Neighborhood Health Plan RI ustekinumab Coverage | OpenPayer
CurrentNeighborhood Health Plan of Rhode IslandPolicy 2010-A
Ustekinumab (Stelara and biosimilars) coverage
Defines prior authorization, documentation, prescriber specialties, and medical necessity criteria for ustekinumab and its biosimilars for FDA-approved and compendial indications for Neighborhood Health Plan of Rhode Island members.
Policy Summary
PayerNeighborhood Health Plan of Rhode Island
PolicyUstekinumab (Stelara and biosimilars) coverage
Policy CodePolicy 2010-A
Change TypeNo material changes noted
Effective DateN/A
Next Review DateN/A
Key ActionObtain prior authorization and submit chart documentation of disease activity and prior therapy history to support approval.
No material clinical or coverage changes in this revision.
12 monthsstandard authorization period for most indications
6 monthsauthorization for ICI-toxicity
6 years+minimum age for PsO/PsA
BSA ≥10% or crucial areaplaque psoriasis coverage example
Prohibitedconcomitant biologic use
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Coverage Criteria
inv-01: Initial Therapy - Plaque Psoriasis
Plaque psoriasis (PsO) — Covered when ANY of the following are met
Plaque psoriasis coverage: Authorization of 12 months may be granted for members 6 years and older for treatment of moderate to severe plaque psoriasis when any of the following criteria is met: crucial body areas are affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); at least 10% body surface area (BSA) is affected; OR at least 3% BSA is affected AND the member either has had an inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin, OR has a clinical reason to avoid methotrexate, cyclosporine, and acitretin (see Appendix).see text
Includes prior biologic/targeted synthetic history allowing 12-month authorization
inv-02: Initial Therapy - Psoriatic Arthritis
Psoriatic arthritis (PsA) — Covered when ANY of the following are met
PsA coverage: Authorization of 12 months may be granted for members 6 years and older for treatment of active psoriatic arthritis when either: (1) member has mild to moderate disease and meets one of: inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD (e.g., sulfasalazine) at adequate dose/duration; OR intolerance/contraindication to methotrexate or leflunomide (or another conventional synthetic DMARD); OR the member has enthesitis; OR (2) member has severe disease.see text
Previous biologic or targeted synthetic use may allow 12-month authorization
inv-03: Initial Therapy - Crohn's Disease
Crohn's disease (CD) — Covered when ALL approval criteria for moderately to severely active CD are met
Crohn's disease coverage: Authorization of 12 months may be granted for treatment of moderately to severely active Crohn's disease when the member meets the approval criteria for this indication.N/A
Documentation of positive response required for continuation
inv-04: Initial Therapy - Ulcerative Colitis
Ulcerative colitis (UC) — Covered when ALL approval criteria for moderately to severely active UC are met
Ulcerative colitis coverage: Authorization of 12 months may be granted for treatment of moderately to severely active ulcerative colitis when the member meets the approval criteria for this indication.N/A
Documentation of positive response required for continuation
Immune checkpoint inhibitor-related toxicity — Covered when ALL of the following are met
ICI-related toxicity coverage: Authorization of 6 months may be granted for treatment of immune checkpoint inhibitor-related diarrhea or colitis when the member has experienced an inadequate response, intolerance, or has a contraindication to infliximab or vedolizumab.N/A
Requires documentation of prior trials, intolerance, or contraindication to infliximab or vedolizumab
inv-06: Continuation Therapy
Continuation therapy — Covered when ALL of the following are met
Continuation general: Authorization of 12 months may be granted when the member is currently using the requested medication for the covered indication and demonstrates maintenance of remission or a positive clinical response per indication-specific measures.12 months
Applies to plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and immune checkpoint inhibitor–related toxicity
inv-07: Plaque psoriasis — continuation
Covered when ALL of the following are met for plaque psoriasis continuation:
plaque_psoriasis_continuation: Member is using the requested medication for moderate to severe plaque psoriasis and achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms (examples: reduction in BSA from baseline; improvement in itching, redness, flaking, scaling, burning, cracking, pain).12-month authorization may be granted
Requires chart notes documenting improvement
inv-08: Psoriatic arthritis — continuation
Covered when ALL of the following are met for psoriatic arthritis continuation:
psoriatic_arthritis_continuation: Member is using the requested medication for psoriatic arthritis and achieves or maintains a positive clinical response as evidenced by improvement from baseline in any of: number of swollen joints, number of tender joints, dactylitis, enthesitis, skin and/or nail involvement, functional status, or C-reactive protein (CRP).12-month authorization may be granted
Requires chart notes documenting improvement
inv-09: Crohn's disease — continuation
Covered when ALL of the following are met for Crohn's disease continuation:
crohns_continuation: Member is using the requested medication for moderately to severely active Crohn's disease and achieves or maintains remission or a positive clinical response as evidenced by improvement from baseline in measures such as abdominal pain/tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or disease activity scores (e.g., CDAI).12-month authorization may be granted
Requires disease-specific documentation
inv-10: Ulcerative colitis — continuation
Covered when ALL of the following are met for ulcerative colitis continuation:
ulcerative_colitis_continuation: Member is using the requested medication for moderately to severely active ulcerative colitis and achieves or maintains remission or a positive clinical response as evidenced by improvement from baseline in stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on disease activity scores (e.g., UCEIS, Mayo).12-month authorization may be granted
Covered when ALL of the following are met for immune checkpoint inhibitor–related toxicity:
ici_toxicity_continuation: All members (including new members) requesting authorization for continuation of therapy for immune checkpoint inhibitor-related toxicity must meet all requirements in the Coverage Criteria; when met, a 12-month authorization may be granted for continuation (per general continuation rules).12-month authorization may be granted when criteria are met
Refer to the Coverage Criteria for specific initial-use requirements including prior inadequate response/intolerance/contraindication to infliximab or vedolizumab
All indications for use not specified as FDA-approved or as an accepted compendial use in this policy are considered experimental/investigational and not medically necessary and therefore are excluded from coverage.
Do not administer the requested medication to members with active tuberculosis infection. A documented negative tuberculosis test (TST or IGRA) within 12 months is required for biologic- or targeted‑synthetic‑naïve persons; if TB screening is positive, additional evaluation (e.g., chest x-ray) to exclude active disease and treatment of latent TB prior to initiation is required.
Use of the medication for indications that are not listed as FDA‑approved or specified compendial uses (for example, uses beyond the listed compendial indication of immune checkpoint inhibitor‑related toxicity) is not medically necessary and is excluded from coverage.
Initial Therapy Criteria by Indication
inv-31: Initial therapy criteria
Initial authorization criteria by indication
PsO initial: See plaque psoriasis criteria: age ≥6 and meet BSA/crucial area/prior therapy or avoidance criteria; authorization of 12 months may be granted.see plaque psoriasis criteria
Requires documentation of prior therapies or clinical reason to avoid them
PsA initial: See psoriatic arthritis criteria: age ≥6 and prior csDMARD failure or intolerance/contraindication, enthesitis, or severe disease; authorization of 12 months may be granted.see psoriatic arthritis criteria
Requires documentation of prior therapies or clinical reason to avoid them
CD initial:
Continuation Therapy Requirements
inv-32: Continuation therapy requirements
Continuation requests require documentation of clinical improvement or remission.
Continuation documentation: Chart notes or medical record documentation demonstrating decreased BSA and/or improvement in signs and symptoms for plaque psoriasis; improvement in joint counts, dactylitis, enthesitis, skin/nail involvement, functional status, or CRP for psoriatic arthritis; and documentation of positive clinical response or remission for Crohn's disease and ulcerative colitis. Continuation approvals are contingent on these records.improvement from baseline
Required for renewal authorization
inv-33: Continuation therapy (general)
Continuation (12-month) authorizations are granted when members demonstrate maintenance of remission or positive clinical response per indication-specific measures.
continuation_general: Member is currently using the requested medication for the covered indication and demonstrates maintained clinical response or remission per indication-specific measures (see respective continuation sections). When criteria are met, a 12-month authorization may be granted for plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and immune checkpoint inhibitor–related toxicity as applicable.
Provider Actions & Documentation Requirements
Prior Authorization
Prior Authorization Required
Prior authorization is required for requests. Typical approvals: 12 months for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis; 6 months for immune checkpoint inhibitor-related diarrhea/colitis when criteria met.
Initial requests: submit chart notes or medical record documentation of the affected area(s) and body surface area (BSA) affected (if applicable). Include chart notes, medical record documentation, or claims history supporting prior medications tried and response to those therapies. If a conventional systemic or prior therapy is not advisable, provide documentation of the clinical reason to avoid that therapy (see examples).
Document affected area(s) and BSA (when applicable).
Included Drug Products & Coding Notes
Included drug productsNDC | mixed
Stelara / ustekinumab
brand and generic names and listed biosimilars included in policy
Imuldosa / ustekinumab-srlf
biosimilar
Otulfi / ustekinumab-aauz
biosimilar
Pyzchiva / ustekinumab-ttwe
biosimilar
Selarsdi / ustekinumab-aekn
biosimilar
Steqeyma / ustekinumab-stba
biosimilar
Wezlana / ustekinumab-auub
biosimilar
Yesintek / ustekinumab-kfce
biosimilar
ustekinumab (unbranded Stelara)
unbranded
ustekinumab-aauz (unbranded Otulfi)
unbranded biosimilar
1–10 of 13
1/2
Body Surface Area (BSA) thresholds — plaque psoriasis coverage
BSA threshold (primary)>= 10% body surface area (BSA)
BSA threshold (alternative)>= 3% BSA affected plus additional criteria (inadequate response/intolerance to phototherapy or methotrexate/cyclosporine/acitretin, or clinical reason to avoid those treatments)
Crucial area clauseAny involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) qualifies regardless of BSA
Minimum age referencedMembers 6 years of age and older for plaque psoriasis coverage
Step Therapy & Prior Treatment Requirements
Requirement
Details
Documentation of prior therapy trials or clinical reason to avoid them is required.
Initial requests must include chart notes or medical record documentation of previous medications tried and response, or a clinical reason to avoid specified therapies. For plaque psoriasis this includes prior inadequate response or intolerance to phototherapy or pharmacologic treatment with methotrexate, cyclosporine, or acitretin, or a documented clinical reason to avoid those agents (see Appendix).
Consideration
Examples / Rationale
Prior use or contraindication/intolerance to conventional systemic agents may be considered when initiating biologic therapy.
Documented clinical reasons to avoid systemic nonbiologic therapies (methotrexate, cyclosporine, acitretin, leflunomide) may justify initiation of biologic therapy. Examples include chronic liver disease, drug interactions, pregnancy or planning pregnancy, breastfeeding, significant comorbidity, hypersensitivity, or history of intolerance or adverse events. For psoriatic arthritis, intolerance or contraindication to methotrexate or leflunomide is an accepted criterion for biologic initiation.
Stelara (ustekinumab) and Biosimilars
Billing Rule
Stelara and listed biosimilars covered when criteria met
Stelara (ustekinumab) and the listed biosimilars and unbranded ustekinumab products are included in this policy as covered products when the coverage criteria are met.
Note
Coverage/continuation criteria apply to ustekinumab and biosimilars
Policy references Stelara and multiple ustekinumab biosimilars in the package insert references; the coverage and continuation criteria in this policy apply to ustekinumab and its biosimilars as presented.
Definitions & Clinical Terms
Covered indications and compendial uses
FDA‑approved indicationsModerate to severe plaque psoriasis (age >=6), active psoriatic arthritis (age >=6), moderately to severely active Crohn's disease (adults), moderately to severely active ulcerative colitis (adults)
Specified compendial useImmune checkpoint inhibitor‑related diarrhea or colitis (compendial use) when inadequate response/intolerance/contraindication to infliximab or vedolizumab)
Other indicationsAll other indications are considered experimental/investigational and not medically necessary
Continuation documentation requirementFor CD/UC, coverage continuation requires documentation of remission or positive clinical response (disease‑specific measures such as CDAI, UCEIS, Mayo, mucosal appearance, weight, CRP, fecal calprotectin)
Ustekinumab (Stelara and referenced biosimilars) is indicated for several immune‑mediated inflammatory conditions, including moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease and ulcerative colitis as described in the prescribing information and referenced compendia.
Policy Summary
PayerNeighborhood Health Plan of Rhode Island
PolicyUstekinumab (Stelara and biosimilars) coverage
Policy CodePolicy 2010-A
Change TypeNo material changes noted
Effective DateN/A
Next Review DateN/A
Key ActionObtain prior authorization and submit chart documentation of disease activity and prior therapy history to support approval.
Moderately to severely active Crohn's disease meeting approval criteria; authorization of 12 months may be granted.
N/A
Documentation of disease severity required
UC initial: Moderately to severely active ulcerative colitis meeting approval criteria; authorization of 12 months may be granted.N/A
Documentation of disease severity required
ICI-toxicity initial: Immune checkpoint inhibitor-related diarrhea or colitis with inadequate response, intolerance, or contraindication to infliximab or vedolizumab; authorization of 6 months may be granted.N/A
Compendial use requires documentation of prior trials or contraindication
Provide prior medication history and response (chart notes/claims).
If therapy avoidance is asserted, include clinical reason (e.g., liver disease, pregnancy, drug interaction, hypersensitivity).
Documentation Required
Continuation Request Documentation
Continuation requests: submit chart notes or medical record documentation demonstrating decreased BSA and/or improvement in signs and symptoms, or other evidence of a positive clinical response or remission as appropriate for the disease indication.
For plaque psoriasis: documentation of reduction in BSA from baseline or improvement in signs/symptoms (e.g., itching, redness).
For psoriatic arthritis: documentation of improvement in swollen/tender joints, dactylitis, enthesitis, skin/nail involvement, functional status, or CRP.
For Crohn's disease and ulcerative colitis: documentation of remission or improvement in disease-specific measures (e.g., abdominal pain, diarrhea, stool frequency, rectal bleeding, CRP, fecal calprotectin, endoscopic appearance, disease activity scores).
For immune checkpoint inhibitor-related toxicity: documentation of positive clinical response or remission; continuation must meet Coverage Criteria.
Disease-specific documentation must include prior medication trials and responses where required, or evidence of clinical response to therapy for continuation requests. For certain indications, trial of and inadequate response or intolerance to specified conventional systemic, biologic, or targeted therapies is required before approval.
Plaque psoriasis: prior biologic/targeted synthetic use or evidence of inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) or documented clinical reason to avoid them.
Psoriatic arthritis: inadequate response to methotrexate, leflunomide, or another conventional synthetic agent (e.g., sulfasalazine), or intolerance/contraindication; enthesitis or severe disease criteria where applicable.
Crohn's disease/Ulcerative colitis: meet criteria for moderately to severely active disease and prior therapy requirements per Coverage Criteria; document remission or improvement on objective measures for continuation.
Immune checkpoint inhibitor-related toxicity: document prior medications tried (including response) and if infliximab/vedolizumab were inadequate/intolerant/contraindicated when requesting 6-month authorization.
Documentation Required
TB Screening Documentation
TB screening is required for all indications prior to initiating therapy for persons naïve to biologic or targeted synthetic drugs: a documented negative tuberculosis test (TST or IGRA) within 12 months. If the test is positive, further evaluation to exclude active TB (e.g., chest x-ray) is required. Do not administer the requested medication to members with active TB. If latent TB is identified, TB treatment must be started before initiating the requested medication.
Documented negative TST or IGRA within 12 months for biologic/targeted-synthetic–naïve persons.
If TB screening positive: provide confirmatory evaluation demonstrating no active disease (e.g., chest x-ray) and initiation of latent TB treatment prior to therapy.
Active TB is a contraindication to administration of these medications.
Denial Risk
Denial Risks & Concomitant Therapy
Concomitant use and active TB: The requested medication cannot be used concomitantly with another biologic or targeted synthetic drug for the same indication. Do not administer if there is active tuberculosis; lack of appropriate TB evaluation or management may result in denial.
Concomitant biologic/targeted synthetic therapy for the same indication will trigger noncoverage/denial.
Lack of required TB screening/evaluation or documentation may result in denial.
Improvement in abdominal pain/tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on CDAI
Ulcerative colitis — positive clinical response/remission measuresImprovement in stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on UCEIS/Mayo score
Psoriasis/Psoriatic arthritis — response examplesFor plaque psoriasis: reduction in BSA or improvement in signs/symptoms (itching, redness, flaking, scaling, burning, cracking, pain); for PsA: improvement in swollen/tender joint counts, dactylitis, enthesitis, skin/nail involvement, functional status, or CRP