Premera Bluecross Psoriatic Arthritis Coverage Update

Medical Necessity and Formulary-Specific Coverage Criteria

Site-of-Service Medical Necessity

Applicable for IV/injectable drugs and medical benefit reviews (age ≥13 for SOS review unless otherwise noted).

Site-of-service medically necessary when

Preferred sites: physician office OR infusion center OR home infusion OR hospital-based outpatient setting
Conditions allowing hospital-based outpatient setting: initial course OR re-initiation after ≥6 months OR no local infusion/home option OR clinical condition increasing infusion risk (e.g., symptomatic cardiac arrhythmia, significant respiratory disease, %FVC ≤ 40%, unstable renal function, difficult vascular access, severe prior infusion reactions)
Hospital‑based outpatient considered medically necessary under these conditions for the first 90 days.

Formulary-specific medical necessity for agents (Section 1: Open/Preferred/Select Plans)

Agents are covered when ALL specified conditions for the agent/class are met (age, prescriber specialty, and prior therapy requirements where listed).

Generic rule: Medication is prescribed by or in consultation with a rheumatologist or dermatologist AND patient meets the agent‑specific age requirement AND patient has required prior inadequate response or intolerance to specified agents when listed.

Agent‑specific age exceptions exist (e.g., Stelara age ≥6; Rinvoq age ≥2 for certain indications).

Examples - IL-17 inhibitors: Taltz (ixekizumab) SC may be considered medically necessary when the individual is aged ≥18 and medication is prescribed by or in consultation with a rheumatologist or dermatologist.age >= 18

Section 1: Open/Preferred/Select plans example

Examples - IL-12/23 inhibitors: Steqeyma and Yesintek (ustekinumab biosimilars) may be considered medically necessary when aged ≥6 and medication is prescribed by or in consultation with a rheumatologist or dermatologist. Stelara (brand) may require prior failure/intolerance to the listed biosimilars for treatment‑naïve individuals.age >= 6

Section 1: Open/Preferred/Select plans example

TNF-a antagonist sequencing and failure requirements

Conditions under which various TNF agents are considered medically necessary.

TNF second-line examples: Certain branded adalimumab products (e.g., Humira) and multiple adalimumab biosimilars may be considered medically necessary when the individual is aged ≥18, medication is prescribed by or in consultation with a dermatologist or rheumatologist, AND the individual has had an inadequate response or intolerance to ALL the following listed adalimumab biosimilars (e.g., Cyltezo OR Hyrimoz OR Simlandi as specified).age >= 18

Some TNF agents (e.g., Cimzia, Simponi) require inadequate response/intolerance to 2 listed agents per plan specifications.

Adalimumab medical necessity (selected plans)

Adalimumab products (selected brands/biosimilars) may be considered medically necessary when ALL of the following are met:

Adalimumab criteria: The individual is aged 18 years or older; medication is prescribed by or in consultation with a dermatologist or rheumatologist; AND the individual has had an inadequate response or intolerance to ALL the following listed adalimumab agents (examples include Cyltezo [adalimumab‑adbm] OR Hyrimoz [adalimumab‑adaz] OR Simlandi [adalimumab‑ryvk], as enumerated in the policy).age >= 18

Applies to specified Open/Preferred formulary plans; check plan exceptions for two custom formularies referenced in policy 5.01.647.

Infliximab biosimilars (site-of-service review)

Avsola and Renflexis IV may be considered medically necessary when ALL of the following are met:

Avsola/Renflexis criteria: The individual is aged 18 years or older; medication is prescribed by or in consultation with a rheumatologist or dermatologist; AND there is a documented trial and treatment failure with Inflectra (infliximab‑dyyb), Infliximab (Janssen unbranded), or Remicade (infliximab).age >= 18

Subject to site‑of‑service review for IV administration.

IL-12/23 inhibitors — ustekinumab products

Ustekinumab family (multiple brands/biosimilars) may be considered medically necessary when ALL of the following are met:

Ustekinumab criteria: The individual is aged 6 years or older; medication is prescribed by or in consultation with a dermatologist or rheumatologist; AND the individual has had an inadequate response or intolerance to ALL the following: Stelara (ustekinumab) and specified ustekinumab biosimilars (Steqeyma, Yesintek) as listed in the policy.age >= 6

Applies to Section 1 Open/Preferred/Select formulary plans; policy update requires trial with specified biosimilars for treatment‑naïve individuals.

IL-17 inhibitors — Bimzelx (bimekizumab)

Bimekizumab (Bimzelx) criteria:

Bimzelx: The individual is aged 18 years or older; has had an inadequate response or intolerance to ONE of the listed prior agents (examples include Enbrel, specified adalimumab biosimilars, Otezla, Skyrizi, Stelara, Taltz, etc.); and medication is prescribed by or in consultation with a rheumatologist or dermatologist per the policy's specialist requirement.age >= 18

Single prior‑agent requirement; subject to plan‑specific step therapy rules.

Secukinumab (Cosentyx) — criteria and IV review

Cosentyx (secukinumab) criteria and site-of-service review:

Cosentyx IV/SC: The individual is aged 2 years or older; medication is prescribed by or in consultation with a dermatologist or rheumatologist; AND the individual has had an inadequate response or intolerance to TWO of the listed agents (including Enbrel, specified adalimumab biosimilars, Otezla, Rinvoq, Skyrizi, Stelara/ustekinumab products, Taltz, Tremfya, Xeljanz).age >= 2

Cosentyx IV is subject to site‑of‑service review; check plan‑specific exceptions.

T-cell costimulation modulators — Orencia (abatacept)

Orencia (abatacept) IV/SC criteria:

Orencia adult criteria: The individual is aged 18 years or older; medication is prescribed by or in consultation with a dermatologist or rheumatologist; AND the individual has had an inadequate response or intolerance to TWO of the listed agents (examples include Enbrel, specified adalimumab biosimilars, Otezla, Rinvoq, Skyrizi, Stelara, Taltz, Tremfya, Xeljanz), OR the individual has a contraindicating comorbid condition (heart failure, previously treated lymphoproliferative disorder, prior serious infection, or demyelinating disorder).age >= 18

Orencia IV is subject to site‑of‑service review. Pediatric SC criteria exist for age ≥2 with different prior‑agent requirements.

JAK inhibitors and PDE4 inhibitor — Section 2 criteria

Janus kinase inhibitors (Rinvoq, Xeljanz) and PDE4 inhibitor (Otezla) criteria in Section 2 Essentials:

Rinvoq (upadacitinib): Rinvoq and Rinvoq LQ may be considered medically necessary when the individual is aged 2 years or older; has had an inadequate response or intolerance to 1 or more TNF blockers; AND medication is prescribed by or in consultation with a rheumatologist or dermatologist.age >= 2

Section 2: Essentials formulary plans.

Xeljanz (tofacitinib): Xeljanz and Xeljanz XR may be considered medically necessary when the individual is aged 18 years or older; has had an inadequate response or intolerance to 1 or more TNF blockers; AND medication is prescribed by or in consultation with a rheumatologist or dermatologist.age >= 18

Section 2: Essentials formulary plans.

Otezla (apremilast): Otezla may be considered medically necessary when the individual is aged 18 years or older AND medication is prescribed by or in consultation with a rheumatologist or dermatologist.

TNF-alpha inhibitors — Section 2 first-line

TNF-alpha antagonists and first-line biologics in Section 2 Essentials:

TNF‑a agents (first‑line Section 2): Cyltezo (adalimumab‑adbm), Simlandi (adalimumab‑ryvk), Hyrimoz (adalimumab‑adaz), Enbrel (etanercept), and Simponi Aria (golimumab IV) may be considered medically necessary when: the individual is aged 18 years or older AND medication is prescribed by or in consultation with a rheumatologist or dermatologist. IV infliximab products are subject to site‑of‑service administration review.age >= 18

Section 2 Essentials formulary plans only; check plan exceptions for custom formularies.

Initial/Agent-specific medical necessity

Covered when ALL of the following are met for specified agents:

Xeljanz (tofacitinib): Patient aged 18 years or older AND inadequate response or intolerance to 1 or more TNF blockers AND prescribed by or in consultation with a dermatologist or rheumatologist.>=18

Section 2 Essentials formulary plans only.

TNF-a Antagonists Second Line / examples

TNF-alpha antagonist coverage (examples):

Cimzia (certolizumab) and Simponi (golimumab): Patient aged 18 years or older AND medication is prescribed by or in consultation with a dermatologist or rheumatologist.>=18

Section 2 Essentials formulary plans only; some TNF agents may require failure of 2 prior agents depending on plan.

IL and T-cell related agent criteria

IL-12/23, IL-17, IL-23, T-cell modulator, and IL-related inhibitors:

Orencia (abatacept): Adult: age >=18 AND medication is prescribed by or in consultation with a dermatologist or rheumatologist AND inadequate response or intolerance to 2 of listed agents; Pediatric SC: age >=2 AND inadequate response or intolerance to ONE listed agent OR specific comorbid conditions (heart failure, prior lymphoproliferative disorder, prior serious infection, demyelinating disorder).adult >=18; pediatric >=2

Orencia IV subject to site‑of‑service review.

Targeted synthetic and oral agent criteria

Janus kinase inhibitors and PDE4 inhibitor criteria:

Otezla (apremilast): Patient aged 18 years or older AND medication is prescribed by or in consultation with a rheumatologist or dermatologist.>=18

PDE4 inhibitor may be first‑line in some formularies.

Administration setting and plan-section restrictions

Site-of-service and formulary section-specific rules:

Infusible biologics (e.g., Inflectra, Infliximab, Remicade, Simponi Aria): These agents may be subject to site‑of‑service administration review and require documentation of prescriber specialty and appropriateness of the administration setting.N/A

Section 3 Individual/Small Group/Student ISHIP METALLIC plans and other sections call out site‑of‑service review for IV agents; hospital‑based outpatient use requires justification per SOS criteria.

Drug-specific medical necessity and step therapy criteria

Coverage is subject to agent-specific criteria and step therapy sequences; many agents require age limits, prescribing specialist consultation, and prior therapy trials or intolerance.

Investigational and Not Medically Necessary uses: Medications used outside the listed conditions or in combinations not outlined are considered investigational; all other uses of the drugs not covered by the listed criteria are considered not medically necessary.N/A

Policy lists investigational/NOT MN stances and plan exceptions.

General coverage criteria and plan-specific variations

Policy provides medical necessity criteria for pharmacologic therapies for PsA, with plan-specific variations and required prior trials for certain agents.

Policy scope: Criteria apply to a broad set of biologic and oral agents for psoriatic arthritis that were moved into this policy from Policy 5.01.550; separate sections exist for Metallic, Essentials, Open/Preferred/Select formulary plans and plans with no pharmacy benefit.

See the plan‑specific sections for differing coverage rules and exceptions (including two custom formularies excluded from this policy).

Stelara/biosimilar step requirement

Stelara (ustekinumab) coverage modification

Stelara trial requirement: Updated coverage criteria require trial with specified ustekinumab biosimilars (Steqeyma and Yesintek) for individuals not previously treated with ustekinumab.

Applies to treatment‑naïve individuals per the 2025 policy update; check formulary section for applicability.

Hospital-based outpatient infusion is considered medically necessary only when the site-of-service (SOS) criteria in this policy are met. The policy lists the preferred administration sites as a physician office, infusion center, or home infusion, with a hospital-based outpatient setting reserved for specified circumstances. The hospital-based outpatient site is explicitly identified as medically necessary for the first 90 days of an initial course or for re-initiation after ≥6 months, or when no outpatient infusion center is available within 50 miles, no contracted home infusion agency will travel to the member's home, or when a patient has clinical conditions that increase the risk of infusion-related complications (for example unstable cardiac or pulmonary disease, severe prior infusion reactions, difficult vascular access, or other specified high-risk conditions).

Certain custom Open and Preferred formulary plans are carved out from the standard criteria in this policy. Specifically, the policy notes that the medical necessity criteria do not apply to one Open formulary (Formulary ID: 6062; Rx Plan F1) and one Preferred formulary (Formulary ID: 6064; Rx Plan G3); coverage rules for members in those plans are found in Policy 5.01.647. Providers should check the member plan booklet or ID card to confirm whether these custom formulary exceptions apply before using the criteria in this policy.

The standard medical necessity criteria contained in this policy do not apply to two custom formularies. Members enrolled in the custom Open formulary (Formulary ID: 6062; Rx Plan F1) or the custom Preferred formulary (Formulary ID: 6064; Rx Plan G3) must follow the alternative criteria specified in Policy 5.01.647. Requests processed under the standard criteria for these members risk denial because their formulary-specific rules are managed separately.

Members covered by the named custom Open and Preferred formularies are subject to different coverage rules. The policy reiterates that the criteria here do not apply to Formulary ID 6062 (Rx Plan F1) and Formulary ID 6064 (Rx Plan G3) and directs providers to Policy 5.01.647 for the appropriate medical necessity criteria for those members. Confirming plan membership and applicable policy prior to authorization submission is essential to avoid incorrect application of these criteria.

This medical necessity criteria explicitly excludes one Open formulary (Formulary ID: 6062; Rx Plan F1) and one Preferred formulary (Formulary ID: 6064; Rx Plan G3) from the coverage rules contained in this policy. The policy states that the coverage rules for members in those formularies are located in Policy 5.01.647, and that the Site-of-Service criteria and other plan-specific rules should not be applied to those members.

Infusion and injectable therapy services administered at sites that do not meet the policy's site-of-service criteria are considered not medically necessary. The policy defines the medically necessary administration sites and the limited conditions under which hospital-based outpatient infusion is allowable; use of hospital outpatient services outside those specified conditions may be denied as not medically necessary.

The policy text in the cited sections focuses on required prior therapy trials and formulary applicability rather than listing individual agents as explicitly not medically necessary. Where prior therapy or step requirements are specified, failure to document those prior inadequate responses or intolerances may lead to denial of coverage, but the document does not present additional standalone 'not medically necessary' listings for specific drugs in these chunks.

Within the cited sections the policy does not provide a discrete list of agents that are explicitly labeled 'not medically necessary.' Instead, it specifies differing coverage criteria and step requirements for members of custom formularies and for plan sections; as a result, certain agents may be ineligible under a given plan if the applicable prior trial, age, prescriber specialty, or formulary rules are not met.

All uses of the drugs listed in this policy that are outside the conditions and indications set forth (for example, combinations not described in the policy or treatment of conditions not outlined here) are considered investigational. The policy further states that other uses of the listed drugs for otherwise approved conditions that are not included in this policy's criteria are considered not medically necessary.

This policy serves as a guide for determining medical necessity; coverage decisions are always subject to the limits and conditions of the member's benefit plan. Providers and members should consult the member benefit booklet or contact customer service for benefit-specific limitations. The policy explicitly states that it does not apply to Medicare Advantage.

Billing Codes and HCPCS/CPT/Q-code Listings

Drugs subject to site-of-service review (selected IV agents)mixed

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

Non-IV biologics and oral targeted agentsmixed

Taltz	ixekizumab SC
Tremfya	guselkumab SC
Skyrizi	risankizumab-rzaa SC
Stelara	ustekinumab SC
Rinvoq	upadacitinib oral
Xeljanz	tofacitinib oral / XR
Otezla	apremilast oral

TNF-a antagonists and biosimilarsmixed

Adalimumab (various biosimilars)	multiple adalimumab biosimilars and branded forms (e.g., Humira, Amjevita, Hyrimoz, Abrilada, Idacio, Yuflyma, Hulio, Hadlima, Yusimry)
Enbrel	etanercept SC
Cimzia	certolizumab pegol SC
Simponi	golimumab SC

Listed biologic and targeted agents (no explicit codes in this segment)mixed

NDC/HCPCS not specified

Multiple IV and SC agents listed (Inflectra, Remicade, Avsola, Renflexis, Simponi Aria, etc.) — no explicit billing codes present in these chunks.

Named agents and biosimilars (no billing codes provided)mixed

N/A	Policy lists drug names and formulations rather than billing codes in these chunks

Covered HCPCS Biologics (selected)HCPCS

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 (Remicade, excludes biosimilar), 10 mg
J3247	Injection, secukinumab, intravenous (Cosentyx), mg
J3357	Injection; ustekinumab (Stelara), 1 mg

Q-codes and unclassified biologics (biosimilars/unbranded)HCPCS|Q-code

J3590	Unclassified biologics (used to report listed biosimilars/unbranded biologics)
Q5098	Injection, (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 (Inflectra), biosimilar, 10 mg
Q5104	Injection, infliximab-abda (Renflexis), biosimilar, 10 mg
Q5115	Injection, rituximab-abbs (Truxima), 10 mg
Q5121	Injection, infliximab-axxq (Avsola), biosimilar, 10 mg
Q5137	Injection, ustekinumab-auub (Wezlana), biosimilar; SC, mg
Q5138	Injection, ustekinumab-auub (Wezlana), biosimilar; IV, mg

1–10 of 19

1/2

Added HCPCS codesHCPCS

Q5098	HCPCS code added for Imuldosa (as listed)
Q5099	HCPCS code added for Otulfi (as listed)
Q5100	HCPCS code added for Yesintek
Q5137	HCPCS code added for Wezlana
Q5138	HCPCS code added for Wezlana (additional)
Q9996	HCPCS code added for Steqeyma
Q9998	HCPCS code added for Steqeyma (additional)
Q9999	HCPCS code Q9999 added (unspecified use)

inv-38: Hospital outpatient initial period — First 90 days for initial course or re-initiation after ≥6 months.

Policy hospital outpatient initial periodHospital-based outpatient setting is considered medically necessary for the first 90 days for the initial course of infusion/injection or re-initiation after ≥6 months following discontinuation

Applies toIV infusion and injection therapy of various biologic and pharmacologic agents listed in the policy (e.g., infliximab products, Orencia)

Purpose/justificationAllows hospital outpatient administration when no appropriate local infusion/home option exists or clinical risk increases infusion complications (e.g., unstable cardiac/pulmonary disease, unstable renal function, difficult vascular access, severe prior infusion reactions)

inv-39: Distance to infusion center — No outpatient infusion center within 50 miles (site-of-service justification metric).

Prior Authorization, Documentation, and Step-Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all drugs listed in this policy. Requests must demonstrate that the member meets the applicable medical necessity and formulary-specific criteria before coverage will be approved.

Prior authorization (PA) required for medical benefit reviews and for drugs moved into this policy (including biologic and oral therapies).
PA required for listed agents administered IV or SC as specified in policy (see drug lists and HCPCS additions in History).

Prior Authorization

Prior Authorization / Site‑of‑Service Review

Certain IV-administered infliximab products and other IV agents will be subject to a site-of-service (SOS) review as part of the PA process. The PA must include justification for the requested site of service (physician office, infusion center, home infusion, or hospital-based outpatient setting). Failure to meet SOS criteria may result in denial or referral to a higher-acuity site.

IV products that commonly trigger SOS review include: Avsola, Inflectra, Infliximab (Janssen unbranded), Remicade, Renflexis, Simponi Aria, Orencia, Cosentyx (IV).

Clinical Background and Scope

Psoriatic arthritis (PsA) is an inflammatory spondyloarthropathy associated with psoriasis that can involve peripheral and axial joints, entheses, dactylitis, and skin and nail disease. This policy establishes medical necessity criteria for biologic and targeted pharmacologic therapies used to treat active PsA and includes site-of-service review provisions and age-based thresholds where applicable.

Key Terms and Definitions

inv-66: Site of service (SOS) — definition and where it applies.

DefinitionSite of service (SOS) is the location where a drug is administered (hospital-based outpatient setting, infusion center, physician office, or home)

When it appliesSOS medical necessity criteria apply to medical benefit reviews and to IV/injectable drugs listed in this policy

Preferred sitesPhysician office, infusion center, home infusion, and hospital-based outpatient setting (hospital site reserved per criteria)

inv-67: IL-12/23 inhibitors — class definition and age thresholds (ustekinumab).

Class definitionIL-12/23 inhibitors: biologic agents targeting interleukin-12 and interleukin-23 (ustekinumab products and biosimilars)

Age thresholdUstekinumab products (Steqeyma, Yesintek, Stelara, and listed biosimilars) — age ≥6 years for PsA when criteria met

Policy Changes and Effective Dates

2025-10-03effective_dateLatest

Policy changes (moved PsA criteria from Policy 5.01.550; added/updated ustekinumab products; new plan sections and HCPCS additions) become effective following 90-day provider notification.

2025-07-01coverage_criteria_change

Updated Stelara (ustekinumab) coverage to require trial with specified ustekinumab biosimilars (Steqeyma and Yesintek) for individuals not previously treated with ustekinumab.

OpenPayer

Pharmacologic Treatment of Psoriatic Arthritis