ph-0117
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Stelara (ustekinumab)

Policy Number: PH-0117

 

(Intravenous/Subcutaneous)

Document Number: IC-0117

Last Review Date: 10/02/2018

Date of Origin: 02/15/2011

Dates Reviewed: 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 03/2013, 06/2013, 09/2013, 11/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 9/2016, 10/2016, 11/2016, 03/2017, 06/2017, 09/2017, 10/2017, 03/2018, 06/2018, 10/2018

 

  1. Length of Authorization

Crohn’s Disease:

Coverage will be provided for 8 weeks initially and may be renewed in 6 month intervals thereafter.

All other indications:

Coverage will be provided for 6 months and may be renewed.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:
  • Stelara 45 mg vial/prefilled syringe:
    • Loading: 1 syringe at weeks 0 & 4
    • Maintenance: 1 syringe every 12  weeks
  • Stelara 90 mg prefilled syringe:
    • Loading: 1 syringe at weeks 0 & 4
    • Maintenance: 1 syringe every 8 weeks
  • Stelara 130 mg (5 mg/mL) single-dose vial: 4 vials

 B. Max Units (per dose and over time) [Medical Benefit]:

Indication

Max Units

Plaque Psoriasis &

Psoriatic Arthritis with co-existent moderate-severe Plaque Psoriasis

Subcutaneous Loading (J3357):

  • 90 billable units at weeks 0 & 4; maintenance dosing 12 weeks later

Subcutaneous Maintenance (J3357):

  • 90 billable units every 12 weeks

Psoriatic Arthritis

Subcutaneous Loading (J3357):

  • 45 billable units at weeks 0 & 4; maintenance dosing 12 weeks later

Subcutaneous Maintenance (J3357):

  • 45 billable units every 12 weeks

Crohn’s Disease

Intravenous Induction (J3358):

  • 520 billable units

Subcutaneous Maintenance (J3357):

  • 90 billable units 8 weeks after induction & every 8 weeks thereafter
  1. Initial Approval Criteria

If Stelara 90 mg is requested, ONE of the following:

  • The patient has a diagnosis of psoriasis AND weighs >100 kg AND the patient has failed (had an inadequate response to) a trial of 45 mg for at least 3 months; OR
  • The patient has a dual diagnosis of psoriasis AND psoriatic arthritis AND the patient is >100 kg

Coverage is provided in the following conditions:

  • Patient is 18 years or older (unless otherwise specified); AND
  • Patient has been evaluated and screened for the presence of latent TB infection prior to initiating 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 other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib); AND
  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND

Plaque Psoriasis †

  • Patient is 12 years or older; AND
  • Patient has moderate to severe plaque psoriasis for at least 6 months with at least one of the following:
  • Involvement of at least 10% of body surface area (BSA); OR
  • Psoriasis Area and Severity Index (PASI) score of 10 or greater; OR
  • Incapacitation due to plaque location (i.e. head and neck, palms, soles or genitalia); AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of topical agents (i.e., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, retinoic acid derivatives, and/or vitamin D analogues); AND
  • Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of at least one systemic agent (i.e., immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND
  • 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)

Psoriatic Arthritis (PsA) †

  • Documented moderate to severe active disease; AND
  • For patients with predominantly axial disease OR active enthesitis and/or dactylitis, an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs), unless use is contraindicated; OR
  • 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

Crohn’s Disease †

  • Documented moderate to severely active disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate)

 

FDA Approved Indication(s)

  1. Renewal Criteria

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: serious infections, malignancy, severe hypersensitivity reactions, reversible posterior leukoencephalopathy syndrome (RPLS), non-infectious pneumonia, etc; AND
  • Patient is receiving ongoing monitoring for presence of TB or other active infections; AND

Plaque Psoriasis

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement (a total BSA involvement ≤1%), and/or an improvement on a disease activity scoring tool [e.g. a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and a four-point reduction in the DLQI from when treatment started.

Psoriatic Arthritis (PsA)

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts and/or an improvement on a disease activity scoring tool [e.g. defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria.]

Crohn’s Disease

  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score.]
  1. Dosage/Administration

Indication

Dose

Plaque Psoriasis &

Psoriatic Arthritis with co-existent moderate-severe Plaque Psoriasis

Adult Subcutaneous Loading Dose:

  • <100 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • >100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Adult Subcutaneous Maintenance Dose:

  • <100 kg: 45 mg every 12 weeks
  • >100 kg: 90 mg every 12 weeks

Pediatric Subcutaneous Loading Dose:

  • <60 kg: 0.75 mg/kg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • 60 – 100 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • >100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Pediatric Subcutaneous Maintenance Dose:

  • <60 kg: 0.75 mg/kg every 12 weeks
  • 60 – 100 kg: 45 mg every 12 weeks
  • >100 kg: 90 mg every 12 weeks

Psoriatic Arthritis

Subcutaneous Loading Dose:

  • 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Subcutaneous Maintenance Dose:

  • 45 mg every 12 weeks

Crohn’s Disease

Intravenous Induction Dose (one-time only):

  • ≤ 55 kg: 260 mg
  • > 55 kg to 85 kg: 390 mg
  • > 85 kg: 520 mg

Subcutaneous Maintenance Dose:

  • 90 mg given 8 weeks after the initial IV dose, then every 8 weeks thereafter
  1. Billing Code/Availability Information

Jcode:

  • J3357 – Ustekinumab, for subcutaneous injection, 1 mg; 1 billable unit = 1 mg
  • J3358 – Ustekinumab, for intravenous injection, 1 mg; 1 billable unit = 1 mg

 

NDC:

  • Stelara 45 mg vial and prefilled syringe: 57894-0060-xx
  • Stelara 90 mg prefilled syringe: 57894-0061-xx
  • Stelara 130 mg (5 mg/mL) single-dose vial: 57894-0054-xx
  1. References
  1. Stelara [package insert]. Horsham, PA; Janssen Biotech, Inc; June 2018. Accessed September 2018.
  2. 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),” Lancet, 2008, 371(9625): 1665-74.
  3. 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),” Lancet, 2008, 371(9625): 1675-84.
  4. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
  5. 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. 2013 Apr;168(4):844-54.
  6. 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. 2008 May;58(5):826-50. doi: 10.1016/j.jaad.2008.02.039.
  7. 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):851-64.
  8. 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. 2015 Dec 7. pii: annrheumdis-2015-208337. doi: 10.1136/annrheumdis-2015-208337.
  9. Lichtenstein GR, Hanauer SB, Sandborn WJ, Practice Parameters Committee of American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009;104(2):465.
  10. Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn's disease. Gastroenterology. 2013 Dec;145(6):1459-63. doi: 10.1053/j.gastro.2013.10.047.
  11. Gomollón F, Dignass A, Annese V, et al. EUROPEAN Evidence-based consensus on the diagnosis and management of Crohn's disease 2016: Part 1: Diagnosis and medical management. J Crohns Colitis. 2016 Sep 22. pii: jjw168.
  12. Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jan 28. doi: 10.1093/ecco-jcc/jjx009.
  13. National Institute for Health and Care Excellence. NICE 2012. Crohn’s Disease: Management. Published 10 October 2012. Clinical Guideline [CG152]. https://www.nice.org.uk/guidance/cg152/resources/crohns-disease-management-pdf-35109627942085.
  14. National Institute for Health and Care Excellence. NICE 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. Published 24 May 2017. Technology Appraisal Guidance [TA445]. https://www.nice.org.uk/guidance/TA445/chapter/1-Recommendations. Accessed August 2017.
  15. National Institute for Health and Care Excellence. NICE 2008. Infliximab for the treatment of adults with psoriasis. Published 23 January 2008. Technology Appraisal Guidance [TA134]. https://www.nice.org.uk/guidance/ta134/resources/infliximab-for-the-treatment-of-adults-with-psoriasis-pdf-82598193811141.
  16. Smith CH, Jabbar-Lopez ZK, Yiu ZK, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. doi: 10.1111/bjd.15665.
  17. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27
  18. Noridian Healthcare Solutions, LLC. Local Coverage Articles (LCA): Chemotherapy Administration (A52991). Centers for Medicare & Medicaid Services, Inc. Updated on 3/15/2018 with effective date 04/01/2018. Accessed September 2018.
  19. Noridian Healthcare Solutions, LLC. Local Coverage Articles (LCA): Chemotherapy Administration (A52953). Centers for Medicare & Medicaid Services, Inc. Updated on 03/15/2018 with effective date 04/01/2018. Accessed September 2018.

Appendix 1 – Covered Diagnosis Codes

Subcutaneous (J3357)

 

ICD-10

ICD-10 Description

K50.00

Crohn’s disease of small intestine without complications

K50.011

Crohn’s disease of small intestine with rectal bleeding

K50.012

Crohn’s disease of small intestine with intestinal obstruction

K50.013

Crohn’s disease of small intestine with fistula

K50.014

Crohn’s disease of small intestine with abscess

K50.018

Crohn’s disease of small intestine with other complication

K50.019

Crohn’s disease of small intestine with unspecified complications

K50.10

Crohn’s disease of large intestine without complications

K50.111

Crohn’s disease of large intestine with rectal bleeding

K50.112

Crohn’s disease of large intestine with intestinal obstruction

K50.113

Crohn’s disease of large intestine with fistula

K50.114

Crohn’s disease of large intestine with abscess

K50.118

Crohn’s disease of large intestine with other complication

K50.119

Crohn’s disease of large intestine with unspecified complications

K50.80

Crohn’s disease of both small and large intestine without complications

K50.811

Crohn’s disease of both small and large intestine with rectal bleeding

K50.812

Crohn’s disease of both small and large intestine with intestinal obstruction

K50.813

Crohn’s disease of both small and large intestine with fistula

K50.814

Crohn’s disease of both small and large intestine with abscess

K50.818

Crohn’s disease of both small and large intestine with other complication

K50.819

Crohn’s disease of both small and large intestine with unspecified complications

K50.90

Crohn’s disease, unspecified, without complications

K50.911

Crohn’s disease, unspecified, with rectal bleeding

K50.912

Crohn’s disease, unspecified, with intestinal obstruction

K50.913

Crohn’s disease, unspecified, with fistula

K50.914

Crohn’s disease, unspecified, with abscess

K50.918

Crohn’s disease, unspecified, with other complication

K50.919

Crohn’s disease, unspecified, with unspecified complications

L40.0

Psoriasis vulgaris

L40.50

Arthropathic psoriasis, unspecified

L40.51

Distal interphalangeal psoriatic arthropathy

L40.52

Psoriatic arthritis mutilans

L40.53

Psoriatic spondylitis

L40.59

Other psoriatic arthropathy

Intravenous (J3358)

 

ICD-10

ICD-10 Description

K50.00

Crohn’s disease of small intestine without complications

K50.011

Crohn’s disease of small intestine with rectal bleeding

K50.012

Crohn’s disease of small intestine with intestinal obstruction

K50.013

Crohn’s disease of small intestine with fistula

K50.014

Crohn’s disease of small intestine with abscess

K50.018

Crohn’s disease of small intestine with other complication

K50.019

Crohn’s disease of small intestine with unspecified complications

K50.10

Crohn’s disease of large intestine without complications

K50.111

Crohn’s disease of large intestine with rectal bleeding

K50.112

Crohn’s disease of large intestine with intestinal obstruction

K50.113

Crohn’s disease of large intestine with fistula

K50.114

Crohn’s disease of large intestine with abscess

K50.118

Crohn’s disease of large intestine with other complication

K50.119

Crohn’s disease of large intestine with unspecified complications

K50.80

Crohn’s disease of both small and large intestine without complications

K50.811

Crohn’s disease of both small and large intestine with rectal bleeding

K50.812

Crohn’s disease of both small and large intestine with intestinal obstruction

K50.813

Crohn’s disease of both small and large intestine with fistula

K50.814

Crohn’s disease of both small and large intestine with abscess

K50.818

Crohn’s disease of both small and large intestine with other complication

K50.819

Crohn’s disease of both small and large intestine with unspecified complications

K50.90

Crohn’s disease, unspecified, without complications

K50.911

Crohn’s disease, unspecified, with rectal bleeding

K50.912

Crohn’s disease, unspecified, with intestinal obstruction

K50.913

Crohn’s disease, unspecified, with fistula

K50.914

Crohn’s disease, unspecified, with abscess

K50.918

Crohn’s disease, unspecified, with other complication

K50.919

Crohn’s disease, unspecified, with unspecified complications

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. 100-2), 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: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

J3358

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 GBA, 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