mellitus with severe non-proliferative
`diabetic retinopathy without macular edema, bilateral
`Type 1 diabetes mellitus with severe non-proliferative
`diabetic retinopathy without macular edema,
`unspecified eye
`Type 1 diabetes mellitus with proliferative diabetic
`retinopathy with macular edema, right eye
`Type 1 diabetes mellitus with proliferative