Page 1 of 5 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016, 07/2016 Developed By: Medical Criteria Committee 09/2014

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1 Moda Health Plan, Inc. Medical Necessity Criteria Subject: Stelara (ustekinumab) Page 1 of 5 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016, 07/2016 Developed By: Medical Criteria Committee 09/2014 Approved: Neal Mills, MD, MBA Date: 07/27/2016 Description: Ustekinumad (Stelara) is a human IgG1-kappa monoclonal antibody that acts as an interleukin (IL)-12 and IL-23 antagonist. These cytokines are involved in inflammatory and immune responses. In in-vitro models, ustekinumab was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interactions of these cytokines with a shared cell-surface receptor chain, IL-12 beta 1. Criteria: CWQI: HCS-0092 I. Stelara is medically necessary for 1 or more of the following: a. Stelara is medically necessary for patients with plaque psoriasis and ALL of the following: i. Adult patient (18 years or older) ii. Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment iii. Patient is free of any clinically important active infections iv. Stelara will not be administered concurrently with live vaccines v. Patient is not on concurrent treatment with any other biological response modifier or biologic DMARD vi. Patient has Moderate to severe plaque psoriasis for at least 6 months with at least 1 or more of the following: 1. Involvement of at least 10% of body surface area (BSA) 2. Psoriasis Area and Severity Index (PASI) score of 12 or greater 3. Incapacitation due to plaque location (i.e. head and neck, palms, soles or genitalia) vii. Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial to topical agents (i.e. Anthralin, Coal Tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, retinoic acid derivatives, and/or Vitamin D analogues) viii. Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of at least 1 systemic agents (i.e. immunosuppressives, retinoic acid derivatives, and/or methotrexate) and 1 or more of the following:

Neal Mills, MD, MBA Date: 07/27/2016 Description: Ustekinumad (Stelara) is a human IgG1-kappa monoclonal antibody that acts as an interleukin (IL)-12 and IL-23 antagonist.

2 1. Patient must try and have an inadequate response, contraindication, or intolerance to at least a three (3) month trial of Enbrel AND Humira; OR 2. Patient is continuing treatment ix. Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of phototherapy (i.e. Psoralens with UVA light (PUVA) or UVB with coal tar or dithranol) b. Stelara is medically necessary for treatment of Psoriatic Arthritis (PsA) i. Adult patient (18 years or older) ii. Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment iii. Documented moderate to severe active disease and 1 or more of the following: 1. For patients with peripheral arthritis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) (such as methotrexate, azathioprine, sulfasalazine, or hydroxychloroquine) 2. For patients with predominantly axial disease or active enthesitis and/or dactylitis, an adequate trial and failure of at least TWO (2) non-steroidal antiinflammatory agents (NSAIDS), unless use is contraindicated iv. Stelara will not be administered concurrently with live vaccines v. Patient is not on concurrent treatment with any other biological response modifier or biologic DMARD and 1 or more of the following: 1. Patient must try and have an inadequate response, contraindication, or intolerance to at least a three (3) month trial of Enbrel AND Humira; OR 2. Patient is continuing treatment vi. Patient is free from any clinically important active infections c. Renewal of Stelara is medically necessary for ALL of the following: i. Patient continues to meet criteria ii. Absence of unacceptable toxicity from the drug iii. Ongoing monitoring for TB iv. Disease response as indicated by improvement in signs and symptoms compared to baseline for appropriate indication Information to be Submitted with Pre-Authorization Request: 1. Chart notes with documentation of prior treatment 2. Laboratory reports Applicable CPT Codes: CPT/HCPC Code J3357 Description Injection; Ustekinumab, 1mg

Stelara is medically necessary for treatment of Psoriatic Arthritis (PsA) i. Adult patient (18 years or older) ii.

3 Dosage/Administration Indication Plaque Psoriasis & Psoriatic Arthritis with co-existent moderate-to-severe plaque psoriasis Psoriatic Arthritis Dose Loading Dose: <100 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 >100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 Maintenance Dose: <100 kg: 45 mg every 12 weeks >100 kg: 90 mg every 12 weeks Loading Dose: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 Maintenance Dose: 45 mg every 12 weeks II. Dosing Limits a. Quantity Limit (max daily dose) (Pharmacy Benefit): Plaque Psoriasis and Psoriatic arthritis with co-existent plaque psoriasis Stelara 90 mg: 1 prefilled syringe at weeks 0 & 4: then begin maintenance dose 12 Stelara 90 mg: 1 prefilled syringe every 84 days Psoriatic arthritis: Stelara 45 mg: 1 prefilled syringe at weeks 0 & 4: then begin maintenance dose 12 Stelara 45 mg: 1 prefilled syringe every 84 days

0 & 4, then begin maintenance dosing 12 Maintenance Dose: 45 mg every 12 weeks II. Dosing Limits a.

4 b. Max Units (per dose and over time) (Medical Benefit): Plaque Psoriasis and Psoriatic arthritis with co-existent plaque psoriasis: 90 billable units weeks 0 & 4: then begin maintenance dose 12 weeks later Female: 90 billable units at weeks 0 & 4: then begin maintenance dose 12 Female: 90 billable units every 84 days 90 billable units every 84 days Psoriatic arthritis: 45 billable units at weeks 0 & 4: then begin maintenance dose 12 Female: 45 billable units at weeks 0 & 4: then begin maintenance dose 12 Female: 45 billable units every 84 days 45 billable units every 84 days Billing Code/Availability Information Jcode: J3357 Stelara (Janssen Biotech) 45 mg, 90 mg Injection: 1 billable unit = 1mg NDC: Stelara 45 mg vial (Janssen Biotech) Stelara 45 mg prefilled syringe (Janssen Biotech) Stelara 90 mg vial (Janssen Biotech) Stelara 90 mg prefilled syringe (Janssen Biotech) Applicable ICD-10 Codes: ICD-10 Codes Diagnosis L40.0 Psoriasis vulgaris L40.50 Arthropathic psoriasis, unspecified L40.51 Distal interphalangeal psoriatic arthropathy L40.52 Psoriatic arthritis mutilans L40.53 Psoriatic spondylitis

weeks 0 & 4: then begin maintenance dose 12 Female: 45 billable units at weeks 0 & 4: then begin maintenance dose 12 Female: 45 billable units every 84 days 45 billable units every 84 days Billing

5 L40.54 Psoriatic juvenile arthropathy L40.59 Other psoriatic arthropathy Review Date Revisions Effective Date 09/2014 New criteria adopted from ICORE guidelines 09/ /2015 Updated Magellan criteria, updated reference, added NDC, added ICD-10 codes 02/2015 Updated with Magellan criteria, deleted ICD-9 codes 02/24/ /2016 Updated with Magellan criteria, references, dosing, 07/27/2016 indications References: Stelara [package insert]. Horsham, PA; Janssen Biotech, Inc; March Accessed February Leonardi CL, Kimball AB, Papp KA, et al, Efficacy and Safety of Ustekinumab, a Human Interleukin-12/23 Monoclonal Antibody, in Patients With Psoriasis: 76-Week Results from a Randomised, Double-Blind, Placebo-Controlled Trial (PHOENIX 1),, 2008, 371(9625): Papp KA, Langley RG, Lebwohl M, et al, Efficacy and Safety of Ustekinumab, a Human Interleukin-12/23 Monoclonal Antibody, in Patients With Psoriasis: 52-Week Results from a Randomised, Double-Blind, Placebo-Controlled Trial (PHOENIX 2),, 2008, 371(9625): Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol Jan;148(1): Papp KA, Griffiths CE, Gordon K, et al. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol Apr;168(4): Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol May;58(5): doi: /j.jaad Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May;58(5): Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis Dec 7. Pii: annrheumdis doi: /annrheumdis

ICD-10 codes 02/2015 Updated with Magellan criteria, deleted ICD-9 codes 02/24/2016 07/2016 Updated with Magellan criteria, references, dosing, 07/27/2016 indications References: Stelara [package

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