CurrentNeighborhood Health Plan of Rhode IslandPolicy 2010-A

Stelara (ustekinumab) coverage for Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis, and immune checkpoint inhibitor-related toxicity

Defines prior authorization, indications covered (FDA and compendial), prescriber specialties, documentation requirements, authorization durations, continuation criteria, TB screening, concomitant use restriction, IV route limitation, dosing limits per label, and clinical reasons to avoid comparator systemic agents.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyStelara (ustekinumab) coverage for Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis, and immune checkpoint inhibitor-related toxicity

Policy CodePolicy 2010-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmission of chart notes or medical record documentation is necessary to initiate prior authorization review, including documentation of affected body surface area, prior medications tried and responses for initial requests, and documentation of positive clinical response for continuation requests.

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria.

5Covered Indications (listed)

12 moTypical authorization length

6 moAuthorization length (ICI-related toxicity)

Coverage Summary

Scope: This policy defines prior authorization requirements for ustekinumab (Stelara) and is covered with criteria. Covered indications include FDA‑approved uses for plaque psoriasis (patients ≥6 years), psoriatic arthritis (patients ≥6 years), Crohn's disease (moderately to severely active, adults), and ulcerative colitis (moderately to severely active, adults), plus compendial use for immune checkpoint inhibitor‑related toxicity. Intravenous (IV) formulation is limited to gastrointestinal indications (Crohn's disease, ulcerative colitis) and immune checkpoint inhibitor‑related toxicity; subcutaneous formulation is implied for other indications. General preconditions include documented negative TB testing prior to initiation (with follow‑up rules if positive) and that the medication be prescribed by or in consultation with the specified specialist for each indication.

Thresholds

Age for PsO and PsA>= 6 years

BSA threshold - major>= 10% BSA

BSA threshold - lesser>= 3% BSA with additional criteria (clinical reason to avoid methotrexate/cyclosporine/acitretin OR inadequate response/intolerance to phototherapy or those systemic agents)

Authorization duration (PsO, PsA, Crohn's disease, Ulcerative colitis)12 months

Authorization duration (Immune checkpoint inhibitor-related toxicity)6 months

Plaque psoriasis — Initial Therapy Criteria

Covered Indications

Covered Indications: The indications below (FDA-approved and compendial uses) are covered when all applicable criteria in this section are met and there are no member exclusions to the prescribed therapy.

ANY of the following

Plaque psoriasis (PsO) — members ≥6 years of age for treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Authorization of up to 12 months may be granted when the initial authorization criteria below are met.
Psoriatic arthritis (PsA) — members ≥6 years of age for treatment of active psoriatic arthritis. Authorization of up to 12 months may be granted when the initial authorization criteria for PsA are met.
Moderately to severely active Crohn’s disease (CD) in adults — authorization of 12 months may be granted when initial criteria for CD are met and IV formulation is used only for CD, UC, or ICI-related toxicity.
Moderately to severely active ulcerative colitis (UC) in adults — authorization of 12 months may be granted when initial criteria for UC are met and IV formulation is used only for CD, UC, or ICI-related toxicity.
Immune checkpoint inhibitor (ICI)-related diarrhea or colitis — authorization of up to 6 months may be granted when the member has inadequate response, intolerance, or contraindication to infliximab or vedolizumab.

General Preconditions

General Preconditions: All of the following preconditions must be met for any indication.

ALL of the following

Documentation of a negative tuberculosis (TB) screening test prior to initiation (a test within 6 months is acceptable for biologic/targeted synthetic–naive persons). If TB screening is positive, further evaluation must confirm no active TB disease. Do not administer therapy for active TB; if latent TB is present, TB treatment must be started before initiation of the requested medication.
Member must not be receiving concomitant therapy with any other biologic drug or targeted synthetic drug at the time of initiation or during treatment with the requested medication.
Prescriber specialty requirement: the medication must be prescribed by or in consultation with an appropriate specialist for the indication (e.g., dermatologist for plaque psoriasis; rheumatologist or dermatologist for psoriatic arthritis; gastroenterologist for Crohn’s disease and ulcerative colitis; hematologist/oncologist for ICI-related toxicity).

Plaque psoriasis — Continuation Criteria

Plaque psoriasis (PsO) — Continuation Criteria

Authorization of 12 months may be renewed when positive clinical response is documented.

Continuation response criteria: Member demonstrates either reduction in BSA affected from baseline OR improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain)

Documentation (chart notes) required to support response

Psoriatic arthritis — Initial and Continuation Criteria

Psoriatic arthritis (PsA) — Initial Authorization Criteria

Authorization of 12 months may be granted for members ≥6 years when criteria below are met.

Initial authorization - PsA

Previous biologic or targeted synthetic: Member has previously received a biologic or targeted synthetic drug indicated for active psoriatic arthritis (e.g., Rinvoq, Otezla)
See documentation requirements
Active disease criteria
- Inadequate response to csDMARD: Member has mild to moderate disease AND has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD (e.g., sulfasalazine) administered at adequate dose and duration
- Intolerance to csDMARD: Member has mild to moderate disease AND has intolerance or contraindication to methotrexate or leflunomide, or another conventional synthetic drug (e.g., sulfasalazine)
  Clinical reasons to avoid detailed in Appendix
- Enthesitis or axial disease: Member has enthesitis or predominantly axial disease
- Severe disease: Member has severe disease

Prescriber specialty: Medication must be prescribed by or in consultation with a rheumatologist or dermatologist

Psoriatic arthritis (PsA) — Continuation Criteria

Authorization of 12 months may be renewed when positive clinical response is documented.

Clinical response measures: Improvement in any of the following from baseline: number of swollen joints; number of tender joints; enthesitis; dactylitis; axial disease; skin and/or nail involvement

Continuation requests require chart notes/medical record documentation supporting positive clinical response

Crohn's disease — Initial and Continuation Criteria

Crohn's disease (CD) — Initial Authorization Criteria

Authorization of 12 months may be granted for adult members for treatment of moderately to severely active Crohn's disease.

Initial authorization - Crohn’s disease: Member is an adult with moderately to severely active Crohn's disease AND prescriber is a gastroenterologist

Crohn's disease (CD) — Continuation Criteria

Authorization of 12 months may be renewed when remission or positive clinical response is documented.

Continuation response criteria - CD: Any of: remission; improvement in diarrhea; improvement in abdominal pain or tenderness; improvement in body weight; improvement in abdominal mass; improvement in hematocrit; improvement on a disease activity scoring tool (e.g., CDAI); improvement in appearance of mucosa on endoscopy, CTE, MRE, or intestinal ultrasound

Chart documentation required

Ulcerative colitis — Initial and Continuation Criteria

Ulcerative colitis (UC) — Initial Authorization Criteria

Authorization of 12 months may be granted for adult members for treatment of moderately to severely active ulcerative colitis.

Initial authorization - Ulcerative colitis: Member is an adult with moderately to severely active ulcerative colitis AND prescriber is a gastroenterologist

Ulcerative colitis (UC) — Continuation Criteria

Authorization of 12 months may be renewed when remission or positive clinical response is documented.

Continuation response criteria - UC: Any of: remission; improvement in rectal bleeding; improvement in stool frequency; improvement in urgency of defecation; improvement in fecal calprotectin (FC); improvement in C-reactive protein (CRP); improvement in appearance of mucosa on endoscopy, CTE, MRE, or intestinal ultrasound; improvement on disease activity scoring tool (e.g., UCEIS; Mayo score)

Chart documentation required

Immune checkpoint inhibitor-related toxicity — Initial and Continuation Criteria

Immune checkpoint inhibitor-related toxicity — Initial Authorization Criteria

Authorization of 6 months may be granted for treatment of immune checkpoint inhibitor-related diarrhea or colitis when criteria below are met.

Initial authorization - ICI-related toxicity: Member has immune checkpoint inhibitor-related diarrhea or colitis; member experienced inadequate response, intolerance, or contraindication to infliximab or vedolizumab; prescriber specialty is hematologist or oncologist

Immune checkpoint inhibitor-related toxicity — Continuation Criteria

All continuation requests must meet initial criteria and include documentation of prior medications/trials and response or reason to avoid.

Continuation requirements - ICI-related toxicity: Continuation requests must meet all initial authorization criteria AND require chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable) and response to therapy; if therapy not advisable, documentation of clinical reason to avoid therapy; chart notes documenting positive clinical response or remission

Continuation authorizations require supporting documentation

Routes, Formulation, and Dosing Limits

Routes and Formulation Limits

Route-specific authorization limits and dosing considerations.

IV formulation limits: Stelara for intravenous administration will only be authorized for the treatment of Crohn's disease, ulcerative colitis, and immune checkpoint inhibitor-related toxicity

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines

Provider Actions and Authorization Workflow

Prior Authorization

Prior authorization required

Submission of chart notes or medical record documentation is required to initiate prior authorization review. For initial requests include documentation of affected body surface area (BSA) for plaque psoriasis and prior medications tried with responses. For continuation requests include chart notes or medical record documentation showing positive clinical response (e.g., decreased BSA or other indication‑specific improvements).

Documentation Required

TB screening documentation required

Documented negative tuberculosis (TB) test is required (within 6 months if the member is naive to biologic or targeted synthetic drugs). If TB screening is positive, further testing must be done to exclude active disease; do not administer the medication if active TB is present. If latent TB is identified, TB treatment must be started before initiating therapy.

Documentation Required

Specialist prescribing or consultation required

The medication must be prescribed by or in consultation with a specialist appropriate to the indication: dermatologist for plaque psoriasis; rheumatologist or dermatologist for psoriatic arthritis; gastroenterologist for Crohn's disease and ulcerative colitis; and hematologist or oncologist for immune checkpoint inhibitor‑related toxicity.

Plaque psoriasis: dermatologist
Psoriatic arthritis: rheumatologist or dermatologist
Crohn's disease and ulcerative colitis: gastroenterologist
Immune checkpoint inhibitor‑related toxicity: hematologist or oncologist

Billing Rule

IV formulation restriction

Intravenous (IV) administration of Stelara will only be authorized for Crohn's disease, ulcerative colitis, and immune checkpoint inhibitor‑related toxicity. Subcutaneous formulations are implied for other indications.

Denial Risk

Concomitant biologic use prohibited

Members may not use Stelara concomitantly with any other biologic drug or targeted synthetic drug; claims may be denied if Stelara is used with another biologic or targeted synthetic agent.

Documentation Required

Continuation requires evidence of response

Continuation authorizations require documentation of remission or positive clinical response using indication‑specific measures and supporting chart notes or medical record documentation. Examples include: for plaque psoriasis — reduction in BSA; for psoriatic arthritis — improvement in swollen/tender joint counts, enthesitis, dactylitis, axial disease, or skin/nail involvement; for Crohn's disease — improvement in CDAI, diarrhea, abdominal pain, weight, hematocrit, or mucosal appearance on imaging/endoscopy; for ulcerative colitis — improvement in rectal bleeding, stool frequency, urgency, fecal calprotectin (FC), CRP, mucosal appearance, or UCEIS/Mayo score. Chart notes or medical record documentation supporting the positive response are required.

BSA reduction (PsO)
Swollen/tender joint counts, enthesitis, dactylitis (PsA)
CDAI, diarrhea, abdominal pain, weight, hematocrit, mucosal appearance (CD)
UCEIS/Mayo, rectal bleeding, stool frequency, urgency, FC, CRP, mucosal appearance (UC)
Chart notes/medical record documentation supporting response

Background

Background: The policy covers ustekinumab (Stelara) for its FDA‑approved indications (plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis) and compendial use for immune checkpoint inhibitor‑related diarrhea/colitis. Prior authorization requires submission of supporting documentation and specialist prescribing or consultation per indication. TB screening is required before initiation (negative test within 6 months if biologic‑naive; if positive, exclude active disease and treat latent TB prior to starting therapy). The IV formulation of Stelara will only be authorized for Crohn's disease, ulcerative colitis, and immune checkpoint inhibitor‑related toxicity. Approvals may be subject to dosing limits consistent with FDA labeling, accepted compendia, and evidence‑based guidelines.

Definitions: BSA = Body Surface Area; CDAI = Crohn's Disease Activity Index; UCEIS = Ulcerative Colitis Endoscopic Index of Severity.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyStelara (ustekinumab) coverage for Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis, and immune checkpoint inhibitor-related toxicity

Policy CodePolicy 2010-A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Stelara (ustekinumab) coverage for Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis, and immune checkpoint inhibitor-related toxicity

Coverage Summary

Plaque psoriasis — Initial Therapy Criteria

Plaque psoriasis — Continuation Criteria

Psoriatic arthritis — Initial and Continuation Criteria

Crohn's disease — Initial and Continuation Criteria

Ulcerative colitis — Initial and Continuation Criteria

Immune checkpoint inhibitor-related toxicity — Initial and Continuation Criteria

Routes, Formulation, and Dosing Limits

Provider Actions and Authorization Workflow

Applicable Codes

Clinical Evidence and References

Background

Revision History