CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Stelara (ustekinumab) — Coverage Criteria

Covers indications, authorization criteria, documentation, prescriber specialties, duration, continuation requirements, TB screening, and dosing limits for ustekinumab (Stelara) for Neighborhood Health Plan of Rhode Island members where approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyStelara (ustekinumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit chart notes or medical records documenting affected areas and body surface area for initial psoriasis requests and documentation of clinical improvement for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization length

6 monthsICI-toxicity authorization

6 yrsmin age (PsO, PsA)

within 6 monthsTB screening required

2023doc copyright year

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when the FDA-approved or compendial indication is met AND the specific criteria below for the indication are satisfied

Plaque psoriasis (initial): Member is >=6 years of age with moderate to severe plaque psoriasis and is a candidate for phototherapy or systemic therapy; AND one of the following: (i) crucial body areas affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); OR (ii) >=10% body surface area (BSA) affected; OR (iii) >=3% BSA affected AND either (a) inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or methotrexate, cyclosporine, or acitretin, OR (b) clinical reason to avoid methotrexate, cyclosporine, and acitretin (see Appendix).age >=6

Authorization of 12 months may be granted.

Psoriatic arthritis (initial): Member is >=6 years of age with active psoriatic arthritis; AND either: (i) mild-to-moderate disease plus one of: inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD at adequate dose/duration; OR intolerance/contraindication to methotrexate or leflunomide (or another conventional synthetic DMARD); OR enthesitis or predominantly axial disease; OR (ii) member has severe disease.age >=6

Authorization of 12 months may be granted.

Crohn's disease (initial): Member is an adult with moderately to severely active Crohn's disease.adult

Authorization of 12 months may be granted. IV formulation limited to CD, UC, and ICI-related toxicity.

Ulcerative colitis (initial): Member is an adult with moderately to severely active ulcerative colitis.adult

Authorization of 12 months may be granted. IV formulation limited to CD, UC, and ICI-related toxicity.

Immune checkpoint inhibitor-related toxicity (initial): Use for ICI-related diarrhea or colitis when member has had an inadequate response, intolerance, or contraindication to infliximab or vedolizumab.N/A

Considered a compendial use; authorization of 6 months may be granted.

Continuation Therapy

Continuation authorization for members (including new members) requires documentation of response or maintenance of remission as specified per indication

Plaque psoriasis (continuation): Member achieves or maintains a positive clinical response demonstrated by reduction in body surface area (BSA) from baseline or improvement in signs and symptoms (e.g., itching, redness, flaking, scaling, burning, cracking, pain).N/A

Authorization of 12 months may be granted.

Psoriatic arthritis (continuation): Member achieves or maintains a positive clinical response demonstrated by improvement in any of: number of swollen joints, number of tender joints, dactylitis, enthesitis, axial disease, or skin and/or nail involvement.N/A

Authorization of 12 months may be granted.

Crohn's disease (continuation): Member achieves or maintains remission or improvement in symptoms or objective markers (e.g., abdominal pain, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on a disease activity scoring tool such as CDAI).

Requests for use of ustekinumab (Stelara) for indications other than the FDA‑approved indications listed in this policy and the compendial use for immune checkpoint inhibitor‑related toxicity are considered experimental/investigational and not medically necessary.

Do not administer ustekinumab to members with active tuberculosis (TB) infection. For biologic‑ or targeted‑synthetic‑naïve persons, document a negative TB test (PPD, IGRA, or chest x‑ray) within 6 months prior to initiating therapy; if TB screening is positive, complete further testing to exclude active disease and treat latent TB before starting therapy. Members may not receive ustekinumab concomitantly with any other biologic or targeted synthetic drug.

This policy document contains confidential and proprietary information of CVS Caremark and may not be reproduced, distributed, or printed without written permission from CVS Caremark. It also includes prescription brand names that are trademarks or registered trademarks of manufacturers not affiliated with CVS Caremark.

What Providers Must Do to Obtain Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for this therapy; the source does not specify PA submission steps or codes within this extract. Initial and continuation approvals are time-limited — commonly 12 months for most indications and 6 months for immune checkpoint inhibitor (ICI)-related toxicity. Requests for indications other than those listed are considered experimental/investigational and are not covered.

Prior authorization timing: 12 months for most indications; 6 months for ICI-related toxicity.
Prior authorization details (submission steps, PA codes) are not specified in this extract — follow payer-specific PA process.
Non-covered uses: all indications not listed (considered experimental/investigational).

Documentation Required

Documentation Requirements

Submit supporting clinical documentation with the prior authorization request. For plaque psoriasis (PsO) include chart notes/medical records documenting affected areas and body surface area (BSA) and records or claims history showing prior medications and responses, or clinical reasons to avoid those therapies. For psoriatic arthritis (PsA) and immune checkpoint inhibitor–related toxicity include chart notes/claims history documenting prior medications and responses (or reasons to avoid). For continuation requests provide chart notes documenting clinical improvement or reduced BSA as applicable. For all indications, document a negative TB test within 6 months prior to initiating therapy for biologic-naïve persons and do not start therapy in members with active TB.

Coding and Measurement Criteria

inv-07: Body surface area (BSA) — thresholds

BSA threshold — primary>= 10% of body surface area (BSA) affected

BSA threshold — conditional>= 3% BSA affected when paired with either: (a) inadequate response or intolerance to phototherapy or methotrexate/cyclosporine/acitretin, or (b) clinical reason to avoid those therapies

Age requirement for psoriasis indicationsMember must be 6 years of age or older for plaque psoriasis coverage

Definitions and Clinical Measures

inv-18: Crucial body areas

Crucial body areas — listHands, feet, face, neck, scalp, genitals/groin, intertriginous areas

Role in coverage for plaque psoriasisInvolvement of any crucial body area meets criteria for authorization (members >=6 years)

Documentation implicationChart notes must document affected area(s) and BSA for prior authorization

inv-19: Clinical response measures (IBD)

IBD clinical response — core symptomsImprovement in abdominal pain/tenderness and diarrhea

IBD clinical response — objective measuresImprovement in body weight, hematocrit, or appearance of mucosa on endoscopy/CTE/MRE/intestinal ultrasound

Background and Indication Summary

Stelara (ustekinumab) is indicated for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis (with pediatric use specified for psoriasis and PsA at age 6 years and older), and for adults with moderately to severely active Crohn's disease and ulcerative colitis. A compendial use included in this policy is management of immune checkpoint inhibitor‑related toxicity (for example, ICI‑related diarrhea or colitis) when criteria are met.