Eylea (aflibercept) Document Number: IC-0026

Transcription

1 Eylea (aflibercept) Document Number: IC-0026 Last Review Date: 3/1/2018 Date of Origin: 02/07/2013 Dates Reviewed: 03/07/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 04/2015, 06/2015, 09/2015, 03/2016, 04/2016, 05/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 3/2018 I. Length of Authorization Coverage will be provided annually and may be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [Pharmacy Benefit]: 2 mg injection: 1 vial per eye every 28 days B. Max Units (per dose and over time) [Medical Benefit]: Diagnosis MU for Initial Dosing MU for Maintenance Dosing Neovascular age-related macular degeneration (AMD) Macular edema following retinal vein occlusion (RVO) Diabetic Macular Edema (DME)/ Diabetic retinopathy (DR) in DME 4 units every 28 days x 3 doses 4 units every days 4 units every 28 days 4 units every 28 days 4 units every 28 days x 5 doses (Max units are based on administration to both eyes) 4 units every days III. Initial Approval Criteria Coverage is provided in the following conditions: Patient is free of ocular and/or peri-ocular infections: AND Patient does not have active intraocular inflammation: AND Patient has a definitive diagnosis of one of the following: o Neovascular (Wet) Age-Related Macular Degeneration (AMD) o Macular Edema following Retinal Vein Occlusion (RVO) o Diabetic Macular Edema (DME) o Diabetic Retinopathy (DR) in patients with Diabetic Macular Edema (DME) FDA Approved Indication(s) Moda Health Plan, Inc. Medical Necessity Criteria Page 1/9

2 IV. Renewal Criteria Coverage can be renewed based upon the following criteria: Patient continues to meet criteria identified in section III; AND Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: Endophthalmitis and retinal detachments; increase in intraocular pressure; arterial thromboembolic events; AND Continued administration is necessary for the maintenance treatment of the condition V. Dosage/Administration Indication Dose Initiation: 2 mg intravitreally once every 4 weeks (monthly) per affected eye for the first 3 months AMD Macular Edema following RVO Maintenance: 2 mg once every 8 weeks (2 months) per affected eye; however Eylea may be dosed as frequently as 2 mg every 4 weeks (monthly) Additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months). 2 mg intravitreally once every 4 weeks (monthly) per affected eye Initiation: Diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema 2 mg intravitreally once every 4 weeks (monthly) per affected eye for the first 5 injections Maintenance: 2 mg once every 8 weeks (2 months) per affected eye; however Eylea may be dosed as frequently as 2 mg every 4 weeks (monthly) Additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months). VI. Billing Code/Availability Information Jcode: J0178 Injection, aflibercept, 1 mg; 1 billable unit = 1 mg NDC: Eylea 2 mg/0.05 ml Solution for Injection: xx VII. References 1. Eylea [package insert]. Tarrytown, NY; Regeneron Pharmaceuticals, Inc.; May Accessed January Moda Health Plan, Inc. Medical Necessity Criteria Page 2/9

3 2. Solomon SD, Chew E, Duh EJ, et al. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care Mar;40(3): American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Diabetic Retinopathy PPP Update Nov American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retinal Vein Occlusions PPP Update Nov American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Age-Related Macular Degeneration PPP Update Nov Royal College of Ophthalmologists. Clinical Guidelines Retinal Vein Occlusion (RVO) Guidelines July Accessed at 7. Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology 2016;123(6): doi.org/ /j.ophtha Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD): Drugs and Biologics (Non-chemotherapy) (L34741). Centers for Medicare & Medicaid Services, Inc. Updated on 11/21/2017 with effective date 12/1/2017. Accessed January National Government Services, Inc. Local Coverage Article for Ranibizumab (e.g., Lucentis ) and Aflibercept (e.g., Eylea ) Related to LCD L33394 (A52451). Centers for Medicare & Medicaid Services, Inc. Updated on 11/22/2017 with effective date of 10/1/2017. Accessed January First Coast Service Options, Inc. Local Coverage Determination (LCD): Vascular Endothelial Growth Factor Inhibitors for the Treatment of Ophthalmological Diseases (L36962). Centers for Medicare & Medicaid Services, Inc. Updated on 9/22/2017 with effective date of 10/02/2017. Accessed January Appendix 1 Covered Diagnosis Codes ICD-10 E Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema E Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, E Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular Moda Health Plan, Inc. Medical Necessity Criteria Page 3/9

4 E Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, E Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, E Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular E Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, E08.37X1 Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, right eye E08.37X2 Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, left eye E08.37X3 Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, bilateral E08.37X9 Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, E Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema E Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, E Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, E Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, E Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular Moda Health Plan, Inc. Medical Necessity Criteria Page 4/9

5 E Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular E Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, E09.37X1 Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E09.37X2 Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E09.37X3 Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E09.37X9 Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, E Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema E Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye E Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye E Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral E Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, E Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, E Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, E Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular E Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular E Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular E Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, E10.37X1 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E10.37X2 E10.37X3 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E10.37X9 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, E Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema E Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye Moda Health Plan, Inc. Medical Necessity Criteria Page 5/9

6 E Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye E Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral E Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, E Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, E Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, E Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular E Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular E Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular E Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, E11.37X1 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E11.37X2 E11.37X3 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E11.37X9 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, E Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema E Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular E Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular E Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular E Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, E Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular E Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, E Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular Moda Health Plan, Inc. Medical Necessity Criteria Page 6/9

7 E Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular E Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, E Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye E Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye E Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral E Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, E13.37X1 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E13.37X2 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E13.37X3 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E13.37X9 Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, H Central retinal vein occlusion, right eye, with macular edema H Central retinal vein occlusion, right eye, with retinal H Central retinal vein occlusion, right eye, stable H Central retinal vein occlusion, left eye, with macular edema H Central retinal vein occlusion, left eye, with retinal H Central retinal vein occlusion, left eye, stable H Central retinal vein occlusion, bilateral, with macular edema H Central retinal vein occlusion, bilateral, with retinal H Central retinal vein occlusion, bilateral, stable H Central retinal vein occlusion,, with macular edema H Central retinal vein occlusion,, with retinal H Central retinal vein occlusion,, stable H Tributary (branch) retinal vein occlusion, right eye, with macular edema H Tributary (branch) retinal vein occlusion, right eye, with retinal H Tributary (branch) retinal vein occlusion, right eye, stable H Tributary (branch) retinal vein occlusion, left eye, with macular edema H Tributary (branch) retinal vein occlusion, left eye, with retinal H Tributary (branch) retinal vein occlusion, left eye, stable H Tributary (branch) retinal vein occlusion, bilateral, with macular edema H Tributary (branch) retinal vein occlusion, bilateral, with retinal H Tributary (branch) retinal vein occlusion, bilateral, stable H Tributary (branch) retinal vein occlusion,, with macular edema H Tributary (branch) retinal vein occlusion,, with retinal H Tributary (branch) retinal vein occlusion,, stable H Exudative age-related macular degeneration, right eye, stage unspecified H Exudative age-related macular degeneration, right eye, with active choroidal Moda Health Plan, Inc. Medical Necessity Criteria Page 7/9

8 H Exudative age-related macular degeneration, right eye, with inactive choroidal H Exudative age-related macular degeneration, right eye, with inactive scar H Exudative age-related macular degeneration, left eye, stage unspecified H Exudative age-related macular degeneration, left eye, with active choroidal H Exudative age-related macular degeneration, left eye, with inactive choroidal H Exudative age-related macular degeneration, left eye, with inactive scar H Exudative age-related macular degeneration, bilateral, stage unspecified H Exudative age-related macular degeneration, bilateral, with active choroidal H Exudative age-related macular degeneration, bilateral, with inactive choroidal H Exudative age-related macular degeneration, bilateral, with inactive scar H Exudative age-related macular degeneration,, stage unspecified H Exudative age-related macular degeneration,, with active choroidal H Exudative age-related macular degeneration,, with inactive choroidal H Exudative age-related macular degeneration,, with inactive scar H35.81 Retinal edema Appendix 2 Centers for Medicare and Medicaid Services (CMS) Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub ), Chapter 15, 50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: Additional indications may be covered at the discretion of the health plan. Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): Jurisdiction(s): 5, 8 NCD/LCD Document (s): L34741 Jurisdiction(s): 6, K NCD/LCD Document (s): A52451 Jurisdiction(s): N (9) NCD/LCD Document (s): L Moda Health Plan, Inc. Medical Necessity Criteria Page 8/9

9 Medicare Part B Administrative Contractor (MAC) Jurisdictions Jurisdiction Applicable State/US Territory Contractor E (1) CA, HI, NV, AS, GU, CNMI Noridian Healthcare Solutions, LLC F (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC 5 KS, NE, IA, MO Wisconsin Physicians Service Insurance Corp (WPS) 6 MN, WI, IL National Government Services, Inc. (NGS) H (4 & 7) LA, AR, MS, TX, OK, CO, NM Novitas Solutions, Inc. 8 MI, IN Wisconsin Physicians Service Insurance Corp (WPS) N (9) FL, PR, VI First Coast Service Options, Inc. J (10) TN, GA, AL Palmetto Government Benefit Administrators, LLC M (11) NC, SC, WV, VA (excluding below) Palmetto GBA, LLC L (12) DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) Novitas Solutions, Inc. K (13 & 14) NY, CT, MA, RI, VT, ME, NH National Government Services, Inc. (NGS) 15 KY, OH CGS Administrators, LLC Moda Health Plan, Inc. Medical Necessity Criteria Page 9/9