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Stelara (ustekinumab) IV solutionLast Review Date: April 17, 2020Number: MG.MM.PH.106Medical Guideline DisclaimerProperty of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidencethat the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will notbe able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determineswhether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review ofcurrently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status ofthe technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leadingnational health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealthexpressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefitprogram defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute arepresentation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage forservices or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefitsprogram, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the FederalGovernment or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurateat time of publication. EmblemHealth Services Company LLC, (“EmblemHealth”) has adopted the herein policy in providing management,administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated, GHI HMOSelect, ConnectiCare, Inc., ConnectiCare Insurance Company, Inc. ConnectiCare Benefits, Inc., and ConnectiCare of Massachusetts, Inc. related tohealth benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealthInc.DefinitionStelara is a human IgG1-kappa monoclonal antibody that binds to the p40 subunits of IL-12 and IL-23cytokines and interferes with inflammatory and immune responses.Length of Authorization Crohn’s Disease and Ulcerative Colitis:o Coverage will be provided for 1 intravenous induction doseStelara Package InsertDosing LimitsMax Units (per dose and over time) [Medical Benefit]:IndicationMax UnitsCrohn’s Disease,Ulcerative ColitisIntravenous Induction (J3358): 520 billable unitsGuidelineI.INITIAL APPROVAL CRITERIACoverage is provided in the following conditions:

Stelara (Ustekinumab)Last review: April 17, 2020Page 2 of 8 Patient is 18 years or older (unless otherwise specified); AND Patient has been evaluated and screened for the presence of latent TB infection prior toinitiating treatment; AND Patient is free of any clinically important active infections; AND Therapy will not be administered concurrently with live vaccines; AND Patient is not on concurrent treatment with a TNF-inhibitor, biologic response modifier or othernon-biologic agent (i.e., apremilast, tofacitinib, baricitinib); AND Physician has assessed baseline disease severity utilizing an objective measure/tool; ANDCrohn’s Disease † Documented moderate to severely active disease; ANDoDocumented failure, contraindication, or ineffective response at maximum tolerated dosesto a minimum (3) month trial of ONE corticosteroid or immunomodulator (e.g. azathioprine,6-mercaptopurine, or methotrexate); ORoDocumented failure, contraindication, or ineffective response at maximum tolerated dosesto a minimum (3) month trial of a TNF modifier (e.g. adalimumab, certolizumab, orinfliximab)Moderately to severely active ulcerative colitis † Documented moderate to severely active disease; ANDoDocumented failure, contraindication, or ineffective response at maximum tolerated dosesto a minimum (3) month trial of ONE corticosteroid or immunomodulator (e.g. azathioprine,6-mercaptopurine); ORoDocumented failure, contraindication, or ineffective response at maximum tolerated dosesto a minimum (3) month trial of a TNF modifier (e.g. adalimumab, or infliximab)† FDA Approved Indication(s)Limitations/ExclusionsStelara (ustekinumab) is not considered medically necessary for indications other those listed abovedue to insufficient evidence of therapeutic value.II. RENEWAL CRITERIACoverage cannot be renewed.

Stelara (Ustekinumab)Last review: April 17, 2020Page 3 of 8Dosing/AdministrationIndicationDoseIntravenous Induction Dose (one-time only):Crohn’s Disease, 55 kg: 260 mgUlcerative Colitis 55 kg to 85 kg: 390 mg 85 kg: 520 mgApplicable Procedure CodesJ3358Ustekinumab, for intravenous injection, 1 mg; 1 billable unit 1 mgApplicable NDC’s57894-0054-xxStelara 130 mg (5 mg/mL) single-dose vialApplicable Diagnosis CodesICD-10ICD-10 DescriptionK50.00K50.011K50.012Crohn’s disease of small intestine without complicationsCrohn’s disease of small intestine with rectal bleedingCrohn’s disease of small intestine with intestinal 11Crohn’s disease of small intestine with fistulaCrohn’s disease of small intestine with abscessCrohn’s disease of small intestine with other complicationCrohn’s disease of small intestine with unspecified complicationsCrohn’s disease of large intestine without complicationsCrohn’s disease of large intestine with rectal rohn’s disease of large intestine with intestinal obstructionCrohn’s disease of large intestine with fistulaCrohn’s disease of large intestine with abscessCrohn’s disease of large intestine with other complicationCrohn’s disease of large intestine with unspecified complicationsCrohn’s disease of both small and large intestine without 0.819Crohn’s disease of both small and large intestine with rectal bleedingCrohn’s disease of both small and large intestine with intestinal obstructionCrohn’s disease of both small and large intestine with fistulaCrohn’s disease of both small and large intestine with abscessCrohn’s disease of both small and large intestine with other complicationCrohn’s disease of both small and large intestine with unspecified .918Crohn’s disease, unspecified, without complicationsCrohn’s disease, unspecified, with rectal bleedingCrohn’s disease, unspecified, with intestinal obstructionCrohn’s disease, unspecified, with fistulaCrohn’s disease, unspecified, with abscessCrohn’s disease, unspecified, with other complication

Stelara (Ustekinumab)Last review: April 17, 2020Page 4 of 8K50.919K51K51.00K51.01K51.011Crohn’s disease, unspecified, with unspecified complicationsUlcerative ColitisUlcerative (chronic) pancolitis without complicationsUlcerative (chronic) pancolitis with complicationsUlcerative (chronic) pancolitis with rectal cerative (chronic) pancolitis with intestinal obstructionUlcerative (chronic) pancolitis with fistulaUlcerative (chronic) pancolitis with abscessUlcerative (chronic) pancolitis with other complicationUlcerative (chronic) pancolitis with unspecified complicationsUlcerative (chronic) lcerative (chronic) proctitis without complicationsUlcerative (chronic) proctitis with complicationsUlcerative (chronic) proctitis with rectal bleedingUlcerative (chronic) proctitis with intestinal obstructionUlcerative (chronic) proctitis with fistulaUlcerative (chronic) proctitis with ative (chronic) proctitis with other complicationUlcerative (chronic) proctitis with unspecified complicationsUlcerative (chronic) rectosigmoiditisUlcerative (chronic) rectosigmoiditis without complicationsUlcerative (chronic) rectosigmoiditis with complicationsUlcerative (chronic) rectosigmoiditis with rectal cerative (chronic) rectosigmoiditis with intestinal obstructionUlcerative (chronic) rectosigmoiditis with fistulaUlcerative (chronic) rectosigmoiditis with abscessUlcerative (chronic) rectosigmoiditis with other complicationUlcerative (chronic) rectosigmoiditis with unspecified complicationsLeft sided t sided colitis without complicationsLeft sided colitis with complicationsLeft sided colitis with rectal bleedingLeft sided colitis with intestinal obstructionLeft sided colitis with fistulaLeft sided colitis with abscessK51.518K51.519K51.8K51.80K51.81K51.811Left sided colitis with other complicationLeft sided colitis with unspecified complicationsOther ulcerative colitisOther ulcerative colitis without complicationsOther ulcerative colitis with complicationsOther ulcerative colitis with rectal bleedingK51.812K51.813K51.814K51.818K51.819Other ulcerative colitis with intestinal obstructionOther ulcerative colitis with fistulaOther ulcerative colitis with abscessOther ulcerative colitis with other complicationOther ulcerative colitis with unspecified complications

Stelara (Ustekinumab)Last review: April 17, 2020Page 5 of 8K51.9K51.90K51.91K51.911K51.912Ulcerative colitis, unspecifiedUlcerative colitis, unspecified without complicationsUlcerative colitis, unspecified with complicationsUlcerative colitis, unspecified with rectal bleedingUlcerative colitis, unspecified with intestinal obstructionK51.913K51.914K51.918K51.919Ulcerative colitis, unspecified with fistulaUlcerative colitis, unspecified with abscessUlcerative colitis, unspecified with other complicationUlcerative colitis, unspecified with unspecified complicationsRevision HistoryThe following ICD 10 Codes were added for Ulcerative .013Ulcerative ColitisUlcerative (chronic) pancolitis without complicationsUlcerative (chronic) pancolitis with complicationsUlcerative (chronic) pancolitis with rectal bleedingUlcerative (chronic) pancolitis with intestinal obstructionUlcerative (chronic) pancolitis with 11Ulcerative (chronic) pancolitis with abscessUlcerative (chronic) pancolitis with other complicationUlcerative (chronic) pancolitis with unspecified complicationsUlcerative (chronic) proctitisUlcerative (chronic) proctitis without complicationsUlcerative (chronic) proctitis with complicationsUlcerative (chronic) proctitis with rectal cerative (chronic) proctitis with intestinal obstructionUlcerative (chronic) proctitis with fistulaUlcerative (chronic) proctitis with abscessUlcerative (chronic) proctitis with other complicationUlcerative (chronic) proctitis with unspecified complicationsUlcerative (chronic) 51.314Ulcerative (chronic) rectosigmoiditis without complicationsUlcerative (chronic) rectosigmoiditis with complicationsUlcerative (chronic) rectosigmoiditis with rectal bleedingUlcerative (chronic) rectosigmoiditis with intestinal obstructionUlcerative (chronic) rectosigmoiditis with fistulaUlcerative (chronic) rectosigmoiditis with abscessK51.318K31.319K51.5K51.50K51.51Ulcerative (chronic) rectosigmoiditis with other complicationUlcerative (chronic) rectosigmoiditis with unspecified complicationsLeft sided colitisLeft sided colitis without complicationsLeft sided colitis with complications