Print

Date Printed: August 22, 2017: 06:53 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-78

Original Effective Date: 12/15/12

Reviewed: 12/14/16

Revised: 06/15/17

Subject: Vascular Endothelial Growth Factor Inhibitors for Ocular Neovascularization

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           

Dosage/ Administration

Position Statement

Billing/Coding

Reimbursement

Program Exceptions

Definitions

           

Related Guidelines

Other

References

Updates

 

Previous Version

           

DESCRIPTION:

Impaired vision and blindness affect more than 3 million individuals in the United States older than the age of 40. Although elderly patients make up about 12% of the population, they account for 69% of cases of blindness. Age-related macular degeneration, glaucoma, cataracts, and diabetic retinopathy are the most common eye disorders in the U.S. adult population. Vascular endothelial growth factor (VEGF) has been implicated in the pathogenesis of a variety of ocular vascular conditions characterized by choroidal neovascularization (CNV) and macular edema. VEGF is a protein that stimulates the growth, proliferation, and survival of vascular endothelial cells.

In April 2017 ranibizumab (Lucentis) became the first VEGF-inhibitor to be FDA-approved for the treatment of diabetic retinopathy (DR) in patients without diabetic macular edema (DME). The approval was based on a subgroup analysis of a secondary endpoint in the Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Protocol S study in which ranibizumab was found to be non-inferior to panretinal photocoagulation (PRP) in patients with proliferative diabetic retinopathy (PDR), including those with and without DME. Proliferative DR, as opposed to non-proliferative DR (NPDR), is defined by the presence of some degree of retinal neovascularization. The VEGF-inhibitors work by inhibiting angiogenesis and neovascularization. At year 2 among patients treated with ranibizumab, 31.7% (13/41) and 28.4% (42/148) of eyes in the subgroups with baseline DME and without baseline DME, respectively, had ≥3-step improvement from baseline in ETDRS-DRSS (Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Score).

A brief overview of covered products is provided in Table 1.

Table 1

Review of covered products

Product

Notes

Aflibercept (Eylea®)

• Humanized recombinant fusion protein

• Inhibits VEGF-A and placental growth factor

Bevacizumab (Avastin®)

• Recombinant humanized monoclonal antibody

• Works by binding to and inhibiting the biologic activity of VEGF to prevent interaction with receptors on the surface of endothelial cells

• Prevents cell proliferation and new blood vessel formation

• Produced in a Chinese hamster ovary mammalian cell expression system

Pegaptanib (Macugen®)

• Pegylated modified oligonucleotide

• Selectively binds to extracellular VEGF-165, the major pathological VEGF isoform for wet AMD

Ranibizumab (Lucentis®)

• Recombinant humanized monoclonal antibody – a fragment derived from the same parent molecule as bevacizumab

• Binds to all active isoforms of VEGF

• Reduces endothelial cell proliferation, vascular leakage, and new blood vessel formation.

POSITION STATEMENT:

The initiation of aflibercept, bevacizumab, pegaptanib, or ranibizumab meets the definition of medical necessity for members meeting agent-specific criteria outlined in Table 2, AND none of these products are used concurrently in combination with each other in the same eye, or used in combination with dexamethasone (Ozurdex®) implant or fluocinolone acetonide (Iluvien®) implant in the same eye [with the exception of bevacizumab (Avastin®) which may be used as rescue therapy for rare members who are refractory to the implant].

Table 2

Criteria for use

Product

Criteria

Aflibercept (Eylea®)

Use is a medical necessity for the following indications in members without ocular or periocular infections and dosage does not exceed 2 mg to each eye every 28 days:

1. Neovascular (wet) age-related macular degeneration (ARMD/AMD)

2. Macular edema following central retinal vein occlusion (CRVO)

3. Macular edema following branch retinal vein occlusion (BRVO)

4. Diabetic macular edema (DME)

5. Diabetic retinopathy (DR) in members with DME

Bevacizumab (Avastin®)

Use is a medical necessity for the below listed non-FDA labeled* indications in members without ocular or periocular infections:

1. Neovascular (wet) age-related macular degeneration (ARMD/AMD)

2. Macular edema following branch retinal vein occlusion (BRVO)

3. Macular edema following central retinal vein occlusion (CRVO)

4. Diabetic macular edema (DME)

5. Diabetic retinopathy (DR) in members with DME

6. Proliferative diabetic retinopathy (PDR) as defined by the presence of retinal neovascularization (with or without macular edema)

7. Proliferative diabetic retinopathy requiring treatment with retinal laser photocoagulation or vitrectomy as a single preoperative dose

8. Secondary angle-closure glaucoma resulting from neovascularization (i.e., neovascular glaucoma)

9. Retinopathy of prematurity when first-line treatment with laser photocoagulation is not possible (e.g., opaque cornea or lens, poor pupillary dilation) and treatment is given as a single dose

10. Choroidal neovascularization secondary to ANY of the following:

a. Pathologic myopia

b. Ocular histoplasmosis syndrome (OHS)

c. Angioid streaks/pseudoxanthoma elasticum

*Physicians should provide appropriate informed consent with respect to the off-label use of bevacizumab.

Pegaptanib (Macugen®)

Use is a medical necessity for the following indications in members without ocular or periocular infections and dosage does not exceed 0.3 mg to each eye every 6 weeks (45 days):

1. Neovascular (wet) age-related macular degeneration (ARMD/AMD)

2. Diabetic macular edema (DME)

Ranibizumab (Lucentis®)

Use is a medical necessity for the following indications in members without ocular or periocular infections:

1. Neovascular (wet) age-related macular degeneration (ARMD/AMD) and dosage does not exceed 0.5 mg to each eye every 28 days

2. Macular edema following branch retinal vein occlusion (BRVO) and dosage does not exceed 0.5 mg to each eye every 28 days

3. Macular edema following central retinal vein occlusion (CRVO) and dosage does not exceed 0.5 mg every to each eye 28 days

4. Diabetic macular edema (DME) and dosage does not exceed 0.3 mg to each eye every 28 days

5. Diabetic retinopathy (DR) in members with DME and dosage does not exceed 0.3 mg to each eye every 28 days

6. Proliferative diabetic retinopathy (PDR) as defined by the presence of retinal neovascularization (with or without macular edema) and dosage does not exceed 0.3 mg to each eye every 28 days

7. Choroidal neovascularization secondary to ANY of the following and dosage does not exceed 0.5 mg to each eye every 28 days:

a. Pathologic myopia

b. Ocular histoplasmosis syndrome (OHS)

c. Angioid streaks/pseudoxanthoma elasticum

Approval duration: 1 year (except retinopathy of prematurity and pre-operative use for diabetic retinopathy requiring treatment with retinal laser photocoagulation or vitrectomy; for these indications only a single dose will be approved)

Continuation of aflibercept, bevacizumab, pegaptanib, or ranibizumab meets the definition of medical necessity for members meeting all of the following criteria:

1. An authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years for an indication listed in Table 2 (except for the use of bevacizumab for retinopathy of prematurity or as a single preoperative dose – see initiation criteria), OR the member has previously met all indication-specific initiation criteria

2. Member has had improvement or stabilization of visual function as compared to before treatment

3. The dosage does not exceed the drug- and indication-specific limit listed in Table 2

4. None of the agents are used in combination with each other in the same eye

5. Eylea, Lucentis, or Macugen are not used in combination with dexamethasone (Ozurdex®) implant or fluocinolone acetonide (Iluvien®) implant in the same eye*

*Bevacizumab (Avastin®) may be used as rescue therapy for rare members who are refractory to the implant.

Approval duration: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Dosage and administration varies considerably with each product. A brief overview of selected products is provided in Table 3, but it is strongly recommended the prescriber reference the product-specific labeling for complete dosing and administration instructions.

Table 3

Dosage and administration

Product

Dosing/Administration

Aflibercept (Eylea®)

Neovascular (Wet) Age-Related Macular Degeneration (AMD)

• 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first 3 months, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months)

• May be dosed as frequently as 2 mg every 4 weeks (monthly); additional efficacy was not demonstrated when dosed every 4 weeks compared to every 8 weeks

Macular Edema Following Central or Branch Retinal Vein Occlusion (CRVO or BRVO)

• 2 mg (0.05 mL) administered by intravitreal injection once every 4 weeks (monthly)

Diabetic Macular Edema (DME) or Diabetic Retinopathy (DR) in patient with DME

• 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first five injections, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months)

• May be dosed as frequently as 2 mg every 4 weeks (monthly); additional efficacy was not demonstrated when dosed every 4 weeks compared to every 8 weeks

Bevacizumab (Avastin®)

Off-label dosing recommendations

• 1.25 mg (0.05 mL) administered by intravitreal injection

Pegaptanib (Macugen®)

Neovascular (Wet) Age-Related Macular Degeneration (AMD)

• 0.3 mg should be administered once every six weeks by intravitreous injection into the eye to be treated

Ranibizumab (Lucentis®)

Neovascular (Wet) Age-Related Macular Degeneration (AMD)

• 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days)

• Although not as effective, patients may be treated with three monthly doses followed by less frequent dosing with regular assessment. In the nine months after three initial monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain. Patients should be assessed regularly

• Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Compared to continued monthly dosing, dosing every 3 months over the next 9 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average. Patients should be assessed regularly

Macular Edema Following Central or Branch Retinal Vein Occlusion (CRVO or BRVO)

• 0.5 mg (0.05 mL) administered by intravitreal injection once a month (approximately 28 days)

Diabetic Macular Edema (DME) or Diabetic Retinopathy (DR) 0.3 mg (0.05 mL) administered by intravitreal injection once a month (approximately 28 days)

Myopic Choroidal Neovascularization (mCNV)

0.5 mg (0.05 mL) administered by intravitreal injection once a month (approximately 28 days) for up to 3 months. May retreat if needed.

PRECAUTIONS:

Specific precautions and warnings are highlighted in Table 4.

Table 4

Precautions and warnings

Product

Precautions/Warnings

Aflibercept (Eylea®)

Contraindications

• Ocular or periocular infection

• Active intraocular inflammation

• Hypersensitivity

Precautions/Warnings

• Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.

• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

Pegaptanib (Macugen®)

Contraindications

• Ocular or periocular infection

• Active intraocular inflammation

• Hypersensitivity

Precautions/Warnings

• Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.

• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

Ranibizumab (Lucentis®)

Contraindications

• Ocular or periocular infection

• Active intraocular inflammation

• Hypersensitivity

Precautions/Warnings

• Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.

• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J2503

Injection, pegaptanib sodium, 0.3 mg

J2778

Injection, ranibizumab, 0.1 mg

J0178

Injection, aflibercept, 1 mg

NOTE: The use of bevacizumab for non-FDA labeled ophthalmic indications should be reported using the unclassified HCPCS code J3490 or, for Outpatient Hospital ONLY, either J3490 or C9257 (please submit with the proper medical documentation) and not HCPCS code J9035 (Injection, bevacizumab, 10mg) since the agent has been processed by a pharmacist.

ICD-10 Diagnoses Codes That Support Medical Necessity for Bevacizumab (Avastin®)(J3490):

B39.4

Histoplasmosis capsulati, unspecified

B39.5

Histoplasmosis duboisii

B39.9

Histoplasmosis, unspecified

E08.311

Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

E08.3211 – E08.3219

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema

E08.3311 – E08.3319

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema

E08.3411 – E08.3419

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema

E08.3511 – E08.3599

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy

E09.311

Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema

E09.3211 – E09.3219

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E09.3311 – E09.3319

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E09.3411 – E09.3419

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E09.3511 – E09.3599

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy

E10.311

Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E10.3211 – E09.3219

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E10.3311 – E10.3319

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E10.3411 – E10.3419

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E10.3511 – E10.3599

Type 1 diabetes mellitus with proliferative diabetic retinopathy

E11.311

Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E11.3211 – E11.3219

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E11.3311 – E11.3319

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E11.3411 – E11.3419

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E11.3511 – E11.3599

Type 2 diabetes mellitus with proliferative diabetic retinopathy

E13.311

Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

E13.3211 – E13.3219

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E13.3311 – E13.3319

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E13.3411 – E13.3419

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E13.3511 – E13.3599

Other specified diabetes mellitus with proliferative diabetic retinopathy

H32

Chorioretinal disorders in diseases classified elsewhere

H34.8110

Central retinal vein occlusion, right eye, with macular edema

H34.8120

Central retinal vein occlusion, left eye, with macular edema

H34.8130

Central retinal vein occlusion, bilateral, with macular edema

H34.8190

Central retinal vein occlusion, unspecified eye, with macular edema

H34.821

Venous engorgement, right eye

H34.822

Venous engorgement, left eye

H34.823

Venous engorgement, bilateral

H34.829

Venous engorgement, unspecified eye

H34.8310

Tributary (branch) retinal vein occlusion, right eye, with macular edema

H34.8320

Tributary (branch) retinal vein occlusion, left eye, with macular edema

H34.8330

Tributary (branch) retinal vein occlusion, bilateral, with macular edema

H34.8390

Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema

H35.051

Retinal neovascularization, unspecified, right eye

H35.052

Retinal neovascularization, unspecified, left eye

H35.053

Retinal neovascularization, unspecified, bilateral

H35.059

Retinal neovascularization, unspecified, unspecified eye

H35.101 – H35.179

Retinopathy of prematurity

H35.3210 – H35.3293

Exudative age-related macular degeneration

H35.33

Angioid streaks of macula

H40.89

Other specified glaucoma

H44.20

Degenerative myopia, unspecified eye

H44.21

Degenerative myopia, right eye

H44.22

Degenerative myopia, left eye

H44.23

Degenerative myopia, bilateral

ICD-10 Diagnoses Codes That Support Medical Necessity for Ranibizumab (Lucentis®)(J2778):

B39.4

Histoplasmosis capsulati, unspecified

B39.5

Histoplasmosis duboisii

B39.9

Histoplasmosis, unspecified

E08.311

Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

E08.3211 – E08.3219

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema

E08.3311 – E08.3319

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema

E08.3411 – E08.3419

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema

E08.3511 – E08.3599

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy

E09.311

Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema

E09.3211 – E09.3219

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E09.3311 – E09.3319

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E09.3411 – E09.3419

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E09.3511 – E09.3599

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy

E10.311

Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E10.3211 – E09.3219

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E10.3311 – E10.3319

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E10.3411 – E10.3419

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E10.3511 – E10.3599

Type 1 diabetes mellitus with proliferative diabetic retinopathy

E11.311

Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E11.3211 – E11.3219

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E11.3311 – E11.3319

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E11.3411 – E11.3419

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E11.3511 – E11.3599

Type 2 diabetes mellitus with proliferative diabetic retinopathy

E13.311

Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

E13.3211 – E13.3219

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E13.3311 – E13.3319

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E13.3411 – E13.3419

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E13.3511 – E13.3599

Other specified diabetes mellitus with proliferative diabetic retinopathy

H34.8110

Central retinal vein occlusion, right eye, with macular edema

H34.8120

Central retinal vein occlusion, left eye, with macular edema

H34.8130

Central retinal vein occlusion, bilateral, with macular edema

H34.8190

Central retinal vein occlusion, unspecified eye, with macular edema

H34.8310

Tributary (branch) retinal vein occlusion, right eye, with macular edema

H34.8320

Tributary (branch) retinal vein occlusion, left eye, with macular edema

H34.8330

Tributary (branch) retinal vein occlusion, bilateral, with macular edema

H34.8390

Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema

H35.3210 – H35.3293

Exudative age-related macular degeneration

H35.33

Angioid streaks of macula

H44.20

Degenerative myopia, unspecified eye

H44.21

Degenerative myopia, right eye

H44.22

Degenerative myopia, left eye

H44.23

Degenerative myopia, bilateral

ICD-10 Diagnoses Codes That Support Medical Necessity for Aflibercept (Eylea™)(J0178):

E08.311

Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

E08.3211 – E08.3219

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema

E08.3311 – E08.3319

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema

E08.3411 – E08.3419

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema

E08.3511 – E08.3419

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema

E09.311

Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema

E09.3211 – E09.3219

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E09.3311 – E09.3319

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E09.3411 – E09.3419

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E09.3511 – E09.3519

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema

E10.311

Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E10.3211 – E10.3219

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E10.3311 – E10.3319

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E10.3411 – E10.3419

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E10.3511 – E10.3519

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema

E11.311

Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E11.3211 – E11.3219

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E11.3311 – E11.3319

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E11.3411 – E11.3419

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E11.3511 – E11.3519

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema

E13.311

Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

E13.3211 – E13.3219

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E13.3311 – E13.3319

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E13.3411 – E13.3419

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E13.3511 – E13.3519

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema

H34.8110

Central retinal vein occlusion, right eye, with macular edema

H34.8120

Central retinal vein occlusion, left eye, with macular edema

H34.8130

Central retinal vein occlusion, bilateral, with macular edema

H34.8190

Central retinal vein occlusion, unspecified eye, with macular edema

H34.8310

Tributary (branch) retinal vein occlusion, right eye, with macular edema

H34.8320

Tributary (branch) retinal vein occlusion, left eye, with macular edema

H34.8330

Tributary (branch) retinal vein occlusion, bilateral, with macular edema

H34.8390

Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema

H35.3210 – H35.3293

Exudative age-related macular degeneration

ICD-10 Diagnoses Codes That Support Medical Necessity for Pegaptanib (Macugen®)(J2503):

E08.311

Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

E08.3211 – E08.3219

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema

E08.3311 – E08.3319

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema

E08.3411 – E08.3419

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema

E08.3511 – E08.3519

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema

E09.311

Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema

E09.3211 – E09.3219

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E09.3311 – E09.3319

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E09.3411 – E09.3419

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E09.3511 – E09.3519

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema

E10.311

Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E10.3211 – E10.3219

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E10.3311 – E10.3319

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E10.3411 – E10.3419

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E10.3511 – E10.3519

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema

E11.311

Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E11.3211 – E11.3219

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E11.3311 – E11.3319

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E11.3411 – E11.3419

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E11.3511 – E11.3519

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema

E13.311

Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

E13.3211 – E13.3219

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E13.3311 – E13.3319

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E13.3411 – E13.3419

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E13.3511 – E13.3519

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema

H35.3210 – H35.3293

Exudative age-related macular degeneration

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Intravitreal BEVACIZUMAB (Avastin®) (L33504), Macugen (PEGAPTANIB sodium injection) (L33919), RANIBIZUMAB (Lucentis) (L33407) located at fcso.com. No National Coverage Determination (NCD) was found at the time of the last guideline revised date.

DEFINITIONS:

None

RELATED GUIDELINES:

None

OTHER:

Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale

DRSS
Level/severity

Definition

10
No retinopathy

Diabetic retinopathy absent

20
Very
mild NPDR

Microaneurysms only

35
Mild NPDR

Hard exudates, cotton-wool spots, and/or mild retinal hemorrhages

47
Moderate NPDR

Retinal hemorrhages: moderate in 4 quadrants or severe in 1 quadrant

Mild intraretinal microvascular abnormalities in 4 quadrants

53
Severe NPDR

≥2 level 47 characteristics

Severe retinal hemorrhages in 4 quadrants

Moderate to severe intraretinal microvascular abnormalities in ≥1 quadrant

Venous beading (or loops) in at least 2 quadrants

61
Mild PDR

New vessels <0.5 disc area in ≥1 quadrant

65
Moderate PDR

New vessels ≥1 disc diameters of the optic disc in ≥1 quadrant <0.25-0.33 disc area

New vessels elsewhere in ≥0.5 disc area in ≥1 quadrant

71, 75
High
-risk PDR

New vessel ≥1 disc diameter of the optic disc ≥0.5 disc area plus preretinal hemorrhage or vitreous hemorrhage, or preretinal hemorrhage or vitreous hemorrhage obscuring ≥1 disc area

81, 85
Advanced PDR

Fundus partially obscured by vitreous hemorrhage and either new vessels ungradable or retina detached at the center of the macula

DRSS = diabetic retinopathy severity score; NPDR = non-proliferative diabetic retinopathy; PDR = proliferative diabetic retinopathy

REFERENCES:

  1. American Academy of Ophthalmology (AAO) Retina Panel. Preferred Practice Pattern® Guidelines. Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology. January 2015.
  2. American Academy of Ophthalmology (AAO) Retina Panel. Preferred Practice Pattern® Guidelines. Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology. February 2016.
  3. American Academy of Ophthalmology (AAO) Retina Panel. Preferred Practice Pattern® Guidelines Retinal Vein Occlusions. San Francisco, CA: American Academy of Ophthalmology. November 2016.
  4. Bhisitkul RB, Mendes TS, Rofagha S, et al. Macular atrophy progression and 7-year vision outcomes in subjects from the ANCHOR, MARINA, and HORIZON studies: the SEVEN-UP study. Am J Ophthalmol. 2015;159(5):915.
  5. Braithwaite T, Nanji AA, Greenberg PB. Anti-vascular endothelial growth factor for macular edema secondary to central retinal vein occlusion. Cochrane Database of Systematic Reviews 2010, Issue 10. Art. No.: CD007325. DOI: 10.1002/14651858.CD007325.pub2.
  6. Chakravarthy U, Harding SP, Rogers CA, et al. on behalf of the IVAN study investigators. Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial. Lancet. 2013;382(9900):1258.
  7. Cionni DA, Lewis SA, Peterson MR, et al. Analysis of Outcomes for Intravitreal Bevacizumab in the Treatment of Choroidal Neovascularization Secondary to Ocular Histoplasmosis. Ophthalmology. 2011 Nov 29.
  8. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016 Nov 29]. Available from: http://www.clinicalpharmacology.com/.
  9. Darlow BA, Ells AL, Gilbert CE, et al. Are we there yet? Bevacizumab therapy for retinopathy of prematurity. Arch Dis Child Fetal Neonatal Ed. 2013 Mar;98(2):F170-4.
  10. Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372(13):1193.
  11. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016 Nov 29]. Available from: http://www.thomsonhc.com/.
  12. Ehlers JP, Spirn MJ, Lam A, et al: Combination intravitreal bevacizumab/panretinal photocoagulation versus panretinal photocoagulation alone in the treatment of neovascular glaucoma. Retina 2008; 28(5):696-702
  13. Ehrlich R, Ciulla TA, Maturi R, et al. Intravitreal Bevacizumab for Choroidal Neovascularization Secondary to Presumed Ocular Histoplasmosis Syndrome. Retina. 2009:29(10); 1418-1423.
  14. El Matri L, Kort F, Bouraoui R, et al. Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Secondary to Angioid Streaks: One Year Follow-Up. Acta Ophthalmol. 2011 Nov; 89(7):641-6.
  15. Eylea (aflibercept) injection [package insert]. Regeneron Pharmaceuticals. Tarrytown, NY. October 2016.
  16. Finger RP, Charbel Issa P, Schmitz-Valckenberg S, et al. Long-Term Effectiveness of Intravitreal Bevacizumab for Choroidal Neovascularization Secondary to Angioid Streaks in Pseudoxanthoma Elasticum. Retina. 2011 Jul-Aug;31(7):1268-78.
  17. Fleck BW. Management of retinopathy of prematurity. Arch Dis Child Fetal Neonatal Ed. 2013;98(5):F454.
  18. Kim M, Lee DH, Byeon SH, et al. Comparison of intravitreal bevacizumab and dexamethasone implant for the treatment of macula oedema associated with branch retinal vein occlusion. Br J Ophthalmol. 2015 Sep;99(9):1271-6.
  19. Lucentis (ranibizumab) injection [package insert]. Genentech. South San Francisco, CA. April 2017.
  20. Macugen (pegaptanib sodium) injection [package insert]. Eyetech Inc. Palm Beach Gardens, FL. October 2011.
  21. Mimoun G, Tilleul J, Leys A, et al. Intravitreal ranibizumab for choroidal neovascularization in angioid streaks. Am J Ophthalmol. 2010 Nov; 150(5):692-700.e1.
  22. Mintz-Hittner HA, Kennedy KA, Chuang AZ, BEAT-ROP Cooperative Group. Efficacy of intravitreal bevacizumab for stage 3+ retinopathy of prematurity. N Engl J Med 2011; 364(7):603-615.
  23. Mitry D, Bunce C, Charteris D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD009510. DOI: 10.1002/14651858.CD009510.pub2.
  24. Mirshahi A, Roohipoor R, Lashay A, et al. Bevacizumab-augmented retinal laser photocoagulation in proliferative diabetic retinopathy: a randomized double-masked clinical trial. Eur J Ophthalmol. 2008;18(2):263
  25. Moja L, Lucenteforte E, Kwag KH, et al. Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014;9:CD011230
  26. Myung JS, Bhatnagar P, Spaide RF, et al. Long-term outcomes of intravitreal antivascular endothelial growth factor therapy for the management of choroidal neovascularization in pseudoxanthoma elasticum. Retina. 2010 May; 30(5):748-55.
  27. Nielsen JS, Fick TA, Saggau DD, Barnes CH. Intravitreal anti-vascular endothelial growth factor therapy for choroidal neovascularization secondary to ocular histoplasmosis syndrome. Retina. 2011 Jul 30.
  28. Reddy U, Krzystolik M. Antiangiogenic therapy with interferon alfa for neovascular age-related macular degeneration. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD005138. DOI: 10.1002/14651858.CD005138.pub2.
  29. Rofagha S, Bhisitkul RB, Boyer DS, et al.Seven-year outcomes in ranibizumab-treated patients in ANCHOR, MARINA, and HORIZON: a multicenter cohort study (SEVEN-UP). Ophthalmology. 2013;120(11):2292.
  30. Simha A, Braganza A, Abraham L, Samuel P, Lindsley K. Anti-vascular endothelial growth factor for neovascular glaucoma. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD007920. DOI: 10.1002/14651858.CD007920.pub2.
  31. Simunovic MP, Maberley DA. ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY FOR PROLIFERATIVE DIABETIC RETINOPATHY: A Systematic Review and Meta-Analysis. Retina. 2015 Oct;35(10):1931-42
  32. Smith JM, Steel DHW. Anti-vascular endothelial growth factor for prevention of postoperative vitreous cavity haemorrhage after vitrectomy for proliferative diabetic retinopathy. Cochrane Database of Systematic Reviews 2011, Issue 5. Art. No.: CD008214. DOI: 10.1002/14651858.CD008214.pub2.
  33. Solomon SD, Lindsley K, Vedula SS, et al. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2014 Aug 29;8:CD005139.
  34. Ushida H, Kachi S, Asami T, et al. Influence of preoperative intravitreal bevacizumab on visual function in eyes with proliferative diabetic retinopathy.Ophthalmic Res. 2013;49(1):30-6. Epub 2012 Sep 29.
  35. Vedula SS, Krzystolik M. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for neovascular age-related macular degeneration. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD005139. DOI: 10.1002/14651858.CD005139.pub2.
  36. VEGF Inhibition Study in Ocular Neovascularization (V.I.S.I.O.N.) Clinical Trial Group1, Chakravarthy U, Adamis AP, Cunningham ET Jr, et al. Year 2 efficacy results of 2 randomized controlled clinical trials of pegaptanib for neovascular age-related macular degeneration. Ophthalmology. 2006 Sep;113(9):1508.e1-25. Epub 2006 Jul 7.
  37. Virgili G, Parravano M, Menchini F, Brunetti M. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for diabetic macular oedema. Cochrane Database of Systematic Reviews 2012, Issue 12. Art. No.: CD007419. DOI: 10.1002/14651858.CD007419.pub3.
  38. Wang E and Chen Y. Intravitreal anti-vascular endothelial growth factor for choroidal neovascularization secondary to pathologic myopia: systematic review and meta-analysis. Retina 2013; 33(7):1375-1392.
  39. Writing Committee for the Diabetic Retinopathy Clinical Research Network, Gross JG, Glassman AR, Jampol LM, et al. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2137-46.
  40. Yeh S, Kim SJ, Ho AC, et al. Therapies for macular edema associated with central retinal vein occlusion: a report by the American Academy of Ophthalmology. Ophthalmology. 2015 Apr;122(4):769-78. Epub 2015 Jan 8.
  41. Zhang ZH, Liu HY, Hernandez-Da Mota SE, et al. Vitrectomy with or without preoperative intravitreal bevacizumab for proliferative diabetic retinopathy: a meta-analysis of randomized controlled trials. Am J Ophthalmol. 2013 Jul;156(1):106-115.e2.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 05/10/17.

GUIDELINE UPDATE INFORMATION:

12/15/12

New Medical Coverage Guideline.

01/01/13

Annual HCPCS Update: added HCPCS code J0178 and removed code Q2046.

01/15/14

Review and revision to guideline; consisting of reformatting and revising the position statement, dosage, administration, precautions sections and updating the references.

10/15/14

Revision to guideline; consisting of position statement, dosing/administration.

01/15/15

Review and revision to guideline; consisting of updating references.

02/15/15

Revision to guideline; consisting of updating position statement and dosing/administration.

03/15/15

Revision to guideline; consisting of position statement.

06/15/15

Revision to guideline; consisting of position statement and updating references.

08/15/15

Revision to guideline; consisting of updating coding.

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

01/15/16

Review and revision to guideline consisting of updates to position statement, coding/billing, and references.

08/15/16

Revision to guideline consisting of updating coding information.

10/01/16

Revision: ICD-10 code updates.

01/15/17

Review and revision to guideline consisting of position statement, coding/billing, and references.

06/15/17

Revision to guideline consisting of updates to the position statement, description section, dosage/administration, billing/coding, and references based on a new FDA-approved indication for ranibizumab (Lucentis).

Date Printed: August 22, 2017: 06:53 AM