ModifiedPremera BluecrossPolicy N/A

Pharmacotherapy of Arthropathies (biologic and injectable agents)

Medical necessity and site-of-service review criteria for intravenous and injectable pharmacologic agents used to treat inflammatory arthropathies; governs provider requirements for medical benefit reviews and site-of-service determinations for Premera members (with an Alaska fully‑insured exception).

Policy Summary

PayerPremera Bluecross

PolicyPharmacotherapy of Arthropathies (biologic and injectable agents)

Policy CodePolicy N/A

Change TypeCoverage criteria updates and formulary/step‑therapy reclassifications

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document required trials of preferred biologic agents and prescriber specialty when requesting covered biologic or injectable therapies.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Kevzara (sarilumab) for treatment of adult polymyalgia rheumatica (PMR).

Updated Actemra (tocilizumab) coverage criteria to require prior inadequate response or intolerance to both methotrexate and Humira (adalimumab) for rheumatoid arthritis.

Added note that use of baricitinib for alopecia is considered cosmetic and not covered.

Updated preferred and non-preferred lists and line-of-therapy placements for multiple adalimumab biosimilars and infliximab products, including movement of Simponi Aria and Avsola to first-line and Inflectra to second-line effective 01/01/2024.

Baricitinib use for alopecia is considered cosmetic and is not covered by this policy.

Coverage criteria added for Kevzara for treatment of adult individuals with polymyalgia rheumatica (PMR).

Multiple adalimumab and infliximab biosimilar product formulary statuses were changed (preferred vs non-preferred), with corresponding coverage criteria adjustments and required trials of preferred products prior to non-preferred.

Site of service review/requirements were added for certain IV products and site-of-service medical necessity criteria exceptions were specified for Alaska fully-insured members and for cytokine release syndrome.

Age and weight requirements were added or updated for many products and indications including ankylosing spondylitis, PJIA, RA, and PsA.

An exception to brand step therapy requirements was added for certain agents if the individual has heart failure, prior lymphoproliferative disorder, prior serious infection, or demyelinating disorder (varies by agent/indication).

Notes that certain medical necessity criteria do not apply to specified custom Open and Preferred formularies (Formulary IDs) were added and updated; cross-reference to policy 5.01.647 provided.

Kevzara PJIA coverage criteria updated to require the individual weigh at least 63 kg.

Added Humira biosimilars Idacio and Adalimumab-fkjp to non-preferred list and added other biosimilars to preferred/non-preferred lists over time.

Updated Cosentyx coverage criteria for psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis including adding Rinvoq as a qualifier.

Changed line-of-therapy status for infliximab and related products (Inflectra, Avsola, Remicade, etc.) across several effective dates.

Added new HCPCS and Q/C codes over time (examples: C9166, Q5133, Q5131, Q5115, J3247, Q5156).

Updated re-authorization duration of approval from 3 years to 12 months.

Added site-of-service reviews and exceptions (e.g., Cosentyx IV, Tofidence IV), and an exception to site-of-service criteria for Alaska fully-insured members.

Added exceptions to brand step therapy requirements for patients with heart failure, previously treated lymphoproliferative disorder, previous serious infection, or demyelinating disorder.

Clarified coverage applicability for certain custom formulary plans and referenced separate policy for those plans.

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13+Drugs listed for SOS review

MultipleStep therapy tiers

SpecifiedAge/weight thresholds

AppliedSite-of-service rules

1+Cosmetic exclusions

12 moRe-authorization duration

Coverage and Medical Necessity Criteria

Site of Service Medical Necessity

Covered when ALL of the following site-of-service conditions are met

When hospital outpatient is necessary due to access: Considered medically necessary when no outpatient infusion center within 50 miles and no contracted home infusion agency will travel, or hospital is the only place that offers infusions or injections of this drugno outpatient center within 50 miles OR no home infusion agency

When patient clinical risk requires higher level of care: Medically necessary when individual has increased risk for infusion complications including known cardiac or pulmonary condition (e.g., symptomatic arrhythmia, significant respiratory disease, %FVC <= 40%), unstable renal function, difficult/unstable vascular access, acute mental status changes impacting safety, or history of severe adverse reactions/anaphylaxisany one listed clinical risk

Agent- and indication-specific medical necessity

Covered when ALL of the following are met for specific agent/indication groups

Ankylosing spondylitis - TNF antagonists (first-line): Individual is aged 18 years or older AND medication is being prescribed by or in consultation with a rheumatologistage >=18

applies to listed TNF agents including adalimumab variants

Ankylosing spondylitis - alternate agents (when required): For some agents (e.g., Cimzia, Simponi), individual has had inadequate response or intolerance to two specified agents (listed per product) AND medication is prescribed by or in consultation with a rheumatologistprior trials per product

See product-specific lists

Agent-specific prior therapy requirement: Certain agents (including infliximab-family and some biologics) require documented prior trials and treatment failures of specified agents or biosimilars before coveragedocumented trial and treatment failure as stated

See individual agent criteria for required sequencing

Polyarticular JIA — biologics and targeted agents

Covered when ALL of the following are met for polyarticular juvenile idiopathic arthritis (JIA) agents listed:

Age and prescriber: Individual is aged 2 years or older AND medication is being prescribed by or in consultation with a rheumatologistage >=2 yrs

applies to many JIA agents

Disease severity: Has aggressive disease where specifiedaggressive disease per Related Information

some agents require 'aggressive disease'

Prior therapy requirement: Has had an inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine OR is being started concurrently with one of these agentsprior DMARD trial or concurrent start

Systemic JIA — IL‑6 inhibitors

IL‑6 inhibitors for systemic juvenile idiopathic arthritis — Covered when ALL of the following are met:

Age: Individual is aged 2 years or olderage >=2 yrs

Prior therapy: Has had an inadequate response or intolerance to a corticosteroid, leflunomide, methotrexate, NSAID, or sulfasalazineprior DMARD/corticosteroid failure

Prescriber: Medication is being prescribed by or in consultation with a rheumatologistrheumatologist involvement

Selected IV forms are subject to site-of-service review

Enthesitis-related arthritis — IL‑17 inhibitor (Cosentyx)

Enthesitis‑related arthritis — IL‑17 inhibitor (Cosentyx) Covered when ALL of the following are met:

Age: Individual is aged 4 years or olderage >=4 yrs

Prescriber: Medication is being prescribed by or in consultation with a rheumatologistrheumatologist involvement

Rheumatoid arthritis — biologics and targeted agents

Moderate to severe rheumatoid arthritis — Covered when ALL of the following are met (agent-dependent):

Age: Individual is aged 18 years or olderage >=18 yrs

Conventional therapy failure: Has not responded to or does not tolerate hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine (varies by agent)prior conventional DMARD failure

some agents require failure of specific biologics or all members of an adalimumab subgroup before approval

Biologic sequencing: For second-line or later agents: has had inadequate response or intolerance to specified first-line biologics or trials of Avsola/Inflectra for infliximab products as notedprior biologic trials per agent

Notable coverage criteria updates

Selected coverage policy changes and indication-specific notes included in this excerpt:

Actemra (tocilizumab) RA requirement: Coverage requires documented inadequate response or intolerance to both methotrexate and adalimumab prior to Actemra for rheumatoid arthritis

Effective January 1, 2021 per update.

Kevzara (sarilumab) for PMR: Kevzara has added coverage criteria for adult PMR patients with inadequate response to corticosteroids or inability to taper; randomized trial evidence showed higher sustained remission and assessed cumulative corticosteroid dose

Trial evidence cited includes sustained remission at 52 weeks and corticosteroid-sparing outcomes.

Baricitinib (Olumiant) cosmetic use: Use of baricitinib for alopecia is considered cosmetic and is not covered

Biosimilar and product sequencing changes:

Aggregated coverage criteria updates (partial)

Coverage and step-therapy criteria were updated across multiple agents; where present the policy requires trials of preferred products, age/weight eligibility, and documents exceptions.

General formulary/step-therapy rule: Member must have trial and inadequate response or intolerance to required preferred products before non-preferred products are approved; preferred product lists and sequences were updated across multiple agents

Applies variably by agent and effective date; see product-specific sections in full policy.

Site-of-service criteria: Site-of-service medical necessity review applies to specified IV formulations (e.g., Cosentyx IV, certain tocilizumab IV products, Tyenne IV)

Exceptions for Alaska fully-insured members and for cytokine release syndrome treatment cases noted.

Age/weight eligibility: Specific agents and indications include minimum age and/or weight requirements (example: Kevzara PJIA requires weight >=63 kg); multiple agents had age requirements added for pediatric indications

Exact age/weight per product listed elsewhere in the policy.

Extracted coverage logic and prerequisite rules

Policy-level coverage logic and prerequisites described in history entries (summarized):

Prescriber specialty and prior therapy prerequisites: Many agents require documentation of prescriber specialty and prior trials of specified conventional DMARDs or TNF blockers before coverage (e.g., RA, PJIA, PsA)see individual drug criteria

Referenced across multiple history entries

Site of service exception: Site-of-service review applies to certain IV agents; exception allowed when no outpatient infusion center within 50 miles, no contracted home infusion agency will travel, or hospital is the only site offering the infusiondistance/access

chunk 96

Biosimilar sequencing: Preferred biosimilars must be tried and failed prior to non-preferred adalimumab products; NDC series used to define preferred vs non-preferred products

Evolving coverage criteria and step therapy

Coverage and step-therapy requirements have been updated over time; specific criteria vary by agent, indication, age, and formulary status. Examples from the history include:

Adalimumab products step therapy: New starts of certain adalimumab products require trial and inadequate response or intolerance to preferred adalimumab products before non-preferred adalimumab products are approvedpreferred product trial required

Preferred/non-preferred lists changed multiple times; re-authorization shortened to 12 months.

Infliximab family sequencing: Certain infliximab products must be tried and failed prior to using non-preferred infliximab agents; line-of-therapy assignments (first vs second line) were updated across datestrial/failure of specified infliximab agents

Inflectra moved to first-line; Avsola and others shifted status.

Site-of-service requirement:

Hospital-based outpatient, outpatient hospital IV infusion department, or hospital-based outpatient clinical level of care are considered medically necessary only in specified circumstances. Hospital-based outpatient care is medically necessary for the initial course of infusion/injection or for re‑initiation after ≥6 months, except when the standard dosing interval between administrations is 6 months or longer. Hospital administration is also medically necessary when no outpatient infusion center is available within 50 miles and no contracted home infusion agency will travel, or when the hospital is the only site that provides the drug. Additionally, hospital administration is appropriate when the patient has clinical risk factors that increase the chance of infusion complications (examples include symptomatic cardiac arrhythmia or significant respiratory disease with %FVC ≤ 40%, unstable renal function, difficult or unstable vascular access, acute cognitive/mental status changes that impact safety, or a history of severe reactions/anaphylaxis to related agents).

Use of tofacitinib (Xeljanz and formulations) for the indication of alopecia is considered a cosmetic use and is not covered under this policy.

The medical necessity criteria in this policy do not apply to members enrolled in one specific custom Open formulary (Formulary ID: 6062; Rx Plan F1). Members covered under that formulary follow the separate medical necessity criteria in policy 5.01.647 (Medical Necessity Criteria for Custom Open Formulary); providers should check the member’s plan booklet or ID card to confirm applicability.

Use of baricitinib (Olumiant) in the setting of alopecia is designated as a cosmetic indication and is not covered by this policy. This exclusion was added in recent policy updates and will result in denial when baricitinib is requested for alopecia.

Requests for baricitinib when the intended use is for alopecia are considered cosmetic and are not covered by this policy; such uses are treated as not medically necessary.

Policy history documents that baricitinib use for alopecia was explicitly classified as cosmetic and not covered effective with the interim review added 06/01/2023; requests for that indication are therefore excluded from coverage under this policy.

This medical policy does not apply to Medicare Advantage members. Providers should consult the member’s benefit booklet or Medicare Advantage plan documents for applicable coverage rules.

Claims for infusion or injectable drugs administered in sites that do not meet the policy’s site‑of‑service (SOS) medical necessity criteria are considered not medically necessary. If the specified SOS conditions (initial course/re‑initiation timing, access limitations, or listed high‑risk clinical criteria) are not met, administration in a hospital outpatient or other higher‑acuity site may be denied.

The use of tofacitinib (Xeljanz) for alopecia is considered cosmetic and is not covered by this policy; requests for this indication will be denied as not medically necessary.

The policy explicitly classifies baricitinib for alopecia as a cosmetic, not medically necessary use and therefore not covered; this exclusion appears repeatedly in the policy history and exclusion lists.

When baricitinib is prescribed for alopecia, the policy treats that indication as cosmetic and not medically necessary, and such requests will not meet coverage criteria under this policy.

Use of baricitinib for alopecia is documented in the policy as a cosmetic exclusion. Requests for coverage for this indication are not supported by this policy and will be denied.

The policy’s change history and exclusion statements make clear that baricitinib in the setting of alopecia is considered a cosmetic indication and is not covered under the medical necessity criteria described here.

Codes and Eligibility (HCPCS / CPT / NDC)

Drugs subject to site-of-service reviewmixed

Actemra (tocilizumab) IV	listed agent subject to SOS review
Avsola (infliximab-axxq)	listed agent subject to SOS review
Avtozma (tocilizumab-anoh) IV	listed agent subject to SOS review
Cosentyx (secukinumab) IV	listed agent; SOS review
Inflectra (infliximab-dyyb)	listed agent subject to SOS review
Infliximab (Janssen - unbranded)	listed agent subject to SOS review
Orencia (abatacept)	listed agent
Remicade (infliximab)	listed agent
Renflexis (infliximab-abda)	listed agent
Rituxan (rituximab)	listed agent

1–10 of 13

1/2

Janus Kinase InhibitorsmixedCovered

Rinvoq	upadacitinib (oral)
Xeljanz	tofacitinib (oral)
Xeljanz XR	tofacitinib extended-release (oral)

TNF-α Antagonists (adalimumab group)mixedCovered

Adalimumab-aaty	adalimumab biosimilar/formulation
Adalimumab-adaz	adalimumab biosimilar/formulation
Adalimumab-adbm	adalimumab biosimilar/formulation (NDCs starting with 00597)
Humira	adalimumab

IL-6 InhibitorsmixedCovered

Actemra	tocilizumab (IV/SC)
Avtozma	tocilizumab-anoh (IV/SC)
Tofidence	tocilizumab-bavi (IV)
Tyenne	tocilizumab-aazg (IV/SC)

IL-17 InhibitorsmixedCovered

Cosentyx

secukinumab (SC)

T-Cell Costimulation ModulatorsmixedCovered

Orencia

abatacept (IV/SC)

Infliximab products (IV)mixedCovered

Infliximab (Janssen - unbranded)	infliximab (IV)
Remicade	infliximab (IV)
Renflexis	infliximab-abda (IV)
Avsola	infliximab-axxq (IV)
Inflectra	infliximab-dyyb (IV)

Referenced HCPCS/HCPCS-like codesHCPCS

J1602	HCPCS code referenced in history for Actemra/site-of-service and other updates
Q5121	HCPCS code added for Avsola
Q5133	HCPCS code added (documented in 04/01/24 coding update)
C9166	HCPCS code added (documented in 04/01/24 coding update)
J3590	HCPCS code used for certain adalimumab products/biosimilars

Historical HCPCS/Q/J code changesHCPCS

C9166	HCPCS code (added then terminated 7/1/2024) referenced in history
Q5133	HCPCS/Q code added (context: coding update)
Q5131	HCPCS code for Idacio (added)
Q5115	HCPCS code added (context in history)
J3247	HCPCS code added
J3590	Noted usage for certain IV biologics (e.g., Tyenne added to J3590)
Q5156	HCPCS code added 11/01/25 for Avtozma

inv-33: weight — individual weighs at least 63 kg

Weight thresholdIndividual must weigh at least 63 kg

Policy change noteKevzara PJIA coverage criteria updated to require individual weights at least 63 kg (06/01/26 history).

Applicable indicationApplies to Kevzara (sarilumab) for polyarticular juvenile idiopathic arthritis (PJIA).

inv-34: age for polyarticular JIA — >= 2 years

Minimum age

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Medical benefit and SOS prior authorization — Prior authorization/medical benefit review and duration

Prior authorization/medical benefit review is required for the IV and injectable drugs listed in this policy. Non-formulary exception authorizations for drugs in this policy may be approved for up to 12 months. Site-of-service (SOS) medical necessity review applies only to medical benefit reviews (not pharmacy) and does NOT apply to Alaska fully-insured members; contact Customer Service or refer to the member plan booklet to determine applicability.

Prior authorization duration for non-formulary exception approvals: up to 12 months (effective 01/03/2025 update and reiterated 2025 Update).
Site-of-service reviews apply to IV/injectable route administrations billed through the medical benefit (not pharmacy).

Documentation Required

Prior authorization required — Document prior trials/failures and prescriber specialty

Prior authorization requests must include documented prior trials and treatment failures with specified preferred agents per the step-therapy sequencing in this policy. For many adalimumab (Humira) family products and infliximab-family products, coverage for non-preferred agents requires documentation that the member has tried and failed all listed preferred adalimumab and preferred infliximab products unless an exception applies (e.g., documented intolerance, heart failure, prior lymphoproliferative disorder, serious infection, or demyelinating disorder). Prescriber specialty (often rheumatologist) and age requirements must be documented where specified.

Background and Scope

Inflammatory arthropathies (for example, ankylosing spondylitis, juvenile idiopathic arthritis, polymyalgia rheumatica, and rheumatoid arthritis) are immune‑mediated disorders characterized by joint inflammation, pain, stiffness, and loss of function. Biologic agents and targeted therapies (TNF inhibitors, IL‑6 inhibitors, IL‑17 inhibitors, JAK inhibitors, T‑cell costimulation modulators, and infliximab products) have expanded treatment options; this policy defines when those therapies and their administration sites are medically necessary, documents agent‑ and indication‑specific prerequisites (age, weight, prior conventional DMARDs or biologic trials, and prescriber specialty), and records recent formulary and site‑of‑service updates that affect prior authorization and coverage decisions.

Key Definitions

inv-66: Arthropathy / inflammatory arthropathies — definition summary

DefinitionGroup of disorders affecting joints characterized by inflammation and immune dysregulation (e.g., ankylosing spondylitis, JIA, nr-axSpA, PMR, RA).

Clinical featuresSymptoms include joint pain, swelling, stiffness, and loss of motion; may involve systemic immune-mediated effects.

Purpose in policyTerm used to group indications for which biologic and targeted therapies and site-of-service rules are specified.

inv-67: Site of Service (SOS) — definition summary

DefinitionSite of Service (SOS) is the location where a drug is administered (e.g., hospital outpatient, infusion center, physician office, home).

Policy applicationSOS medical necessity review applies to medical benefit IV/injectable administration for ages 13 and older and determines if hospital outpatient setting is required.

Policy Summary

PayerPremera Bluecross

PolicyPharmacotherapy of Arthropathies (biologic and injectable agents)

Policy CodePolicy N/A

Change TypeCoverage criteria updates and formulary/step‑therapy reclassifications

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document required trials of preferred biologic agents and prescriber specialty when requesting covered biologic or injectable therapies.

SourceLink

On This Page

Polyarticular Juvenile Idiopathic Arthritis - TNF antagonists: Individual is aged >=2 years AND has aggressive disease AND has had an inadequate response or intolerance to leflunomide, methotrexate, or sulfasalazine OR is being started concurrently with one of these agents AND medication is being prescribed by or in consultation with a rheumatologistage >=2; prior csDMARD failure or concurrent start

applies to listed adalimumab products and Enbrel

Polyarticular JIA - Janus kinase inhibitors (first-line): Individual is aged >=2 years AND has had an inadequate response or intolerance to one or more TNF blockers AND medication is being prescribed by or in consultation with a rheumatologistage >=2; prior TNF failure

applies to Rinvoq, Xeljanz formulations

Renflexis requires documented failure of Avsola AND Inflectra

Prescriber: Medication is being prescribed by or in consultation with a rheumatologistrheumatologist involvement

Selected IV agents are subject to site-of-service review

Preferred and non-preferred placements updated; some biosimilars and NDC-specified products added to preferred lists to be tried prior to non-preferred agents; Simponi Aria and Avsola moved to first-line and Inflectra moved to second-line effective 01/01/2024

NDC-based identifications referenced in the policy.

Cosentyx requirement change for PsA: For psoriatic arthritis, Cosentyx requirement changed from trying three products to two products and removed requirement to try agents from two or more drug classes

Cosmetic exclusion: Use of baricitinib for alopecia is cosmetic and not covered

Will be denied under the policy.

Exceptions to brand step therapy exist for individuals with heart failure, previously treated lymphoproliferative disorder, previous serious infection, or demyelinating disorder for specified agents/indications

Applies to tocilizumab products, Kevzara, Orencia, and others as specified.

trial and failure of preferred products

Site-of-service medical necessity review was added for some IV administrations (e.g., Cosentyx IV, Tofidence IV); exceptions exist for Alaska fully-insured members and for cytokine release syndrome cases

site-of-service review required when applicable

Alaska exception per HB 226; CRS exception added.

Brand step therapy exceptions: Exceptions to brand step therapy are allowed for members with heart failure, previously treated lymphoproliferative disorder, previous serious infection, or demyelinating disorderclinical exception documented

Applied to multiple agents including Orencia and others.

Age requirements: Age-specific coverage requirements were added/updated for many agents and indications (examples include lowering age for Cosentyx ankylosing spondylitis to 12 years and adding pediatric criteria for PJIA/SJIA agents)age per-product criteria

See individual agent criteria in main policy sections.

Applicable indicationPolyarticular juvenile idiopathic arthritis (PJIA) — many JIA agents require age >=2 years.

Prescriber requirementMedication must be prescribed by or in consultation with a rheumatologist for PJIA criteria.

inv-35: age for enthesitis-related arthritis (Cosentyx) — >= 4 years

Minimum age>= 4 years

Applicable agentCosentyx (secukinumab) for enthesitis-related arthritis

Prescriber requirementMedication must be prescribed by or in consultation with a rheumatologist.

inv-36: age for rheumatoid arthritis — >= 18 years

Minimum age>= 18 years

Applicable conditionModerate to severe rheumatoid arthritis — adult patients aged 18 years or older.

Prior therapy typicalRequires prior failure/intolerance to conventional DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) per agent-specific criteria.

inv-37: Kevzara PJIA weight requirement — >= 63 kg

Kevzara PJIA weight requirement>= 63 kg

Evidence/contextKevzara coverage criteria for PJIA updated in 2026 history to require body weight at least 63 kg.

IndicationApplies to Kevzara (sarilumab) when used for polyarticular juvenile idiopathic arthritis.

inv-38: Age requirements — Age requirements added or updated for numerous agents and indications (AS, PJIA, RA, PsA, nr-axSpA) as specified per product in the policy.

Scope of updatesAge requirements were added or updated for numerous agents and indications (AS, PJIA, RA, PsA, nr-axSpA) as specified per product in the policy.

ExamplesCosentyx, Rinvoq, Xeljanz, Cimzia, Simponi, infliximab and adalimumab products had age thresholds added/updated in 2025–2026 updates.

Reference noteExact minimum ages vary by product and indication; see individual product criteria in the policy history and sections.

inv-39: weight threshold for Kevzara in PJIA — at least 63 kg

Weight threshold for Kevzara in PJIAAt least 63 kg

Policy historyHistory entry notes update Kevzara PJIA criteria to require individual weights at least 63 kg (06/01/26).

Applies toKevzara (sarilumab) when used for polyarticular juvenile idiopathic arthritis (PJIA).

Document trials/failures with all preferred adalimumab biosimilars listed (examples updated 2023–2025): Cyltezo LCF/adbm, Hyrimoz HCF/adaz, Adalimumab-adaz HCF (Sandoz-unbranded), Amjevita (when preferred NDC noted).
For infliximab-family products, document trial/failure with preferred infliximab products (e.g., Inflectra, Avsola, infliximab [Janssen/unbranded], Remicade, Renflexis) as required by the indication and the current sequencing rules.
If an exception to step therapy is claimed (e.g., heart failure, prior lymphoproliferative disorder, prior serious infection, or demyelinating disorder), include clinical documentation supporting the exception.

Denial Risk

Site-of-Service denial triggers

Use of a hospital-based outpatient site beyond the medically necessary conditions in this policy may trigger a site-of-service denial. SOS denials commonly occur when outpatient hospital infusion is requested but site-of-service criteria are not met (for example, initial course beyond the first 90 days without clinical justification, or lack of access exceptions).

Hospital-based outpatient setting is considered medically necessary for the first 90 days for initial course of infusion or re-initiation after ≥6 months only when criteria met.
Requests for hospital-based outpatient administration may be denied if there is an outpatient infusion center within 50 miles of the member's home and a contracted home infusion agency will travel to the home, unless other clinical exceptions apply.
Claims for IV-administered drugs must be processed through the medical benefit; inappropriate billing route may affect processing.

Note

Site-of-Service access limitation that can affect coverage

An access-based exception to SOS may permit hospital-based outpatient administration when there is no outpatient infusion center within 50 miles of the individual’s home and no contracted home infusion agency will travel to the home. Lack of local outpatient/home infusion access is a recognized criterion for SOS approval; absence of that access is a common reason for denial.

Site-of-service exception criterion: no outpatient infusion center within 50 miles AND no contracted home infusion agency that will travel to the home.
If the access exception is claimed, include documentation of distance/access attempts and confirmation that no contracted home infusion agency is available.
Alaska fully-insured members: SOS criteria do not apply pursuant to Alaska HB 226 — check member coverage.

Step Therapy

Preferred/non-preferred sequencing for biosimilars and infliximab products

Preferred and non-preferred placements for adalimumab biosimilars and infliximab-family products have been updated repeatedly; providers must follow the current sequencing and document trials of preferred products before non-preferred products will be authorized. Recent updates (2023–2026) moved multiple adalimumab and infliximab products between preferred and non-preferred tiers — verify the member’s plan and the policy effective dates when documenting prior trials.

2023–2024 updates: preferred Humira biosimilars included Cyltezo LCF, Hyrimoz HCF, Adalimumab-adaz HCF and Amjevita (specified NDCs) to be tried prior to non-preferred agents.
2024–2025 updates: Avsola and Inflectra sequencing changed (Inflectra moved to first-line; Avsola moved between first/second line at different points); Inflectra was later moved to first-line and Avsola to second-line then updated again — follow current policy table.
2025–2026 updates: Several adalimumab products (Simlandi, adbm variants) were moved from preferred to non-preferred and preferred alternatives were updated to include specific adalimumab products with listed NDC groupings; new preferred infliximab products (e.g., Avsola when listed preferred) may be required to be tried first.

ExceptionsSOS criteria do not apply to Alaska fully‑insured members; see policy notes and history for exceptions (Alaska HB 226).

inv-68: enthesitis-related arthritis — definition summary

DefinitionEnthesitis-related arthritis is a JIA category that includes children with arthritis and enthesitis (inflammation at tendon/ligament insertion sites).

Typical age/criteriaCosentyx coverage for enthesitis-related arthritis requires the individual be aged 4 years or older and rheumatologist involvement.

ClassificationListed under JIA subtypes in policy step-therapy tiers (IL‑17 inhibitors first-line).

inv-69: JIA — Juvenile Idiopathic Arthritis (JIA)

TermJuvenile Idiopathic Arthritis (JIA)

Clinical noteMost common type of arthritis in children; diagnosed with clinical assessment and tests (ESR, ANA, RF, CCP); treatment aims to control symptoms and prevent joint damage.

Policy relevanceMultiple JIA subtypes appear in policy with age-specific criteria (e.g., PJIA age >=2 yrs).

inv-70: PMR — Polymyalgia Rheumatica (PMR)

TermPolymyalgia Rheumatica (PMR)

Clinical featuresInflammatory rheumatic condition with symmetrical aching and morning stiffness in shoulder/hip girdle and neck; typically affects adults >50 yrs with elevated ESR/CRP.

Policy relevanceKevzara coverage criteria were added for adult PMR in policy history with trial evidence cited.

inv-71: Custom formulary exception — Members enrolled in specified custom Open or Preferred formularies follow different medical necessity rules (Formulary ID references)

DefinitionCustom formulary exception: Members enrolled in specified custom Open or Preferred formularies (Formulary ID: 6062 and previously 6064) follow different medical necessity criteria referenced in policy 5.01.647.

Action for providersCheck member plan booklet or ID card to determine whether this policy applies or if policy 5.01.647 governs.

Policy effectCertain criteria/age applicability notes may not apply to members on these custom formularies.

inv-72: Site of Service review — definition summary

DefinitionSite of Service review is a review determining whether infusion administration must occur in a hospital outpatient setting versus alternate settings (infusion center, office, home).

Access exceptionAn exception may be allowed when no outpatient infusion center is available within 50 miles and no contracted home infusion agency will travel; hospital may be necessary.

Applies toSpecified IV products listed in the policy (e.g., certain tocilizumab IV forms, Cosentyx IV, Tyenne) are subject to SOS review.

inv-73: brand step therapy exception — definition summary

DefinitionBrand step therapy exception: an allowance to bypass brand-specific step therapy when the member has specified clinical conditions (heart failure, previously treated lymphoproliferative disorder, prior serious infection, or demyelinating disorder).

ApplicabilityExceptions applied to specified agents/indications (e.g., Orencia and others) per history entries; documentation required.

Provider requirementDocument qualifying clinical condition to support brand step therapy exception request.

inv-74: site-of-service review — definition summary (alternate chunk)

DefinitionSite-of-service review: A review determining medical necessity for administration in a particular setting (e.g., IV infusion) for specified drugs such as Cosentyx IV and certain tocilizumab products.

Policy noteSOS criteria apply to individuals aged 13 and older for medical benefit reviews; Alaska fully-insured members are excepted per HB 226.

ImplicationSelected IV agents listed in the policy will trigger SOS review and may require justification for hospital outpatient administration.