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MAXIMUM DOSAGE & FREQUENCY Policy Number: CSLA2020D0034X Effective Date: TBD

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MAXIMUM DOSAGE & FREQUENCY Policy Number: CSLA2020D0034X 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 2020 United HealthCare Services, Inc. UnitedHealthcare® Community Plan Medical Benefit Drug Policy MAXIMUM DOSAGE & FREQUENCY Policy Number: CSLA2020D0034X Effective Date: TBD Table of Contents Page Related Community Plan Policies APPLICATION .......................................................... 1 Cimzia® (Certolizumab Pegol) COVERAGE RATIONALE ............................................. 1 Complement Inhibitors (Soliris® & Ultomiris™) APPLICABLE CODES ................................................. 3 Denosumab (Prolia® & Xgeva®) CLINICAL EVIDENCE ................................................ 21 Entyvio® (Vedolizumab) CENTERS FOR MEDICARE AND MEDICAID SERVICES ... 21 ® REFERENCES .......................................................... 22 Infliximab (Remicade , Inflectra™, Renflexis™) POLICY HISTORY/REVISION INFORMATION ................ 24 Oncology Medication Clinical Coverage INSTRUCTIONS FOR USE ......................................... 24 Onpattro™ (Patisiran) Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors Rituximab (Rituxan®, Ruxience™, & Truxima®) Stelara® (Ustekinumab) White Blood Cell Colony Stimulating Factors Xolair® (Omalizumab) Commercial Policy Maximum Dosage APPLICATION This Medical Benefit Drug Policy only applies to 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: abatacept (Orencia®) nivolumab (Opdivo®) bevacizumab (Avastin®) omalizumab (Xolair®) bevacizumab-awwb (Mvasi™) patisiran (Onpattro™) bevacizumab-bvzr (Zirabev™) pegfilgrastim (Neulasta®) certolizumab pegol (Cimzia®) pegfilgrastim-cbqv (Udenyca™) denosumab (Prolia® & Xgeva®) pegfilgrastim-jmdb (Fulphila™) eculizumab (Soliris®) pegfilgrastim-bmez (Ziextenzo™) emicizumab-kxwh (Hemlibra®) ravulizumab-cwvz (Ultomiris™) golimumab (Simponi Aria®) rituximab (Rituxan®) infliximab (Remicade®) rituximab-pvvr (Ruxience™) infliximab-axxq (Avsola™) rituximab-abbs (Truxima®) infliximab-dyyb (Inflectra™) rituximab and hyaluronidase (Rituxan infliximab-abda (Renflexis™) Hycela®) 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 2020 United HealthCare Services, Inc. testosterone cypionate (Depo-Testosterone®) testosterone enanthate (Delatestryl®) testosterone pellets (Testopel®) testosterone undecanoate (Aveed®) tildrakizumab-asmn (Ilumya™) tocilizumab (Actemra®) 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®) 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 2020 United HealthCare Services, Inc. The use of medications included in this policy when given within the maximum dosage and/or frequency based upon body surface area or patient weight or a set of maximal dosage and/or frequency independent of patient body size are proven when used according to labeled indications or when otherwise supported by published clinical evidence. The medications included in this policy when given beyond maximum dosages and/or frequency 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. Maximum Allowed Quantities by HCPCs Units Medication Name Maximum Dosage HCPCs Diagnosis Maximum Allowed Brand Generic per Administration Code 800 HCPCs units Actemra tocilizumab 800 mg J3262 (1 mg per unit) 192 HCPCs units J9035 bevacizumab (10 mg per unit) Avastin 15 mg/kg bevacizumab- 192 HCPCs units Mvasi 15 mg/kg Q5107 awwb (10 mg per unit) Zirabev 15 mg/kg bevacizumab-bvzr 192 HCPCs units Q5118 (10 mg per unit) testosterone 750 HCPCs units Aveed 750mg J3145 undecanoate (1 mg per unit) 400 HCPCs units Cimzia certolizumab pegol 400 mg total dose J0717 (1 mg per unit) testosterone 400 HCPCs units Delatestryl 400 mg J3121 enanthate (1 mg per unit) Depo- testosterone 400 HCPCs units Testosteron 400 mg J1071 cypionate (1 mg per unit) e 300 HCPCs units Entyvio vedolizumab 300 mg J3380 (1 mg per unit) Emicizumab- 1,536 HCPCs units Hemlibra 6 mg/kg J7170 kxwh (0.5 mg per unit) J9355 103 HCPCs units Q5113 (10 mg per unit) 103 HCPCs units Q5117 Herceptin trastuzumab 8 mg/kg (10 mg per unit) Herzuma trastuzumab-pkrb 8 mg/kg Q5114 103 HCPCs units Kanjinti trastuzumab-anns 8 mg/kg Q5112 (10 mg per unit) Ogivri trastuzumab-dkst 8 mg/kg 103 HCPCs units Ontruzant trastuzumab-dttb 8 mg/kg (10 mg per unit) Trazimera trastuzumab-qyyp 8 mg/kg 103 HCPCs units Q5116 (10 mg per unit) 103 HCPCs units (10 mg per unit) Maximum Dosage Page 3 of 24 UnitedHealthcare Community Plan Medical Benefit Drug Policy Effective TBD Proprietary Information of UnitedHealthcare. Copyright 2020 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 2020 United HealthCare Services, Inc. Medication Name Maximum Dosage HCPCs Diagnosis Maximum Allowed Brand Generic per Administration Code tildrakizumab- 100 HCPCs units Ilumya 100 mg J3245 asmn (1 mg per unit) 1 HCPCs unit Neulasta pegfilgrastim 6 mg total dose J2505 (6 mg per unit) pegfilgrastim-jmdb Q5108 12 HCPCs units Fulphila pegfilgrastim-cbqv 6 mg total dose (0.5mg per unit) Udenyca Q5111 pegfilgrastim- 6 mg total dose 12 HCPCs units Ziextenzo bmez TBD (0.5mg per unit) 480 HCPCs units Opdivo nivolumab 480 mg J9299 (1 mg per unit) 100 HCPCs units Orencia Abatacept 1000 mg J0129 (10 mg per unit) Reclast 5 mg total dose zoledronic 5 mg total dose 5 HCPCs units zoledronic acid J3489 acid 4 mg total dose (1 mg per unit) Zometa 4 mg total dose J1745 128 HCPCs units Remicade infliximab (10 mg per unit) 10 mg/kg TBD Avsola infliximab-axxq 128 HCPCs units 10 mg/kg Q5104 Renflexis infliximab-abda (10 mg per unit) 10 mg/kg Inflectra infliximab-dyyb Q5103 128 HCPCs units (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) 120 HCPCs units Xgeva denosumab Oncology 120 mg J0897 (1 mg per unit) J9312 123 HCPCs units Rituxan rituximab 1,225 mg total dose (10 mg per unit) Ruxience rituximab-pvvr TBD 1,225 mg total dose 123 HCPCs units Truxima rituximab-abbs Q5115 (10 mg per unit) Rituxan rituximab and 160 HCPCs units 1,600 mg J9311 Hycela hyaluronidase (10 mg per unit) Simponi 256 HCPCs units golimumab 2 mg/kg J1602 Aria (1 mg per unit) 90 HCPCs units PNH 900 mg J1300 (10 mg per unit) Soliris eculizumab aHUS, MG, 120 HCPCs units 1200 mg J1300 NMOSD (10 mg per unit) 90 HCPCs units 90 mg J3357 (1 mg per unit) Stelara ustekinumab Crohn’s 520 HCPCs units 520 mg J3358 Disease (1 mg per unit) Maximum Dosage Page 4 of 24 UnitedHealthcare Community Plan Medical Benefit Drug Policy Effective TBD Proprietary Information of UnitedHealthcare. Copyright 2020 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 2020 United HealthCare Services, Inc. Medication Name Maximum Dosage HCPCs Diagnosis Maximum Allowed Brand Generic per Administration Code testosterone 6 HCPCs units Testopel 450 mg S0189 pellet (75 mg per unit) 360 HCPCs units Ultomiris ravulizumab-cwvz 3,600 mg total dose J1303 (10 mg per unit) 90 HCPCs units Asthma 375 mg J2357 (5 mg per unit) Xolair omalizumab Chronic 60 HCPCs units 300 mg J2357 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. Absence of a specific NDC does not mean that
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