CurrentPremera BluecrossPolicy 5.01.645

PHARMACY MEDICAL POLICY 5.01.645 Pharmacologic Treatment of Psoriatic Arthritis

Defines medical necessity, site-of-service review, step therapy tiers, and formulary-specific coverage criteria for numerous biologic, biosimilar, small-molecule, and oral therapies for active psoriatic arthritis across multiple Premera formulary sections (Open/Preferred/Select, Essentials, Individual/Small Group). Applies site-of-service medical necessity for IV/IM/SC injectable therapies for medical-benefit reviews and specifies age and prior-treatment requirements for each agent or class.

Policy Summary

PayerPremera Bluecross

PolicyPHARMACY MEDICAL POLICY 5.01.645 Pharmacologic Treatment of Psoriatic Arthritis

Policy CodePolicy 5.01.645

Change TypeRevised; added agents/Q-codes; formulary-specific sections

Effective DateSee header (changes effective 2026-01-02 referenced)

Next Review Date

Key ActionDocument specialty involvement: ensure medications are prescribed by or in consultation with a rheumatologist or dermatologist and submit chart notes showing prior trials/intolerance as required.

POLICY UPDATE CHANGES

Policy revised and changes effective January 2, 2026 (reference in header).

Moved psoriatic arthritis criteria for multiple products from Policy 5.01.550 to 5.01.645 and added coverage criteria for several ustekinumab products and biosimilars.

Added new policy sections for Metallic, Essentials, Open/Preferred/Select formularies and plans with no pharmacy benefit coverage with different coverage criteria for specified drugs.

Removed Idacio (adalimumab-aacf) from the policy as it has been removed from the market.

30+HCPCS/Q-codes listed

MultipleAgents with criteria

2/6/18+Age thresholds vary

13Minimum age for SOS review

Coverage Summary

Policy 5.01.645 defines medical necessity and formulary-based coverage for pharmacologic treatment of psoriatic arthritis (biologics, biosimilars, JAK inhibitors, and oral agents). It applies across multiple formulary sections: Open/Preferred/Select (Section 1), Essentials (Section 2), and ISHIP/Metallic (Section 3), with plan-specific step-therapy and step/line distinctions. The policy includes a site-of-service (SOS) review for IV/SC/IM agents≥13 years), and many agents require prescribing by or in consultation with a rheumatologist or dermatologist. Age thresholds and prior-therapy requirements vary by agent (common thresholds: ≥2 years, ≥6 years, ≥18 years), and several agents have explicit prior-treatment or failure requirements before second-line or nonpreferred products are approved.

Quick thresholds & scope facts

Age thresholdsVaries by agent: common thresholds include >=2 years (Rinvoq), >=6 years (ustekinumab family), >=18 years (many biologics/JAK inhibitors/others)

Prior therapy requirementVaries by agent: examples include inadequate response/intolerance to 1+ TNF blockers (for JAK inhibitors/Xeljanz) and documented trial/failure with specified infliximab products for some IV agents

Minimum SOS age13 years (site-of-service medical necessity review applies to individuals age 13 and older)

Formulary sections referencedSection 1 (Open/Preferred/Select and plans with no pharmacy benefit), Section 2 (Essentials), Section 3 (Individual/Small Group/ISHIP Metallic); custom formulary exceptions referenced in policy 5.01.647 (Formulary IDs 6062 and 6064)

Policy mapping / notePsoriatic arthritis criteria moved into policy 5.01.645 (moved from 5.01.550); Stelara coverage updated to require trial with Steqeyma and Yesintek for previously untreated individuals

Medical-Necessity Criteria (by criteria group)

Site of Service Medical Necessity (general)

Site of service is reviewed for age 13+ and applies only to medical benefit reviews (not Alaska fully-insured members). Preferred medically necessary sites:

ALL of the following

Preferred medically necessary sites
- Physician office / infusion center / home infusion: Physician's office, infusion center, or home infusion are medically necessary sites for IV infusion and injection therapy when appropriate, safe, and cost-effective.
- Hospital-based outpatient setting — initial/reinitiation (first 90 days): Hospital-based outpatient setting (outpatient hospital IV infusion department) is considered medically necessary for the first 90 days for: initial course of infusion/injection or re-initiation after >= 6 months following discontinuation (does not include standard dosing intervals >= 6 months).90 days

Coding

HCPCS / J-codes listedHCPCS

J0129	Injection, abatacept (Orencia), 10 mg
J0139	Injection, adalimumab (Humira), 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), mg; for intravenous use
J1628	Injection, guselkumab (Tremfya), mg
J1745	Injection; infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J3247	Injection, secukinumab, intravenous (Cosentyx), mg
J3357	Injection; ustekinumab (Stelara), 1 mg
J3590	Unclassified biologics (use to report multiple listed products)

Q-codes / biosimilar HCPCS listedHCPCS

Q5098	mg (new code effective 07/01/25)
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, mg (new code effective 07/01/25)
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar; mg (new code effective 07/01/25)
Q5103	Injection, infliximab-dyyb, biosimilar (Inflectra), 10 mg
Q5104	Injection, infliximab-abda; biosimilar (Renflexis), 10 mg
Q5115	Injection, rituximab-abbs, biosimilar (Truxima), 10 mg
Q5121

HCPCS codes (medical-benefit biologics and biosimilars) listedHCPCS

J0129	Injection, abatacept (Orencia), 10 mg
J0139	Injection, adalimumab (Humira), 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), mg; for intravenous use
J1628	Injection, guselkumab (Tremfya), mg
J1745	Injection; infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J3247	Injection, secukinumab, intravenous (Cosentyx), mg
J3357	Injection; ustekinumab (Stelara), 1 mg
J3590	Unclassified biologics (used to report many products listed in policy)

1–10 of 28

1/3

Drugs subject to site-of-service review (listed agents in document)mixed

Avsola	infliximab-axxq IV
Cosentyx	secukinumab IV/SC
Inflectra	infliximab-dyyb IV
Infliximab (Janssen unbranded)	IV
Orencia	abatacept IV/SC
Remicade	infliximab IV
Renflexis	infliximab-abda IV
Simponi Aria	golimumab IV

Agents listed across policy (examples, non-exhaustive per part)mixed

Taltz	ixekizumab SC
Stelara	ustekinumab SC
Steqeyma	ustekinumab-stba SC
Yesintek	ustekinumab-kfce SC
Skyrizi	risankizumab-rzaa SC
Tremfya	guselkumab SC
Rinvoq	upadacitinib oral
Rinvoq LQ	upadacitinib oral (low dose)
Xeljanz	tofacitinib oral
Xeljanz XR	tofacitinib extended-release oral

1–10 of 19

1/2

Provider Actions and Operational Requirements

Documentation Required

Prescriber specialty requirement

Many agents require that the medication be prescribed by or in consultation with a rheumatologist or dermatologist. The provider must document the treating prescriber's specialty (rheumatology or dermatology) in the medical record when submitting a request or claim.

Prior Authorization

Site-of-service prior review for IV/IM/SC agents

Specific IV/SC (and other injectable) agents are subject to site-of-service medical necessity review for medical-benefit claims (applies for age ≥13). Providers should request a site-of-service review when planning administration in a non-preferred setting and document the clinical rationale for the chosen site — including distance to outpatient infusion center or lack of home infusion agency, patient-specific risk factors (cardiac, pulmonary, unstable renal function, difficult vascular access, acute mental status changes, history of severe reactions/anaphylaxis), and whether the visit is an initial infusion or re-initiation after ≥6 months.

Background & Evidence

This policy covers a broad range of pharmacologic agents used to treat active psoriatic arthritis including biologics and biosimilars (TNF inhibitors, IL-17, IL-12/23, IL-23 agents, and T-cell modulators), JAK inhibitors (e.g., upadacitinib, tofacitinib), and oral agents (e.g., apremilast). The policy explicitly lists IV/SC agents that are subject to site-of-service medical necessity review (examples: infliximab products, Simponi Aria, Cosentyx IV, Orencia IV) and defines preferred medically necessary sites (physician office, infusion center, home infusion) with hospital-based outpatient setting considered medically necessary for the first 90 days in specified circumstances. Formulary-specific step therapy and line-of-therapy rules are included: distinct First-Line and Second-Line designations and prior-treatment/failure requirements are defined per formulary section (Open/Preferred/Select, Essentials, ISHIP) and differ by agent.

Evidence

Incidence estimate6-42% of individuals with psoriasis (25% reasonable estimate)

Guideline/evidence sourcesMultiple clinical trials and product prescribing information referenced (etanercept, infliximab, adalimumab, certolizumab, golimumab, ustekinumab, apremilast, etc.)

Key definitions used in the policy: Site of Service (SOS) — the location where the drug is administered (hospital-based outpatient setting, infusion center, physician office, or home); SOS medical necessity criteria apply to medical-benefit reviews for individuals aged ≥13 years (excludes Alaska fully-insured members). Medically necessary hospital-based outpatient setting (first 90 days) — hospital outpatient infusion is considered medically necessary for the initial course of infusion/injection or re-initiation after ≥6 months off therapy (standard dosing intervals ≥6 months are excluded). Inadequate response or intolerance — a clinical determination documented in chart notes indicating lack of efficacy or intolerable adverse effects to prior agent(s). (These terms are used throughout the formulary-specific criteria and site-of-service rules.)

Revision History

2026-01-02header revision

Policy revised and changes effective January 2, 2026 (reference in header); header notes a revision with link to view changes effective 2026-01-02.

2025-10-03moved/revised criteria and added HCPCSLatest

Moved psoriatic arthritis criteria for multiple products from Policy 5.01.550 to 5.01.645; added HCPCS/Q-codes including Q9999, Q5137, Q5138, Q9996, Q9998, Q5098, Q5099, Q5100 and clarified site-of-service applicability; updated Stelara coverage to require trial with Steqeyma and Yesintek for previously untreated individuals.

2025-07-01added formulary sections and agent criteria

Policy Summary

PayerPremera Bluecross

PolicyPHARMACY MEDICAL POLICY 5.01.645 Pharmacologic Treatment of Psoriatic Arthritis

Policy CodePolicy 5.01.645

Change TypeRevised; added agents/Q-codes; formulary-specific sections

Effective DateSee header (changes effective 2026-01-02 referenced)

Next Review Date

On This Page

Hospital-based outpatient when no alternative within 50 miles: Hospital-based outpatient setting is medically necessary when no outpatient infusion center or contracted home infusion agency within 50 miles or when hospital is the only place offering infusion/injection.50 miles

Clinical risk conditions (ONE of)

Cardiac condition: Known cardiac condition (symptomatic cardiac arrhythmia).
Pulmonary condition (significant respiratory disease, serious obstructive airway disease, %FVC <= 40%).%FVC <= 40%
Unstable renal function decreasing ability to respond to fluids.
Difficult vascular access: Difficult or unstable vascular access.
Acute mental status changes impacting safety of infusion/injection therapy.
History of severe adverse reaction/anaphylaxis: Known history of severe adverse drug reactions and/or anaphylaxis to related/similar drug.

CRS criteria

CRS grade 3 or 4 - evidence: CRS grade 3 or 4 evidenced by ALL of: temperature >= 38°C; hypotension requiring one or more vasopressors; hypoxia requiring high-flow oxygen device or positive pressure ventilation.
Planned inpatient admission: The individual will be admitted to an inpatient setting as soon as clinically appropriate.

Applicability note: Site of Service Medical Necessity criteria applies ONLY to medical benefit reviews and does NOT apply to Alaska fully-insured members.age >=13 for SOS review

Formulary-based agent-specific medical necessity (Section 1: Open/Preferred/Select and Plans with No Pharmacy Benefit)

Agents and classes with age, prescriber, and prior-treatment criteria; many agents are designated First Line or Second Line with specific prior-therapy requirements.

General prescriber requirement: General requirement for many agents: Medication must be prescribed by or in consultation with a rheumatologist or dermatologist (explicit per agent).

TNF-alpha Antagonists First Line (examples)

Cyltezo / Simlandi / Hyrimoz: Cyltezo (adalimumab-adbm) SC; Simlandi (adalimumab-ryvk) SC; Adalimumab-adaz (Hyrimoz unbranded) SC — First Line.
Enbrel & Simponi Aria: Enbrel (etanercept) SC and Simponi Aria (golimumab) IV — may be considered medically necessary when individual >=18 years AND prescribed by/consult with rheumatologist or dermatologist (Simponi Aria subject to site-of-service review).>=18 years

IL-17 Inhibitors First Line: Taltz (ixekizumab) SC; Cosentyx (secukinumab) IV/SC — listed among IL-17 inhibitors as First Line; agent-specific age/prescriber rules apply.typically >=18 years unless specified

IL-12/23 Inhibitors First Line: Stelara (ustekinumab) SC, Steqeyma (ustekinumab-stba) SC, Yesintek (ustekinumab-kfce) SC — may be considered medically necessary when: individual >=6 years AND prescribed by/consult with rheumatologist or dermatologist. Stelara may require prior trial with Steqeyma and Yesintek per updated criteria.>=6 years

IL-23 Inhibitors First Line: Tremfya (guselkumab) SC and Skyrizi (risankizumab-rzaa) SC — may be considered medically necessary when individual >=18 years AND prescribed by/consult with dermatologist or rheumatologist.>=18 years

JAK Inhibitors First Line: Rinvoq (upadacitinib) oral and Rinvoq LQ oral may be considered medically necessary when individual >=2 years AND has had inadequate response or intolerance to 1 or more TNF blockers AND prescribed by/consult with rheumatologist or dermatologist. Xeljanz and Xeljanz XR are similar but for age >=18 years.Rinvoq >=2 years; Xeljanz >=18 years

PDE4 Inhibitor First Line: Otezla (apremilast) oral — may be considered medically necessary when individual >=18 years AND prescribed by/consult with rheumatologist or dermatologist.>=18 years

T-Cell Costimulation Modulator: Orencia (abatacept) IV/SC — listed with specific second-line criteria (see second-line section).varies by indication

Section 1: Second-line and step-specific agent criteria (Open/Preferred/Select)

Second-line designations include prior-treatment/failure requirements and age/prescriber constraints.

TNF-alpha Antagonists Second Line examples: Humira and other adalimumab-branded/biosimilars may require documented inadequate response or intolerance to specified adalimumab biosimilars/agents; Cimzia and Simponi SC may require inadequate response/intolerance to 2 listed agents.>=18 years; prior-failure as specified

See agent-specific lists

IL-12/23 and IL-23 Second Line (ustekinumab group): Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara (brand/unbranded), Wezlana and others may be considered medically necessary when individual >=6 years, prescribed by/consult with dermatologist or rheumatologist, AND has had inadequate response or intolerance to ALL the following: Stelara SC, Steqeyma SC, Yesintek SC.>=6 years; failure of listed ustekinumab agents

IL-17 Inhibitors Second Line: Bimzelx may be considered medically necessary when >=18 years and has had inadequate response/intolerance to one of listed agents; Cosentyx may be considered when >=2 years and has had inadequate response/intolerance to 2 of listed agents; prescriber specialty required.agent-specific prior failures

Cosentyx IV subject to site-of-service review

Orencia (abatacept) Second Line: Orencia IV for adults: >=18 years AND inadequate response/intolerance to 2 of listed agents; Orencia SC pediatrics: >=2 years AND inadequate response/intolerance to ONE listed agent OR presence of contraindicating comorbidities (heart failure, prior lymphoproliferative disorder, previous serious infection, demyelinating disorder).adult >=18; pediatric >=2

Infliximab biosimilar linkage: Avsola (infliximab-axxq) and Renflexis (infliximab-abda) are subject to site-of-service review and may be considered medically necessary when individual >=18 years AND prescribed by/consult with rheumatologist or dermatologist AND has documented trial and treatment failure with Inflectra (infliximab-dyyb), Infliximab (Janssen unbranded), or Remicade (infliximab).>=18 years; documented trial and failure

site-of-service review applies

Section 2: Essentials Formulary Plans (Rx E1/E3/E4) — tiering and general requirements

Section 2 lists First Line agents and step-therapy flow (some repetition of Section 1 structure applied to Essentials formulary).

Essentials mirroring Section 1: Many agents mirror Section 1 but with Essentials-specific First Line and Second Line designations; prescriber must be rheumatologist or dermatologist and age thresholds are preserved (e.g., Steqeyma/Yesintek >=6 years; Taltz, Tremfya, Skyrizi >=18 years except where specified).

TNF-alpha inhibitors Essentials: TNF-a inhibitors (Cyltezo, Simlandi, adalimumab biosimilars, Enbrel, Simponi Aria) may be considered medically necessary when individual >=18 years and prescribed by/consult with rheumatologist or dermatologist; Inflectra/Infliximab/Remicade subject to site-of-service review.>=18 years

General prescriber and age requirement (recurrent across agents)

Covered when ALL of the following are met:

Age requirement: The individual is the age specified for the agent (varies by agent; see agent-specific nodes)agent-specific

Prescriber requirement: Medication is being prescribed by or in consultation with a rheumatologist or dermatologist

Rinvoq (upadacitinib) and Rinvoq LQ - Essentials (Section 2) and ISHIP (Section 3)

Covered when ALL of the following are met:

Rinvoq criteria: The individual is aged 2 years or older; has had an inadequate response or intolerance to 1 or more TNF blockers; medication is being prescribed by or in consultation with a rheumatologist or dermatologist.>=2 years; prior TNF failure

Applies to Rinvoq and Rinvoq LQ

Xeljanz (tofacitinib) and Xeljanz XR - Essentials (Section 2) and ISHIP (Section 3)

Covered when ALL of the following are met:

Xeljanz criteria: The individual is aged 18 years or older; has had an inadequate response or intolerance to 1 or more TNF blockers; medication is being prescribed by or in consultation with a rheumatologist or dermatologist.>=18 years; prior TNF failure

Applies to Xeljanz and Xeljanz XR

Otezla (apremilast) - PDE4 Inhibitor First Line

Covered when ALL of the following are met:

Otezla criteria: The individual is aged 18 years or older; medication is being prescribed by or in consultation with a rheumatologist or dermatologist.>=18 years

PDE4 inhibitor first line

IL-23 inhibitors (Skyrizi, Tremfya, Steqeyma, Yesintek) - First Line (plan/age varies)

Covered when ALL of the following are met (plan- and agent-specific age limits apply):

Steqeyma / Yesintek: The individual is aged 6 years or older; medication is being prescribed by or in consultation with a rheumatologist or dermatologist.>=6 years

ustekinumab biosimilars (Essentials/ISHIP)

Tremfya: The individual is aged 18 years or older; medication is being prescribed by or in consultation with a rheumatologist or dermatologist.>=18 years

guselkumab (Essentials/ISHIP)

Skyrizi: The individual is aged 18 years or older; medication is being prescribed by or in consultation with a rheumatologist or dermatologist.>=18 years

risankizumab (Essentials/ISHIP)

TNF-alpha antagonists - First and Second Line rules (plan-specific)

Covered when ALL of the following are met (agent- and plan-specific step/line requirements):

Baseline requirements: The individual is aged 18 years or older; medication is being prescribed by or in consultation with a rheumatologist or dermatologist.>=18 years

Agents listed: Includes many adalimumab biosimilars/brands, certolizumab, golimumab, etanercept, infliximab products, Avsola, Renflexis.

Second-line prior-failure statement: Second-line TNF agents may require prior inadequate response/intolerance to specified other agents (documented trials) — see agent-specific second-line lists.agent-specific

Avsola (infliximab-axxq) and Renflexis (infliximab-abda) - IV agents site-of-service review

Covered when ALL of the following are met:

Avsola / Renflexis criteria: The individual is aged 18 years or older; medication is being prescribed by or in consultation with a rheumatologist or dermatologist; has had a documented trial and treatment failure with Inflectra (infliximab-dyyb), Infliximab (Janssen unbranded), or Remicade (infliximab); subject to review for site of service administration.>=18 years; documented trial and failure

IV agents subject to SOS review

IL-12/23 inhibitors second-line (ustekinumab products) - ISHIP and Essentials

Covered when ALL of the following are met:

Ustekinumab products second-line: The individual is aged 6 years or older; medication is being prescribed by or in consultation with a dermatologist or rheumatologist; has had a documented trial and treatment failure with Inflectra (infliximab-dyyb), Infliximab (Janssen unbranded), or Remicade (infliximab); AND has had an inadequate response or intolerance to ALL the following agents: Steqeyma (ustekinumab-stba) SC OR Yesintek (ustekinumab-kfce) SC (for specific second-line approvals).>=6 years; documented trial/failure

Applies to ISHIP and Essentials second-line ustekinumab products

IL-17 inhibitors (Taltz, Cosentyx, Bimzelx) - First/Second-line and failure requirements

Covered when agent- and plan-specific criteria are met:

Bimzelx (Second Line): The individual is aged 18 years or older; has had an inadequate response or intolerance to 1 of the following agents: Enbrel; adalimumab biosimilars/brands; Otezla; Skyrizi; Stelara family; Taltz; and medication is being prescribed by/consult with dermatologist or rheumatologist.>=18 years; prior failure to one listed agent

Cosentyx (IV/SC) criteria: The individual is aged 2 years or older (for certain indications); has had an inadequate response or intolerance to 2 of the listed agents; medication is prescribed by/consult with dermatologist or rheumatologist; IV administration subject to site-of-service review.>=2 years; prior failure to 2 agents

Taltz (First Line): The individual is aged 18 years or older; medication is being prescribed by or in consultation with a dermatologist or rheumatologist.>=18 years

Orencia (abatacept) - T-Cell costimulation modulators (Second Line) - adult & pediatric

Covered when ALL of the following are met:

Orencia IV/SC adults - Second Line: The individual is aged 18 years or older; medication is being prescribed by or in consultation with a dermatologist or a rheumatologist; has had an inadequate response or intolerance to 2 of the following agents: Enbrel; adalimumab biosimilars/brands; Otezla; Rinvoq; Skyrizi; Stelara family; Taltz.>=18 years; prior failure to 2 agents

IV subject to SOS review

Orencia SC pediatrics: The individual is aged 2 years or older; medication is being prescribed by or in consultation with a dermatologist or a rheumatologist; has had an inadequate response or intolerance to ONE of the following agents: Enbrel; Rinvoq; Steqeyma/Yesintek OR has heart failure, previously treated lymphoproliferative disorder, previous serious infection, or demyelinating disorder.>=2 years; pediatric prior failure to 1 agent or qualifying comorbidity

Investigational / Not Medically Necessary / Combination exclusions

Policy-level exclusions:

Investigational combination/uses: Medications used in combination with each other or for conditions not outlined in this policy are considered investigational.

Not medically necessary uses: All other uses of the drugs for approved conditions listed in this policy that are not specified are considered not medically necessary.

Approval duration and reauthorization

Operational rules:

Initial authorization duration: Initial authorization and re-authorization may be approved up to 12 months.12 months

Re-authorization requirements: Re-authorization requires meeting drug-specific coverage criteria and chart notes demonstrating positive clinical response.

Documentation required for medical necessity review

The individual's medical records submitted for review should include:

Office visit notes that contain the diagnosis, relevant history, physical evaluation and medication history.

Site of Service and Age Considerations

Site of service medical necessity age requirement and rationale:

Age for SOS medical necessity: Age for site of service medical necessity is 13 years of age or older.>=13 years

Based on FDA-approved indications and pediatric administration complexity; site of service defined as hospital outpatient, infusion center, physician office, or home.

Policy-level applicability / exceptions

Applicability notes and exclusions:

Custom formulary exceptions: This medical necessity criteria does not apply to one Open formulary (Formulary ID: 6062; Rx Plan F1) and one Preferred formulary (Formulary ID: 6064; Rx Plan G3); see policy 5.01.647 for those members.

Members with these custom plans referenced to policy 5.01.647.

Medicare Advantage exclusion: This medical policy does not apply to Medicare Advantage.

Scope explicitly excludes Medicare Advantage.

Documentation Required

Prior-treatment/failure documentation

For second-line agents and other step requirements, the provider must document prior trials and the reason they failed (inadequate response or intolerance). The number of required prior trials varies by agent (examples in policy: inadequate response or intolerance to 1 or more TNF blockers for some JAK agents; inadequate response to 2 listed agents for Cosentyx; documented trial and treatment failure with specified infliximab products for certain infliximab agents). Evidence of intolerance or inadequate response should be in chart notes.

Denial Risk

Site-of-service not medically necessary when criteria not met

Claims for infusion/injection services performed in non-preferred sites or without meeting the site-of-service clinical criteria (distance, specified high-risk clinical conditions, or initial/re-initiation exceptions) may be considered not medically necessary and denied. Providers should be aware of this denial risk when SOS criteria are not met.

Prior Authorization

Prior authorization / medical necessity review required

Certain agents and administrations require medical necessity review / prior authorization. Codes associated with medical-benefit review include J1745, Q5103, Q5104, J1602, J3247, and J0129. Approvals (initial and reauthorization) may be granted for up to 12 months when criteria are met.

Documentation Required

Documentation to submit with request

Submit office visit notes with the request. The reviewer expects documentation that includes the diagnosis, relevant clinical history, physical evaluation, and complete medication history showing prior trials, intolerance, or inadequate responses as required by the agent-specific criteria.

Denial Risk

Investigational / not medically necessary uses

Use of listed medications in combination with each other or for conditions not outlined in this policy is considered investigational. Other unlisted uses are considered not medically necessary and may be denied.

Billing Rule

Site-of-service review requirement

Site-of-service reviews are triggered for specific IV-administered agents. The HCPCS/J- and Q-codes associated with SOS review include J1745, Q5103, Q5104, J1602, and J3247 — administration of these agents may require prior SOS review and appropriate billing consistent with the policy.

Documentation Required

Site-of-service age documentation

For SOS medical necessity determinations, document the patient age. The policy requires that site-of-service medical necessity review for administration be applied only for patients aged 13 years or older; age must be recorded in the chart notes submitted for review.

Note

Prior authorization and policy mapping changes

Psoriatic arthritis coverage criteria and SOS rules were moved into policy 5.01.645 from 5.01.550. Providers should note this mapping and that formulary exceptions and specific custom-formulary rules reference policy 5.01.647.

Added new policy sections for Metallic (ISHIP), Essentials, and Open/Preferred/Select formularies with different coverage criteria for multiple biologics and JAK inhibitors (distinct coverage criteria by formulary type).

2025-10-01administrative removalLatest

Removed Idacio (adalimumab-aacf) from the policy as it has been removed from the market.