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MAXIMUM DOSAGE Policy Number: CSLA2020D0034W Effective Date:TBD

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MAXIMUM DOSAGE Policy Number: CSLA2020D0034W Effective Date:TBD Proprietary Information of United Healthcare: The information contained in this document is proprietary and the sole property of United HealthCare Services, Inc. Unauthorized copying, use and distribution of this information are strictly prohibited. Copyright 2019 United HealthCare Services, Inc. UnitedHealthcare® Community Plan Medical Benefit Drug Policy MAXIMUM DOSAGE Policy Number: CSLA2020D0034W Effective Date:TBD Instructions for Use Table of Contents Page Related Community Plan Policies Cimzia Complement Inhibitors (Soliris® & Ultomiris™) APPLICATION ...... ERROR! BOOKMARK NOT DEFINED. Denosumab (Prolia® & Xgeva®) COVERAGE RATIONALE ......... ERROR! BOOKMARK NOT Entyvio® (Vedolizumab) DEFINED. Infliximab (Remicade®, Inflectra™, Renflexis™) (for APPLICABLE CODES ................................................. 6 Iowa, Louisiana, and Pennsylvania Only) CLINICAL EVIDENCE ................................................ 9 ® CENTERS FOR MEDICARE AND MEDICAID SERVICES ... 9 Infliximab (Remicade , Inflectra™, Renflexis™) (for REFERENCES ......................................................... 10 States Other Than Iowa, Louisiana, and POLICY HISTORY/REVISION INFORMATION .............. 11 Pennsylvania) INSTRUCTIONS FOR USE ........................................ 12 Oncology Medication Clinical Coverage Onpattro Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors Rituximab (Rituxan® & Truxima®) Stelara® (Ustekinumab) White Blood Cell Colony Stimulating Factors Xolair® (Omalizumab) Commercial Policy Maximum Dosage APPLICATION This Medical Benefit Drug Policy only applies to the state of Louisiana. COVERAGE RATIONALE This policy provides information about the maximum dosage per administration for certain medications administered by a medical professional. Most medications have a maximum dosage based upon body surface area or patient weight or a set maximal dosage independent of patient body size. Drug Products Bevacizumab (Avastin®) Bevacizumab-awwb (Mvasi™) Bevacizumab-bvzr (Zirabev™) Certolizumab pegol (Cimzia®) Denosumab (Prolia® & Xgeva®) Eculizumab (Soliris®) Infliximab (Remicade®) Infliximab-abda (Renflexis™) Maximum Dosage Page 1 of 12 UnitedHealthcare Community Plan Medical Benefit Drug Policy Effective TBD Proprietary Information of UnitedHealthcare. Copyright 2019 United HealthCare Services, Inc. Proprietary Information of United Healthcare: The information contained in this document is proprietary and the sole property of United HealthCare Services, Inc. Unauthorized copying, use and distribution of this information are strictly prohibited. Copyright 2019 United HealthCare Services, Inc. Infliximab-dyyb (Inflectra™) Nivolumab (Opdivo®) Omalizumab (Xolair®) Patisiran (Onpattro™) Pegfilgrastim (Neulasta®) Pegfilgrastim-cbqv (Udenyca™) Pegfilgrastim-jmdb (Fulphila™) Ravulizumab-cwvz (Ultomiris™) Rituximab-abbs (Truxima®) Rituximab (Rituxan®) Trastuzumab (Herceptin®) Trastuzumab-anns (Kanjinti™) Trastuzumab-dkst (Ogivri™) Trastuzumab-dttb (Ontruzant™) Trastuzumab-pkrb (Herzuma®) Trastuzumab-qyyp (Trazimera™) Ustekinumab (Stelara®) Vedolizumab (Entyvio®) Zoledronic acid (zoledronic acid, Reclast® and Zometa®) Most medications have a maximum dosage based upon body surface area or patient weight or a set maximal dosage independent of patient body size, and are proven when used according to labeled indications or when otherwise supported by published clinical evidence. The use of medications included in this policy when given within the beyond maximum dosages based upon body surface area or patient weight or a set maximal dosage independent of patient body size are proven when used according to labeled indications or when otherwise supported by published clinical evidence. are not supported by package labeling or published clinical evidence and are unproven. The medications included in this policy when given beyond maximum dosages based upon body surface area or patient weight or a set maximal dosage independent of patient body size are not supported by package labeling or published clinical evidence and are unproven. This policy creates an upper dose limit based on the clinical evidence and the 95th percentile for adult body weight (128 kg) and body surface area (2.59 meters2) in the U.S. (adult male, 30 to 39 years, Fryar, 2016). In some cases, the maximum allowed units and/or vials may exceed the upper level limit as defined within this policy due to an individual patient body weight > 128 kg or body surface area > 2.59 meters2. Medication Name Maximum Dosage HCPCS Diagnosis Maximum Allowed Brand Generic per Administration Code 192 HCPCS units Avastin bevacizumab 15 mg/kg J9035 (10 mg per unit) bevacizumab- 192 HCPCS units Mvasi 15 mg/kg Q5107 awwb (10 mg per unit) bevacizumab- 192 HCPCS units Zirabev 15 mg/kg Q5118 bvzr (10 mg per unit) Cimzia certolizumab 400 mg total dose J0717 400 HCPCS units (1 mg pegol per unit) 300 HCPCS units Entyvio vedolizumab 300 mg J3380 (1 mg per unit) 103 HCPCS units Herceptin trastuzumab 8 mg/kg J9355 (10 mg per unit) trastuzumab- 103 HCPCS units Herzuma 8 mg/kg Q5113 pkrb (10 mg per unit) trastuzumab- 103 HCPCS units Kanjinti 8 mg/kg Q5117 anns (10 mg per unit) Maximum Dosage Page 2 of 12 UnitedHealthcare Community Plan Medical Benefit Drug Policy Effective TBD Proprietary Information of UnitedHealthcare. Copyright 2019 United HealthCare Services, Inc. Proprietary Information of United Healthcare: The information contained in this document is proprietary and the sole property of United HealthCare Services, Inc. Unauthorized copying, use and distribution of this information are strictly prohibited. Copyright 2019 United HealthCare Services, Inc. Medication Name Maximum Dosage HCPCS Diagnosis Maximum Allowed Brand Generic per Administration Code trastuzumab- 103 HCPCS units Ogivri 8 mg/kg Q5114 dkst (10 mg per unit) trastuzumab- 103 HCPCS units Ontruzant 8 mg/kg Q5112 dttb (10 mg per unit) trastuzumab- 103 HCPCS units Trazimera 8 mg/kg Q5116 qyyp (10 mg per unit) 1 HCPCS unit Neulasta pegfilgrastim 6 mg total dose J2505 (6 mg per unit) 12 HCPCS unit Fulphila pegfilgrastim 6 mg total dose Q5108 (0.5mg per unit) pegfilgrastim- 12 HCPCS units Udenyca 6 mg total dose Q5111 cbqv (0.5mg per unit) 480 HCPCS units Opdivo nivolumab 480 mg J9299 (1 mg per unit) Reclast 5 mg total dose Zoledronic Acid 5 HCPCS units zoledronic acid J3489 Zometa (1 mg per unit) 4 mg total dose Zoledronic Acid 128 HCPCS units Remicade infliximab 10 mg/kg J1745 (10 mg per unit) 128 HCPCS units Inflectra infliximab-dyyb 10 mg/kg Q5103 (10 mg per unit) 300 HCPCS units Onpattro patisiran 30 mg total dose J0222 (0.1 mg per unit) 60 HCPCS units Prolia denosumab Osteoporosis 60 mg J0897 (1 mg per unit) 128 HCPCS units Renflexis infliximab-abda 10 mg/kg Q5104 (10 mg per unit) 123 HCPCS units Rituxan rituximab 1,225 mg total dose J9312 (10 mg per unit) rituximab- 1,225 mg total 123 HCPCS units Truxima Q5115 abbs dose (10 mg per unit) 90 HCPCS units PNH 900 mg (10 mg per unit) Soliris eculizumab J1300 120 HCPCS units aHUS, MG 1200 mg (10 mg per unit) 90 HCPCS units 90 mg J3357 (1 mg per unit) Stelara ustekinumab 520 HCPCS units Crohn’s Disease 520 mg J3358 (1 mg per unit) ravulizumab- 3,600 mg total 360 HCPCS units Ultomiris J1303 cwvz dose (10 mg per unit) 120 HCPCS units Xgeva denosumab Oncology 120 mg J0897 (1 mg per unit) 90 HCPCS units Xolair omalizumab Asthma 375 mg J2357 (5 mg per unit) Maximum Dosage Page 3 of 12 UnitedHealthcare Community Plan Medical Benefit Drug Policy Effective TBD Proprietary Information of UnitedHealthcare. Copyright 2019 United HealthCare Services, Inc. Proprietary Information of United Healthcare: The information contained in this document is proprietary and the sole property of United HealthCare Services, Inc. Unauthorized copying, use and distribution of this information are strictly prohibited. Copyright 2019 United HealthCare Services, Inc. Medication Name Maximum Dosage HCPCS Diagnosis Maximum Allowed Brand Generic per Administration Code Chronic 60 HCPCS units 300 mg Urticaria (5 mg per unit) Maximum Allowed Quantities for National Drug Code (NDC) Billing The allowed quantities in this section are calculated based upon both the maximum dosage information supplied within this policy as well as the process by which NDC claims are billed. This list may not be inclusive of all available NDCs for each drug product and is subject to change. Medication Name National Drug Maximum Diagnosis How Supplied Brand Generic Code Allowed 100 mg/4 mL solution in vials 50242-0060-01 Avastin bevacizumab 77 mL 400 mg/16 mL solution in vials 50242-0061-01 55513-0206- 100 mg/4 mL solution in vials 77 mL bevacizumab- 01 Mvasi awwb 400 mg/16 mL solution in 55513-0207- 77 mL vials 01 00069-0315- 100 mg/4 mL solution in vials 77 mL bevacizumab- 01 Zirabev bvzr 400 mg/16 mL solution in 00069-0342- 77 mL vials 01 2 x 200mg kit 50474-0700- 2 vials 62 Certolizumab 2 x 200mg/ml prefilled 50474-0710- 2 mL Cimzia pegol syringe kit 79 6 x 200 mg/ml prefilled 50474-0710- 2 mL syringe kit 81 Entyvio Vedolizumab 300 mg powder for reconstitution 64764-0300-20 1 vial Fulphila pegfilgrastim 6 mg/0.6ml prefilled syringe 67457-0833-06 0.6 mL Herceptin trastuzumab 440 mg powder for reconstitution 50242-0056-56 3 vials 440 mg powder for reconstitution 50242-0134-68 3 vials 420 mg powder for reconstitution 50242-0333-01 3 vials Herceptin trastuzumab 150 mg powder for reconstitution 50242-0132-01 3 vials 420 mg powder for 63459-0305- 3 vials trastuzumab- reconstitution
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