ModifiedPremera BluecrossPolicy N/A

Medical Necessity and Coverage Criteria for Biologic and Targeted Therapies for Psoriatic Arthritis (including Site-of-Service Review)

Defines medical necessity, site-of-service review, step therapy tiers, and specific drug coverage criteria for biologic, oral, and other pharmacologic treatments for active psoriatic arthritis for covered members and providers.

Policy Summary

PayerPremera Bluecross

PolicyMedical Necessity and Coverage Criteria for Biologic and Targeted Therapies for Psoriatic Arthritis (including Site-of-Service Review)

Policy CodePolicy N/A

Change TypeMaterial updates: added ustekinumab biosimilars, age/weight criteria revisions, HCPCS code additions

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document specialist consultation, age/weight criteria, and prior trials/failures as required for the requested agent.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for multiple ustekinumab products and biosimilars (Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Steqeyma, Yesintek, Wezlana, and related unbranded forms).

Updated age and weight requirements for several agents (Tremfya age to 6+, Otezla age to 6+ and weight >=20 kg, Xeljanz age to 2+, Simponi Aria age to 2+).

Clarified that site-of-service medical necessity criteria can apply to injection drugs and defined site-of-service age threshold as 13 years or older for site-of-service review.

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

Added HCPCS codes Q9999, Q5137, Q5138, Q9996, Q9998, Q5098, Q5099, and Q5100 for specific products.

Updated multiple product-specific coverage criteria including age requirements (e.g., Tremfya, Xeljanz, Simponi Aria) and added/removed products as market availability changed.

~40+

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Coverage Criteria and Medical Necessity

inv-01: Site of Service Medical Necessity

Site-of-service medical necessity

Site-of-service general: Site-of-service medical necessity criteria applies to medical benefit reviews for individuals aged 13 years and older and applies to IV and injectable drugs; the site is considered medically necessary only when the criteria are met.age >= 13

Hospital outpatient may be medically necessary for the first 90 days for an initial course or for re-initiation after >=6 months; hospital outpatient is also medically necessary if no outpatient infusion center or contracted home infusion agency is available within 50 miles or if the individual has specified clinical risk conditions.

inv-02: Adalimumab first-line criteria

TNF-α antagonists — First Line

Adalimumab first-line: Adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm (NDCs starting with 00597) may be considered medically necessary for treatment of active psoriatic arthritis when the individual is aged 18 years or older AND the medication is prescribed by or in consultation with a rheumatologist or dermatologist.age >= 18

This criteria does not apply to one Open formulary (Formulary ID: 6062; Rx Plan F1).

inv-03: Non-TNF first-line biologic and oral agent criteria

IL-23 inhibitors / JAK / PDE4 / TYK2 — First Line and specific requirements

Tremfya and Skyrizi first-line: Tremfya (guselkumab) and Skyrizi (risankizumab-rzaa) may be considered medically necessary when age and weight thresholds are met AND medication is prescribed by or in consultation with a dermatologist or rheumatologist; many IL‑23 agents require prior inadequate response or intolerance to specified ustekinumab products for individuals not previously treated with the requested therapy.Tremfya: age >= 6 and weight >= 40 kg; Skyrizi: age >= 18

Requirement to have had inadequate response or intolerance to specified ustekinumab biosimilars (e.g., Steqeyma, Yesintek) applies to individuals not previously treated with requested therapy.

JAK inhibitors: Rinvoq (upadacitinib) and Xeljanz (tofacitinib) formulations may be considered medically necessary when age-specific thresholds are met, there is documented inadequate response or intolerance to required prior agents (including TNF blockers or specified ustekinumab products as indicated), and medication is prescribed by or in consultation with a rheumatologist or dermatologist.Rinvoq: age >= 2 (for some formulations); Xeljanz: age >=2 for some formulations, Xeljanz XR age >=18 for extended-release per product-specific criteria

inv-04: Second-line TNF antagonist criteria

TNF-α antagonists — Second Line and biosimilars

Second-line adalimumab biosimilars: Designated adalimumab biosimilars (e.g., Abrilada, Amjevita, Cyltezo, Hulio, Humira, Simlandi, etc.) may be considered medically necessary for individuals aged 18 years or older who have had an inadequate response or intolerance to ALL of: adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm (NDCs starting with 00597), and when medication is prescribed by or in consultation with a dermatologist or rheumatologist.age >= 18

Exclusion for one Open formulary (Formulary ID: 6062; Rx Plan F1) may apply.

Cimzia/Simponi second-line: Cimzia (certolizumab pegol) and Simponi (golimumab) may be considered medically necessary for individuals aged 18 years or older who have had an inadequate response or intolerance to two specified agents (see product criteria lists) AND medication is prescribed by or in consultation with a dermatologist or rheumatologist.age >= 18

Acceptable prior agents include products such as Enbrel, adalimumab products, Otezla, Rinvoq, Skyrizi, Sotyktu, Stelara, Taltz, Tremfya, Xeljanz, among others as listed per product.

inv-05: Infliximab sequencing

Infliximab products — sequence requirement

Infliximab branded/unbranded: Infliximab (Janssen unbranded) and Remicade may be considered medically necessary for treatment of active psoriatic arthritis in individuals aged 18 years or older who have had a documented trial and treatment failure with Avsola (infliximab-axxq) AND Inflectra (infliximab-dyyb), and when medication is prescribed by or in consultation with a rheumatologist or dermatologist.age >= 18

Renflexis (infliximab-abda) has similar sequence requirements requiring documented failure of Avsola and Inflectra prior to coverage.

inv-06: Clinical risk exemptions for site of service

Clinical conditions requiring hospital outpatient infusion

High-risk clinical conditions: Hospital outpatient infusion is medically necessary when the individual has increased risk of complications including any one of: known cardiac condition (e.g., symptomatic cardiac arrhythmia), significant respiratory disease (e.g., serious obstructive airway disease or %FVC <= 40%), unstable renal function, difficult or unstable vascular access, acute mental status changes or cognitive conditions impacting safety, or a known history of severe adverse drug reactions and/or anaphylaxis to prior related treatment.%FVC <= 40%

Also medically necessary for grade 3–4 cytokine release syndrome when admission to inpatient setting is planned and criteria for CRS (fever >=38°C, hypotension requiring vasopressor, hypoxia requiring high-flow oxygen or positive pressure ventilation) are met.

inv-07: Drug-specific medical necessity criteria (selected examples)

Examples of drug-specific medical necessity criteria (drug-level requirements vary):

Renflexis (infliximab-abda): Patient aged 18 years or older AND documented trial and treatment failure with Avsola (infliximab-axxq) AND Inflectra (infliximab-dyyb) AND medication is prescribed by or in consultation with a rheumatologist or dermatologist.age >= 18

Specific biosimilar sequencing/step requirements apply.

Ustekinumab products (Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Steqeyma, Yesintek, Wezlana, others): Patient aged 6 years or older AND inadequate response or intolerance to ALL of: Stelara (ustekinumab) SC, Steqeyma (ustekinumab-stba) SC, and Yesintek (ustekinumab-kfce) SC AND medication is prescribed by or in consultation with a dermatologist or rheumatologist.age >= 6

Applies to multiple ustekinumab biosimilars and formulations; requirement to fail specified ustekinumab agents applies to individuals not previously treated with requested therapy.

inv-08: Product-level coverage criteria and formulary-specific rules

Policy contains product-specific coverage criteria, formulary distinctions, and age/weight eligibility updates

policy_changes: This policy consolidates and includes moved psoriatic arthritis coverage criteria for multiple biologic and targeted products from prior policy 5.01.550 and adds or updates product-specific age, weight, and preferred-status criteria; detailed AND/OR clinical criteria per product are located in the full policy document.

New HCPCS/Q-codes were added for several ustekinumab biosimilars and other products; formulary applicability and preferred-status updates vary by plan and were updated in interim/annual reviews.

The Site-of-Service (SOS) medical necessity criteria apply to medical benefit reviews for individuals aged 13 years and older and cover both IV and injectable therapies. Preferred medically necessary sites include the physician’s office, infusion center, and home infusion. A hospital-based outpatient setting may be considered medically necessary for the first 90 days of an initial course or when re‑initiating therapy after a gap of >= 6 months, when there is no outpatient infusion center within 50 miles or no contracted home infusion agency able to travel, or when the individual has clinical risk factors that increase the likelihood of complications (for example, significant cardiac or pulmonary disease such as %FVC ≤ 40%, unstable renal function, difficult vascular access, acute mental status changes, or history of severe infusion-related reactions).

Requests for agents used outside the drug’s FDA‑approved dosing/administration or for indications, combinations, or conditions not specified in this policy (or in Related Medical Policies) are considered investigational and may be denied. The medications listed in this policy are evaluated according to the product’s FDA prescribing information for dosage and administration when determining medical necessity.

This policy contains product‑level coverage criteria and formulary distinctions; certain formulary plans have separate exception processes. For members assigned to specified custom Open or Preferred formularies, product-specific criteria and exception handling may be found in Policy 5.01.647 (Medical Necessity Criteria for Custom Open and Preferred Formularies). Additionally, periodic updates have revised preferred alternatives and plan‑specific notes that may affect formulary exception determinations.

Hospital‑based outpatient infusion and injection services are considered not medically necessary when the site‑of‑service criteria in this policy are not met. Exceptions permitting hospital outpatient care include the initial 90‑day treatment period or re‑initiation after ≥6 months, lack of a nearby outpatient infusion option within 50 miles or no available home infusion service, or presence of specified high‑risk clinical conditions that increase the risk of complications.

All other uses of the drugs listed in this policy for approved conditions that do not meet the stated medical necessity criteria are considered not medically necessary. Documentation should demonstrate that FDA dosing/administration and the policy’s drug‑specific criteria are met; off‑label combinations or indications not addressed by this policy are considered investigational and may be denied.

Reference to review of non‑formulary exception requests has been removed from this policy. Explicit not‑medically‑necessary conditions and any exception processes for specific plan types are detailed elsewhere in the policy or in plan‑specific documents; consult the member’s benefit booklet or applicable formulary policy for exception review instructions.

Coding and Billing

IV agents subject to site-of-service reviewmixed

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

SC biologics and biosimilars (examples)mixed

Adalimumab-aaty	SC
Adalimumab-adaz	SC
Adalimumab-adbm	SC (NDCs starting with 00597)
Enbrel	etanercept SC
Taltz	ixekizumab SC
Stelara	ustekinumab SC

Oral small-molecule agentsmixed

Rinvoq	upadacitinib oral
Rinvoq LQ	upadacitinib oral
Xeljanz	tofacitinib oral
Xeljanz XR	tofacitinib extended-release oral
Otezla	apremilast oral
Otezla XR	apremilast extended-release oral
Sotyktu	deucravacitinib oral

IL-23 / IL-17 class biologicsmixed

Tremfya	guselkumab SC
Skyrizi	risankizumab-rzaa SC
Bimzelx	bimekizumab-bkzx SC

Covered HCPCS/J CodesHCPCS

J0129	Injection, abatacept (Orencia), 10 mg
J0139	Injection, adalimumab (Humira), 1 mg
J0717	Injection, certolizumab pegol (Cimzia), 1 mg
J1438	Injection, etanercept (Enbrel), 25 mg
J1602	Injection, golimumab (Simponi Aria), 1 mg, IV use
J1628	Injection, guselkumab (Tremfya), 1 mg
J1745	Injection, infliximab, excludes biosimilar, 10 mg
J3247	Injection, secukinumab, intravenous (Cosentyx) 1 mg
J3357	Injection, ustekinumab, subcutaneous injection (Stelara), 1 mg
J3590	Unclassified biologics (used to report various biosimilars/unbranded)

Covered Q-Codes / Biosimilar CodesHCPCS

Q5098	Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg
Q5103	Injection, infliximab-dyyb (Inflectra), biosimilar, 10 mg
Q5104	Injection, infliximab-abda (Renflexis), biosimilar, 10 mg
Q5121	Injection, infliximab-axxq (Avsola), biosimilar, 10 mg
Q5137	Injection, ustekinumab-auub (Wezlana), biosimilar, 1 mg (SC)
Q5138	Injection, ustekinumab-auub (Wezlana), biosimilar, 1 mg (IV)
Q5140	Injection, adalimumab-fkjp (Hulio), biosimilar, 1 mg
Q5141	Injection, adalimumab-aaty (Yuflyma), biosimilar, 1 mg

1–10 of 18

1/2

HCPCS codes added/updatedHCPCS

Q9999	HCPCS code added (ustekinumab-aauz Otulfi)
Q5137	HCPCS code added for Wezlana (ustekinumab-auub)
Q5138	HCPCS code added for Wezlana (ustekinumab-auub)
Q9996	HCPCS code added for Pyzchiva (ustekinumab-ttwe)
Q9998	HCPCS code added for Selarsdi (ustekinumab-aekn)
Q5098	HCPCS code added for Imuldosa (ustekinumab-srlf)
Q5099	HCPCS code added for Otulfi (ustekinumab-aauz)
Q5100	HCPCS code added for Yesintek (ustekinumab-kfce)

Outpatient infusion center distance

Applies toSite-of-service review for listed IV and injectable drugs when individual is age 13 or older (site-of-service age rule cited elsewhere).

Exception noteDoes not include standard dosing intervals of 6 months or longer between infusions when re-initiation is defined differently.

Hospital outpatient medically necessary period

Medically necessary periodHospital-based outpatient setting is considered medically necessary for the first 90 days for the initial course of infusion or injection, or for re-initiation of therapy after 6 months or longer following discontinuation.

Re-initiation exception

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Documentation Required

Prior authorization is required for all drugs listed in this policy. Initial and re-authorization requests may be approved for up to 12 months when drug-specific coverage criteria are met and chart notes document continued clinical benefit.

All drugs in this policy require prior authorization; approval length up to 12 months.
Medical records must include office visit notes with diagnosis, relevant history, physical exam, and medication history.
Requests for investigational uses or combinations not described in the policy will be denied as investigational.

Prior Authorization

Site-of-Service Prior Authorization Required

Site-of-service prior authorization applies to medical-benefit-administered IV and injectable drugs. Site-of-service medical necessity criteria must be met; failure to meet criteria may require an alternate site or result in denial. SOS criteria do not apply to Alaska fully-insured members (see Member plan booklet) and may not apply to certain custom formulary plans noted in related policies.

Background and Context

Psoriatic arthritis (PsA) is an inflammatory spondyloarthropathy associated with psoriasis that can involve peripheral joints, axial disease, enthesitis, and nail or skin manifestations. Management includes nonsteroidal anti‑inflammatory drugs and traditional DMARDs for milder disease, with escalation to targeted biologic or oral agents for moderate to severe or progressive disease. This policy provides medical necessity guidance for biologic, biosimilar, and targeted oral therapies used to treat active PsA, including age and weight thresholds, specialty prescriber requirements, and site‑of‑service considerations.

Definitions and Key Terms

Site of service (SOS)

ScopeSOS Medical Necessity criteria applies to medical benefit reviews and to IV and injectable drugs; for site-of-service determinations, age 13+ is reviewed.

ExclusionSOS criteria does NOT apply to Alaska fully-insured members; refer to infusion and injection drug Medical Necessity criteria for those members.

Medically necessary sites

Hospital outpatient roleHospital-based outpatient setting may be medically necessary for the initial 90 days of therapy or re-initiation after >=6 months, or when no outpatient infusion center within 50 miles or no contracted home infusion agency is available.

Clinical risk indicationsHospital outpatient is medically necessary when individual has clinical conditions increasing infusion risk (e.g., known cardiac condition, significant respiratory disease with %FVC <= 40%, unstable renal function, difficult vascular access, acute mental status changes, or history of severe adverse reactions/anaphylaxis).

Policy Summary

PayerPremera Bluecross

PolicyMedical Necessity and Coverage Criteria for Biologic and Targeted Therapies for Psoriatic Arthritis (including Site-of-Service Review)

Policy CodePolicy N/A

Change TypeMaterial updates: added ustekinumab biosimilars, age/weight criteria revisions, HCPCS code additions

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document specialist consultation, age/weight criteria, and prior trials/failures as required for the requested agent.

SourceLink

On This Page

Orencia (abatacept) IV/SC: Adult patient aged 18 years or older AND inadequate response or intolerance to two listed agents (e.g., Enbrel, adalimumab products, Otezla, Rinvoq, Skyrizi, Sotyktu, Stelara, Taltz, Tremfya, Xeljanz) AND prescribed by or in consultation with a dermatologist or rheumatologist. For pediatric patients (>=2 years), criteria may be met with inadequate response to one agent or presence of specific comorbidities (heart failure, prior lymphoproliferative disorder, prior serious infection, demyelinating disorder).age >= 18 for adult criteria; pediatric criteria >= 2

IV formulation is subject to site-of-service review.

Step Therapy

Step Therapy / Prior Trial Requirements

Step therapy and prior trial requirements must be followed per the drug-specific coverage criteria. For some agents (for example certain infliximab, ustekinumab and IL‑23 agents), documented trials and failures of specified biosimilars or preferred alternatives are required before coverage of the requested product will be considered.

Examples: Infliximab (Janssen unbranded) and Remicade require documented trial and treatment failure with Avsola and Inflectra prior to coverage.
Stelara (ustekinumab) criteria require trial with specified ustekinumab biosimilars (Steqeyma, Yesintek) for individuals not previously treated.
Refer to drug-specific sections for complete step therapy tiers and required prior agents.

Documentation Required

Prescriber Specialty and Consultation Requirements

Prescriber specialty requirements and consultation notes: many biologic and targeted therapies must be prescribed by or in consultation with a dermatologist or rheumatologist (or other specialty as specified). Include specialist consultation notes when required.

Examples: Psoriatic arthritis and IL‑23/IL‑17 agents commonly require prescription by or consultation with a rheumatologist or dermatologist.
Include documentation of the consulting specialist and relevant visit notes with the prior authorization request.

Billing Rule

Prior Authorization, HCPCS Coding, and Claim Documentation

Claims billing and coding: Use the HCPCS/J‑code indicated for the administered product. New HCPCS codes for ustekinumab biosimilars and other product-specific Q‑codes have been added — failure to report the correct code may result in claim denial or special handling.

Report the appropriate HCPCS/J‑code on claims (examples: J1745 for infliximab excluding biosimilar, J1602 for golimumab IV, J3357 for ustekinumab SC).
New Q‑codes effective 07/01/25 and other updates (e.g., Q5098, Q5099, Q5137, Q5138, Q9999, Q9996, Q9998) must be used where applicable.
Unlisted biologic code J3590 may be used for certain unbranded or biosimilar products as directed in coding guidance.

Note

Plan/Formulary Preferred Product Lists and Status Updates

Reference plan/formulary preferred product lists and custom formulary exceptions: coverage and applicable criteria may vary by the member's pharmacy/medical plan. Some Open, Preferred, and custom formulary plans have different criteria or exclusions; consult the member's plan booklet and related policy 5.01.647 for plan-specific rules.

Certain policy criteria do not apply to specific Open, Preferred, or Metallic formulary plans (e.g., Formulary ID: 6062; Rx Plan F1 and Formulary ID: 6064; Rx Plan G3).
Check formulary preferred alternatives (e.g., preferred adalimumab products) when selecting alternatives or meeting step therapy requirements.
Use related policy 5.01.647 for Custom Open and Preferred formulary plan details.