DraftPremera BluecrossPolicy 5.01.550

Pharmacotherapy of Arthropathies (biologic and infusion therapies)

This policy governs medical necessity, site-of-service review, and step-therapy requirements for intravenous and injectable biologic and targeted agents used to treat inflammatory arthropathies (e.g., ankylosing spondylitis, juvenile idiopathic arthritis, rheumatoid arthritis) for Premera Bluecross members.

Policy Summary

PayerPremera Bluecross

PolicyPharmacotherapy of Arthropathies (biologic and infusion therapies)

Policy CodePolicy 5.01.550

Change TypeMultiple additions and revisions (biosimilars, site-of-service, step therapy, age/line updates)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document prior trials and rheumatology consultation per step-therapy and site-of-service criteria; approvals generally granted up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Added criteria for newly approved Janus Kinase inhibitor; Olumiant (baricitinib).

Added criteria for Skyrizi (risankizumab-rzaa) and expanded Cimzia (certolizumab pegol) criteria for non-radiographic axial spondyloarthritis.

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

Added Xeljanz Oral Solution (tofacitinib) as first-line for polyarticular JIA.

Added numerous biosimilars and updated preferred/non-preferred status of adalimumab and infliximab products (multiple 2023-2025 updates).

Removed Stelara SC site-of-service requirement and added multiple site-of-service reviews for IV products (2024).

Site-of-service medical necessity criteria exception for Alaska fully-insured members pursuant to Alaska HB 226 (effective 2025-01-03).

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

12+IV drugs listed for site-of-service review

Multiple

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Step therapy tiers referenced

>=2Minimum pediatric age threshold

12 moRe-authorization duration

multipleHCPCS/NDC coding changes

Coverage Criteria and Medical Necessity

Site-of-Service Medical Necessity Criteria

Site of Service Medical Necessity criteria (medical benefit reviews):

SOS Medical Necessity - general: Apply SOS criteria for individuals aged 13 and older for medical benefit IV/injectable administration; initial course or re-initiation after >=6 months counts as medical necessity for hospital outpatient infusion in certain circumstances.

SOS does not apply to Alaska fully-insured members; see chunk 113.

Medically necessary hospital outpatient infusion (examples): Hospital outpatient infusion site is medically necessary for the first 90 days when no outpatient infusion center within 50 miles exists or no contracted home infusion agency will travel, or when the individual has clinical conditions increasing infusion risk (e.g., symptomatic cardiac arrhythmia; significant respiratory disease with %FVC <= 40%; unstable renal function; difficult vascular access; acute mental status changes; history of severe anaphylaxis).no outpatient infusion center within 50 miles

Also applied for grade 3-4 cytokine release syndrome with specified physiologic criteria (temperature >=38 C; hypotension requiring vasopressor; hypoxia requiring high-flow oxygen or positive pressure ventilation).

Ankylosing Spondylitis — Coverage and Sequencing

Agent-specific medical necessity and step therapy rules for Ankylosing Spondylitis:

General agent criteria: Individual is aged 18 years or older AND medication is prescribed by or in consultation with a rheumatologist.age >= 18 years

Applies to TNF inhibitors, IL-17 inhibitors, and JAK inhibitors per agent-specific sections.

First-line and second-line sequencing: TNF-alpha antagonists are listed as first-line agents; IL-17 inhibitors and JAK inhibitors may be first- or second-line depending on agent and prior therapy. Some agents require inadequate response or intolerance to specified prior agents as detailed per drug (e.g., Cosentyx IV requires prior inadequate response to two listed agents).per agent

Examples: Infliximab products and certain IL-17/ JAK agents are subject to site-of-service review and step sequencing.

Polyarticular Juvenile Idiopathic Arthritis — Coverage

Polyarticular Juvenile Idiopathic Arthritis (PJIA) coverage tiers:

PJIA first-line: TNF-alpha antagonists (multiple adalimumab products, Enbrel) may be considered medically necessary for PJIA when age and prior DMARD criteria are met; medication should be prescribed by or in consultation with a rheumatologist.age >= 2 years

Specific agent and formulation distinctions (preferred vs non-preferred biosimilars) are listed in policy.

PJIA second-line: Second-line options include T-cell costimulation modulators (eg, abatacept/Orencia) and IL-6 inhibitors depending on prior therapy failure and step therapy rules.per agent

Step therapy prerequisites and site-of-service review may apply for IV formulations.

Polyarticular Juvenile Idiopathic Arthritis — TNF-a Antagonists First Line

Covered when ALL of the following are met for polyarticular juvenile idiopathic arthritis first-line TNF antagonists:

PJIA TNF-a Antagonist First Line criteria: The individual is aged 2 years or older 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 those DMARDs AND medication is prescribed by or in consultation with a rheumatologist.age >= 2 years

Applies to listed TNF-alpha antagonists including adalimumab biosimilars and Enbrel; criteria exceptions for certain custom formularies noted.

Systemic Juvenile Idiopathic Arthritis — IL-6 Inhibitors

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

SJIA IL-6 inhibitor criteria: The individual is aged 2 years or older AND has had an inadequate response or intolerance to a corticosteroid, leflunomide, methotrexate, NSAID, or sulfasalazine AND medication is prescribed by or in consultation with a rheumatologist.age >= 2 years

IV/SC formulations (eg, Actemra, Tofidence, Tyenne) may be subject to site-of-service review.

Enthesitis-Related Arthritis — IL-17 Inhibitors

Covered when ALL of the following are met for enthesitis-related arthritis — IL-17 inhibitor:

Enthesitis-related arthritis criteria: The individual is aged 4 years or older AND medication is prescribed by or in consultation with a rheumatologist.age >= 4 years

Applies to IL-17 agents such as secukinumab (Cosentyx) per agent-specific criteria.

Rheumatoid Arthritis — First-line and subsequent therapy

Covered when ALL of the following are met for moderate to severe rheumatoid arthritis — TNF antagonists, IL-6 inhibitors, or JAK inhibitors depending on line:

RA biologic/JAK criteria: The individual is aged 18 years or older AND has not responded to or does not tolerate methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine (for first-line biologics) OR has had an inadequate response or intolerance to 1 or more TNF blockers (for JAK inhibitors) AND medication is prescribed by or in consultation with a rheumatologist.age >= 18 years

Some IV agents and specific agents (eg, tocilizumab IV/SC) are subject to site-of-service review and step therapy prerequisites.

Second-line biologic/JAK therapy

Second-line or later biologic criteria (examples across classes):

Second-line TNF or other biologic criteria: For certain second-line TNF antagonists or other classes, the individual must be aged 18 or older AND have aggressive disease AND have had inadequate response or intolerance to conventional DMARDs AND to specified prior biologic agents (eg, failure of 2 specified agents) AND medication is prescribed by or in consultation with a rheumatologist.age >= 18 years

Agent-specific sequences (which agents and number of failures) are detailed in each drug section; prior trials of preferred biosimilars may be required.

IL-6 inhibitors (tocilizumab) — Initial

Tocilizumab biosimilars and Actemra for moderate to severe rheumatoid arthritis covered when ALL of the following are met

Tocilizumab-class criteria: Individual is aged 18 years or older AND has had an inadequate response or intolerance to hydroxychloroquine, leflunomide, methotrexate, or sulfasalazine AND medication is prescribed by or in consultation with a rheumatologist.age >= 18 years

Some tocilizumab products list prior trials of specified adalimumab biosimilars or account for heart failure/lymphoproliferative history in tiering.

JAK inhibitors — Initial

Janus kinase inhibitors (Rinvoq, Xeljanz) covered when ALL of the following are met

JAK inhibitor criteria: Individual is aged 18 years or older AND has had an inadequate response or intolerance to 1 or more TNF blockers AND medication is prescribed by or in consultation with a rheumatologist.age >= 18 years

Use in alopecia (tofacitinib) is considered cosmetic and not covered for that indication.

TNF inhibitors — Initial/Second-line per tier

TNF-alpha antagonists covered when ALL of the following are met

TNF antagonist criteria: Individual is aged 18 years or older AND has not responded to or does not tolerate methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine AND medication is prescribed by or in consultation with a rheumatologist AND has had an inadequate response or intolerance to specified prior adalimumab biosimilars as required by step tiering.age >= 18 years

Formulary exceptions and NDC-based preferred product rules affect which adalimumab/biosimilar must be tried first.

Infliximab products — Site-of-service and step requirements

Infliximab and biosimilars — coverage and site-of-service considerations

Infliximab criteria: Individual is aged 18 years or older AND has not responded to or does not tolerate methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine AND medication is prescribed by or in consultation with a rheumatologist AND may require documented trial/failure of specified infliximab biosimilars (eg, Avsola, Inflectra) prior to coverage of certain agents.age >= 18 years

Infliximab IV products are subject to site-of-service review; some agents require prior documented trials of preferred infliximab products.

IL-6 inhibitors and second-line biologics

IL-6 inhibitors (e.g., Kevzara) and other second-line biologics covered when ALL of the following are met

Kevzara/other IL-6 criteria: Individual is aged 18 years or older AND has not responded to or does not tolerate methotrexate/leflunomide/sulfasalazine/hydroxychloroquine AND medication is prescribed by or in consultation with a rheumatologist AND has had inadequate response or intolerance to 2 of the listed agents (eg, Actemra, tocilizumab biosimilars, Enbrel, adalimumab biosimilars, JAK inhibitors) OR has heart failure or previously treated lymphoproliferative disorder.age >= 18 years

Heart failure or prior lymphoproliferative disorder may influence tiering and exceptions to brand-step requirements.

T-cell costimulation modulators (abatacept)

Orencia (abatacept) coverage criteria

Abatacept criteria: Individual is aged 18 years or older AND has not responded to or does not tolerate methotrexate/leflunomide/sulfasalazine/hydroxychloroquine AND medication is prescribed by or in consultation with a rheumatologist AND has had an inadequate response or intolerance to 2 of the listed agents (eg, Actemra, tocilizumab biosimilars, Enbrel, adalimumab biosimilars, JAK inhibitors) OR has heart failure, previously treated lymphoproliferative disorder, previous serious infection, or demyelinating disorder.age >= 18 years

Orencia IV may be subject to site-of-service review.

Janus kinase inhibitors — Baricitinib specifics

Baricitinib (Olumiant) coverage

Baricitinib criteria: Individual is aged 18 years or older AND has not responded to or does not tolerate methotrexate/leflunomide/sulfasalazine/hydroxychloroquine AND medication is prescribed by or in consultation with a rheumatologist AND has had an inadequate response or intolerance to 2 of the listed agents (eg, Actemra/tocilizumab biosimilars, Enbrel, adalimumab biosimilars, JAK inhibitors).age >= 18 years

Use of baricitinib for alopecia is considered cosmetic and not covered.

Non-radiographic axial spondyloarthritis — criteria

Non-radiographic axial spondyloarthritis (nr-axSpA) coverage

Cimzia/Taltz/Rinvoq criteria: Individual is aged 18 years or older AND has objective signs of inflammation (elevated CRP OR sacroiliitis on MRI) AND, for some agents, has had inadequate response or intolerance to prior specified agents (eg, Cimzia prior to Rinvoq).Objective signs of inflammation (CRP elevated OR sacroiliitis on MRI)

Some IL-17 agents and Cosentyx IV may be subject to site-of-service review; step tiers vary by class.

Selected coverage and evidence statements

Selected coverage-related criteria and evidentiary notes contained in this document portion

Actemra (tocilizumab) RA coverage: Coverage requires inadequate response or intolerance to both methotrexate and adalimumab (Humira) prior to Actemra.prior MTX + adalimumab failure/intolerance

Change effective Jan 1, 2021.

Olumiant (baricitinib): Criteria added for baricitinib (Olumiant) per 2018 update.per added criteria

Full criteria referenced in policy history.

Skyrizi and Cimzia updates: Criteria added for Skyrizi and expanded Cimzia criteria for nr-axSpA per 2019 update.per added criteria

Coverage criteria examples and policy logic

Coverage and line-of-therapy assignments and prerequisite trials have been updated across multiple indications; examples follow.

Biosimilar preference logic: Certain adalimumab biosimilars are designated preferred vs non-preferred based on NDC prefixes; preferred status affects prerequisite step requirements and which agents must be tried first.NDC prefix match

See coding and history sections for specific NDC prefixes and effective dates.

Infliximab class hierarchy: Inflectra, Avsola, and Infliximab (Janssen unbranded) moved between first- and second-line positions in recent updates; some non-preferred infliximab products require prior inadequate response to preferred infliximab products.trial and failure with preferred infliximab

Effective dates noted in policy history (01/01/24, 01/03/25).

Cosentyx prerequisites change: For psoriatic arthritis and related indications, number and class requirements of prior products were changed (eg, changed from three to two products in PsA); Rinvoq was added as a qualifier for ankylosing spondylitis and nr-axSpA.

High-level coverage criteria

Coverage and step therapy criteria applied (examples extracted from history and changes):

Preferred product trial: For many non-preferred adalimumab and infliximab products, coverage requires an adequate trial and treatment failure with specified preferred biosimilars or preferred agents as listed in policy history.trial and failure as specified

Provider notification and effective dates apply; consult drug-specific sections.

Age requirement: Many agents include age requirements for indications such as AS, PJIA, RA, PsA, and nr-axSpA; member age must meet agent-specific criteria.age per agent indication

Age updates recorded across history entries.

Site-of-service medical necessity review applies for certain IV and some injection-administered products; exceptions exist (eg, Alaska fully-insured members, CRS).per product/site criteria

Site-of-service (SOS) review applies to medical-benefit IV and injectable administration for individuals aged 13 years and older. When SOS criteria are not met, hospital‑based outpatient infusion and other higher‑acuity sites are considered not medically necessary for infusion/injectable therapy. Examples of circumstances where hospital outpatient infusion may be considered medically necessary include limited local access (no outpatient infusion center within 50 miles and no home infusion agency that will travel) and acute clinical risk factors (e.g., unstable cardiopulmonary status, difficult vascular access, severe anaphylaxis or grade 3–4 cytokine release syndrome).

Claims for drugs administered via the intravenous route must be processed through the medical benefit (not pharmacy); failure to meet SOS criteria on medical‑benefit review can result in denial of the infusion/injectable service as not medically necessary.

Some members are governed by custom formulary rules and are excluded from these SOS/medical necessity criteria. Specifically, this policy does not apply to members covered under certain custom Open and Preferred formularies (examples: Formulary ID: 6062; Rx Plan F1 and Formulary ID: 6064; Rx Plan G3); those members follow the referenced policy 5.01.647 and the member’s plan booklet or ID card should be consulted to determine which criteria apply.

Non‑formulary exception approvals for drugs listed in this policy may be authorized for up to 12 months when granted; check member‑specific benefit limits and prescribing information for applicability.

Uses of the listed agents that are not described in this policy or in related disease‑specific policies, as well as combinations or novel uses not included in the policy text, are considered investigational or not medically necessary and may be denied on review. Providers should reference related policies for coverage of other conditions.

Requests that exceed FDA‑labeled dosing or that seek coverage for indications not enumerated in the policy should be considered investigational unless otherwise supported by a related policy section.

Use of tofacitinib or baricitinib (Olumiant) for the indication of alopecia is classified as cosmetic in this policy and is not covered. Requests for these agents when the primary diagnosis is alopecia will be denied as not medically necessary.

Within the excerpted policy text there are sections where no additional explicit exclusions are listed. Absent explicit exclusion language in a specific subsection, the general investigational and not‑medically‑necessary rules (see related sections) should be applied.

The policy history and criteria explicitly note that baricitinib (Olumiant) use for alopecia is considered cosmetic and not covered; this exclusion appears repeatedly across change notes and the baricitinib coverage section.

Multiple history entries reiterate that use of baricitinib for alopecia is considered cosmetic and is not covered by this policy. Providers should not submit medical‑benefit requests for baricitinib where the sole diagnosis is alopecia.

Two custom formulary plans are explicitly excluded from this medical necessity criteria: members on the specified Open and Preferred formularies (Formulary ID: 6062; Rx Plan F1 and Formulary ID: 6064; Rx Plan G3) follow policy 5.01.647 for coverage determination. Always verify the member’s plan booklet or ID card to determine whether the policy applies.

The Site‑of‑Service Medical Necessity criteria within this policy does not apply to Alaska fully‑insured members; for those members, only the infusion and injection drug Medical Necessity criteria apply pursuant to Alaska HB 226. Contact Customer Service or consult the member’s plan documents for guidance.

Requests for uses not specified in this policy or in related policies are considered not medically necessary or investigational. Providers should reference disease‑specific policies when requesting coverage for indications not listed here.

Some excerpts of the policy text do not contain explicit 'not medically necessary' statements for every circumstance. In those instances, reviewers should apply the policy’s general investigational/not‑medically‑necessary logic and denial triggers (e.g., unsupported indications, combinations not listed, or dosing beyond FDA labeling).

As restated in the baricitinib coverage and in step‑therapy notes, use of baricitinib for alopecia is considered cosmetic and is not covered by this policy; repeated history entries document this exclusion.

Indications or dosing regimens that are listed as investigational — for example, dosing that exceeds FDA‑labeled amounts for the condition — are placed in the policy’s investigational table and are not covered. Such items should be treated as not covered when encountered on review.

Denials commonly result when requests fail to meet documented step‑therapy requirements, age thresholds, or site‑of‑service criteria. Reviewers should confirm that required prior trials, prescriber specialty documentation, age criteria, and SOS/access exceptions are met before approving requests.

Coding, HCPCS and Billing

Listed agents (brand / biosimilars)mixed

Enbrel (etanercept) SC	etanercept
Adalimumab-aaty (Yuflyma) SC	adalimumab biosimilar Yuflyma
Adalimumab-adaz (Hyrimoz) SC	adalimumab biosimilar Hyrimoz
Adalimumab-adbm (Cyltezo) SC	adalimumab biosimilar Cyltezo
Adalimumab-ryvk (Simlandi) SC	adalimumab biosimilar Simlandi
Simponi Aria (golimumab) IV	golimumab IV
Actemra (tocilizumab) IV/SC	tocilizumab
Rinvoq (upadacitinib) oral	upadacitinib
Xeljanz (tofacitinib) oral / oral solution	tofacitinib
Cimzia (certolizumab pegol) SC	certolizumab pegol

1–10 of 15

1/2

HCPCS codes (selected)HCPCS

J0129	Injection, abatacept (Orencia), 10 mg
J0135	Injection, adalimumab (Humira), 20 mg (code terminated 12/31/24)
J0139	Injection, adalimumab (Humira), 1 mg (new code effective 01/01/25)
J0717	Injection, certolizumab pegol (Cimzia), 1 mg
J1438	Injection, etanercept (Enbrel), 25 mg
J1602	Injection, golimumab (Simponi Aria), for intravenous use
J1628	Injection, guselkumab (Tremfya)
J1745	Injection; infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J3247	Injection, secukinumab, intravenous (Cosentyx)
J3262	Injection; tocilizumab (Actemra)

1–10 of 11

1/2

Q-codes for biosimilars and related agentsHCPCS

Q5104	Injection, infliximab-abda; biosimilar; (Renflexis), 10 mg
Q5121	Injection, infliximab-axxq; biosimilar; (Avsola), 10 mg
Q5131	Injection, adalimumab-aacf (Idacio), biosimilar; 20 mg (code terminated 12/31/24)
Q5132	Injection, adalimumab-aacf (Abrilada), biosimilar; 10 mg (code terminated 12/31/24)
Q5133	Injection; tocilizumab-bavi (Tofidence), biosimilar
Q5135	Injection, tocilizumab-aazg (Tyenne), biosimilar
Q5140	Injection, adalimumab-fkjp, biosimilar; mg (new code effective 01/01/25)
Q5141	Injection, adalimumab-aaty, biosimilar; mg (new code effective 01/01/25)
Q5142	Injection, adalimumab-ryvk biosimilar; 1 mg (new code effective 01/01/25)
Q5143	Injection, adalimumab-adbm, biosimilar; mg (new code effective 01/01/25)

1–10 of 12

1/2

Policy HCPCS/Coding actions (added/removed/updated)HCPCS

J1602	HCPCS code added/used in policy
J0717	HCPCS code referenced as added
Q5121	HCPCS code for Avsola added
J3590	HCPCS code referenced for multiple agents (adalimumab products)
J3245	HCPCS code added (2019) then later removed
J3358	HCPCS code added (2019) then later removed

HCPCS / Unclassified biologicsHCPCS

J3590	Unclassified biologics — multiple adalimumab and other products added
Q5131	HCPCS for Idacio
Q5115	HCPCS for Truxima
J3247	New HCPCS code added
C9166	Terminated HCPCS code effective 7/1/2024

New HCPCS codes addedHCPCS

Q5098	Imuldosa
Q5099	Steqeyma
Q5137	Wezlana
Q5138	Wezlana
Q9996	Pyzchiva
Q9997	Pyzchiva
Q9998	Selarsdi
Q9999	Otulfi

Minimum age for pediatric indications

Minimum pediatric age>= 2 years

Applies toPolyarticular juvenile idiopathic arthritis and related pediatric biologic criteria

Prescriber requirementMedication prescribed by or in consultation with a rheumatologist

Minimum age for adult rheumatoid arthritis

Minimum adult age (RA)>= 18 years

Applies to

Provider Actions, Prior Authorization & Documentation

Billing Rule

Site-of-Service and Prior Review Required

Site-of-service review applies to listed IV biologics; these IV-administered drugs must be processed under the medical benefit (not pharmacy) and may require prior site-of-service review before payment. A site-of-service exception may be granted when there is no outpatient infusion center within 50 miles or no contracted home infusion agency available, or when there is a clinical exception such as cytokine release syndrome (CRS) when noted in History. Refer to the policy drug list for agents subject to SOS review (e.g., Actemra IV, Avsola IV, Cosentyx IV, Inflectra IV, Infliximab [Janssen unbranded], Orencia IV, Remicade IV, Renflexis IV, Rituxan IV, Simponi Aria IV, Tofidence IV, Tyenne IV).

Claims for IV-administered drugs must be processed through the medical benefit only (not pharmacy).
Site-of-service exception: no outpatient infusion center within 50 miles and no contracted home infusion available (historical clarification).
CRS exception noted in History: certain individuals receiving treatment for cytokine release syndrome may be excepted from SOS requirements.

Initial Therapy and Line Placement

Step Therapy Rules and Sequences

Requirement	Details
Prior trial and documented inadequate response or intolerance	Policy requires a documented prior trial with inadequate response or intolerance to specified agents before progression to later-line therapies; step therapy tiers and exact prior agents vary by drug and indication (see specific drug sections).
Processing/benefit	Claims for IV-administered drugs must be processed through the medical benefit (not pharmacy); site-of-service criteria apply for IV/injectable administration.

Step Tier	Typical Classes / Examples
First-line	TNF-alpha antagonists (e.g., adalimumab products, etanercept, golimumab) and selected infliximab biosimilars when designated first-line; some IL‑17 or JAK inhibitors may be first-line depending on agent and indication.
Second-line	IL-6 inhibitors, JAK inhibitors, T‑cell costimulation modulators, or alternate biologic classes depending on prior therapy failure and indication; some TNF agents may be positioned as second-line per update.

Prescriber Requirement	Enumerated Prior Trials Required
Rheumatologist involvement	Medication must be prescribed by or in consultation with a rheumatologist for many indications (ankylosing spondylitis, RA, JIA, nr‑axSpA).
Enumerated prior trials	Policy requires documented inadequate response or intolerance to specified prior agents per class and line (examples include prior trial(s) of conventional DMARDs for first‑line biologics; failure of TNF blockers before JAK inhibitors; failure of 2 agents before some second‑line biologics).

Example requirement (Actemra)	Required prior failures
Actemra (tocilizumab) — rheumatoid arthritis	Coverage updated to require inadequate response or intolerance to both methotrexate and adalimumab (Humira) prior to Actemra (change effective Jan 1, 2021).

Brand / Line Placement	Failure of Preferred Agents Required
Adalimumab and infliximab products (brand/biosimilar status)	Policy history documents changes to preferred vs non‑preferred status and line placement; non‑preferred agents generally require prior trial and failure of designated preferred products or biosimilars before approval.

Agents Requiring Specified Biologic Trials	Policy Example / Note
Adalimumab family and selected agents	Many agents require prior trials of specified biologic classes or named drugs (examples: Humira/Amjevita or designated preferred adalimumab biosimilars must be tried/failed per step requirements).
Infliximab products	Updates moved some infliximab products between first‑ and second‑line; policy may require trial/failure of preferred infliximab biosimilars (e.g., Inflectra, preferred infliximab list) before non‑preferred infliximab agents.

Preferred biosimilar/first‑line trial requirement	Variation by indication
Trial and failure of preferred biosimilars or designated first‑line agents	Policy requires an adequate trial and documented failure/intolerance to preferred biosimilars or line‑designated agents prior to approval of many non‑preferred agents; exact sequence and number of agents varies by indication and drug (see drug‑specific sections).
Examples of variation	Examples in history include Cosentyx PsA prerequisites changing (number of prior products reduced) and infliximab/adalimumab biosimilar preference and line changes effective on various dates—sequencing depends on disease state and updated formularies.

Site-of-Service Review and Preferred Sites

Note

Preferred and Medically Necessary Sites of Service

Preferred medically necessary sites of service include the physician's office, infusion center, and home infusion; hospital-based outpatient infusion is considered medically necessary in limited circumstances (e.g., first 90 days when access or clinical risk criteria are met).

Hospital outpatient infusion is medically necessary for the initial course or when access/clinical risk criteria apply.
Providers should document the rationale for hospital-based infusion when requested.

Prior Authorization

IV Agents Subject to Site-of-Service / Prior Review

Certain IV agents (including Simponi Aria, Actemra IV, Avsola, Inflectra) are specifically subject to site-of-service review; prior review and PA are required when these products are administered IV.

Simponi Aria (golimumab) IV and infliximab biosimilars are noted as subject to site-of-service review.
Providers must include site-of-service justification in PA submissions for these agents.

Biosimilars and Product Status

Billing Rule

Infliximab (Remicade) — Coverage with SOS Review for IV Administration

Remicade (infliximab) and its biosimilars are listed as medically necessary treatment options for rheumatoid arthritis and related indications and are subject to site-of-service review when administered IV.

Infliximab products may require documented trial/failure sequencing per policy.
Providers must follow SOS and step-therapy requirements for infliximab IV products.

Billing Rule

Tocilizumab (Actemra) and Biosimilars — Coverage and Q-code Billing

Tocilizumab (Actemra) and its biosimilars (Tyenne, Tofidence) are listed as covered IL-6 inhibitors; the policy lists specific biosimilar Q-codes for billing and notes site-of-service review for IV formulations.

Tocilizumab IV/SC products are subject to site-of-service review in relevant indications.
Use the Q-code mappings (e.g., Q5133, Q5135) for biosimilar billing as listed in the coding section.

Continuation, Re-authorization and Maintenance

Background and Policy Scope

Inflammatory arthropathies (including ankylosing spondylitis, juvenile idiopathic arthritis subtypes, and rheumatoid arthritis) are chronic immune‑mediated disorders characterized by joint inflammation, pain, stiffness, and loss of function. This policy governs medical‑benefit review of IV and injectable biologic and targeted therapies across these conditions and defines age thresholds, step‑therapy sequencing (first‑line and second‑line biologics/JAK inhibitors), site‑of‑service review requirements, and applicable exclusions for Premera Blue Cross members.

Definitions and Key Terms

Arthropathy / Arthritis definition

DefinitionInflammation of the joint resulting in pain, swelling, stiffness, and loss of motion

IncludesAutoimmune-mediated inflammatory arthropathies addressed in this policy (e.g., AS, JIA, RA)

Clinical relevanceBasis for considering biologic therapy when disease is inflammatory and progressive

Enthesitis-related arthritis definition

DefinitionA category of juvenile idiopathic arthritis that includes children with arthritis and enthesitis (inflammation at tendon/ligament/bone insertion sites)

Typical age for coverage criteriaEnthesitis-related arthritis criteria referenced for individuals aged >= 4 years

Revision History and Policy Changes

03/10/2014policy_created

Policy created (new prescription drug policy focusing on arthropathies) and replaced multiple prior policies.

07/01/2016site_of_service_added

Site-of-service drug administration review criteria added to the policy (applicable to specific drugs and part of the review process).

06/01/2022coding_and_line_changes

Infliximab (Janssen unbranded) added with identical site-of-service requirements; Inflectra moved to first-line and coverage updates for Renflexis and Avsola requiring prior trial/failure of preferred infliximab agents.

Policy Summary

PayerPremera Bluecross

PolicyPharmacotherapy of Arthropathies (biologic and infusion therapies)

Policy CodePolicy 5.01.550

Change TypeMultiple additions and revisions (biosimilars, site-of-service, step therapy, age/line updates)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document prior trials and rheumatology consultation per step-therapy and site-of-service criteria; approvals generally granted up to 12 months.

SourceLink

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Full criteria in respective sections.

Tocilizumab efficacy evidence: Randomized trials (RADIATE, OPTION, AMBITION, TOWARD) showed higher ACR20 responses at 24 weeks for tocilizumab vs placebo or MTX; overall serious infection rate ~4.7/100 person-years.ACR20 endpoints at 24 weeks

Safety considerations noted in evidence section.

Sarilumab (Kevzara): Efficacy demonstrated in RA and PMR trials with endpoints including ACR20 and sustained remission; supportive evidence summarized in policy.study endpoints

No explicit coverage logic text in excerpt.

number of prior products tried

Effective 09/01/23 per policy history.

See policy history for products added to site-of-service review (eg, Cosentyx IV, Tyenne).

Re-authorization duration for approvals updated to 12 months for non-formulary exceptions and routine re-authorizations where applicable.12 months

Changed from 3 years to 12 months per history.

Moderate to severe rheumatoid arthritis initial and subsequent biologic/JAK criteria

Prescriber requirementMedication prescribed by or in consultation with a rheumatologist

Objective signs of inflammation

Objective signs definitionC-reactive protein (CRP) elevated beyond the upper limit of normal for the reporting laboratory OR sacroiliitis reported on MRI

Clinical useRequired for diagnosis/coverage of non-radiographic axial spondyloarthritis for certain agents

DocumentationRecord laboratory CRP result or MRI report demonstrating sacroiliitis

Site-of-service access distance

Site-of-service access thresholdNo outpatient infusion center within 50 miles of the patient’s home (and no contracted home infusion agency will travel)

Exception effectIf outpatient infusion center available within 50 miles, SOS exception for hospital outpatient infusion is not met

OriginClarified in policy history (site-of-service exception criterion)

Non-formulary exception approval duration

Non-formulary exception approval durationUp to 12 months

Applies toNon-formulary exception reviews for drugs listed in this policy

Policy history noteAdded in Annual Review (02/01/25) per history section

Prior Authorization

Site-of-service / prior review — specific IV agents subject to SOS review

Certain IV agents included on the policy have been added or had PA/site-of-service review clarified in recent updates — providers must check that the requested agent is covered and whether site-of-service review applies. Examples of agents recently added to SOS or updated include Cosentyx IV, Tyenne IV, Tofidence IV, Avsola, Inflectra, Infliximab (Janssen), and additional tocilizumab products. New HCPCS/J-codes and additions to J3590 have also been made historically; check coding guidance.

Cosentyx (secukinumab) IV was added to SOS review.
Tyenne (tocilizumab-aazg) IV and Tofidence (tocilizumab-bavi) IV added to SOS coverage and review.
Infliximab products (Avsola, Inflectra, Renflexis, Infliximab unbranded) had SOS and line-of-therapy updates.

Prior Authorization

Prior authorization and approval length — PA required; initial approvals up to 12 months

Prior authorization is required for the drugs listed in this policy. Initial non-formulary exception reviews and other authorization types may be approved for up to 12 months. Re-authorization requires documentation of continued clinical benefit and may be approved for up to 12 months.

Prior authorization required for all drugs listed.
Initial approvals (including non-formulary exception reviews) may be approved up to 12 months.
Re-authorization approvals updated from prior longer durations to 12 months; chart notes must show continued positive clinical response.

Billing Rule

Prior authorization and coding updates — many agents and biosimilars added to coverage lists and HCPCS/J-codes

Prior authorization criteria and coding have been updated repeatedly: many agents and biosimilars were added to coverage lists, new HCPCS codes were added (e.g., J0139, Q5140–Q5144 and others), and adalimumab biosimilars were added to J3590. Providers must submit correct HCPCS/NDC and check the most recent coding table.

New HCPCS codes added (examples in History): J0139, Q5140–Q5144 and others.
Multiple adalimumab biosimilars and products were added to J3590 historically.
Check code updates in the History and coding sections before billing.

Prior Authorization

Prior authorization and coding — PA required; agents added to J3590 and new HCPCS codes

Prior authorization applies and some agents were specifically added to billing/code lists; check member-specific benefit limits and the policy coding guidance. Examples: additions of adalimumab biosimilars (Cyltezo, Hyrimoz, Abrilada, Hadlima, Hulio, Yusimry, Yuflyma) and movement of products between preferred/non-preferred lists affect PA and step requirements.

Adalimumab biosimilars moved between preferred and non-preferred lists — this affects which agents must be tried first under step therapy.
Cyltezo LCF, Hyrimoz HCF, and other biosimilars were updated in coverage and moved into J3590 in prior updates.
Provider should verify NDCs and formulary status when submitting a PA.

Denial Risk

Denial triggers

Denials may occur if step therapy, brand-preference, site-of-service, or documentation requirements are not met. Uses outside FDA-labeled indications or investigational combinations are considered not medically necessary. Failure to demonstrate required prior trials, lack of prescriber specialty (when required), or missing medical records may trigger denial.

Investigational or off-label combinations not outlined in policy are considered not covered.
Denial triggers include: failure to meet step therapy or brand-step requirements; lack of required prior agent trials; missing documentation of response/intolerance.
Site-of-service exception not met (e.g., outpatient infusion center available within 50 miles or contracted home infusion exists) can result in payment denial.

Documentation Required

Medical record requirements

Medical record documentation submitted with PA requests must include office visit notes with diagnosis, relevant history, physical exam, and medication history. Additional records should support prior trials, intolerance or inadequate response, and any clinical exceptions (e.g., heart failure or lymphoproliferative disorder when applicable to brand-step exceptions).

Office visit notes that include diagnosis, relevant history, physical exam findings, and medication history.
Documentation of prior agent trials, dates, doses, and reason for discontinuation (intolerance or inadequate response).
If an exception is claimed (e.g., SOS exception, brand-step exception for heart failure), include documentation supporting the exception.

Documentation Required

Diagnostic and prior therapy documentation

Diagnostic testing and documentation of prior therapy are required where indicated — for example, ESR/CRP or MRI evidence for non-radiographic axial spondyloarthritis, and documented trials/failures of specified agents per step therapy. Lab or imaging results used to establish objective inflammation should be in the medical record.

Objective signs of inflammation (e.g., elevated CRP above lab normal or sacroiliitis on MRI) for axial spondyloarthritis indications.
Documentation of prior therapy trials (agents tried, dates, duration, and outcome) required to satisfy step therapy.
For juvenile indications, include age-appropriate labs and prior DMARD trials as specified in the coverage criteria.

Note

Prescribing information and formulary note

Follow the product's FDA dosing and administration prescribing information. Also verify member-specific benefit limits, formulary status, and whether the member's plan (some custom Open/Preferred formularies) is excluded from these criteria — see policy 5.01.647 for custom formulary plans.

Medication must be prescribed consistent with FDA dosing and administration.
Check member-specific benefit limits and formulary exceptions prior to submitting PA.
Certain custom Open and Preferred formulary plans are excluded; see policy 5.01.647.

Documentation Required

Required documentation and benefit check

When submitting prior authorization requests, include all required documentation and verify member benefits and formulary status. Non-formulary exception reviews and other reviews may be approved for up to 12 months. Ensure chart notes demonstrate continued benefit for re-authorization.

Submit office visit notes, medication history, prior therapy documentation, and objective testing as applicable.
Verify whether the member's plan is subject to these criteria or is a custom plan with different rules.
Non-formulary exception approvals may be granted up to 12 months; re-authorization requires evidence of continued clinical benefit.

Step Therapy

Step therapy requirements — policy defines multiple tiers and required trials

Step therapy rules require trials of preferred/first-line agents before non-preferred or second-line agents are authorized. The policy defines multiple tiers (first-line, second-line, class-specific sequences) and lists specific required trials for different indications and agents. Non-preferred agents generally require failure of preferred biosimilars or designated first-line agents.

Step therapy tiers are agent- and indication-specific; review the policy section for the exact sequence for the requested indication.
Non-preferred agents require documented trial and failure of preferred agents or biosimilars.
Some classes (e.g., TNF inhibitors, IL-6 inhibitors, JAK inhibitors, IL-17 inhibitors) have defined first- and second-line members that must be tried in sequence.

Step Therapy

Example step requirement for Actemra — requires inadequate response/intolerance to methotrexate and Humira prior to Actemra

Example: Actemra (tocilizumab) for rheumatoid arthritis now requires documented inadequate response or intolerance to both methotrexate and Humira (adalimumab) prior to Actemra. Failure to document these prior trials will be a basis for denial.

Actemra RA coverage updated (effective Jan 1, 2021) to require inadequate response/intolerance to methotrexate AND Humira (adalimumab) prior to Actemra.
Ensure chart notes document trials, durations, and reasons for discontinuation of prior agents.

Step Therapy

Brand/preferred product step requirements and exceptions — examples and exceptions to brand step therapy

Brand/preferred product step requirements and exceptions: many agents have brand-step or preferred-product requirements (e.g., preferred adalimumab biosimilars must be tried before non-preferred adalimumab products). Exceptions to brand-step requirements exist for specific clinical situations (for example, tocilizumab products and Kevzara may have brand-step exceptions if the individual has heart failure or a previously treated lymphoproliferative disorder; additional exceptions for PJIA include prior serious infection or demyelinating disorder).

Preferred biosimilars (e.g., Cyltezo LCF, Hyrimoz HCF, Adalimumab-adaz HCF) may be required trials before non-preferred adalimumab products.
Tocilizumab and Kevzara brand-step exceptions: heart failure or previously treated lymphoproliferative disorder may allow bypassing brand-step.
PJIA-specific exceptions include heart failure, previously treated lymphoproliferative disorder, previous serious infection, or demyelinating disorder for certain agents.

Step Therapy

Step therapy updates — prerequisites changed for multiple agents (Cosentyx, TNF blockers, etc.)

Step therapy prerequisites have been updated across multiple agents (e.g., Cosentyx, TNF blockers, Olumiant, Rinvoq, Xeljanz) — check the 2023–2025 History and 2024–2025 updates for current required sequences. Many agents moved between first-line and second-line designations and preferred status changed for several biosimilars, which affects which agents must be tried first.

Inflectra was moved to first-line in recent updates while Avsola and Renflexis criteria were updated to require trial/failure with other infliximab products.
Olumiant and other JAK inhibitors have been added/updated in step sequences.
Preferred status changes for adalimumab biosimilars (multiple updates 2023–2025) alter required prior trials.

Prior Authorization

IV Products Subject to Site-of-Service Review (age limit applies)

IV-administered products such as infliximab, Orencia IV, and Cosentyx IV are subject to site-of-service review; the policy limits SOS review to individuals aged 13 years and older for site-of-service determination.

Site-of-service review applies to individuals aged 13+ per policy guidance.
Include age and clinical justification in the PA when SOS review is relevant.

Prior Authorization

SOS Reviews Added for Additional IV Products; CRS and Alaska Exceptions

Site-of-service reviews were added for additional IV products (e.g., Cosentyx IV, Tofidence IV, Tyenne IV); exceptions exist for cytokine release syndrome (CRS) treatment and for Alaska fully-insured members per HB 226.

An SOS exception exists for CRS when specified physiologic criteria are met.
SOS criteria do not apply to Alaska fully-insured members per Alaska HB 226 — verify member status.

Documentation Required

SOS Exception Criteria — No Infusion Center Within 50 Miles or No Home Infusion Available

A site-of-service exception allowing home infusion or hospital outpatient infusion is permitted only if no outpatient infusion center exists within 50 miles or no contracted home infusion agency will travel; providers must document access limitations when requesting alternative sites.

Document travel-distance check and contracted home infusion availability.
Access documentation is required to justify hospital outpatient infusion beyond the preferred outpatient sites.

Billing Rule

SOS Review Applies to Listed IV and Some Injection Products

Site-of-service medical necessity review applies to specified IV and some injection products (e.g., Cosentyx IV, Tofidence IV, Tyenne IV); providers must include site-of-service rationale and appropriate coding on PA requests and claims.

Site-of-service review affects payment and may render services not medically necessary if criteria are unmet.
Use the correct HCPCS/Q-codes as listed in the coding section when submitting claims.

Billing Rule

Infliximab Products — Line Placement and Coverage Updates

Infliximab products (Inflectra, Avsola, Remicade, Renflexis, and Janssen unbranded infliximab) have had line-of-therapy placements and coverage sequencing changed in updates; providers must follow the current preferred/non-preferred and trial/failure sequencing in the policy history.

Line placement changes (e.g., Inflectra to first-line, Avsola moved between first/second-line) impact which products must be tried first.
Document prior trials with specific infliximab biosimilars per updated criteria.

Billing Rule

Humira (Adalimumab) — Preferred/Non-preferred Status and Required Trials

Humira (adalimumab) and multiple adalimumab biosimilars have had preferred vs non-preferred status updates across 2023–2025; providers must adhere to the policy's required trial of designated preferred biosimilars before non-preferred adalimumab products are approved.

Preferred biosimilars (e.g., Cyltezo LCF, Hyrimoz HCF) may be required to be tried and failed before non-preferred Humira products.
NDC-based preference distinctions are noted in the history — verify the member's effective date and NDC when submitting PA.

Prescriber requirementMedication prescribed by or in consultation with a rheumatologist

Aggressive disease — referenced definition

Referenced meaning'Aggressive disease' denotes PJIA with clinical features associated with more severe, progressive disease (e.g., younger age <10, rheumatoid factor positivity, anti-CCP antibodies, HLA-DR4)

ContextUsed as a criterion for initiating biologic therapy in PJIA

ImplicationPatients meeting aggressive disease features may qualify for earlier biologic use

PJIA — polyarticular juvenile idiopathic arthritis term

Term expansionPolyarticular juvenile idiopathic arthritis (PJIA)

Clinical notePJIA in this policy includes age-based criteria (often >=2 years) and step therapy requirements prior to biologic use

Related criteriaMay require inadequate response to leflunomide, methotrexate, or sulfasalazine before TNF antagonists

RA — rheumatoid arthritis term

Term expansionRheumatoid arthritis (RA)

Clinical featuresPersistent synovial inflammation, cartilage loss, and bone erosion; typical adult onset and systemic features

Policy relevanceRA coverage criteria apply to adults aged >=18 years with inadequate response to conventional DMARDs prior to biologics/JAKs

JIA — juvenile idiopathic arthritis term

Term expansionJuvenile idiopathic arthritis (JIA) — chronic inflammatory arthritis in children under 17

DiagnosticsIncludes ESR, ANA, RF, CCP testing as part of evaluation

Treatment contextTreatment may include NSAIDs, DMARDs, biologics; age- and disease-subtype specific criteria apply

SpA — spondyloarthropathies term

Term expansionSpondyloarthropathies (SpA) — heterogeneous disorders with axial skeletal involvement and frequent HLA-B27 association (includes ankylosing spondylitis and psoriatic arthritis)

Clinical featuresAxial skeleton involvement, sacroiliitis, and possible peripheral arthritis; may require biologic therapy when moderate to severe

Policy relevanceCoverage and sequencing rules for TNF, IL-17, JAK agents apply to SpA indications

PMR — polymyalgia rheumatica term

Term expansionPolymyalgia rheumatica (PMR) — inflammatory condition in adults >50 with symmetrical aching and morning stiffness, often responsive to low-dose glucocorticoids

DiagnosticsDiagnosis based on history, physical exam, elevated ESR/CRP, and sometimes imaging

Policy relevanceSarilumab (Kevzara) evidence noted for PMR in policy history; agent-specific criteria referenced elsewhere

biosimilar — biosimilar term and NDC-based distinctions

DefinitionBiosimilar — a biologic product highly similar to a reference biologic; policy distinguishes preferred vs non-preferred biosimilars by NDC prefixes for adalimumab products

Coding noteMultiple adalimumab biosimilars referenced with NDC-based preferred status distinctions (e.g., NDC prefixes cited in history)

Coverage impactPreferred biosimilars may be required to be tried before non-preferred agents under step therapy

site-of-service review — definition/term

DefinitionSite-of-service review — medical necessity review to determine appropriate administration site (e.g., office, infusion center, home, hospital outpatient) for IV/injectable biologics

Age and applicabilitySOS review criteria apply to individuals aged 13 years and older for medical benefit IV/injectable administration (except Alaska fully-insured members)

Exception/Access criterionSOS exception allowed only if no outpatient infusion center within 50 miles and no contracted home infusion agency will travel; CRS exceptions documented

08/01/2023biosimilar_and_preferred_updates

Multiple adalimumab biosimilars added to HCPCS J3590 and preferred/non-preferred listings updated (preferred Humira biosimilars designated and listed for required trial prior to non-preferred agents).

09/01/2023coverage_and_line_changes_effective

Policy changes effective 2023-09-01 included addition of Humira biosimilars as non-preferred/preferred products and Cosentyx, Rinvoq, and other coverage/step-therapy updates (effective 09/01/23).

01/01/2024preferred_medical_benefit_changes_effective

Effective 01/01/2024 after 90-day provider notification: Simponi Aria and Avsola moved to first-line for all indications; Inflectra moved to second-line (non-preferred); Avsola added to preferred infliximab list to be tried prior to non-preferred infliximab products.

01/03/2025formulary_and_age_updates_effective

Effective January 3, 2025: multiple adalimumab/infliximab product status and NDC-based preference changes (Avsola moved to second-line per other updates noted for 01/03/2025 in history).

05/06/2025site_of_service_addition

Effective May 6, 2025 (per history): site-of-service review added for Tyenne (tocilizumab-aazg) IV.

07/01/2025humira_status_update_effectiveLatest

Effective July 1, 2025 (after 90-day notification): Humira (adalimumab) [AbbVie NDCs starting with 00074] updated from preferred to non-preferred status for new starts.

2019added_criteria

Added criteria for Skyrizi (risankizumab-rzaa) and expanded Cimzia criteria for non-radiographic axial spondyloarthritis.

2020-01-01actemra_step_change_effective

Actemra (tocilizumab) RA criteria updated to require prior inadequate response or intolerance to both methotrexate and Humira (change effective January 1, 2021 noted in 2020 update but listed with effective date).

2021added_product

Xeljanz Oral Solution (tofacitinib) added as first-line for polyarticular juvenile idiopathic arthritis.

2023biosimilar_and_pref_updates

Reviewed prescribing information and added numerous adalimumab biosimilars with preferred/non-preferred assignments and coverage alignment to Amjevita; cosmetic exclusion for baricitinib clarified.

2023-09-01major_policy_changes_effective

Effective September 1, 2023: additions of Humira biosimilars as non-preferred/preferred and updates to Cosentyx and step-therapy qualifiers including Rinvoq.

2024site_of_service_and_product_updates

Removed Stelara SC site-of-service requirement; added site-of-service review for Cosentyx IV and Tofidence IV; multiple adalimumab status updates and preferred/non-preferred reclassifications effective Jan 1, 2024 and Jan 3, 2025 noted.

2025-01-03alaska_hb226_exception_effective

Policy updated to indicate Site of Service Medical Necessity criteria does not apply to Alaska fully-insured members pursuant to Alaska HB 226 (accessed January 3, 2025).

2025age_and_reauth_updates

Multiple agents updated to include age requirements across indications; re-authorization duration updated from 3 years to 12 months (noted in 2025 updates).

2025-05-06site_of_service_tyenna_added_effective

Effective May 6, 2025 (following notification): site-of-service review added for Tyenne (tocilizumab-aazg) IV.

2025-07-01humira_status_change_effectiveLatest

Effective July 1, 2025 following 90-day notification: Humira (adalimumab) (AbbVie) [NDCs starting with 00074] updated from preferred to non-preferred for new starts.

2023biosimilars_added

Added coverage for multiple adalimumab biosimilars (Hyrimoz LCF, Abrilada, Hulio, Yusimry, Hadlima, Yuflyma) and designated certain biosimilars as preferred or non-preferred with identical coverage criteria to Amjevita/ Humira in 2023 updates.

08/01/2023coding_update

August 2023 interim review added many adalimumab products to HCPCS code J3590 and updated preferred Humira biosimilars to be tried and failed prior to non-preferred agents.

09/01/2023effective_biosimilar_changes

Effective September 1, 2023: Idacio and Adalimumab-fkjp added as non-preferred products; multiple adalimumab and infliximab status updates implemented.

01/01/2024preferred_product_reclassifications

Effective January 1, 2024 (after provider notification): Amjevita NDCs starting with 55513 updated to non-preferred; Avsola and Simponi Aria moved to first-line for indications; HCPCS/Q-code assignments updated for biosimilars.

01/03/2025adalimumab_ndc_and_line_updates

Effective January 3, 2025: additional NDC-based preference distinctions and status changes for several adalimumab products (Avsola moved between line placements noted across history entries).

07/01/2025humira_ndc_status_change_effectiveLatest

Effective July 1, 2025 (after 90-day provider notification): Humira (AbbVie) [NDCs starting with 00074] updated from preferred to non-preferred for new starts, impacting biosimilar sequencing requirements.