Intravitreal Injections/Implants
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Intravitreal Injections/Implants Last Review Date: September 2, 2021 Number: MG.MM.PH.18 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, (“EmblemHealth”) has adopted the herein policy in providing management, administrative and other services to, EmblemHealth Plan, Inc., EmblemHealth Insurance Company, EmblemHealth Services Company, LLC and Health Insurance Plan of Greater New York (HIP), ConnectiCare, Inc., ConnectiCare Insurance Company, Inc. ConnectiCare Benefits, Inc., and ConnectiCare of Massachusetts, Inc. related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definition Intravitreal injections into the vitreous of the eye are used to treat a variety of eye diseases. Guideline Intravitreal injections are considered medically necessary as follows: A. Pegaptanib sodium (Macugen®); any: 1. Wet age-related macular degeneration if therapy with Avastin (bevacizumab) has failed or is contraindicated. (Step protocol not mandated for Medicare members) i. Macugen – 0.3mg via intravitreal injection once every 6 weeks B. Ranibizumab (Lucentis®), Aflibercept (Eylea™), and Brolucizumab (Beovu); any: 1. Wet age-related macular degeneration when treatment with bevacizumab (Avastin) has failed or is contraindicated (Step protocol not mandated for Medicare members) i. Lucentis – 0.5mg via intravitreal injection every 4 weeks ii. Eylea – 2mg via intravitreal injection every 4 weeks iii. Avastin – 1.25mg via intravitreal injection every 4 weeks iv. Beovu – 6 mg via intravitreal injection every 4 weeks for the first three doses, followed by 6 mg by intravitreal injection every 8-12 weeks. 2. Diabetic macular edema (DME) and diabetic retinopathy in patients with DME when treatment with bevacizumab (Avastin) has failed or is contraindicated (Step protocol not mandated for Medicare members) i. Lucentis – 0.3mg via intravitreal injection every 4 weeks ii. Eylea – 2mg via intravitreal injection every 4 weeks Intravitreal Injections/Implants Last review: September 2, 2021 Page 2 of 58 iii. Avastin – 1.25mg via intravitreal injection every 4 weeks 3. Macular edema following retinal vein occlusion 4. Myopic choroidal neovascularization (mCNV) for Ranibizumab (Lucentis®) only C. Bevacizumab (Avastin, biosimilars Mvasi, Zirabev are not preferred agents); any: 1. Central serous chorioretinopathy 2. Choroidal neovascularization due to angioid streaks 3. Choroidal rupture or trauma 4. Diabetic macular edema 5. Idiopathic choroidal neovascularization 6. Macular edema following retinal vein occlusion 7. Multifocal choroiditis 8. Neovascular glaucoma 9. Pathologic myopia 10. Proliferative diabetic retinopathy as an adjunctive treatment to vitrectomy or photocoagulation 11. Rubeosis (neovascularization of the iris) 12. Treatment of retinopathy of prematurity 13. Wet age-related macular degeneration 14. Presumed ocular histoplasmosis syndrome 15. Uveitis central D. Ocriplasmin (Jetrea®) — single intravitreal injection for symptomatic vitreomacular adhesion (VMA); all: 1. Member is ≥ 18 years of age 2. Optical coherence tomography (OCT) demonstrates all: i. Vitreous adhesion within 6-mm of the fovea (center of macula) ii. Elevation of the posterior vitreous cortex (outer layer of the vitreous) iii. Best-corrected visual acuity of ≤ 20/25 in the eye to be treated with ocriplasmin Repeat intravitreal injection of ocriplasmin in the affected eye is considered experimental/investigational E. Fluocinolone acetonide intravitreal implant (Retisert®, Iluvien®, or Yutiq), as specified per indication: 1. Chronic non-infectious uveitis (including birdshot chorioretinopathy) affecting the posterior segment of the eye in members nonresponsive (or intolerant) to conventional pharmacotherapy (e.g., corticosteroids, immunosuppressive therapy) i. Retisert- Coverage available for one implant (0.59 mg) per eye every 30 months ii. Yutiq- Coverage available for one implant (0.18 mg) per eye every 36 months 2. Diabetic macular edema when previous treatment with course of corticosteroids did not have a clinically significant rise in intraocular pressure i. Iluvien- Coverage available for one implant (0.19 mg) per eye every 36 months F. Dexamethasone intravitreal implant (Ozurdex®); any 1. Macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) i. Coverage available for one implant per eye every 4 weeks. 2. Non-infectious uveitis affecting the posterior segment of the eye Intravitreal Injections/Implants Last review: September 2, 2021 Page 3 of 58 i. Coverage available for one implant per eye every 8 weeks. 3. Diabetic macular edema i. Coverage available for one implant per eye every 16 weeks. G. Dexamethasone intraocular suspension (Dexycu®); 1. Member is ≥ 18 years of age; AND 2. Member has undergone ocular surgery and requires treatment for postoperative inflammation; AND 3. Postoperative treatment with corticosteroid ophthalmic drops has previously failed or is contraindicated (Step protocol not mandated for Medicare members) H. Dexamethasone intracanalicular insert (Dextenza®); 1. Member has undergone ophthalmic surgery and requires treatment for postoperative pain; AND 2. Postoperative treatment with corticosteroid ophthalmic drops has previously failed or is contraindicated (Step protocol not mandated for Medicare members) I. Bimatoprost implant for intracameral administration (Durysta®); 1. Reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT); i. Member is ≥ 18 years of age; AND ii. Member has had a trial and failure or intolerance to at least two IOP eye-drop agents with different mechanisms of action, and one of which must include a prostaglandin analog (for example, bimatoprost, latanoprost, travoprost, or tafluprost) (Step protocol not mandated for Medicare members); AND iii. The affected eye has not had received prior treatment with Durysta Limitations/Exclusions Above listed drugs are considered experimental or investigational for all indications not listed above. Revision History 9/2/2021 Clarified Retisert, Iluvien, and Yutiq dosing and quantity limits Avastin frequency changed from q6 weeks to q 4 weeks for the treatment of Diabetic macular edema 2/9/2021 (DME) and diabetic retinopathy in patients with DME. 1/14/2021 Clarified Ozurdex quantity limits 1/6/2021 Removed: “Avastin is the preferred agent for Medicare members.” 12/18/2020 Added CPT 66030 Added J-Code (J7351) Injection, bimatoprost, intracameral implant, 1 microgram (Durysta). J-Code 9/11/2020 effective date: 10/01/2020 Added Durysta (J3490/C9399) for indication, Reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT); added criteria of member is ≥ 18 years of age; AND Member has had a trial and failure or intolerance to at least two IOP eye-drop agents with 9/2/2020 different mechanisms of action, and one of which must include a prostaglandin analog (for example, bimatoprost, latanoprost, travoprost, or tafluprost); AND The affected eye has not had received prior treatment with Durysta Intravitreal Injections/Implants Last review: September 2, 2021 Page 4 of 58 For J9035: 1 billable unit (10mg) intravitreal injection will no longer require a prior authorization, anything >1 billable unit continues to require prior authorization. 05/07/2020 Code Removal: C9257 (Injection, bevacizumab, 0.25 mg) was removed from this Medical Policy. 03/17/2020 - Added Mvasi (Q5107) and Zirabev (Q5118) applicable procedure codes The following diagnosis codes and their accompanied description have been