Medical Necessity Criteria for Custom Open Formulary (IV and Injectable Biologics)
Defines prior authorization, step therapy tiers, medical necessity, and site-of-service review criteria for specific biologic and immunologic drugs under a custom Open formulary (Formulary ID: 6062; Rx Plan F1). Applies to providers treating members of that specific plan and addresses IV/injectable site-of-service determinations for ages including pediatric indications where noted.
Policy Summary
PayerPremera Bluecross
PolicyMedical Necessity Criteria for Custom Open Formulary (IV and Injectable Biologics)
Policy CodePolicy N/A
Change TypeCoverage additions and product status updatesre-authorization shortened to 12 months
Effective DateJun. 1, 2026
Next Review DateN/A
Key ActionObtain prior authorization with documentation of indication, age, prior therapy trials and specialist consultation when requesting coverage.
Added coverage criteria for multiple adalimumab biosimilars and branded adalimumab products and specified they are subject to FDA dosing and administration.
Updated re-authorization duration of approval from 3 years to 12 months.
Updated product preferred/non-preferred status for multiple infliximab and adalimumab products and added/removed products from the policy as market availability changed.
Added coverage criteria for several rituximab products, tocilizumab products, vedolizumab SC, anakinra SC, sarilumab SC, bimekizumab, secukinumab, brodalumab, tildrakizumab, baricitinib, ozanimod, abatacept, certolizumab, and golimumab for various indications.
Updated age and weight requirements for certain indications (e.g., Cosentyx for ankylosing spondylitis from 18 to 12 years; Kevzara PJIA criteria changed to weight >=63 kg).
ID: 6062Formulary
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F1
Rx Plan
~20+Drugs referenced
90 daysSite-of-service initial-course rule
0.92 mg/dayZeposia dose limit
12 monthsRe-authorization duration
Coverage Criteria and Medical Necessity
Site-of-Service Medical Necessity
Covered when the site's clinical or operational conditions require hospital outpatient infusion; initial-course and re-initiation rules apply.
Preferred medically necessary sites: Physician's office OR infusion center OR home infusion are the preferred medically necessary sites for IV infusion and injectable therapy of specified agents
From policy: preferred medically necessary sites for specified drugs
Hospital-based outpatient setting — initial course or re-initiation: Hospital-based outpatient setting is considered medically necessary for the initial course of infusion/injection therapy or for re-initiation after ≥6 months when the drug is being startedFirst 90 days
Hospital-based outpatient setting is medically necessary for the first 90 days for initial course or re-initiation ≥6 months following discontinuation
Hospital-based outpatient setting — access or sole-provider reasons: Hospital-based outpatient setting is considered medically necessary when there is no outpatient infusion center within 50 miles AND no contracted home infusion agency will travel to the individual's home, OR a hospital is the only place that offers infusions or injections of the drug50 miles
Operational access criteria from policy
Hospital-based outpatient setting — increased clinical risk: Hospital-based outpatient setting is considered medically necessary when the individual has a clinical condition that increases risk for infusion/injection complications (any one of the listed conditions) including symptomatic cardiac arrhythmia, significant respiratory disease or serious obstructive airway disease, percent predicted FVC ≤ 40%, unstable renal function, difficult or unstable vascular access, acute mental status changes impacting safety, or history of severe adverse reactions/anaphylaxis to a related agent%FVC ≤ 40% cited as risk threshold
Clinical risk criteria support use of hospital-based outpatient site
Cytokine Release Syndrome (CRS) — inpatient admission required: CRS grade 3 or 4 (temperature ≥38°C AND hypotension requiring one or more vasopressors AND hypoxia requiring high-flow oxygen or positive pressure ventilation) AND the individual will be admitted to an inpatient settingCRS grade 3 or 4
When CRS criteria met, hospital-based outpatient setting is appropriate only with plan for inpatient admission
Indication-specific medical necessity criteria — master grouping
Indication- and trial-specific medical necessity criteria apply for listed agents; many agents require documentation of prior trials, specialist prescribing, and age/weight thresholds.
Specialist prescriber requirement: Medication is prescribed by or in consultation with the relevant specialist (e.g., gastroenterologist for Entyvio, rheumatologist for RA agents, dermatologist for psoriasis agents, ophthalmologist for uveitis)
See indication-specific nodes for specialty requirement
Age and weight thresholds vary by indication: Minimum age or weight requirements apply per agent and indication (examples: AS age ≥12 for Cosentyx; Crohn's disease age ≥6 for adalimumab products; non-infectious uveitis age ≥2 for infliximab/adalimumab products; PJIA weight ≥63 kg for Kevzara)Varies by indication
Refer to indication-specific nodes for exact thresholds
Prior conventional therapy requirement: For many indications, individuals must have had an inadequate response or intolerance to appropriate conventional therapies (e.g., corticosteroids, NSAIDs, methotrexate, leflunomide, sulfasalazine, azathioprine, 6-mercaptopurine) prior to biologic/targeted agents
Entyvio (vedolizumab) SC — Crohn's disease
Entyvio SC for Crohn's disease is covered only when ALL of the following are met:
Age: The individual is aged 18 years or older>=18 years
Prior conventional Crohn's therapy: Has tried one corticosteroid OR has tried one other conventional agent for Crohn's disease (e.g., azathioprine, 6‑mercaptopurine, methotrexate, mesalamine) OR has enterocutaneous/rectovaginal fistulas OR has had ileocolonic resection
Prior biologic/targeted agent failures: Has had a trial and treatment failure with 2 of the listed biologics/targeted agents (examples include adalimumab products [Humira or listed biosimilars], Cimzia, Omvoh [mirikizumab SC], Rinvoq [upadacitinib], Stelara/ustekinumab products, Skyrizi, etc.)2 of list
Entyvio (vedolizumab) SC — Ulcerative colitis
Entyvio SC for ulcerative colitis is covered only when ALL of the following are met:
Age: The individual is aged 18 years or older>=18 years
Prior biologic/targeted agent failures: Has had a trial and treatment failure with 2 of the listed agents (examples include adalimumab products [Humira or listed biosimilars], Omvoh [mirikizumab SC], Rinvoq, Simponi [golimumab], Skyrizi, Stelara, Tremfya, Velsipity, Xeljanz/tofacitinib),2 of list
Entyvio IV induction: Has received induction therapy with Entyvio (vedolizumab) IV OR is currently undergoing induction with Entyvio IV
Prescriber:
Rituxan / Rituxan Hycela — Rheumatoid arthritis
Rituxan (rituximab) IV or Rituxan Hycela SC for rheumatoid arthritis is covered when ALL of the following are met:
Disease severity: Treating moderately to severely active rheumatoid arthritis (e.g., at least 8 swollen and at least 8 tender joints)clinical
Concomitant methotrexate: Administered in combination with methotrexate
Second-line use: Used as second-line therapy when the individual has tried and failed any one of the listed first‑line therapies OR the individual has had inadequate response to methotrexate/other csDMARD and is not a suitable candidate for TNF inhibitors (e.g., recent malignancy, latent TB contraindicating prophylaxis)
Prior rituximab biosimilar trial: Has had an inadequate response or intolerance to Riabni AND Ruxience AND Truxima (rituximab biosimilars)
Kineret (anakinra) — Rheumatoid arthritis
Kineret (anakinra) for rheumatoid arthritis is covered when ALL of the following are met:
Age: The individual is aged 18 years or older>=18 years
Prior conventional csDMARD failure: Has not responded to or does not tolerate hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine
Prior biologic/targeted failures: Has had an inadequate response or intolerance to 2 of the listed agents (examples: tocilizumab [Actemra/Avtozma/Tyenne], etanercept, adalimumab products, Rinvoq, Xeljanz)2 of list
Prescriber: Medication is prescribed by or in consultation with a rheumatologist
Kevzara (sarilumab) — JIA and RA
Kevzara (sarilumab) for polyarticular JIA and rheumatoid arthritis is covered when ALL of the following are met:
PJIA weight/age: For polyarticular JIA: the individual weighs at least 63 kg and has aggressive disease>=63 kg
Prior conventional csDMARD failure: Has had inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine
Prior biologic/targeted failures: Has had inadequate response or intolerance to 2 of the listed drugs (examples: tocilizumab products, etanercept, adalimumab products, Rinvoq, Xeljanz)2 of list
Bimzelx (bimekizumab) is covered for listed dermatology and rheumatology indications when ALL indication‑specific criteria are met:
Age: Individual is aged 18 years or older for adult indications>=18 years
Ankylosing spondylitis prior failure: Has had inadequate response or intolerance to 1 listed drug for AS (e.g., etanercept, adalimumab, ixekizumab)1 of list
Plaque psoriasis severity: For plaque psoriasis: chronic plaque psoriasis involving ≥10% BSA OR special-site exception (face, hands/feet pustular, genital) documented>=10% BSA or exception
Cosentyx (secukinumab) — multiple indications
Cosentyx (secukinumab) is covered for ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis when ALL indication‑specific criteria are met:
Age by indication: Age requirements vary: AS age ≥12 years; plaque psoriasis age ≥6 years; PsA age ≥2 years for active diseasevaries by indication
Prior biologic/targeted failures: Has had inadequate response or intolerance to 2 of the listed agents for AS and PsA (agents include etanercept, adalimumab products, Rinvoq, Taltz, Xeljanz) and for plaque psoriasis inadequate response to 2 of listed agents2 of list
Prior systemic therapy for psoriasis: History of adequate trial and treatment failure with at least 1 approved systemic therapy unless contraindicated1 therapy
Siliq (brodalumab) — Plaque psoriasis
Siliq (brodalumab) is covered for plaque psoriasis when ALL of the following are met:
Age: The individual is aged 18 years or older>=18 years
BSA or special-site exception: Chronic plaque psoriasis involving at least 10% BSA OR exception for extensive recalcitrant facial, pustular hands/feet, or genital involvement>=10% BSA or exception
Prior systemic therapy: History of adequate trial and treatment failure with at least 1 approved systemic therapy unless contraindicated1 therapy
Ilumya (tildrakizumab) — Plaque psoriasis
Ilumya (tildrakizumab) is covered for plaque psoriasis when ALL of the following are met:
Age: The individual is aged 18 years or older>=18 years
BSA or special-site exception: Chronic plaque psoriasis involving at least 10% BSA OR special-site exception documented>=10% BSA or exception
Prior systemic therapy: History of adequate trial and treatment failure with at least 1 approved systemic therapy unless contraindicated1 therapy
Olumiant (baricitinib) — Rheumatoid arthritis
Olumiant (baricitinib) for rheumatoid arthritis is covered when ALL of the following are met:
Age: The individual is aged 18 years or older>=18 years
Prior conventional csDMARD failure: Has not responded to or does not tolerate hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine
Prior biologic/JAK failures: Has had an inadequate response or intolerance to 2 of the listed agents (examples: tocilizumab products, etanercept, adalimumab products, Rinvoq, Xeljanz)2 of list
Prescriber: Medication is prescribed by or in consultation with a rheumatologist
Zeposia (ozanimod) — Ulcerative colitis
Zeposia (ozanimod) for ulcerative colitis is covered when ALL of the following are met:
Age: The individual is aged 18 years or older>=18 years
Prior biologic/targeted failures: Has had a trial and treatment failure with 2 of the listed agents (examples include adalimumab products, Omvoh [mirikizumab], Rinvoq, Simponi, Skyrizi, Stelara, Tremfya, Velsipity, Xeljanz)2 of list
Prescriber: Zeposia is prescribed by or in consultation with a gastroenterologist
Dose/quantity limits: Dose is limited to 0.92 mg per day; quantity limited to 30 tablets per 30 days when managed as pharmacy benefit
Orencia (abatacept) — multiple indications
Orencia (abatacept) IV/SC is covered for polyarticular JIA, psoriatic arthritis, and rheumatoid arthritis when ALL of the following are met (indication‑specific):
PJIA age/weight: For polyarticular JIA: individual is aged 2 years or older and has aggressive disease>=2 years
Prior conventional csDMARD failure: Has had an inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine
Prior biologic/targeted failures: Has had an inadequate response or intolerance to 2 of the listed drugs (examples: tocilizumab products, enbrel, adalimumab products, Rinvoq, Xeljanz)2 of list
Second-line TNF‑α inhibitors (multiple adalimumab products and biosimilars) for ankylosing spondylitis are covered when ALL of the following are met:
Age: Individual is aged 18 years or older>=18 years
Prior requirement — adalimumab product trials: Has had an inadequate response or intolerance to ALL the listed adalimumab products (adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, Humira [AbbVie] NDCs starting with 00074)all listed
Prescriber: Medication is prescribed by or in consultation with a rheumatologist
Adalimumab-class products and biosimilars are covered for specified indications when ALL general requirements below AND the indication‑specific prerequisites are met:
General requirement — specialist prescriber: Medication is prescribed by or in consultation with the relevant specialist (rheumatologist, dermatologist, gastroenterologist, ophthalmologist, pulmonologist as specified)
Prior therapy requirement — adalimumab product trials: Has had an inadequate response or intolerance to ALL the listed adalimumab products (adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, Humira [AbbVie]) or other specified therapies per indication
Many indications require failure of listed adalimumab products or alternatives
Infliximab-class coverage criteria
Infliximab products (Remicade, Janssen unbranded, Renflexis, biosimilars) are covered for non‑infectious uveitis and other listed indications when ALL of the following are met:
Age: Individual is aged 2 years or older for non-infectious intermediate/posterior/panuveitis>=2 years
Pediatric threshold for uveitis
Prior therapies attempted: Has tried periocular, intraocular, or systemic corticosteroids OR immunosuppressives and had inadequate response or intolerance to specified adalimumab agents; may require trial/failure of infliximab biosimilars (Avsola, Inflectra) before some products
Prescriber: Medication is prescribed by or in consultation with an ophthalmologist
Certolizumab / Golimumab and other TNF inhibitors — coverage criteria
Certolizumab (Cimzia), golimumab (Simponi), and other TNF inhibitors are covered for listed indications when ALL indication‑specific requirements are met:
Ankylosing spondylitis (Cimzia/Simponi): Individual is aged ≥18 AND has had inadequate response or intolerance to 2 listed drugs (examples: etanercept, adalimumab products, Rinvoq, Taltz, Xeljanz) AND medication prescribed by/consult with a rheumatologist
Crohn's disease (Cimzia): Individual is aged ≥18 AND has tried a corticosteroid or other Crohn's agent OR has fistula/ileocolonic resection AND trial/failure of listed adalimumab agents AND medication prescribed by/consult with a gastroenterologist
Plaque psoriasis (Cimzia): Individual is aged ≥18 with chronic plaque psoriasis ≥10% BSA (or exception) AND prior trial/failure of at least 1 systemic therapy AND inadequate response/intolerance to 2 specified agents AND prescribed by/consult with a dermatologistBSA ≥10% or exception
Benefit Management — benefit classification and operational notes
Benefit management: where agents are managed and any pharmacy/medical distinctions that affect authorization.
Medical benefit managed agents: Actemra IV, Avsola, Avtozma IV, Cosentyx IV, Inflectra, Infliximab (Janssen unbranded), Orencia IV, Remicade, Renflexis, Riabni, Rituxan, Rituxan Hycela, Ruxience, Tofidence IV, Tyenne IV, and Truxima are managed through the medical benefit.
Medical / Pharmacy benefit agents: Multiple agents (examples include Abrilada, several adalimumab biosimilars, Actemra SC, Bimzelx, Cimzia, Cosentyx SC, Entyvio SC, Kevzara, Kineret, Orencia SC, Siliq, Simponi, Tyenne SC, Yusimry, etc.) are managed through both the pharmacy and medical benefit per product listing.
Pharmacy-only agents: Olumiant (baricitinib) and Zeposia (ozanimod) are managed through the pharmacy benefit; Zeposia quantity limits and dose limits apply when managed as pharmacy benefit.
Evidence-supported indications and safety considerations
Evidence summaries and safety considerations supporting use of TNF‑alpha inhibitors and related agents; informational only.
Psoriasis efficacy evidence: Randomized trials (e.g., REVEAL, CHAMPION) demonstrated significant PASI‑75 improvement with adalimumab versus placebo (REVEAL: 71% vs 6.5% at week 16; CHAMPION: 80% at week 16) and maintenance of response; loss-of-response observed when therapy withdrawnPASI-75 at 16 weeks
Psoriatic arthritis and spondyloarthropathies context: PsA and other spondyloarthropathies share pathogenic features with RA; TNFα inhibitors are therapeutic options for moderate-severe disease when conventional DMARDs/NSAIDs are insufficientclinical judgement
Pyoderma gangrenosum context: For refractory pyoderma gangrenosum, after failure of topical/systemic therapies, biologic therapy including TNF inhibitors has been reported as successful in some cases
Coverage criteria updates (partial)
Recent coverage criteria updates and operational changes
Formulary and product updates: Multiple biologic products and biosimilars were added, removed, or had preferred status changes; some products discontinued or removed from market per change history
Authorization duration change: Re-authorization duration for approvals updated from 3 years to 12 months12 months
Preferred-adalimumab trial modification: For some indications (e.g., uveitis) the requirement was changed from trial of ALL preferred adalimumab products to trial of ONE preferred adalimumab product1 preferred adalimumab trial
Age/weight eligibility administrative updates:
Hospital-based outpatient infusion or injection services are considered not medically necessary when the policy’s site-of-service criteria are not met. The policy specifies preferred medically necessary settings (physician’s office, infusion center, or home infusion) and limits hospital-based outpatient use to defined circumstances (for example, the first 90 days of an initial course or re‑initiation after ≥6 months, lack of any outpatient infusion center within a reasonable travel distance, no contracted home infusion agency available, or clinical conditions that increase the risk of complications). Site‑of‑service reviews may deny claims billed to a hospital outpatient department if documentation does not support one of the hospital‑based exceptions or the stated medical‑risk criteria (e.g., symptomatic cardiac or significant pulmonary disease, unstable renal function, difficult vascular access, acute cognitive impairment, or history of severe drug reactions).
Use of baricitinib (Olumiant) for treatment of alopecia is considered a cosmetic indication under this policy and therefore is not covered. Providers should not submit authorization requests for baricitinib for alopecia as a covered medical indication under this policy.
All uses of the agents named in this policy outside the specific indications and criteria listed — including combinations of the listed agents for indications not described in the policy — are considered investigational and are not covered. Requests for indications or combinations not enumerated in the policy should be denied as not meeting the published medical‑necessity criteria.
Refer to the full policy document for detailed criteria, coding, and prior authorization instructions when the specific exclusion or coverage question is not addressed in a summary.
The policy discusses safety concerns associated with biologic and targeted therapies — for example, increased risks of serious infections and the mixed evidence regarding malignancy risk with TNFα inhibitors — but these safety considerations are presented to inform clinical decision‑making rather than to establish absolute, blanket exclusions. Treatment decisions may be influenced by individual risk factors and documented safety concerns, and the policy requires prescribers to follow FDA dosing and monitoring guidance when assessing benefit versus risk.
This medical policy does not apply to Medicare Advantage. Member eligibility, benefit limits, and plan‑specific conditions determine coverage; providers and members should consult the member benefit booklet or customer service to verify whether the policy applies to a given plan.
If the site‑of‑service medical‑necessity criteria are not documented or met, use of a hospital‑based outpatient infusion department for administration of IV or injectable therapy is considered not medically necessary and may be denied on site‑of‑service review. Documentation supporting an approved hospital outpatient exception (for example, CRS grade 3–4 requiring imminent inpatient admission, or one of the listed increased‑risk clinical conditions) must be provided to justify hospital outpatient billing.
The policy reiterates that the use of baricitinib for alopecia is categorized as a cosmetic indication and is not covered; this statement appears in multiple sections of the policy to emphasize the exclusion for that specific use.
Consistent with the policy’s investigational/coverage stance, all other uses of the drugs listed in this policy — meaning indications, combinations, or treatment contexts not explicitly outlined — are considered not medically necessary or investigational and are excluded from coverage under the policy’s criteria.
Reserved for additional coverage‑clarification language or source references as needed. Refer to the full policy for any supplemental or jurisdiction‑specific wording.
Evidence cited in the policy shows that a low‑dose adalimumab induction regimen for ulcerative colitis did not achieve statistically significant improvement versus placebo in clinical remission, whereas the higher‑dose induction regimen did. This trial result is noted in the policy to inform that lower‑dose induction regimens are not supported by the cited evidence and may not meet medical‑necessity criteria for induction in UC.
Coverage under this policy is subject to the limits and conditions of the member’s benefit plan. Member contracts vary; services that fall outside a member’s benefit limits or are excluded by the member’s plan will not be covered. Providers and members should confirm plan applicability and benefit details in the member benefit booklet or by contacting customer service.
Coding: Products, HCPCS, and Dosing Limits
Listed biologic and targeted agents (by product name)mixed
Actemra
tocilizumab (IV/SC)
Avtozma
tocilizumab-anoh (IV/SC)
Tofidence
tocilizumab-bavi (IV)
Tyenne
tocilizumab-aazg (IV/SC)
Riabni
rituximab-arrx (IV)
Ruxience
rituximab-pvvr (IV)
Truxima
rituximab-abbs (IV)
Humira
adalimumab (SC) and biosimilars
Avsola
infliximab-axxq (IV)
Inflectra
infliximab-dyyb (IV)
1–10 of 22
1/3
Product identifiers and dosing limits referencedNDC | mixed
NDCs starting with 00074
Humira (adalimumab) (AbbVie) reference
NDCs starting with 00597
adalimumab-adbm reference
NDCs starting with 00597
adalimumab-adbm (alternate listing)
NDCs starting with 82009
adalimumab-adbm (other listing) referenced in second-line TNF-α
0.92 mg/day
Dose limit for Zeposia (ozanimod)
HCPCSHCPCS
J0129
Injection, abatacept (Orencia), 10 mg
J0139
Injection, adalimumab (Humira) 1 mg
J0717
Injection, certolizumab pegol (Cimzia), 1 mg
J1745
Injection, infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J3245
Injection, tildrakizumab (Ilumya), 1 mg
J3247
Injection, secukinumab (Cosentyx), IV, 1 mg
J3262
Injection, tocilizumab (Actemra), 1 mg
J3590
Unclassified biologics (use to report: Amjevita, Bimzelx, Cyltezo, Hadlima, Hulio, Hyrimoz, Kevzara, Kineret, Siliq, Simlandi, Yuflyma and Yusimry)
J9311
Injection, rituximab 10 mg and hyaluronidase (Rituxan Hycela)
J9312
Injection, rituximab (Rituxan), 10 mg
1–10 of 11
1/2
HCPCSHCPCS
J0129
Injection, abatacept (Orencia), 10 mg
J0139
Injection, adalimumab (Humira) 1 mg
J0717
Injection, certolizumab pegol (Cimzia), 1 mg
J1745
Injection, infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J3245
Injection, tildrakizumab (Ilumya), 1 mg
J3247
Injection, secukinumab (Cosentyx), IV, 1 mg
J3262
Injection, tocilizumab (Actemra), 1 mg
J3590
Unclassified biologics (use to report: Amjevita, Bimzelx, Cyltezo, Hadlima, Hulio, Hyrimoz, Kevzara, Kineret, Siliq, Simlandi, Yuflyma and Yusimry)
J9311
Injection, rituximab 10 mg and hyaluronidase (Rituxan Hycela)
inv-40: Hospital outpatient site-of-service initial period — first 90 days rule
Hospital outpatient initial-period ruleHospital-based outpatient site-of-service is considered medically necessary for the first 90 days for the initial course of infusion or injection, or for re-initiation of therapy after 6 months or longer (does not include standard dosing intervals ≥6 months)
Alternate access exceptionsHospital outpatient site is medically necessary when no outpatient infusion center exists within 50 miles or no contracted home infusion agency will travel to the individual, or hospital is the only place offering the drug
Clinical-risk indicationHospital outpatient site is medically necessary when the individual has a clinical condition that increases risk of complications from infusion/injection (see risk criteria)
Preferred non-hospital sitesPhysician's office, infusion center, or home infusion are the preferred medically necessary sites of service for specified drugs
Provider Actions, Prior Authorization, and Documentation Requirements
Prior Authorization
Prior Authorization Required
Prior authorization and step therapy apply to agents listed in this policy. Confirm the member's Formulary ID (6062) and Rx Plan (F1) before submitting an authorization request; this policy applies only to members enrolled in the custom Open formulary plan. Prior authorization may be required under either the pharmacy benefit, the medical benefit, or both depending on the product (see benefit-specific guidance).
Check Formulary ID: 6062 and Rx Plan: F1 prior to submission
Verify member benefit booklet or ID card for plan applicability
Confirm whether the drug is managed under pharmacy, medical, or both benefits
Many drugs in this policy require a clinical prior authorization that documents the specific indication, age, prior therapies tried and failed, and the specialty of the prescriber. Some agents additionally require specialty prescriber prescribing or consultation (e.g., gastroenterologist for Entyvio SC/IV, rheumatologist for many biologics used in RA).
Clinical Background and Evidence
This policy governs the use of specified biologic and targeted immunomodulatory agents for autoimmune, inflammatory, and other immune‑mediated conditions and defines prior authorization, step therapy, and site‑of‑service criteria for those agents. It includes indication‑specific medical‑necessity requirements (age/weight minima, required trials of conventional therapies and prior biologics, specialist prescriber requirements), dose and quantity limits (for example, Zeposia limited to 0.92 mg per day and some oral agents limited to 30 tablets per 30 days), safety considerations (infections, potential malignancy concerns), benefit management distinctions (medical vs pharmacy benefit), and operational updates (addition/removal of products and HCPCS/Q‑codes and change of re‑authorization duration to 12 months). The policy applies to the specified custom Open Formulary (Formulary ID and Rx plan should be confirmed) and is intended to support consistent coverage decisions and prior‑authorization reviews for the listed agents when the policy’s conditions are met.
inv-76: Definition Site of Service (SOS) term
Site of Service (SOS) definitionThe location where the drug is administered, such as physician's office, infusion center, home infusion, or hospital-based outpatient infusion department
Preferred medically necessary sitesPhysician's office, infusion center, and home infusion are the preferred medically necessary sites for specified drugs
Hospital-based outpatient role
Policy Changes and Revision History
2026-06-01criteria_updateLatest
Updated criteria for Cosentyx (secukinumab) in ankylosing spondylitis lowering the age requirement from 18 to 12 years and removed coverage criteria for Yuflyma (adalimumab-aaty) after discontinuation; multiple products (Simlandi, adalimumab-ryvk, adalimumab-adbm) were changed from preferred to non-preferred and several second-line/related product criteria were updated.
2026-04-01annual_review
Annual review added Otezla XR (apremilast XR) as a preferred alternative to Bimzelx and included other administrative and criteria updates noted during the March 10, 2026 approval.
Policy Summary
PayerPremera Bluecross
PolicyMedical Necessity Criteria for Custom Open Formulary (IV and Injectable Biologics)
Policy CodePolicy N/A
Change TypeCoverage additions and product status updatesre-authorization shortened to 12 months
Effective DateJun. 1, 2026
Next Review DateN/A
Key ActionObtain prior authorization with documentation of indication, age, prior therapy trials and specialist consultation when requesting coverage.
Conventional therapy requirement referenced across criteria
Prior biologic/targeted agent trials: Most agents require documented trial and treatment failure or intolerance to a defined number of specified biologic or targeted therapies (commonly 1–2 agents listed for the indication) before approvalTypically 1–2 of listed agents
See each agent's indication-specific criteria for the exact list and number
Authorization duration and documentation: Initial approvals may be granted up to 12 months; medical records (office visit notes, diagnosis, history, physical evaluation, medication history) must be submitted to demonstrate medical necessity and clinical response for re-authorizationUp to 12 months
Operational requirement across listed agents
Entyvio IV induction: Has received induction therapy with Entyvio (vedolizumab) IV OR is currently undergoing induction with Entyvio IV
Prescriber: Entyvio SC is prescribed by or in consultation with a gastroenterologist
Entyvio SC is prescribed by or in consultation with a gastroenterologist
Rituxan Hycela SC exception for difficult access: Exception for Rituxan Hycela (rituximab + hyaluronidase) may be granted when documentation of difficult venous access is provided
Documentation of difficult venous access required for SC exception
Presence of heart failure, previously treated lymphoproliferative disorder, previous serious infection, or demyelinating disorder is relevant to therapy choice
Prescriber: Medication is prescribed by or in consultation with a rheumatologist
Prior systemic therapy for psoriasis: History of adequate trial and treatment failure with at least 1 approved systemic therapy unless contraindicated1 systemic therapy
Prior biologic failure: Has had inadequate response or intolerance to at least 1 listed biologic agent (e.g., adalimumab products, Cosentyx, Skyrizi, Stelara, Tremfya)1 of list
Prescriber: Medication prescribed by or in consultation with the relevant specialist (dermatologist or rheumatologist)
Prescriber: Medication is prescribed by or in consultation with a dermatologist or rheumatologist as appropriate
Prior biologic failures:
Has had inadequate response or intolerance to 2 listed agents (examples include etanercept and another specified biologic)
2 of list
<=0.92 mg/day; 30 tablets/30 days
Presence of heart failure, previously treated lymphoproliferative disorder, previous serious infection, or demyelinating disorder may influence therapy choice
Prescriber: Medication prescribed by or in consultation with dermatologist or rheumatologist as appropriate
Polyarticular JIA (Cimzia): Individual aged ≥2 with aggressive disease AND inadequate response/intolerance to leflunomide/methotrexate/sulfasalazine AND inadequate response/intolerance to 2 listed biologic/targeted agents AND prescribed by/consult with appropriate specialist
Rheumatoid arthritis (Cimzia/Simponi): Individual aged ≥18 AND failed or intolerant to conventional DMARDs AND inadequate response/intolerance to 2 listed agents AND prescribed by/consult with rheumatologist
refractory disease
Ulcerative colitis induction dose-dependence: High-dose adalimumab induction increased clinical remission at Week 8 versus placebo while low-dose did not differ from placebo, indicating dose matters for induction efficacyinduction regimen (HD vs LD)
Safety and monitoring: TNFα antagonists carry risks including serious infections and potential malignancy concerns; long-term safety monitoring and clinical judgment are necessarymonitoring
Age and weight-based eligibility were updated for certain agents and indications (examples: Cosentyx for AS age >=12 years; Kevzara PJIA weight >=63 kg)
see thresholds module
inv-41: Pulmonary function threshold (risk) — Percent predicted FVC 40%
Pulmonary function risk thresholdPercent predicted forced vital capacity (FVC) ≤ 40% is cited as an increased risk criterion making hospital-based outpatient administration medically necessary
Context of useListed among clinical conditions (cardiac/pulmonary, unstable renal function, difficult vascular access, acute mental status changes, prior severe adverse reactions) that may require hospital-based outpatient setting
Implication for site-of-service reviewPresence of %FVC ≤ 40% supports designation of hospital outpatient site-of-service for infusion/injection due to increased complication risk
inv-42: Zeposia daily dose limit 0.92 mg/day
Zeposia maximum daily doseDose is limited to 0.92 mg per day for Zeposia (ozanimod)
Prescriber requirementZeposia must be prescribed by or in consultation with a gastroenterologist for ulcerative colitis
Associated quantity controlQuantity limits and pharmacy benefit management apply (see quantity limit block) when dispensed orally
inv-43: Oral quantity limit 30 tablets per 30 days
Oral quantity limitQuantity is limited to 30 tablets per 30 days for listed oral agents (applies to specified classes and agents)
Applies toReferenced in context of second-line S1P receptor modulators and T-cell costimulation modulators as well as other oral agents in the policy
Benefit/dispensing implicationQuantity limit enforced under pharmacy or combined medical/pharmacy management as specified in benefit section
inv-44: CDAI threshold for moderate-severe Crohn's disease CDAI 220 and 450
Clinical implicationCDAI within this range is used to identify patients with moderate-severe disease for biologic therapy consideration
inv-45: Kevzara PJIA weight requirement individual weighs at least 63 kg
Kevzara PJIA weight requirementFor polyarticular juvenile idiopathic arthritis (PJIA), the individual must weigh at least 63 kg to meet Kevzara (sarilumab) criteria
Associated disease characteristicKevzara PJIA criteria also require aggressive disease and prior csDMARD failure per policy
Prescriber requirementMedication must be prescribed by or in consultation with a rheumatologist
inv-46: Cosentyx ankylosing spondylitis age requirement 12 years or older
Cosentyx age requirement for ASCosentyx (secukinumab) is indicated for ankylosing spondylitis in individuals aged 12 years or older (age requirement updated from 18 to 12)
Indication-specific variationAge minima vary by indication for Cosentyx (e.g., plaque psoriasis and PsA age thresholds differ) as noted in indication nodes
Prescriber requirementMedication must be prescribed by or in consultation with a dermatologist or rheumatologist as appropriate
inv-47: Simponi psoriatic arthritis age requirement 18 years or older
Simponi age requirement for PsASimponi (golimumab) for psoriatic arthritis is for individuals aged 18 years or older
Age correctionsPolicy administrative updates corrected pediatric/adult age references for Simponi across indications
Prescriber requirementMedication should be prescribed by or in consultation with a rheumatologist or dermatologist as appropriate
Documented diagnosis and indication for use
Patient age per drug-specific criteria (examples: Entyvio SC/IV: ≥18 years for adults; Cosentyx: ≥12 years or per indication)
Specialty prescriber requirement or documented specialist consultation when specified (e.g., gastroenterologist for IBD agents, rheumatologist for RA agents)
Billing Rule
Benefit-Specific Prior Authorization
Benefit routing: list whether the agent is managed through the medical benefit, pharmacy benefit, or both. Submit medical benefit requests for IV-administered agents and pharmacy or combined requests for SC/oral/dispensed products as outlined below.
Medical benefit: IV/inpatient-administered agents (e.g., Actemra IV, Remicade, Rituxan IV, infliximab products)
Pharmacy & Medical benefit (both): selected SC/administered agents that may be billed through either channel (see list in policy)
Authorization requests must include sufficient clinical documentation of indication and efficacy. For dermatology and gastroenterology indications, include trial outcomes and objective response measures (for psoriasis, PASI-75/PASI-90; for ulcerative colitis, induction remission and Mayo scores where available). For continuation requests provide documentation of ongoing clinical benefit.
Psoriasis: Include PASI-75 or PASI-90 results when available and dates of assessment
Ulcerative colitis: Provide induction/remission data and Mayo scores or documented clinical remission/response
Continuation requests: chart notes demonstrating sustained clinical improvement or maintenance of response
Denial Risk
Site-of-Service Denial Triggers
Site-of-service denials may occur when medical benefit site-of-service criteria are not met. Hospital outpatient billing may be denied if administration could appropriately occur in a physician office, infusion center, or home infusion and the SOS criteria (including clinical risk factors or initial course rules) are not met.
SOS criteria apply only to medical benefit reviews (does not apply to Alaska fully-insured members)
Hospital-based outpatient setting considered medically necessary only for initial 90 days for initial course or re-initiation after ≥6 months unless clinical exceptions apply
Prior therapy trials are required for many second-line and specialty agents. Authorization requests must document prior trials, trial durations, and reasons for failure or intolerance. Commonly required trials include specific adalimumab products or other listed alternatives before escalation to second-line agents.
Document prior trials and failures with first-line agents per indication (many criteria require failure/intolerance to one or more listed agents)
For Entyvio SC: document trial and treatment failure with two listed alternatives and prior IV induction where required
Many indications require trial of preferred adalimumab products before non-preferred alternatives (see preferred-product trial requirement)
Denial Risk
Documentation Absent or Insufficient
Incomplete or absent documentation will increase denial risk. Medical records must include office visit notes, medication history, prior therapy details, and specialist consultation notes when required. Lack of documented trials, insufficient clinical measures, or missing office notes may result in denial or request for more information.
Include office visit notes with diagnosis, relevant history, physical evaluation, and medication history
Provide dates, durations, and reasons for discontinuation or failure of prior therapies
If specialist prescribing is required, include the consultation notes or a clear statement from the specialist
Documentation Required
Documentation Insufficiency
When evidence of meeting criteria is incomplete (e.g., missing diagnostic confirmation, missing prior therapy documentation, or absent specialist sign-off), the request may be denied or delayed. Ensure submitted records explicitly demonstrate each required coverage criterion.
Operational note: missing records demonstrating prior therapy failures or objective outcome measures (e.g., PASI, Mayo scores) will prompt a request for records or denial
Ensure diagnostic criteria and objective measures are clear in the chart notes
Dose matters for clinical effectiveness in certain indications. For ulcerative colitis, low-dose adalimumab induction was not effective in randomized trial data; authorization justification should reflect evidence-based dosing and induction regimens.
UC evidence: High-dose adalimumab induction (e.g., 180/60/40/40 mg) led to higher remission rates; low-dose induction did not differ from placebo
Provide induction dosing and response data when using adalimumab for UC
Note
Benefit Limitations / Plan Exclusion
Coverage is subject to the member's benefit plan limits and exclusions. Even if medical necessity criteria are met, benefits may be limited or excluded by the member's contract. Always verify benefit coverage and any applicable quantity or dosing limits prior to authorization.
Authorization is not a guarantee of payment — check member contract for exclusions and limits
Quantity limits noted for certain agents (e.g., Zeposia dose limit 0.92 mg/day; baricitinib limited to 30 tablets/30 days)
Documentation Required
Required Clinical Documentation & Exceptions for SC Formulations
Required clinical documentation for all prior authorization submissions includes office visit notes with diagnosis, relevant history, physical exam, medication history, age, prescriber specialty or consultation notes, and documentation of prior therapies (including dates, doses, and reason for discontinuation). For certain SC formulation exceptions (e.g., Rituxan Hycela), document difficult venous access when requesting an exception.
Office visit notes with diagnosis, history, physical evaluation, and medication history
Age and indication must be documented per drug-specific age requirements
Specialty prescriber or documented specialist consultation when required
For Rituxan Hycela SC exceptions: document difficult venous access with clinical details
Documentation Required
Dosage and Administration Adherence
All drugs listed in this policy are subject to FDA dosing and administration. Authorization will consider whether dosing, frequency, and route match product labeling and evidence cited in the policy. Requests above stated dose/quantity limits risk denial.
Ensure dosing and administration adhere to FDA-approved labeling
Quantity limits: e.g., Zeposia limited to 0.92 mg per day; baricitinib limited to 30 tablets per 30 days
Requests exceeding labeled dosing or quantity limits should include supporting clinical rationale
Step Therapy
Step Therapy Tiers and Preferred-Product Trial Requirement
Step therapy tiers and specific required trial sequences are described in the policy. Providers must document trials of first-line and second-line agents and the reason for failure before approval of higher-tier products. Preferred-product trials may be required (e.g., trial of specified preferred adalimumab products).
Follow tier definitions: first-line and second-line groupings per policy tables
Document inadequate response or intolerance to required number of agents (commonly 1–2 trials depending on indication)
Preferred-product trial requirement: some criteria require trial of preferred adalimumab products (e.g., adalimumab-aaty, adalimumab-adaz, adalimumab-adbm) prior to escalation
Step Therapy
Conventional Therapy Before Biologic
Conventional therapy expectations: many biologic approvals require prior trial and inadequate response to conventional systemic therapies (e.g., methotrexate, leflunomide, sulfasalazine) or other non-biologic agents before initiating biologic therapy. Document trials, durations, and intolerance/contraindication rationale if conventional therapy was not used.
For arthritis and juvenile idiopathic arthritis: document inadequate response to conventional DMARDs (e.g., methotrexate) before biologic use unless contraindicated
If conventional therapy is not appropriate, provide clinical rationale and supporting documentation
Prior Authorization
Approval Length and Re-Authorization
Initial and re-authorization approvals: when criteria are met, drugs may be approved for up to 12 months. Re-authorization requires documentation of continued clinical benefit and adherence to criteria.
Initial authorization: up to 12 months when criteria are met
Re-authorization: up to 12 months with chart notes documenting ongoing positive clinical response
Hospital outpatient infusion department is a defined SOS that may be medically necessary under specific initial-period, access, or clinical-risk conditions
inv-77: Definition Cytokine Release Syndrome (CRS) grade 3 or 4
CRS grade 3 or 4 definitionCytokine release syndrome (CRS) grade 3 or 4 is defined by ALL: temperature ≥38°C; hypotension requiring one or more vasopressors; and hypoxia requiring high-flow oxygen or positive pressure ventilation (CPAP/BiPAP/intubation/mechanical ventilation)
Disposition requirementCRS grade 3 or 4 accompanied by plan for inpatient admission makes hospital-based outpatient setting medically necessary
Entyvio SC induction requirementCandidates for Entyvio (vedolizumab) SC must have received or be undergoing induction therapy with Entyvio IV before SC formulation is considered
Prescriber requirementEntyvio SC must be prescribed by or in consultation with a gastroenterologist
Prior-failure requirementEntyvio SC criteria require trials and treatment failure with two listed biologics/agents prior to approval
PJIA - aggressive disease featuresPolyarticular juvenile idiopathic arthritis (PJIA) can be relentlessly progressive in children <10 years; features associated with aggressive disease include rheumatoid factor (RF) positivity, HLA-DR4 positivity, or anti-CCP antibodies
Clinical implicationAggressive disease designation supports consideration of biologic therapy such as IL-6 or other advanced agents per policy criteria
Use in criteria'Aggressive disease' is referenced as a requirement for Kevzara and certain PJIA coverage criteria
Crohn's disease severity contextTherapeutic recommendations depend on disease location, severity, and complications; biologic trials evaluated efficacy in moderately to severely active disease defined by CDAI between 220 and 450
Treatment componentsPharmacologic approaches include corticosteroids, immunosuppressants (azathioprine, methotrexate), 5-ASAs, and biologics; surgical resection is common in CD
Evidence baseAdalimumab demonstrated induction and maintenance efficacy in randomized controlled trials (CLASSIC-I/II, GAIN, CHARM) informing policy thresholds
Hidradenitis suppurativa overviewHidradenitis suppurativa (HS) is a recurrent inflammatory skin disease with painful, deep-seated nodules, abscesses, sinus tracts, and scarring; moderate-severe HS was studied with Humira achieving superior HiSCR response at Week 12
Clinical featuresCommonly affected areas include axillae, groin, buttocks, and inframammary regions; severe cases may have extensive draining lesions
Treatment pathwayBiologic therapy (adalimumab) is indicated for moderate-severe HS after standard therapies; HiSCR is used as a trial endpoint
JIA backgroundJuvenile idiopathic arthritis (JIA) is immune-mediated arthritis in children; treatments include NSAIDs, DMARDs, and TNF inhibitors for refractory or moderate-severe disease
Diagnosis/testingDiagnosis may use ESR, ANA, RF, and anti-CCP testing; treatment choices depend on extent and individual needs
Treatment goalsFocus on controlling pain, improving function, and preventing joint damage; early therapy may include DMARDs and biologics for severe disease
inv-85: Definition Psoriasis clinical background and efficacy trial metrics
Psoriasis backgroundPsoriasis is a chronic immune-mediated skin disease; systemic agents and biologics are used for moderate to severe disease with trial metrics including PASI-75 and PASI-90
Efficacy trial metricsPASI-75 at 16 weeks (e.g., REVEAL, CHAMPION) is a primary efficacy endpoint cited for adalimumab and other biologics in psoriasis trials
Treatment spectrumTopical therapies are first-line; phototherapy and systemic agents (methotrexate, cyclosporine) and biologics are used when topicals fail
Psoriatic arthritis backgroundPsoriatic arthritis is a spondyloarthropathy associated with psoriasis, characterized by peripheral and axial inflammation, joint destruction, dactylitis, and enthesitis
Treatment considerationsPharmacologic therapy combined with rehabilitation is effective; early pharmacologic therapy is needed to avoid joint damage
TNF inhibitor roleTNFα inhibitors are used for moderate-severe disease when DMARDs/NSAIDs are insufficient
Ankylosing spondylitis backgroundAnkylosing spondylitis (AS) is a spondyloarthropathy with progressive vertebral enthesitis and facet joint inflammation of the spine and sacroiliac joints, potentially leading to spinal fusion and decreased mobility
Epidemiology/associationAS affects approximately 1-3 per 1000 in the U.S.; sacroiliitis may be associated with inflammatory bowel disease in some patients
TreatmentNSAIDs, corticosteroids, sulfasalazine for mild disease; TNF inhibitors and biologics for moderate to severe or progressive disease
Pyoderma gangrenosum backgroundPyoderma gangrenosum is an inflammatory dermatologic condition with painful necrotic ulcerations often at sites of minor injury; treatment is empirical and may include systemic immunosuppressants and biologics when other therapies fail
Clinical approachDue to heterogeneity and rarity, management is individualized; first-line options include topical agents, systemic corticosteroids, and immunosuppressants
Biologic useBiologic therapy including TNF inhibitors may be tried when conventional therapies fail
inv-89: Re-authorization duration updated from 3 years to 12 months
Re-authorization duration updateRe-authorization (ongoing approval) duration was updated from 3 years to 12 months in this policy
Operational impactApprovals previously granted up to 3 years are now limited to a maximum re-authorization period of 12 months per the update
Change effective dateChange documented in policy history and change log entries associated with criteria updates
inv-90: Preferred vs non-preferred product formulary designation changes and status notes
Preferred vs non-preferred product changesMultiple products had formulary designation changes (examples: Cyltezo and Simlandi moved to non-preferred; Yuflyma removed/discontinued; Idacio removed from market); preferred status updates are reflected in indication criteria
Effect on step therapyPreferred-product trials and sequencing were updated in some indication criteria (e.g., uveitis criteria changed from trial of ALL preferred adalimumab products to trial of ONE preferred product)
Administrative notesProduct additions, removals, and HCPCS code updates were applied across criteria as market availability and formulary status changed
2026-01-02product_and_code_update
Effective Jan 2, 2026 following 90-day notification: title changed to 'Medical Necessity Criteria for Custom Open Formulary' and HCPCS J0135 was removed; additional product and status adjustments implemented.
2025-12-01coverage_addition
Added coverage criteria for Remicade (infliximab), brand infliximab, and Renflexis (infliximab-abda) for selected indications and made administrative pediatric coverage updates for Simponi (golimumab).
2025-10-01status_and_market_changes
Removed Idacio (adalimumab-aacf) from the policy after market removal; changed Cyltezo from preferred to non-preferred; updated preferences for several infliximab and adalimumab products with effective dates and provider notifications noted.
Interim review approved June 23, 2025 updated policy title and changed re-authorization duration from 3 years to 12 months; added multiple rituximab, tocilizumab, vedolizumab SC, anakinra, sarilumab, bimekizumab, secukinumab, brodalumab, tildrakizumab, baricitinib, ozanimod, abatacept, certolizumab, and golimumab criteria and associated HCPCS codes.
2025-04-01annual_review
Annual review approved March 11, 2025 updated listings and age requirements for multiple adalimumab products and related criteria.
2025-01-01new_policy
New policy approved December 10, 2024 became effective Jan 1, 2025, adding coverage criteria for a broad set of adalimumab branded products and biosimilars and adding HCPCS codes J0135, J3590, Q5131, and Q5132.
Medications listed in this policy are subject to the product’s FDA dosing and administration prescribing information. The policy also documents dose‑specific limits and quantity caps where applicable (for example, Zeposia 0.92 mg/day and a 30‑tablet per 30‑day oral quantity limit for specified agents); providers must adhere to FDA‑approved dosing regimens and the policy’s stated dose/quantity limits when requesting authorization.