Pharmacotherapy of Inflammatory Bowel Disorder — Medical Benefit IV and Injectable Therapies
Medical necessity criteria and site-of-service review for intravenous and injectable pharmacologic and biologic treatments for inflammatory bowel disorders (Crohn's disease and ulcerative colitis) for Premera members; includes formulary-specific sections and infusion site-of-service rules.
Policy Summary
PayerPremera Bluecross
PolicyPharmacotherapy of Inflammatory Bowel Disorder — Medical Benefit IV and Injectable Therapies (coverage criteria)
Policy CodePolicy N/A
Change TypeMaterial updates to coverage, step therapy, and site-of-service requirements (multiple added/revised items)
Effective DateJan. 2, 2026
Next Review DateN/A
Key ActionObtain prior authorization and document age, specialist involvement, and required prior therapy failures per agent before submitting for coverage
Added coverage criteria for Rinvoq (upadacitinib) for treatment of adult Crohn's disease.
Added coverage criteria for Velsipity (etrasimod) for the treatment of ulcerative colitis.
Added coverage criteria for Omvoh (mirikizumab-mrkz) and moved Omvoh from non-preferred to preferred; added as brand step therapy option for certain agents.
Updated step therapy and preferred/non-preferred designations across multiple adalimumab and infliximab biosimilars and branded products with effective dates and product-specific trial/failure sequencing.
Added coverage criteria for Entyvio (vedolizumab) SC and Omvoh for the treatment of ulcerative colitis; updated Entyvio SC to include Crohn's disease.
Added Simlandi (adalimumab-ryvk) and adalimumab-ryvk (Simlandi unbranded) as preferred products.
Updated coverage criteria for Entyvio (vedolizumab) SC to include treatment of Crohn's disease.
Updated non-preferred adalimumab coverage criteria to require trial and treatment failure with all preferred adalimumab products.
Added site of service requirement for Tyruko (natalizumab-sztn).
Updated Skyrizi (risankizumab-rzaa) IV/SC coverage criteria to include treatment of certain individuals with ulcerative colitis; added age requirement for Skyrizi IV/SC and Tremfya IV/SC for ulcerative colitis.
Added coverage criteria for Tremfya (guselkumab) IV/SC for the treatment of ulcerative colitis and clarified Tremfya SC as a brand step therapy option for Entyvio SC and Zeposia.
Changed Avsola (infliximab-axxq) to a second-line agent and updated Avsola and Renflexis criteria to require prior trial/failure with Inflectra, unbranded infliximab (Janssen), or Remicade effective Jan 3, 2025.
Updated multiple adalimumab and infliximab products to include age requirements for Crohn's disease and ulcerative colitis coverage criteria.
Re-authorization duration of approval changed from 3 years to 12 months.
Updated Humira (adalimumab) (AbbVie) [NDCs starting with 00074] from preferred to non-preferred; new-starts require inadequate response or intolerance to a preferred product.
Added site-of-service review for Zymfentra (infliximab-dyyb).
New policy sections added for Metallic, Essentials, Open/Preferred/Select formulary plans and plans with no pharmacy benefit; different coverage criteria defined for some plan types.
Clarified that Section 2 applies to plans with the High Cost Low Value (HCLV) drug list.
2024–2025policy changes timeline
2026-01-02effective date
12 more-authorization
≥13site-of-service age threshold
≤0.92 mg/dayZeposia dose cap
3Omvoh induction infusions
Coverage and Medical Necessity Criteria
Site of Service Medical Necessity
Site of Service (SOS) Medical Necessity criteria for medical benefit IV and injectable therapy
SOS applicability: SOS criteria applies only to medical benefit reviews and does NOT apply to Alaska fully‑insured members; for ages 13 and older a site-of-service review is performed
From policy: SOS applies ONLY to medical benefit reviews; does not apply to Alaska fully‑insured members; site-of-service review for ages 13+
Medically necessary site selection: Preferred sites: physician's office, infusion center, or home infusion; Hospital‑based outpatient setting is considered medically necessary when ANY of the following apply: initial course of infusion/injection (first 90 days), re‑initiation after ≥6 months since discontinuation, no outpatient infusion center within 50 miles and no contracted home infusion agency available, or individual has a clinical condition that increases infusion risk90 days; >=6 months; 50 miles
Clinical conditions include symptomatic cardiac arrhythmia or serious respiratory disease (e.g., %FVC ≤40%), unstable renal function, difficult/unstable vascular access, acute mental status changes, prior severe adverse reactions/anaphylaxis, or CRS grade 3–4 with inpatient admission anticipated; hospital outpatient setting otherwise not medically necessary when criteria not met
Crohn's Disease — Agent-specific Criteria
Agent-specific medical necessity criteria for Crohn's disease under Section 1 (Open/Preferred/Select formulary and plans with no pharmacy benefit)
General Crohn's disease criteria for many biologics: Medication may be considered medically necessary when ALL: individual meets agent-specific age requirement; has tried one corticosteroid or is currently taking one OR has tried one other conventional Crohn's agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection; and medication is prescribed by or in consultation with a gastroenterologistvaries by agent
Applies to adalimumab biosimilars, infliximab products, vedolizumab, ustekinumab, etc.
Adalimumab-class (selected biosimilars) first-line: May be considered medically necessary when: individual is aged >=6 years AND meets the general Crohn's prior‑therapy/clinical feature requirement AND medication prescribed by or in consultation with a gastroenterologist>=6 years
Specific adalimumab products listed in Section 1 (Simlandi, Yuflyma, etc.)
Entyvio (vedolizumab) IV — Initial coverage criteria
Entyvio (vedolizumab) IV considered medically necessary when ALL of the following are met:
Entyvio IV criteria: Individual is aged 18 years or older AND has tried one corticosteroid or is currently taking a corticosteroid OR has tried one other agent for Crohn's disease OR has enterocutaneous or rectovaginal fistulas OR has had ileocolonic resection; AND Entyvio IV is being prescribed by or in consultation with a gastroenterologist>=18 years
From Entyvio IV Section 1 criteria (chunk 18)
Ustekinumab (Stelara/Steqeyma/Yesintek) — Induction and maintenance
Stelara / Steqeyma / Yesintek (ustekinumab products) — IV and SC formulations
IV one-time induction: Individual aged >=18 years; has tried one corticosteroid or one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection; medication prescribed by or in consultation with a gastroenterologist; IV used only as a one‑time induction dose>=18 years
Ustekinumab IV induction only per policy (chunks 19–21)
SC maintenance: Individual aged >=18 years; has received a single IV induction dose; has tried one corticosteroid or one other agent OR has fistulas OR had ileocolonic resection; medication prescribed by or in consultation with a gastroenterologist; SC maintenance permitted after IV induction>=18 years; single IV induction required
SC use restricted to after IV induction for specified products (chunks 19–21)
Omvoh (mirikizumab) — Induction and maintenance
Omvoh (mirikizumab) — IV induction and SC maintenance
Omvoh IV induction: Individual aged >=18 years; has tried one corticosteroid or one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection; Omvoh IV prescribed by or in consultation with a gastroenterologist; Omvoh IV is used only for induction therapy administered at Week 0, Week 4, and Week 8 (3 IV infusions)>=18 years; induction at weeks 0,4,8
Chunk 22: IV induction only
Omvoh SC maintenance: Individual aged >=18 years; has received induction therapy with Omvoh IV; meets general prior‑therapy/clinical criteria; Omvoh SC prescribed by or in consultation with a gastroenterologist>=18 years
Chunk 23: SC only after IV induction
Skyrizi and Tremfya — Induction and maintenance
Skyrizi (risankizumab) and Tremfya (guselkumab) — IV induction and SC maintenance
Skyrizi IV induction: Individual aged >=18 years; meets general prior‑therapy/clinical feature requirements; Skyrizi IV prescribed by or in consultation with a gastroenterologist; Skyrizi IV used only for induction therapy (Week 0, Week 4, Week 8 — total 3 IV infusions)>=18 years; induction at weeks 0,4,8
Chunk 24: IV induction only
Skyrizi SC maintenance: Individual aged >=18 years; has received induction with Skyrizi IV; meets prior‑therapy/clinical criteria; Skyrizi SC prescribed by or in consultation with a gastroenterologist>=18 years
SC continuation requires IV induction (chunk 24)
Tremfya IV induction: Individual aged >=18 years; meets general prior‑therapy/clinical criteria; Tremfya IV prescribed by or in consultation with a gastroenterologist; Tremfya IV used only for induction therapy (Week 0, Week 4, Week 8)
Rinvoq (upadacitinib) — Criteria
Rinvoq (upadacitinib) — JAK inhibitor
Rinvoq criteria: Individual aged >=18 years; meets general prior‑therapy/clinical feature requirements OR has enterocutaneous/rectovaginal fistulas OR had ileocolonic resection; AND has had a trial and treatment failure with one or more TNF blockers OR treatment with a TNF blocker is clinically inadvisable and individual has tried at least one systemic therapy; Rinvoq prescribed by or in consultation with a gastroenterologist>=18 years; prior TNF failure or contraindication
Chunks 26–27 and 85: TNF failure requirement or clinical inadvisability alternative
TNF-α antagonists — Adalimumab and Infliximab families
TNF-α antagonists (adalimumab products, certolizumab, infliximab products) — indications and special review notes
Adalimumab group: Adalimumab products may be considered medically necessary when: individual is aged >=6 years AND meets the general prior‑therapy/clinical feature requirement (trial of one corticosteroid or one other agent OR fistulas OR ileocolonic resection) AND medication is prescribed by or in consultation with a gastroenterologist; certain adalimumab products require documented trials/failures of listed adalimumab biosimilars prior to approval>=6 years
Chunks 15, 27–29
Infliximab group: Infliximab products may be considered medically necessary when: individual is aged >=6 years AND meets the general prior‑therapy/clinical feature requirement; some infliximab products require documented inadequate response or intolerance to Avsola and Inflectra (and other preferred infliximab agents) before approval and infliximab products are subject to site‑of‑service review>=6 years
Chunks 30, 33, 90: prior biosimilar failure and site‑of‑service review
Entyvio SC criteria: Individual aged >=18 years; meets general prior‑therapy/clinical feature requirement; Entyvio SC prescribed by or in consultation with a gastroenterologist; AND has had a trial and treatment failure with TWO of a specified list (preferred adalimumab products, Cimzia, Omvoh SC, Rinvoq, preferred ustekinumab SC, Skyrizi SC, Tremfya SC, Velsipity, Xeljanz); AND has received or is undergoing Entyvio IV induction>=18 years; failure of 2 listed agents; prior Entyvio IV induction
Chunks 33–34: Entyvio SC second‑line and IV induction requirement
Natalizumab and Second-line IL-12/23 Antagonists
Natalizumab (Tysabri/Tyruko) and second-line IL-12/23 antagonists
Natalizumab: Individual aged >=18 years; meets general prior‑therapy/clinical feature requirement; AND has had a trial and treatment failure with one or more TNF blockers; subject to site‑of‑service review and TOUCH program requirements per label>=18 years; prior TNF failure
Chunks 35 and 222: TOUCH program and PML risk considerations
Second-line IL-12/23 antagonists: Specified ustekinumab formulations (IV/SC biosimilars and branded variants) may be considered medically necessary for adults >=18 when meeting general prior‑therapy/clinical criteria; some IV products limited to one‑time induction and SC requires prior IV induction or prior inadequate response to listed IV ustekinumab agents>=18 years; some require prior inadequate response to listed IV agents
Chunks 36–37: induction‑only limitations for select ustekinumab IV products
Ustekinumab — Crohn's disease
Ustekinumab for Crohn's disease - covered when ALL of the following are met
Ustekinumab Crohn's criteria: Individual aged >=18 years AND has tried one corticosteroid or is currently taking a corticosteroid OR has tried one other agent for Crohn's disease OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection; medication prescribed by or in consultation with a gastroenterologist; SC maintenance requires single IV induction where specified>=18 years
Applies to multiple ustekinumab formulations (chunks 36, 38)
Ustekinumab IV — special one-time induction
Ustekinumab IV — one-time induction for fistulizing disease or post-resection
One-time IV induction: Has enterocutaneous or rectovaginal fistulas OR has had ileocolonic resection AND has had inadequate response or intolerance to ALL the following agents (Steqeyma IV, Yesintek IV, where specified) AND medication is prescribed by or in consultation with a gastroenterologist AND used only as a one‑time IV induction dose
Chunk 37: one‑time IV induction limitation
IL-12/23 and IL-23 inhibitors — UC
IL-12/23 and IL-23 inhibitors for ulcerative colitis — induction and maintenance distinctions
Steqeyma/Yesintek (IV) UC induction: Individual aged >=18 years; medication prescribed by or in consultation with a gastroenterologist; medication used only as a one‑time induction dose>=18 years; one‑time induction
Chunks 47–48: IL‑12/23 IV induction only for UC
Steqeyma/Yesintek (SC) maintenance: Individual aged >=18 years; has received single IV induction dose; medication prescribed by or in consultation with a gastroenterologist; SC maintenance requires prior IV induction>=18 years; prior IV induction
Chunks 47–48
Stelara (IV) UC induction: Individual aged >=18 years; medication prescribed by or in consultation with a gastroenterologist; medication used only as a one‑time induction dose AND has had inadequate response or intolerance to listed IV agents where specified
Oral small molecules — UC
JAK inhibitors and S1P modulators for ulcerative colitis
Rinvoq: Individual aged >=18 years AND has had trial and treatment failure with one or more TNF blockers OR TNF blocker is clinically inadvisable and individual has tried at least one systemic therapy; medication prescribed by or in consultation with a gastroenterologist>=18 years; prior TNF failure or contraindication
Chunks 50–51: Rinvoq UC criteria
Xeljanz/Xeljanz XR: Individual aged >=18 years AND has had a trial and treatment failure with one or more TNF blockers; medication prescribed by or in consultation with a gastroenterologist>=18 years; prior TNF failure required
Chunk 52
Velsipity: Individual aged >=18 years; prescribed by or in consultation with a gastroenterologist; dose ≤ 2 mg per day
Entyvio SC and Zeposia — second-line
Entyvio SC and Zeposia — second-line criteria requiring prior failures
Entyvio SC: Individual aged >=18 years; Entyvio SC prescribed by or in consultation with a gastroenterologist; has had trial and treatment failure with TWO of a specified list (preferred adalimumab products, Omvoh SC, Rinvoq, Simponi, Skyrizi SC, preferred ustekinumab SC, Tremfya SC, Velsipity, Xeljanz); AND has received Entyvio IV induction or is undergoing induction>=18 years; failure of 2 listed agents; prior Entyvio IV induction
Chunks 52–53: Entyvio SC second‑line and IV induction requirement
Zeposia: Individual aged >=18 years; has had trial and treatment failure with TWO of the listed agents; Zeposia prescribed by or in consultation with a gastroenterologist; dose ≤ 0.92 mg/day<= 0.92 mg/day; failure of 2 listed agents
Chunks 54–55: Zeposia second‑line and dose limit
Zeposia (ozanimod) — Initial coverage criteria
Zeposia (ozanimod) — Ulcerative colitis coverage when ALL are met:
Zeposia for UC: Individual is aged 18 years or older AND has had a trial and treatment failure with TWO of the listed agents (preferred adalimumab product; Omvoh; Rinvoq; Simponi; Skyrizi; preferred ustekinumab product; Tremfya; Velsipity; Xeljanz) AND Zeposia is prescribed by or in consultation with a gastroenterologist AND dose is ≤ 0.92 mg per day<= 0.92 mg/day; prior failures = 2
Chunks 54–55
Adalimumab biosimilars — UC criteria
Adalimumab products — Ulcerative colitis coverage when ALL are met (per listed plan sections):
Adalimumab biosimilars for UC: Individual is aged 5 years or older AND has had a trial and treatment failure with ALL specified adalimumab unbranded/biosimilar products as listed in the policy AND medication is prescribed by or in consultation with a gastroenterologist>=5 years; failure of all listed adalimumab products where required
Chunks 56–57: adalimumab UC criteria and required failures for some plan sections
Infliximab products — UC criteria
Infliximab products — Ulcerative colitis coverage when ALL are met:
Infliximab (Remicade, Janssen unbranded, Renflexis) for UC: Individual is aged >=6 years AND has had an inadequate response or intolerance to Avsola AND Inflectra (applies to individuals not previously treated with requested therapy) AND medication is prescribed by or in consultation with a gastroenterologist; some infliximab products subject to site‑of‑service review>=6 years; prior failure of Avsola and Inflectra when applicable
Chunks 59–60
Ustekinumab (IL-12/23) — Second-line criteria
Ustekinumab (IL-12/23) — Second-line Ulcerative colitis coverage when ALL are met:
IV ustekinumab for UC (one-time induction): Individual aged >=18 years AND medication prescribed by or in consultation with a gastroenterologist AND medication is used only as a one‑time IV induction dose AND has had an inadequate response or intolerance to ALL the listed IV agents where specified>=18 years; one‑time induction
Chunk 61
SC ustekinumab for UC (maintenance): Individual aged >=18 years AND has received a single IV induction dose AND has had an inadequate response or intolerance to ALL the listed SC agents where specified AND medication prescribed by or in consultation with a gastroenterologist>=18 years; prior single IV induction
Chunk 62
Avsola/Inflectra — Crohn's disease criteria
Avsola and Inflectra — Crohn's disease coverage when ALL are met:
Avsola/Inflectra for Crohn's: Individual is aged >=6 years AND has tried one corticosteroid or is currently taking a corticosteroid OR has tried one other agent for Crohn's disease OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection; AND medication is prescribed by or in consultation with a gastroenterologist>=6 years
Chunks 71–73: Avsola/Inflectra Crohn's criteria and site‑of‑service review
First-line step therapy: First‑line options include TNF‑α inhibitors, IL‑12/23 IV induction agents, α4‑integrin inhibitors, and JAK inhibitors as listed; specific agent selection depends on plan‑specific step tier listingplan‑specific
Chunks 64, 70–73: step tiers and plan applicability
Entyvio (vedolizumab) — initial criterion
Entyvio (vedolizumab) — Crohn's disease coverage when ALL are met:
Entyvio for Crohn's: Entyvio IV may be considered medically necessary when individual is aged >=18 years AND meets the general prior‑therapy/clinical feature requirement; medication prescribed by or in consultation with a gastroenterologist>=18 years
Chunk 73 indicates age criterion; remaining detailed criteria captured elsewhere in policy (chunk 18)
General criteria for many biologics (examples: Avsola, Inflectra)
Covered when ALL of the following are met
Age: Individual is aged 6 years or older (where specified for many agents)>=6 years
Agent‑specific age thresholds vary; see agent nodes
Prior therapy or clinical features: Has tried one corticosteroid OR is currently taking one OR has tried one other agent for Crohn's disease OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
At least one required; logical OR grouping
Prescriber: Medication is prescribed by or in consultation with a gastroenterologist
Prescriber requirement per policy
Ustekinumab SC maintenance (Steqeyma/Yesintek)
Covered when ALL of the following are met
Age: Individual is aged 18 years or older>=18 years
Applicable to ustekinumab SC maintenance products
Induction: Has received a single IV induction dose (SC maintenance only after IV induction)single IV induction
SC maintenance requires prior IV induction (chunk 76)
Prior therapy or clinical features: Has tried one corticosteroid OR has tried one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
At least one required
Skyrizi (risankizumab) induction and maintenance
Covered when ALL of the following are met
Age: Individual is aged 18 years or older>=18 years
Skyrizi IV/SC criteria
Prior therapy or clinical features: Has tried one corticosteroid OR one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
At least one required
Prescriber: Skyrizi IV prescribed by or in consultation with a gastroenterologist
Induction only for IV: Skyrizi IV used only for induction (Week 0, 4, 8 — total 3 IV infusions); SC requires prior IV induction
Rinvoq (upadacitinib)
Covered when ALL of the following are met
Age: Individual is aged 18 years or older>=18 years
Rinvoq adult age requirement
Prior therapy or clinical features: Has tried one corticosteroid OR one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
At least one required
TNF experience: Has had trial and treatment failure with one or more TNF blockers OR treatment with a TNF blocker is clinically inadvisable
TNF failure or clinical inadvisability alternative (chunk 85)
Prescriber:
Adalimumab family (including biosimilars)
Covered when ALL of the following are met
Age: Individual is aged 6 years or older (where specified for adalimumab products)>=6 years
Adalimumab family age thresholds vary by product
Prior therapy or clinical features: Has tried one corticosteroid OR one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Standard prior‑therapy/clinical feature grouping
Prior failure for some products: Has had trial and treatment failure with ALL specified adalimumab‑listed biosimilars when required (documented list in policy)failure of listed agents where required
Prior therapy or clinical features: Has tried one corticosteroid OR one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Standard prior‑therapy/clinical feature grouping
Prior failure for some infliximab: Individual has had inadequate response or intolerance to Avsola AND Inflectra (applies to individuals not previously treated with requested therapy) before certain infliximab products are allowedfailure of specified biosimilars when applicable
Chunk 90: prior biosimilar failure requirement
Cimzia (certolizumab pegol)
Covered when ALL of the following are met
Age: Individual is aged 18 years or older>=18 years
Cimzia adult age requirement
Prior therapy or clinical features: Has tried one corticosteroid OR one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Standard prior‑therapy/clinical feature grouping
Prior failure: Has had a trial and treatment failure with ONE of specified adalimumab biosimilars when requiredfailure of one listed adalimumab product where applicable
Chunks 88–89
Infliximab products for Crohn's disease
Infliximab (Janssen unbranded), Remicade, Renflexis may be considered medically necessary when:
Infliximab general criteria: Individual is aged >=6 years AND has tried one corticosteroid or is currently taking a corticosteroid OR has tried one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection; AND the individual has had an inadequate response or intolerance to Avsola and Inflectra (applies to individuals not previously treated with requested therapy) AND medication is prescribed by or in consultation with a gastroenterologist>=6 years; prior failure of Avsola and Inflectra when applicable
Chunk 90: infliximab Crohn's criteria and site‑of‑service review
Zymfentra (infliximab-dyyb) SC and related infliximab SC/IV
Criteria for Zymfentra SC and other infliximab SC/IV formulations:
Zymfentra/SC infliximab criteria: Individual is aged >=18 years AND has tried one corticosteroid or is currently taking a corticosteroid OR has tried one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection; AND has received an intravenous infliximab induction regimen (e.g., Remicade, Avsola, Inflectra, or Renflexis) AND medication is prescribed by or in consultation with a gastroenterologist>=18 years; prior IV infliximab induction required
Chunks 91–92: Zymfentra SC requires prior IV induction and prescriber involvement; subject to site‑of‑service review
Ustekinumab (IL-12/23) products for Crohn's disease
Ustekinumab IV and SC products may be considered medically necessary when:
Ustekinumab general criteria: Individual is aged >=18 years AND has tried one corticosteroid or is currently taking a corticosteroid OR has tried one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection; AND has had an inadequate response or is intolerant to specified IV ustekinumab agents when required AND medication is prescribed by or in consultation with a gastroenterologist; some products limited to one‑time IV induction>=18 years
Chunks 94–96: IV vs SC use and induction‑only limitations specified
Omvoh (mirikizumab) IL-23 antagonist criteria for Crohn's disease
Mirikizumab IV and SC for moderately to severely active Crohn's disease:
Omvoh IV induction criteria: Individual is aged >=18 years AND meets general prior‑therapy/clinical feature requirement; AND has had an inadequate response or intolerance to TWO of the listed agents (preferred adalimumab, Entyvio IV, preferred infliximab, Rinvoq, Skyrizi SC, Tremfya SC, preferred ustekinumab SC, Velsipity, Xeljanz) AND Omvoh IV is prescribed by or in consultation with a gastroenterologist AND Omvoh IV is used only for induction therapy (Week 0, 4, 8 — total of 3 IV infusions)>=18 years; prior failures = 2; induction = 3 IV infusions
Chunks 98–101: Omvoh IV limited to induction and requires 2 prior agent failures
Omvoh SC continuation criteria: Individual is aged >=18 years AND has received induction therapy with Omvoh IV AND has had inadequate response or intolerance to TWO of the same listed agents; AND Omvoh SC is prescribed by or in consultation with a gastroenterologist>=18 years; prior IV induction required; prior failures = 2
SC requires prior IV induction (chunks 100–101)
Adalimumab products for ulcerative colitis
Preferred adalimumab biosimilars for ulcerative colitis first-line placement:
Adalimumab UC criteria: Simlandi, Yuflyma, and listed adalimumab biosimilars may be considered medically necessary for treatment of ulcerative colitis when the individual is aged >=5 years AND medication is prescribed by or in consultation with a gastroenterologist>=5 years
Chunk 109: preferred adalimumab biosimilars first‑line for UC
TNF-α Inhibitors - First Line
TNF-α Inhibitors — First Line (Ulcerative colitis)
TNF-α first-line criteria: Agent (e.g., Simlandi, Yuflyma, adalimumab biosimilars) may be considered medically necessary when: individual is aged >=5 years AND medication is being prescribed by or in consultation with a gastroenterologist>=5 years
Chunk 109
Infliximab biosimilars - First Line
Infliximab biosimilars (Avsola, Inflectra) — First Line (Ulcerative colitis)
Infliximab first-line criteria: Avsola and Inflectra may be considered medically necessary when: individual is aged >=6 years AND medication is prescribed by or in consultation with a gastroenterologist; subject to site‑of‑service review>=6 years
Chunk 110
α-4 Integrin Inhibitor - First Line
Vedolizumab (Entyvio) — First Line (Ulcerative colitis)
Vedolizumab first-line criteria: Entyvio IV may be considered medically necessary when: individual is aged >=18 years AND prescribed by or in consultation with a gastroenterologist>=18 years
Chunk 111: Entyvio IV first‑line for UC; site‑of‑service review may apply
IL-12 and IL-23 Inhibitor - First Line
IL-12/23 inhibitors — First Line (Ulcerative colitis, IV induction only)
IL-12/23 IV induction criteria: Steqeyma and Yesintek IV may be considered medically necessary when: individual is aged >=18 years AND medication prescribed by or in consultation with a gastroenterologist AND used only as a one‑time induction dose>=18 years; one‑time induction
Chunks 47, 48
IL-23 Inhibitor - First Line
IL-23 inhibitor (Skyrizi) — First Line (Ulcerative colitis)
Skyrizi IV induction criteria: Skyrizi IV may be considered medically necessary when: individual is aged >=18 years AND prescribed by or in consultation with a gastroenterologist AND used only for induction therapy (Week 0, 4, 8 — total 3 IV infusions)>=18 years; induction = 3 IV infusions
Chunk 112
Skyrizi SC continuation criteria: Skyrizi SC on‑body injector may be considered medically necessary when: individual is aged >=18 years AND has received induction therapy with Skyrizi IV AND prescribed by or in consultation with a gastroenterologistprior IV induction required
Chunk 112
Janus Kinase Inhibitors
Janus kinase inhibitors (Rinvoq, Xeljanz) — First Line or later (Ulcerative colitis)
Rinvoq criteria: Rinvoq may be considered medically necessary for adults (>=18) when: has had trial and treatment failure with one or more TNF blockers OR TNF blocker is clinically inadvisable and the individual has tried at least one systemic therapy; prescribed by or in consultation with a gastroenterologist>=18 years; prior TNF failure or contraindication
Chunks 114–115
Xeljanz criteria: Xeljanz/XR may be considered medically necessary for adults (>=18) when: has had trial and treatment failure with one or more TNF blockers; prescribed by or in consultation with a gastroenterologist>=18 years; prior TNF failure required
Velsipity criteria: Velsipity may be considered medically necessary for adults (>=18) when prescribed by or in consultation with a gastroenterologist AND dose is ≤ 2 mg per day<= 2 mg/day; age >=18
Chunk 52/115: Velsipity dose limit
Zeposia criteria: Zeposia may be considered medically necessary for adults (>=18) when has had trial and treatment failure with TWO of a listed group AND prescribed by or in consultation with a gastroenterologist AND dose is ≤ 0.92 mg per day<= 0.92 mg/day; prior failures = 2
Chunks 54–55, 120–121
TNF-α Inhibitors - Second Line
TNF-α Inhibitors — Second Line and other TNF products
Adalimumab second-line group criteria: Multiple adalimumab products may be considered medically necessary when: individual is aged >=5 years AND has had a trial and treatment failure with ALL specified adalimumab products (policy lists products) AND medication prescribed by or in consultation with a gastroenterologist>=5 years; prior failures = ALL listed adalimumab products where specified
Chunks 115, 122–123
Simponi criteria (pediatric): Simponi (golimumab) may be considered medically necessary when: individual weighs at least 15 kg AND has had trial and treatment failure with listed adalimumab products or specified alternatives AND medication prescribed by or in consultation with a gastroenterologistweight >=15 kg; prior failure per policy
Chunk 123
IL-23 Inhibitor - Second Line
IL-23 Inhibitor - Second Line (Omvoh / mirikizumab)
Omvoh IV induction criteria: Omvoh IV may be considered medically necessary for adults (>=18) when: inadequate response or intolerance to TWO agents from a listed group (preferred adalimumab, Entyvio IV, preferred infliximab, Rinvoq, Skyrizi SC, Tremfya SC, preferred ustekinumab SC, Velsipity, Xeljanz) AND Omvoh IV is prescribed by or in consultation with a gastroenterologist AND used only for induction therapy (Week 0, 4, 8 for total 3 IV infusions)>=18 years; prior failures = 2; induction = 3 IV infusions
Chunks 118–120
Omvoh SC continuation criteria: Omvoh SC may be considered medically necessary when individual aged >=18 has received Omvoh IV induction AND has had inadequate response/intolerance to TWO listed agents AND Omvoh SC prescribed by or in consultation with a gastroenterologistprior IV induction required; prior failures = 2
Chunks 119–120
α-4 Integrin Inhibitor - Second Line
Vedolizumab (Entyvio) — Second Line (Ulcerative colitis) SC formulation
Entyvio SC criteria: Entyvio SC may be considered medically necessary for adults (>=18) when: prescribed by or in consultation with a gastroenterologist AND has had trial and treatment failure with TWO of the listed agents AND has received induction therapy with Entyvio IV OR is currently undergoing Entyvio IV induction>=18 years; prior failures = 2; prior IV induction required or in progress
Chunks 52–53, 116
General medical necessity for many biologics (e.g., adalimumab biosimilars, infliximab biosimilars, Avsola, Inflectra)
Covered when ALL of the following are met
age: The individual is aged 6 years or older (for many adalimumab products) or aged 18 years or older for some agents as specified>=6 or >=18 years as noted
Age requirement varies by agent (chunk 134)
prior therapy: Has tried one corticosteroid OR has tried one other agent for Crohn's disease OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Applies as prior therapy or specific clinical features
prescriber: Medication is prescribed by or in consultation with a gastroenterologist
Explicit prescriber requirement
Infliximab (Avsola, Inflectra) and Entyvio specific criteria
Covered when ALL of the following are met
age: Avsola and Inflectra: individual is aged >=6 years; Entyvio IV: individual is aged >=18 years>=6 or >=18 depending on agent
Chunks 135–136
prior therapy or clinical condition: Has tried one corticosteroid OR has tried one other agent for Crohn's disease OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Prior therapy/clinical condition requirement
administration review: Avsola and Inflectra are subject to review for site‑of‑service administration; Entyvio IV subject to site‑of‑service reviewsite‑of‑service review required
May impact authorization (chunks 135–136)
IL-12/23 and IL-23 antagonists (Steqeyma/Yesintek/Skyrizi/Tremfya) medical necessity
Covered when ALL of the following are met
age: Individual is aged >=18 years for agents Steqeyma/Yesintek IV, Skyrizi IV/SC, Tremfya IV/SC>=18 years
Chunks 137–140
prior therapy or clinical condition: Has tried one corticosteroid OR one other agent OR has fistulas OR has had ileocolonic resection
Prior therapy/clinical features allow coverage
induction requirement: IV formulations (Steqeyma, Yesintek, Skyrizi, Tremfya) are indicated for induction only (one‑time or series at specified weeks) and SC forms require prior IV induction for maintenance where statedIV induction required where specified
Specific schedules noted for Skyrizi and Tremfya (Week 0,4,8)
TNF-α antagonists (adalimumab products) and second-line TNF criteria
Covered when ALL of the following are met
age: For many adalimumab products the individual is aged >=6 years>=6 years
Chunk 142–144
prior therapy or clinical condition: Has tried one corticosteroid OR has tried one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Prior therapy/clinical conditions
treatment failure for certain second-line use: For TNF‑α antagonists second‑line use, has had a trial and treatment failure with ALL the specified adalimumab products (adalimumab‑adbm, adalimumab‑adaz, Simlandi/adl‑ryvk, Yuflyma/adl‑aaty)trial and failure with all listed products where specified
Detailed list in policy (chunk 144)
Cimzia and infliximab products criteria
Covered when ALL of the following are met
age: Cimzia may be considered medically necessary for individuals aged >=18 years; infliximab product age criteria noted elsewhere>=18 years for Cimzia
Chunks 144–145
prior therapy or clinical condition: Has tried one corticosteroid OR has tried one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Standard prior‑therapy/clinical condition criteria
prior biologic failure for some uses: For some agents, has had trial and treatment failure with one or more specified adalimumab products prior to coverage (details vary)trial and failure with specified adalimumab products where applicable
Chunks 144–145
Adalimumab product requirement set
Cimzia-related adalimumab criteria (excerpted variant): Covered when ANY of the following are met and additional medication-specific prior therapy requirements are satisfied
Adalimumab criteria: Has enterocutaneous or rectovaginal fistulas OR has had ileocolonic resection AND has had trial and treatment failure with ALL the following: adalimumab‑adbm, adalimumab‑adaz, Simlandi/adalimumab‑ryvk, Yuflyma/adalimumab‑aaty; medication prescribed by or in consultation with a gastroenterologist
Chunk 144 (note: does not apply to one Open formulary – see policy)
Infliximab IV products (Remicade, Renflexis, etc.)
Infliximab IV products: Covered when ALL of the following are met
Infliximab IV eligibility: Individual is aged >=6 years AND has tried one corticosteroid or is currently taking one OR has tried one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection; AND the individual has had an inadequate response or intolerance to Avsola AND Inflectra when applicable; medication prescribed by or in consultation with a gastroenterologist>=6 years
Chunk 145: applies to Remicade/Renflexis/Janssen infliximab; inadequate response/intolerance to Avsola/Inflectra applies to individuals not previously treated with requested therapy
Renflexis (infliximab-abda) criteria
Renflexis and other infliximab formulations: Covered when ALL of the following are met
Renflexis-specific eligibility: Individual is aged >=6 years AND meets the general prior‑therapy/clinical feature requirement AND has had an inadequate response or intolerance to Avsola AND Inflectra where applicable; medication prescribed by or in consultation with a gastroenterologist>=6 years
Chunks 149–151: repeated emphasis on prior IV infliximab induction and biosimilar failure where applicable
SC infliximab (Zymfentra) criteria
SC infliximab (Zymfentra) mention
Zymfentra eligibility: Zymfentra (infliximab‑dyyb) SC may be considered medically necessary when individual is aged >=18 years AND meets the general prior‑therapy/clinical feature requirement AND has received an IV infliximab induction regimen (e.g., Remicade, Avsola, Inflectra, or Renflexis) AND medication is prescribed by or in consultation with a gastroenterologist>=18 years; prior IV induction
Chunk 150: SC infliximab subject to site‑of‑service review and age restriction
Entyvio SC may be considered medically necessary for adults with Crohn's disease when ALL of the following are met:
Age: The individual is aged 18 years or older>=18 years
Chunk 173: Entyvio SC age requirement
Prior conventional therapy: Has tried one corticosteroid OR has tried one other agent for Crohn's disease OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Chunk 173
Specific biologic/JAK failure: Has had a trial and treatment failure with TWO of the following: a preferred adalimumab product, Cimzia, or Rinvoq>=2 of list
Chunk 173: Entyvio SC requires failure of 2 listed biologics/JAKs
Tyruko (natalizumab-sztn) and Tysabri (natalizumab) — Second-line option
Age: Individual is aged 18 years or older>=18 years
Chunk 175
Prior conventional therapy: Has tried one corticosteroid OR one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Chunk 175
TNF blocker failure: Has had a trial and treatment failure with one or more TNF blockers
Age: The individual is aged 18 years or older>=18 years
Chunks 177–179
Prior conventional therapy: Has tried one corticosteroid OR one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Chunks 177–179
Prior biologic failure for IV one-time induction: Has had an inadequate response or is intolerant to ALL the following agents: Steqeyma IV and Yesintek IV when applicable, and medication is prescribed by or in consultation with a gastroenterologist AND used only as a one‑time induction doseall listed agents failed where specified
Omvoh IV/SC may be considered medically necessary for moderately to severely active Crohn's disease when ALL of the following are met:
Age: The individual is aged 18 years or older>=18 years
Chunk 180–181
Prior conventional therapy: Has tried one corticosteroid OR has tried one other agent OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Chunk 180
Prior biologic/intolerance requirement for IV: Has had an inadequate response or intolerance to TWO of the following: a preferred adalimumab product, Entyvio IV, a preferred infliximab product (Avsola or Inflectra), Rinvoq, Skyrizi, Tremfya, or a preferred ustekinumab product>=2 agents failed
Chunk 181
Omvoh (mirikizumab-mrkz) — Crohn's disease
Omvoh (mirikizumab-mrkz) for Crohn's disease
Primary conditions: Individual aged >=18 years AND medication prescribed by or in consultation with a gastroenterologist>=18 years
Chunk 180
Prior therapies (one of): Has tried one corticosteroid or is currently taking one OR has tried one other agent for Crohn's disease OR has enterocutaneous or rectovaginal fistulas OR has had ileocolonic resection
Chunk 180
Additional requirement: Has had an inadequate response or intolerance to TWO specified agents (list includes preferred adalimumab product, Entyvio, preferred infliximab products, Rinvoq, Skyrizi, Tremfya, preferred ustekinumab products)>=2 agents failed
Chunk 181
Ulcerative colitis — first-line, induction, and oral agents
Therapies for ulcerative colitis — first-line and induction rules
Avsola/Inflectra: Individual aged >=6 years AND medication prescribed by or in consultation with a gastroenterologist; subject to site‑of‑service review>=6 years
Chunk 192
Entyvio IV (α4 integrin) first-line: Individual aged >=18 years AND prescribed by or in consultation with a gastroenterologist; subject to site‑of‑service review>=18 years
Chunk 192
Ustekinumab IV dosing: Steqeyma/Yesintek IV may be used only as a one‑time induction dose in adults (>=18) with gastroenterologist prescriber>=18 years; one‑time induction
Entyvio SC and Omvoh — second-line criteria for ulcerative colitis
Second-line and alternative sequencing rules for ulcerative colitis
Entyvio SC second-line: Individual aged >=18 years AND prescribed by/consult with gastroenterologist AND has had trial and treatment failure with TWO specified agents (preferred adalimumab, Rinvoq, Simponi, Skyrizi SC, preferred ustekinumab SC, Tremfya SC, Velsipity, Xeljanz) AND has received induction therapy with Entyvio IV or is currently undergoing induction>=18 years; prior failures = 2; prior Entyvio IV induction
Chunk 197
Omvoh IV/SC second-line in UC: Individual aged >=18 years AND inadequate response/intolerance to TWO specified agents (preferred adalimumab, Entyvio IV, preferred infliximab, Rinvoq, Skyrizi, Tremfya, preferred ustekinumab, Velsipity, Xeljanz) AND Omvoh IV prescribed by/with gastroenterologist AND Omvoh IV used only for induction (Week 0,4,8); SC maintenance allowed after IV induction>=18 years; prior failures = 2; induction only for IV
Chunks 197–199
IL-23 inhibitor (Omvoh) coverage
Omvoh (mirikizumab-mrkz) — Induction (IV) and SC maintenance criteria for ulcerative colitis
Omvoh IV induction criteria: Individual aged >=18 years AND has had inadequate response or intolerance to TWO of the listed agents (preferred adalimumab, Entyvio IV, preferred infliximab, Rinvoq, Skyrizi, Tremfya, preferred ustekinumab, Velsipity, Xeljanz/XR) AND Omvoh IV is prescribed by or in consultation with a gastroenterologist AND Omvoh IV is used only for induction therapy administered at Week 0, Week 4, and Week 8 (3 IV infusions)>=18 years; prior failures = 2; induction = 3 IV infusions
Chunks 198–199
IL-12/23 antagonist (ustekinumab) coverage
Ustekinumab products — second-line and induction requirements
IV ustekinumab induction coverage: For specified IV ustekinumab products, individual is aged >=18 AND has had inadequate response or intolerance to ALL the following agents: Steqeyma IV AND Yesintek IV AND medication is prescribed by or in consultation with a gastroenterologist AND medication is used only as a one‑time induction dose>=18 years; prior failures to listed IV agents
Chunks 199–206: IV induction limitations and SC continuation requirements
TNF-α inhibitors coverage
TNF-α inhibitors — adalimumab and related biosimilars
Adalimumab-series for ulcerative colitis: For specified adalimumab products, individual is aged >=5 years AND has had trial and treatment failure with ALL specified listed adalimumab biosimilars/products AND medication is prescribed by or in consultation with a gastroenterologist>=5 years; prior failures = ALL listed products where required
Chunks 201–202
Infliximab coverage
Infliximab products — criteria and site-of-service review
Infliximab IV agents: For Remicade and branded infliximab products, individual is aged >=6 years AND has had an inadequate response or intolerance to Avsola and Inflectra AND medication is prescribed by or in consultation with a gastroenterologist; certain infliximab products are subject to review for site‑of‑service administration>=6 years; prior biosimilar failure where applicable
Chunks 204–205
Evidence-based coverage rationale
Covered when supported by evidence from randomized controlled trials and consistent with labeled indications and trial populations; coverage considerations vary by agent and require documentation of disease activity and prior therapy history.
General coverage considerations: Therapies (biologics, small molecules) supported by RCT evidence for induction and/or maintenance in moderate to severe CD or UC; selection should reflect trial inclusion criteria (e.g., CDAI or Mayo score thresholds) and prior treatment exposure/response; prior authorization should document disease severity and prior therapy historysee individual agent nodes
Chunks 216–227, 233–235 summarize trial evidence and rationale
Agent-specific evidence snapshots: Agent nodes include trial outcomes: infliximab (Remicade/Inflectra) mucosal healing and symptom reduction; adalimumab induction/maintenance (CLASSIC, CHARM, GAIN); certolizumab (PRECiSE); vedolizumab (GEMINI) remission rates; ustekinumab (STELARA) induction/maintenance; tofacitinib and ozanimod trial evidence and safety signals—these data inform coverage and prior authorization documentation expectationsagent-specific endpoints
Chunks 216–227, 233–235
Summary of recent coverage additions and step-therapy revisions
Rinvoq for UC and CD: Coverage criteria added for Rinvoq (upadacitinib) for UC and for Crohn's disease; criteria reflect trial populations and prior biologic exposure patterns
Chunk 247 and updates
Velsipity (etrasimod): Coverage criteria added for Velsipity for UC with dose and step therapy updates
Chunks 249–250
Omvoh (mirikizumab-mrkz): Added coverage criteria and moved Omvoh from non‑preferred to preferred in prior updates; included as brand step therapy option for select agents; IV induction only with SC maintenance after induction
Chunks 249–252
Adalimumab and infliximab biosimilars:
Summary criteria updates
Coverage and medical necessity criteria updated for multiple agents; key logical requirements summarized below.
Adalimumab products (non-preferred) coverage: Coverage requires trial and treatment failure with all preferred adalimumab products before approving non‑preferred adalimumab agents; plan exceptions (Formulary IDs 6062/6064) may applytrial and failure documented
Chunk 252: revised adalimumab step requirements
Avsola and Renflexis (post 2025-01-03): For new starts, individual must have an adequate trial and failure with Inflectra, infliximab (Janssen unbranded), or Remicade before Avsola or Renflexis are covered (effective Jan 3, 2025)trial and failure documented
Chunks 253, 258: effective date and prior biosimilar requirements
Age requirements: Multiple agents now include age‑based eligibility (e.g., adalimumab, infliximab, vedolizumab, ustekinumab, Skyrizi, Rinvoq, Cimzia, Tyruko/Tysabri, Simponi, Omvoh, Tremfya); providers must document age eligibility per product
This policy does not address IV and injectable therapy services provided to individuals who are admitted as inpatients. Refer to the inpatient benefit for IV and injectable drug administration when the member is receiving inpatient care; outpatient site-of-service criteria and medical-benefit reviews in this policy apply only to non‑inpatient settings.
Some plan-specific exceptions apply: this medical necessity criteria does not apply to one Custom Open Formulary (Formulary ID: 6062; Rx Plan F1). Members on that formulary follow the Custom Open Formulary criteria in policy 5.01.647; check the member plan booklet or ID card to determine applicability.
Additional formulary exceptions are noted throughout the policy: where indicated, specific criteria for certain Open/Preferred/Select formulary plans do not apply to the Custom Open Formulary (Formulary ID: 6062; Rx Plan F1). Providers should verify the member’s formulary (including Preferred formulary exceptions) and, when applicable, use policy 5.01.647 for the custom plan rules.
This policy includes repeated notices that criteria do not apply to the Custom Open Formulary (Formulary ID: 6062; Rx Plan F1) and that members on that plan follow policy 5.01.647; verify plan assignment before applying the criteria or prior authorization requirements.
Formulary applicability varies by plan segment (Open/Preferred/Select, Essentials, Metallic/ISHIP). Members in Custom Open or Preferred formulary plans (Formulary IDs noted in-policy) are governed by alternate criteria; always confirm the member’s plan and refer to the applicable policy section or to policy 5.01.647 for custom plan rules.
Certain ustekinumab IV formulations are limited to a one‑time IV induction dose (used to support subsequent SC maintenance or for specified induction-only indications). Check the agent-specific node for which products are induction‑only and the required documentation for prior therapies and specialist involvement.
Formulary and product-class exceptions may change product status: for example, Entyvio (vedolizumab) SC and related sequencing were added and revised in recent updates; confirm whether Entyvio SC criteria or formulary placement applies to the member’s plan before authorization decisions.
Several recent formulary adjustments (preferred/non‑preferred reclassifications and step‑therapy updates) affect which agents must be tried before others; providers should confirm the current preferred product list and required trial/failure sequencing for the member’s formulary prior to submission.
Formulary exception notes also reference effective-dates for product status changes (e.g., changes effective 01/03/2025) and plan‑specific distinctions (Custom Open, Preferred, Essentials, Metallic). Verify effective dates and plan type when evaluating prior‑therapy requirements.
Many coverage criteria include the caveat that they apply to specified plan sections (for example, Individual/Small Group/Student ISHIP Metallic plans or Essentials plans). Confirm the member’s Rx Plan (e.g., M1/M2/M4, E1/E3/E4) to determine which step‑therapy tiers and site‑of‑service reviews apply.
Updates to product preference and step‑therapy require attention: non‑preferred adalimumab products now require documented trial and failure of all preferred adalimumab products before coverage of a non‑preferred agent; check the current formulary lists and prior‑trial documentation.
All other uses of the listed agents in combination with each other or for indications not described in this policy are considered investigational and are not covered under these criteria.
Use of natalizumab (Tyruko/Tysabri) in combination with other immunosuppressive therapies is discouraged and not approved due to concerns about increased risk of progressive multifocal leukoencephalopathy (PML). Natalizumab use requires adherence to the manufacturer’s risk‑management program (TOUCH) and individual registration/documentation.
The policy history documents that the section addressing TNF‑inhibitor toxicities was revised (2018) to exclude non‑IBD disease states; historical clarifications do not alter current IBD‑specific safety considerations but are noted for context.
Historical updates to the TNF inhibitor toxicities section and product listings are recorded in the policy history; these are provided as context for prior decisions but do not substitute for current agent‑specific criteria.
Formulary applicability is plan dependent: several notes in the update language specify that criteria for some agents do not apply to Custom Open and Preferred formulary plans (Formulary IDs referenced). Always confirm the member’s formulary before applying the standard Section 1/2/3 criteria.
Hospital‑based outpatient settings are considered medically necessary only when site‑of‑service criteria in this policy are met (for example, initial infusion course up to 90 days, re‑initiation after ≥ 6 months, or when no outpatient infusion center is available within 50 miles); otherwise, hospital‑based outpatient administration is not considered medically necessary for infusion/injectable services.
No items are explicitly listed as 'Not medically necessary' in this excerpt beyond the site‑of‑service provisions; however, the policy specifies that uses outside approved indications or combinations not described within the policy are considered investigational or not medically necessary.
Uses of the listed therapies for indications or combinations not outlined in this policy are considered not medically necessary or investigational and are not covered under these criteria.
Per guideline interpretation and policy updates, use of 5‑ASA as a required step before TNF‑α inhibitor therapy is no longer required for Crohn's disease. Therefore, policies that mandate a 5‑ASA trial before biologic initiation in Crohn’s disease are no longer applicable under this policy’s current criteria.
New‑start coverage for some infliximab and adalimumab products is contingent on documented failure of preferred products. For example, Avsola and Renflexis coverage was updated to require prior trial/failure with Inflectra, Janssen unbranded infliximab, or Remicade for new starts effective January 3, 2025. Confirm required prior trials before initiating non‑preferred agents.
Provider Requirements, Prior Authorization and Step Therapy
Prior Authorization
Prior authorization for induction-dose biologics
Prior authorization is required for many biologic and injectable therapies, and separate medical-benefit review for site-of-service (SOS) may also apply. Induction-dose (IV) biologics (for example: Omvoh IV, Skyrizi IV, Tremfya IV, Omvoh IV induction schedule Week 0/4/8, and single‑dose IV inductions such as ustekinumab IV) often require authorization specifically for the induction course; requests for continuation/maintenance beyond the authorized induction schedule may be denied if not supported. For IV induction-only agents, document the intended induction schedule in the request (dates/doses) and the prescribing clinician specialty. Failure to request induction-dose authorization may result in claim denial or retrospective noncoverage.
Obtain PA for induction courses (Omvoh IV: Week 0, 4, 8 — total 3 infusions; Skyrizi IV and Tremfya IV: induction approvals may be limited to 90 days).
For one-time IV induction agents (eg, ustekinumab IV), authorization may be issued for 30 days to allow the single induction dose.
Billing Codes and Dose/Age Limits
Ustekinumab productsmixed
ustekinumab (Stelara) IV
listed biologic - IV formulation
Stelara (ustekinumab) SC
listed biologic - SC formulation
Starjemza (ustekinumab-hmny) SC
listed biosimilar/alternate formulation SC
Imuldosa (ustekinumab-srlf) IV
listed biosimilar/alternate formulation IV
Adalimumab products (preferred)mixed
Simlandi (adalimumab-ryvk) SC
preferred adalimumab product
Yuflyma (adalimumab-aaty) SC
preferred adalimumab product
Integrin/IL-23/IL-12/23 productsmixed
Entyvio (vedolizumab) IV/SC
α4-integrin inhibitor
Omvoh (mirikizumab) IV/SC
IL-23 inhibitor
Skyrizi (risankizumab-rzaa) IV/SC
IL-23 inhibitor
Tremfya (guselkumab) IV/SC
IL-23 inhibitor
Oral small molecules (JAK inhibitors, S1P modulators)mixed
Rinvoq (upadacitinib) oral
Janus kinase inhibitor
Xeljanz (tofacitinib) oral / Xeljanz XR
Janus kinase inhibitor
Velsipity (etrasimod) oral
S1P receptor modulator
Zeposia (ozanimod) oral
S1P receptor modulator
Listed biologic and targeted agents (no billing codes in excerpt)mixed
not provided
Multiple biologic and biosimilar drug names listed (e.g., Avsola, Inflectra, Stelara, Rinvoq, etc.) — document provides drug names but no billing codes in this excerpt.
Injection, infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J1748
Injection, infliximab-dyyb (Zymfentra), 10 mg
J3357
Injection, ustekinumab (Stelara), 1 mg
J3358
Ustekinumab, for intravenous injection, (Stelara), 1 mg
J3380
Injection, vedolizumab (Entyvio), 1 mg
J3590
Unclassified biologics (use to report certain adalimumab products and others)
1–10 of 29
1/3
Historical HCPCS codes referenced in policy historyHCPCS
Q9989
HCPCS code added previously (referenced history)
J3358
HCPCS code added previously (referenced history)
Velsipity/Zeposia daily dose limits — dose caps
Velsipity (etrasimod) maintenance limitDose must be ≤ 2 mg per day
Zeposia (ozanimod) daily limitDose must be ≤ 0.92 mg per day
Policy reference — S1P modulators dose capsVelsipity and Zeposia dose limits specified in Sphingosine 1‑Phosphate Receptor Modulators sections
ozanimod daily dose — Zeposia ≤ 0.92 mg/day
High-Priority Provider Alerts
Note
Note
Note
Note
Note
Clinical Background and Evidence Summary
Randomized controlled trials support the efficacy of multiple agents listed in this policy for induction and/or maintenance of remission. Examples include infliximab (Remicade) and its biosimilars for Crohn’s disease, adalimumab (Humira) trials demonstrating induction and maintenance efficacy in CD, vedolizumab (Entyvio) GEMINI trials showing higher remission rates versus placebo in UC and CD, ustekinumab (Stelara) induction and maintenance trials (CD‑1/2 and CD‑3) demonstrating corticosteroid‑free remission, and UC trials showing efficacy for tofacitinib and ozanimod. Coverage aligns with labeled indications and trial populations; prior‑therapy and disease‑severity documentation consistent with trial eligibility are required for authorization.
The policy history documents revisions to the TNF inhibitor toxicity section (2018) and subsequent updates (2025) that adjusted which non‑IBD disease states are included. Historical changes to content about TNF inhibitor toxicities were made to restrict non‑IBD references and to reflect ongoing safety review timelines.
Historical review notes indicate that no therapies were designated explicitly not medically necessary in several prior reviews; the policy record also captures additions of new agents (e.g., Rinvoq, Omvoh, Velsipity) and step‑therapy changes implemented across 2023–2025 updates.
Background statistics contextualize disease burden in Crohn's disease: surgical intervention is common (reports of up to 57% requiring at least one surgery in a year and 71% within 10 years of disease onset). Clinical trial outcomes cited in the evidence summary include maintenance remission percentages (for example, ustekinumab maintenance producing corticosteroid‑free remission rates around 47% in Study CD‑3 at Week 44). These data support the medical benefit of biologic therapy for selected moderate‑to‑severe IBD populations.
Definitions and Key Terms
Site of Service — definition and examples
Site of service definitionLocation where the drug is administered (e.g., hospital outpatient, infusion center, physician office, home)
Examples triggering hospital outpatient necessityInitial course (first 90 days), re‑initiation after ≥6 months, or when no outpatient infusion center within 50 miles
SOS review age ruleSite-of-service review performed for ages 13 and older for medical‑benefit IV/injectable drugs
Prior corticosteroid or agent trial — definition of required prior therapy
Prior corticosteroid or agent trial — definitionMost therapies require the individual to have tried at least one corticosteroid or one other listed Crohn's agent (e.g., azathioprine, 6‑mercaptopurine, methotrexate, mesalamine ER)
Alternative clinical features
Policy Revisions and Effective Dates
2022addition
Added coverage for Rinvoq (upadacitinib) for ulcerative colitis and added Infliximab (Janssen - unbranded) to the policy with coverage equivalent to Remicade.
2023-01-01formulary_change
Avsola moved to preferred first-line and Inflectra moved to non-preferred effective Jan 1, 2024; multiple adalimumab biosimilars reclassified with preferred/non-preferred status changes for 2024.
2024addition
Added coverage criteria for Tyruko (natalizumab-sztn), Entyvio SC, Omvoh (mirikizumab-mrkz) for UC, Tremfya IV/SC for UC, and Velsipity (etrasimod); Omvoh and Velsipity moved from non-preferred to preferred and several adalimumab products reclassified.
Policy Summary
PayerPremera Bluecross
PolicyPharmacotherapy of Inflammatory Bowel Disorder — Medical Benefit IV and Injectable Therapies (coverage criteria)
Policy CodePolicy N/A
Change TypeMaterial updates to coverage, step therapy, and site-of-service requirements (multiple added/revised items)
Effective DateJan. 2, 2026
Next Review DateN/A
Key ActionObtain prior authorization and document age, specialist involvement, and required prior therapy failures per agent before submitting for coverage
Avsola/Inflectra (infliximab biosimilars): May be considered medically necessary when: individual is aged >=6 years AND meets the general Crohn's prior‑therapy/clinical feature requirement AND medication is prescribed by or in consultation with a gastroenterologist; these agents are subject to site‑of‑service review>=6 years
Avsola and Inflectra subject to site‑of‑service review
Entyvio (vedolizumab) IV: May be considered medically necessary when: individual is aged >=18 years AND meets the general Crohn's prior‑therapy/clinical feature requirement AND Entyvio IV is prescribed by or in consultation with a gastroenterologist>=18 years
Entyvio IV subject to site‑of‑service review
Ustekinumab (IV/SC formulations) - induction and SC maintenance: IV ustekinumab products may be used as a one‑time induction in adults (>=18); SC maintenance formulations may be considered when individual is >=18, has received a single IV induction dose, meets general prior‑therapy/clinical criteria, and medication is prescribed by or in consultation with a gastroenterologist>=18 years; single IV induction for SC maintenance
SC maintenance restricted to after IV induction for specified products
>=18 years; induction at weeks 0,4,8
Chunk 25: IV induction only
Tremfya SC maintenance: Individual aged >=18 years; has received induction with Tremfya IV or SC (400 mg at Week 0, 4, 8); meets prior‑therapy/clinical criteria; Tremfya SC prescribed by or in consultation with a gastroenterologist>=18 years
Chunk 26
Cimzia (certolizumab pegol): Cimzia may be considered medically necessary when: individual is aged >=18 years AND meets the general prior‑therapy/clinical feature requirement AND, where specified, has had a trial and treatment failure with required adalimumab products; medication prescribed by or in consultation with a gastroenterologist>=18 years
Chunks 29–30
>=18 years; one‑time induction
Chunk 48
<= 2 mg/day
Chunk 52: Velsipity dose limit
Prescriber: Medication is prescribed by or in consultation with a gastroenterologist
3 IV infusions induction
Chunk 24/79
Rinvoq prescribed by or in consultation with a gastroenterologist
Prescriber: Medication is prescribed by or in consultation with a gastroenterologist
Prescriber: Medication is prescribed by or in consultation with a gastroenterologist
Prescriber: Medication is prescribed by or in consultation with a gastroenterologist
prescriber: Medication is prescribed by or in consultation with a gastroenterologist
Explicit prescriber requirement
prescriber: Medication is prescribed by or in consultation with a gastroenterologist
Specialist involvement: Medication is being prescribed by or in consultation with a gastroenterologist
Chunk 173
Medication is being prescribed by or in consultation with a gastroenterologist
Chunk 176
SC maintenance after IV induction: For SC formulations: individual is >=18, has received a single IV induction dose, and meets the same conventional therapy/prior agent or surgical/fistula criteriaprior IV induction required
Chunks 179–180
Induction-only for IV: Omvoh IV is used only for induction therapy (Week 0, 4, 8 for total 3 IV infusions) and is prescribed by or in consultation with a gastroenterologist3 IV induction infusions
Chunk 181
SC maintenance after IV induction: Omvoh SC may be used for maintenance after receiving Omvoh IV induction therapy and meeting prior therapy conventionsprior IV induction required
Chunk 181
Induction-specific: Omvoh IV is used only for induction therapy administered at Week 0, Week 4, and Week 8 (3 IV infusions)3 induction infusions
Chunk 181
Chunk 193
Skyrizi and Tremfya induction: Skyrizi IV and Tremfya IV are used only for induction therapy (Week 0, 4, 8); SC maintenance requires prior IV induction or completion of induction regimenWeek 0/4/8 induction
Chunks 193–195
Rinvoq/Xeljanz: Rinvoq and Xeljanz/XR may be considered medically necessary in adults (>=18) after trial and treatment failure with one or more TNF blockers (Rinvoq allows clinical inadvisability alternative and trial of ≥1 systemic therapy)prior TNF blocker failure
Chunk 196
Velsipity may be used in adults (>=18) when prescribed by or in consultation with a gastroenterologist and dose is ≤ 2 mg per daydose <= 2 mg/day; age >=18
Chunk 196
Multiple reclassifications among preferred/non‑preferred products and required trial/failure sequencing updated with effective dates in 2024 and 2025
Chunks 249–253
age per product
Chunks 255–256: age updates
Re-authorization duration: Re‑authorization approvals for listed drugs limited to 12 months (was 3 years)12 months
Chunk 256
Site-of-service requirements: Certain agents (e.g., Tyruko, Zymfentra, select infliximab products) have site‑of‑service review requirements or restrictions; exceptions for specified plans may applysite‑of‑service documented where required
Chunks 252, 258
Step Therapy
TNF-α / infliximab prior therapy
Requests for certain infliximab and TNF‑α agents require documentation of prior trials and failures with specified preferred infliximab or biosimilar products before non‑preferred infliximab agents will be authorized. For new starts, the policy requires evidence of inadequate response or intolerance to preferred infliximab products (examples: Avsola, Inflectra, or Remicade/Infliximab Janssen per plan) before approving other infliximab products. Missing or insufficient prior‑therapy documentation is a common reason for denial.
For Infliximab (Janssen unbranded) and Remicade: document inadequate response or intolerance to Avsola and Inflectra for individuals not previously treated with requested therapy.
For Avsola/Renflexis (per Jan 3, 2025 update): an adequate trial and failure with Inflectra, Infliximab (Janssen unbranded), or Remicade is required prior to approval.
If prior‑therapy records are incomplete (dates, doses, clinical response), requests may be denied.
Prior Authorization
Site-of-service prior authorization and SOS medical‑benefit review
Many IV infliximab and other listed agents are subject to site‑of‑service (SOS) medical‑necessity review when administered in a hospital outpatient or infusion center versus another setting. For members aged 13 and older the SOS for medical necessity will be reviewed. Failure to obtain SOS medical‑benefit review when applicable may lead to denial of facility or drug administration charges.
Drugs explicitly subject to SOS review include: Avsola, Inflectra, Inflectra (IV), Infliximab (Janssen unbranded), Remicade, Renflexis, Entyvio IV, Tyruko/Tysabri, Zymfentra SC, and others listed in the policy.
SOS review applies to medical‑benefit reviews (not to Alaska fully‑insured members per policy note).
For ages ≥13, include intended administration site and justification for that site in the PA.
Denial Risk
Site-of-service review risk and required justification
Requests for the agents listed as SOS triggers (for example Avsola, Inflectra, Remicade, Entyvio IV/SC, Zymfentra, Skyrizi IV, Zymfentra SC and others) carry increased denial risk if the administration site or SOS justification is missing. SOS review may deny facility administration charges if the site is not appropriate per medical‑necessity criteria.
Include clinical rationale for hospital‑based outpatient vs office vs home infusion when submitting PA.
Expect SOS review to examine alternatives and clinical necessity of the chosen site; missing documentation or lack of justification may result in denial.
Denial Risk
Site-of-service review — agents at risk
Some requests for IV biologics or biosimilars may trigger SOS review and potential denial if prior‑therapy sequencing or SOS justification is not met. Review the policy’s SOS list and ensure prior trials, induction documentation, prescriber specialty, and intended administration site are supplied.
Avsola, Inflectra, Remicade, Entyvio, Zymfentra, Skyrizi IV and other listed agents are commonly subject to SOS review.
For members ≥13 years, SOS review will evaluate medical necessity of the administration site.
Documentation Required
Documentation gaps for prior therapy — denial risk
Incomplete prior‑therapy documentation (eg, absence of dates, lack of clinical response description, missing trial durations or doses, or missing gastroenterology chart notes) is a frequent cause for denial. Ensure submitted records clearly show the agent tried, duration, reason for discontinuation (inadequate response or intolerance), and dates.
Submit office visit notes, infusion records, or medication administration records demonstrating prior therapy and clinical outcome.
If a prior agent was tried outside the health system, include external chart copies, pharmacy fill history, or provider attestation with specifics.
Entyvio SC has explicit prior‑trial requirements: for Crohn’s disease and ulcerative colitis the SC formulation requires trials and documented treatment failure with TWO specified agents (including a preferred adalimumab product, certolizumab, Rinvoq, preferred ustekinumab, Skyrizi, Tremfya, etc.) and documentation of prior IV Entyvio induction or current IV induction therapy. Lack of documentation of two prior agent failures or absence of Entyvio IV induction can lead to denial.
Entyvio SC approval requires: age ≥18 (where specified), gastroenterologist prescribing/consultation, trial and treatment failure with TWO listed agents, AND prior/ongoing Entyvio IV induction or documentation of having received induction.
For Entyvio SC in ulcerative colitis, acceptable prior agents include a preferred adalimumab, Omvoh SC, Rinvoq, Simponi, Skyrizi SC, preferred ustekinumab SC, Tremfya SC, Velsipity, Xeljanz, among others per policy lists.
Prior Authorization
Omvoh (mirikizumab) IV site/usage restriction and induction documentation
Omvoh (mirikizumab) IV is authorized only for induction therapy administered at Week 0, Week 4, and Week 8 (three IV infusions). Omvoh IV requests must document that the agent is being used solely for induction and include the planned induction schedule and gastroenterologist involvement. Requests for maintenance/continuation beyond induction without SC transition documentation may be denied.
Omvoh IV: Week 0, 4, and 8 induction only — include schedule and dates in PA.
Omvoh SC requires prior IV induction (document induction completion) or documentation of IV induction in progress for SC continuation eligibility.
Note
Custom Open Formulary exception — plan‑specific criteria
One Open formulary (Formulary ID: 6062; Rx Plan F1) and one Preferred formulary (Formulary ID: 6064; Rx Plan G3) follow different criteria (Custom Open/Preferred Formularies). The policy’s standard criteria (including step sequencing, preferred/non‑preferred lists, and SOS rules) do not apply to these custom plans — refer to policy 5.01.647 for custom plan criteria. Always verify the member’s formulary before submitting a PA.
Check member plan booklet or ID card to confirm whether the custom Open/Preferred formulary exception applies.
If member is on the custom formulary, use policy 5.01.647 for applicable coverage rules and step therapy sequencing.
Step Therapy
Formulary-dependent coverage and step therapy sequencing
Coverage, step‑therapy, and preferred vs non‑preferred sequencing vary by formulary section (Open/Preferred/Select, Essentials, ISHIP Metallic). Agents and required prior steps differ across these plan types; ensure the member's plan section is identified and that step‑therapy requirements for that plan are satisfied.
Examples: Avsola/Inflectra placement and required prior agents differ between Sections 1, 2, and 3; Omvoh and Entyvio step requirements differ by plan section.
For members on ISHIP Metallic (M1/M2/M4) or Essentials (E1/E3/E4) plans, follow the plan‑specific step lists in the policy.
Step Therapy
Adalimumab step requirement
Non‑preferred adalimumab (brand or non‑preferred biosimilars) requires prior trial and documented failure of all preferred adalimumab products before approval (brand‑step and non‑preferred sequencing). For ulcerative colitis and Crohn’s disease many adalimumab products have age requirements and plan‑specific sequencing.
Document trials and failures with each preferred adalimumab product (eg, Simlandi, Yuflyma, Cyltezo/adbm, Hyrimoz/adaz where listed as preferred) prior to approving non‑preferred adalimumab or Humira brand starts.
For pediatric patients ensure the age eligibility in the policy is met (many adalimumab criteria include age minimums).
Step Therapy
Infliximab prior therapy requirement
For infliximab products (Avsola, Inflectra, Remicade, Renflexis, Zymfentra, Janssen unbranded) the policy often requires documented prior trials/failures with specific preferred infliximab biosimilars before authorizing other infliximab products; check the effective‑date updates (eg, Jan 3, 2025) that changed Avsola/Inflectra/Renflexis sequencing. New starts may require failure of the preferred infliximab options.
Per recent updates, Avsola moved between preferred/non‑preferred tiers; Renflexis and Avsola approvals may require prior failure of Inflectra, Infliximab (Janssen unbranded), or Remicade depending on effective dates and plan.
Include prior infusion records and documentation of inadequate response/intolerance when requesting non‑preferred infliximab.
Documentation Required
Prescriber specialty documentation
Prescriber specialty and supporting clinical documentation are required for many agents. Most biologics for IBD must be prescribed by or in consultation with a gastroenterologist; the PA should include the gastroenterologist’s name and clinical notes documenting involvement.
Include the prescribing clinician’s specialty (gastroenterology) and relevant office visit notes or consultation notes.
If another specialist initiates therapy, include documentation of gastroenterology consultation per policy requirement.
Documentation Required
Required clinical documentation
Required clinical documentation should demonstrate the diagnosis, disease severity, prior treatment history (agents, doses, durations), reason for discontinuation of prior therapies (intolerance vs inadequate response), and any surgical history (eg, ileocolonic resection) or complications (fistulas). Office visit notes, endoscopy reports, and infusion records should be included.
Submit office visit notes with diagnosis, relevant history, physical exam, and medication history.
Provide objective evidence of disease activity or treatment failure when available (eg, endoscopy, imaging, labs).
Documentation Required
Required documentation — operational checklist
The policy frequently requires specific documentation elements: age verification, prior corticosteroid or immunomodulator trials where specified, dates and outcomes of prior biologic trials, prescriber specialty, and induction dosing details for induction‑only agents. Missing any of these elements may lead to denial or request for additional information.
Document patient age to confirm eligibility thresholds (many agents have age minimums).
Show trials of corticosteroids, immunomodulators, or specific biologics as required by the drug‑specific criteria, including dates and reasons for discontinuation.
Documentation Required
Omvoh documentation
Omvoh documentation must include gastroenterologist involvement and the IV induction schedule (Week 0, 4, 8). For SC conversion or continuation, include documentation that IV induction was completed or is in progress. Omvoh SC approvals generally require prior IV induction unless policy indicates otherwise for a specific plan.
For Omvoh IV: include planned infusion dates/doses and gastroenterology consult note.
For Omvoh SC: include evidence of completed IV induction or documentation of IV induction in progress.
Documentation Required
Clinical history and prior therapy documentation
Clinical history and prior therapy documentation should mirror the populations included in clinical trials where applicable (eg, prior biologic exposure, corticosteroid use). High‑quality documentation improves likelihood of approval and expedites review.
Include trial durations, objective response measures (if available), and reason for discontinuation.
When possible, include trial of 5‑ASA for UC where the policy still requires it (note: 5‑ASA step applies in UC but not CD per policy change).
Documentation Required
Age requirement documentation
Where an age requirement was added, age must be documented in the chart notes or PA request. Many recent updates (2024–2025) added age minimums for agents such as Skyrizi IV/SC, Tremfya IV/SC, infliximab products, Entyvio IV/SC, and several adalimumab biosimilars — verify and document the patient’s age against the drug‑specific criteria.
Include patient date of birth or age in the submission to confirm eligibility.
If a pediatric exception is being requested, provide supporting rationale and specialty consultation notes.
Step Therapy
Step therapy requirements
Step‑therapy rules apply across the policy with defined sequencing (first‑line, second‑line, etc.). Patients must try and have documented failure or intolerance to lower‑step agents before higher‑step or non‑preferred agents will be authorized. The policy lists specific acceptable prior agents for each step and for each plan section — follow the plan‑specific step lists.
Ensure documentation shows trial and treatment failure with required lower‑step agents (eg, preferred adalimumab products before non‑preferred adalimumab; preferred infliximab biosimilars before non‑preferred infliximab products).
Where a TNF blocker trial is explicitly required prior to JAKs or other classes, include documentation of that trial and outcome.
Several drugs have explicit sequence/line requirements (eg, Omvoh requires prior inadequate response or intolerance to two specified agents in some plan sections; Entyvio SC requires prior IV induction plus two prior failed agents). Confirm the required number and identity of prior agents per the member’s plan section before submitting the PA.
Follow the step/sequence requirements in the policy tables for the member’s plan (Sections 1, 2, or 3).
Document each prior agent trial and the clinical rationale for escalation to the requested therapy.
Step Therapy
5‑ASA step in ulcerative colitis (UC) but not in Crohn’s disease (CD)
The policy clarifies that a 5‑ASA trial remains a step for ulcerative colitis in many plan sections but is not required for Crohn’s disease. When UC criteria list 5‑ASA as a required step, document trial and lack of adequate response or intolerance; do not include 5‑ASA as required prior therapy for Crohn’s disease criteria unless the drug‑specific criteria state otherwise.
For UC: document trial of 5‑ASA agents when the policy requires it prior to biologics for that plan section.
For CD: 5‑ASA is not a required prior step per policy change — do not add as a required step unless drug criteria specify.
Ozanimod (Zeposia) capDose must be ≤ 0.92 mg per day
Prescriber requirementZeposia must be prescribed by or in consultation with a gastroenterologist
Prior-failure requirementCoverage requires documented trial/failure with TWO listed agents per Zeposia criteria
age minima — examples of minimum ages across agents
Minimum age examples — pediatric adalimumabSome adalimumab products: ≥5 years
Minimum age examples — infliximab/adalimumab for Crohn'sSelected infliximab and adalimumab entries: ≥6 years
Adult-only examplesMany biologics (e.g., ustekinumab, vedolizumab, IL‑23/IL‑12 agents): ≥18 years
Age eligibility — agents specify >=6 years or >=18 years depending on product
Two common age bandsAgents specify either ≥6 years or ≥18 years depending on product
Pediatric-specific agentsSome adalimumab formulations and Simponi have lower age/weight-specific criteria (e.g., 5 years or weight ≥15 kg)
Check product-specific nodesAge eligibility varies by formulary section and product — verify the agent-specific criteria
Velsipity exampleVelsipity (etrasimod) maintenance dose must be ≤ 2 mg per day
Zeposia exampleZeposia (ozanimod) daily dose must be ≤ 0.92 mg per day
ContextBoth dose limits are specified in the S1P receptor modulators sections for UC
Weight — Simponi requires patient weight ≥ 15 kg
Simponi (golimumab) pediatric weight thresholdPatient must weigh at least 15 kg for Simponi SC
Simponi prior-failure noteSimponi requires prior trial/failure of listed adalimumab products in pediatric UC criteria
Prescriber requirementMedication must be prescribed by or in consultation with a gastroenterologist
Velsipity dose — ≤ 2 mg per day
Velsipity maintenance limitDose must be ≤ 2 mg per day
Agent classVelsipity listed as an S1P receptor modulator for ulcerative colitis
Prescriber requirementPrescribed by or in consultation with a gastroenterologist
Age thresholds — summary of age thresholds and site-of-service age limits
Age ≥5 yearsSelected adalimumab products (UC) specify minimum age of 5 years
Age ≥6 yearsMany infliximab and some adalimumab Crohn's criteria specify minimum age of 6 years
Age ≥18 years and SOS age limitMultiple biologics require age ≥18 years; site-of-service IV review applies for ages ≥13 per policy notes
Note
Inflammatory bowel diseases (Crohn's disease and ulcerative colitis) are chronic inflammatory disorders of the gastrointestinal tract that can cause abdominal pain, diarrhea, bleeding, fatigue and weight loss. Medical therapy includes aminosalicylates, corticosteroids, immunomodulators, biologics, and small‑molecule agents; the policy frames which agents require prior authorization and the clinical criteria used to determine medical necessity.
Presence of enterocutaneous/rectovaginal fistulas or prior ileocolonic resection can substitute for prior‑therapy trial
Prescriber involvementDocumentation of gastroenterologist prescribing/consultation typically required with prior therapy documentation
Induction dose — meaning and examples
Induction dose meaningInitial dosing regimen intended to induce remission (examples: Skyrizi/Omvoh/Tremfya IV administered at Week 0, Week 4, and Week 8)
Induction-use restrictionSome IV regimens permitted only for induction prior to SC maintenance (one‑time or multi‑infusion induction as specified)
ExamplesSkyrizi IV, Tremfya IV, Omvoh IV — 3 IV infusions at Weeks 0,4,8 for induction
Prescribing requirement — gastroenterologistMany agents must be prescribed by or in consultation with a gastroenterologist for medical necessity to be met
Documentation expectationPrior authorization requests should include documentation of gastroenterology involvement and relevant clinical notes
Applies broadlyRequirement appears across Crohn's and UC agent-specific criteria
One-time induction dose — definition for ustekinumab IV limited use
One-time IV induction definitionCertain ustekinumab IV products are limited to a single IV induction dose (used only as induction) prior to SC maintenance eligibility
Induction-only contextOne-time IV induction is used for fistulizing disease, post‑ileocolonic resection, or when SC maintenance follows IV induction
DocumentationPrior authorization must document indication and single IV induction administration where applicable
Induction therapy — definition and examples
Induction therapy general definitionInitial course of IV infusions intended to induce remission prior to maintenance (examples: IV at Weeks 0,4,8)
SC continuationSC maintenance often requires prior completion of IV induction as specified
Induction therapy — additional examples and definition
Induction therapy additional examplesOmvoh IV induction (Week 0, 4, 8) with SC maintenance after IV induction; SC allowed only after documented IV induction
Other agentsSkyrizi IV and Tremfya IV have similar induction-only IV schedules before SC maintenance
Authorization implicationsRequests for continued IV beyond induction or without documented induction are likely to be denied
Induction therapy — general note
Induction therapy note — generalInduction refers to the initial course to induce remission; documentation of induction dosing is required when transitioning to maintenance formulations
Examples of documentationMedical records should show dates/doses for Week 0, 4, 8 infusions for agents requiring induction
Prescriber involvementGastroenterologist prescribing/consultation should be documented for induction approvals
Induction therapy — IV induction then SC maintenance concept
IV induction then SC maintenance conceptSome products require IV induction (e.g., Remicade/Avsola/Inflectra induction) prior to SC maintenance formulations such as Zymfentra or other SC infliximab forms
ExampleZymfentra SC eligibility often requires prior IV infliximab induction (Remicade/Avsola/Inflectra/Renflexis)
Site-of-service noteIV induction courses may be subject to site‑of‑service review
Enterocutaneous/rectovaginal fistulas — clinical indicationPerianal or abdominal enterocutaneous fistulas or rectovaginal fistulas are listed as clinical features that can meet criteria for biologic therapy
Role in criteriaPresence of fistulas can substitute for prior trial of corticosteroid or other agent in some agent-specific criteria
Applies toBoth Crohn's disease and some UC agent rules reference fistulizing disease as qualifying feature
Intravenous infliximab induction regimen — definitionAn IV induction course using Remicade, Avsola, Inflectra, or Renflexis (examples cited) required prior to certain maintenance or SC infliximab formulations
Documentation needMedical records should show receipt of IV induction regimen when required for SC continuation
Products mentionedRemicade, Avsola, Inflectra, Renflexis cited as IV induction options
Entyvio (vedolizumab) SC — definition and use
Entyvio SC — definition and useSubcutaneous vedolizumab formulation used as second-line option for adults after specified prior trials and typically following or with Entyvio IV induction
Prior‑trial requirementEntyvio SC requires documented failure of TWO listed agents and evidence of Entyvio IV induction or current induction
Prescriber requirementMust be prescribed by or in consultation with a gastroenterologist
Omvoh (mirikizumab) IV/SC — definition and induction schedule
Omvoh (mirikizumab) IV/SC — definitionMirikizumab available as IV induction (Weeks 0,4,8) and SC maintenance after IV induction; IV is induction‑only in many criteria
Induction scheduleIV induction administered at Week 0, Week 4, and Week 8 (3 infusions)
Prior-failure requirementOmvoh IV often requires documented inadequate response or intolerance to TWO listed agents before induction approval
Induction therapy — mirikizumab example
Mirikizumab induction exampleOmvoh IV induction: Week 0, Week 4, Week 8 (total 3 IV infusions) — used only for induction in many criteria
SC continuation exampleOmvoh SC allowed for maintenance only after documented IV induction
Prescriber requirementPrescribed by or in consultation with a gastroenterologist
Maintenance dose limit — VelsipityVelsipity (etrasimod) maintenance dose must be ≤ 2 mg per day
Policy locationSpecified in the Sphingosine 1‑Phosphate Receptor Modulators sections for UC
ImplicationPrior authorization decisions should enforce the ≤2 mg/day limit for maintenance use
Remicade / infliximab — brief definition
Remicade / infliximab — brief definitionInfliximab (Remicade) is an anti‑TNF biologic used for moderate‑to‑severe IBD with evidence for symptom reduction and mucosal healing
Biosimilar contextInflectra and Avsola are biosimilars to Remicade and are referenced in induction/step therapy sequencing
Site‑of‑service noteSome infliximab products are subject to site‑of‑service review
Deep remission — definition (CDAI <150 + mucosal healing)
Deep remission definitionTherapeutic goal defined as Crohn's Disease Activity Index (CDAI) <150 plus complete mucosal healing on endoscopy
Clinical relevanceReferenced as an emerging therapeutic goal in Crohn's disease management
Use in trials/policyTrial populations and outcomes referenced to support coverage decisions
Serious infection risk — safety signal summary across classes
Serious infection risk — class signalAcross classes, trials and retrospective analyses report higher rates of serious infections for certain agents (e.g., JAK inhibitors, TNFα antagonists)
Other safety signalsNoted risks include herpes zoster, non‑melanoma skin cancer, cardiovascular events, elevated lipids, and bradycardia/AV block for some agents
Implication for prescribingSafety signals may influence agent selection and prior authorization documentation
Clinical remission (trial definitions) — Mayo score variants used in trials
Clinical remission (trial definitions)Trials use Mayo or modified Mayo scores for UC and CDAI thresholds for Crohn's; examples include 3‑component Mayo (rectal bleeding, stool frequency, endoscopy) and CDAI <150 for remission
Trial endpointsClinical remission, clinical response, endoscopic improvement and steroid‑free remission used as endpoints in Phase 3 trials
Use in coverage rationalePolicy aligns coverage decisions with trial populations and labeled indications
Custom Open and Preferred formulary exception — mapping to policy 5.01.647
Custom Open/Preferred formulary exceptionCertain custom Open/Preferred formulary plans (Formulary IDs 6062, 6064) follow different criteria — refer to policy 5.01.647
Policy cross-referencePolicy directs providers to 5.01.647 for members on specified custom formularies
Practical noteVerify member plan booklet or ID card to determine applicable criteria
2025-01-03step_therapy_revision
Effective Jan 3, 2025 Avsola changed to second-line and Avsola/Renflexis require prior trial/failure with Inflectra, Janssen infliximab, or Remicade for new starts; Humira (selected NDCs) and other adalimumab products had product-status and trial sequencing updates.
2025criteria_update
Updated age-based eligibility for multiple agents (adalimumab, infliximab, vedolizumab, ustekinumab, Skyrizi, Rinvoq, Cimzia, Tyruko/Tysabri, Simponi, Omvoh, Tremfya) and changed re-authorization duration from 3 years to 12 months.
2025site_of_service_change
Added site-of-service reviews for select agents (e.g., Zymfentra) and updated site-of-service and preferred/non-preferred requirements across infliximab products and Omvoh in certain sections.
2025-07product_status_update
Multiple infliximab and adalimumab product status adjustments (preferred ↔ non-preferred) and new-start requirements for infliximab and Remicade were clarified in mid-2025 updates.
2024coverage_addition
Updated Entyvio (vedolizumab) SC coverage criteria to include Crohn's disease and added Entyvio SC as a treatment option; clarified Tremfya SC as a brand step therapy option for Entyvio SC and Zeposia.
2024formulary_change
Added Simlandi (adalimumab-ryvk) and adalimumab-ryvk as preferred products and updated non-preferred adalimumab criteria to require failure of all preferred adalimumab products.
2025-01-03prior_therapy_requirement
Effective Jan 3, 2025 Avsola (infliximab-axxq) changed to second-line and Avsola and Renflexis require prior trial/failure with Inflectra, Janssen unbranded infliximab, or Remicade for new starts; Hyrimoz (adalimumab-adaz) reclassified to non-preferred and Humira (selected NDCs) new-start rules updated.
2025age_and_duration_updates
Added or updated age requirements across numerous agents and shortened re-authorization durations from 3 years to 12 months for listed drugs.
2025coverage_scope_changeLatest
Introduced distinct policy sections for Metallic, Essentials, and Open/Preferred/Select formularies with plan-specific coverage logic and site-of-service rules.
Formulary applicability and coverage rules changed for multiple plans: the policy now identifies plan‑specific sections and indicates that some criteria do not apply to Custom Open or Preferred formularies (Formulary IDs noted). Providers should verify plan and formulary, as changes include reclassification of preferred/non‑preferred products and adjusted step‑therapy sequencing.
Recent updates to prior authorization and step‑therapy requirements are summarized in the policy history: additions include coverage criteria for Rinvoq, Velsipity, Omvoh, Entyvio SC and other agents; reclassifications among adalimumab and infliximab biosimilars; and adjusted effective dates for some changes (including effective dates in 2024 and January 3, 2025). Non‑formulary exception approvals and re‑authorization durations were also revised (most approvals now limited to 12 months).