ModifiedPremera Blue Cross of WashingtonPolicy 5.01.645

Pharmacologic Treatment of Psoriatic Arthritis

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Governs medical necessity, prior authorization, step therapy, and site-of-service review for biologic and other pharmacologic treatments of active psoriatic arthritis.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyPharmacologic Treatment of Psoriatic Arthritis

Policy CodePolicy 5.01.645

Change TypeModified

Effective DateJanuary 1, 2027

Last ReviewSep 8, 2026

Next Review DateNot specified

Key ActionFor previously untreated individuals seeking Stelara coverage, document trials with Steqeyma and Yesintek.

SourceLink

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedPremera Blue Cross of WashingtonPolicy 5.01.645

Pharmacologic Treatment of Psoriatic Arthritis

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Sign up for premerabluecrossofwashington Policy 5.01.645 alerts

Get alerted when Policy 5.01.645 changes without checking for updates manually.

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Governs medical necessity, prior authorization, step therapy, and site-of-service review for biologic and other pharmacologic treatments of active psoriatic arthritis.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyPharmacologic Treatment of Psoriatic Arthritis

Policy CodePolicy 5.01.645

Change TypeModified

Effective DateJanuary 1, 2027

Last ReviewSep 8, 2026

Next Review DateNot specified

Key ActionFor previously untreated individuals seeking Stelara coverage, document trials with Steqeyma and Yesintek.

SourceLink

POLICY UPDATE CHANGES

The 2026 update added coverage criteria for Otezla XR and added it to the preferred alternatives for Cimzia, Simponi, Bimzelx, Cosentyx, and Orencia.

The 2026 update revised Otezla criteria to require an individual weight of at least 20 kg and revised Tremfya criteria to require an individual weight of at least 40 kg.

The 2026 update changed the minimum age for Simponi Aria from 18 years to 2 years or older.

The policy added or expanded coverage references for multiple ustekinumab products and biosimilars, including Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Steqeyma, Yesintek, and Wezlana.

Added coverage criteria for Sotyktu (deucravacitinib) for active psoriatic arthritis.

Added Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi) IV with criteria matching the corresponding Simponi products.

Updated Skyrizi (risankizumab-rzaa) psoriatic arthritis criteria to allow individuals aged 6 years or older.

Updated Stelara coverage for previously untreated individuals to require a trial with Steqeyma and Yesintek.

Removed Idacio (adalimumab-aacf) because the product was removed from the market.

Removed Yuflyma (adalimumab-aaty) coverage criteria because the product was discontinued.

Removed Stelara as a preferred alternative for all non-preferred agents effective January 1, 2027.

Clarified that Site of Service Medical Necessity criteria can apply to injection drugs.

12 monthsMaximum authorization period

13 yearsSite-of-service review age threshold

2 yearsUpdated Simponi Aria minimum age

20 kgOtezla minimum weight

40 kgTremfya minimum weight

ExcludedMedicare Advantage coverage

Medical Necessity and Coverage Criteria

Site of Service — Medical-Benefit IV and Injectable Drugs

Site-of-service medical necessity criteria apply only to medical-benefit reviews. They do not apply to Alaska fully insured members; refer to the infusion and injection drug medical necessity criteria. For individuals age 13 and older, site of service is also reviewed for medical necessity.

Medical-benefit site-of-service review

Medically necessary sites of service
- Physician's office or infusion center.
- Home infusion.
- Hospital-based outpatient setting, including an outpatient hospital IV infusion department.
The drug is administered in the most appropriate, safe, and cost-effective site.
Hospital-based outpatient setting may be medically necessary when
- It is the initial course of infusion or injection of a pharmacologic or biologic agent, or therapy is being re-initiated after 6 months or longer following discontinuation. This does not include standard dosing intervals of 6 months or longer.first 90 days
- There is no outpatient infusion center within 50 miles of the individual's home and no contracted home infusion agency will travel to the home, or a hospital is the only place that offers infusions or injections of the drug.
- The individual has a clinical condition that increases the risk of infusion or injection complications
  - Known cardiac condition, such as symptomatic cardiac arrhythmia, or significant pulmonary disease.
  - Unstable renal function that decreases the ability to respond to fluids.

TNF-Alpha Inhibitor — First Line

The following agents may be considered medically necessary for active psoriatic arthritis when all criteria are met.

ALL of the following

The individual is aged 18 years or older.
The medication is prescribed by or in consultation with a rheumatologist or dermatologist.

First-Line Biologics

First-line biologics may be considered medically necessary for active psoriatic arthritis when the applicable age and prescriber requirements are met.

Applicable first-line biologic

Taltz (ixekizumab) SC
- The individual is aged 18 years or older.
- The medication is prescribed by or in consultation with a rheumatologist or dermatologist.
Steqeyma (ustekinumab-stba) SC or Yesintek (ustekinumab-kfce) SC
- The individual is aged 6 years or older.
- The medication is prescribed by or in consultation with a rheumatologist or dermatologist.

Janus Kinase Inhibitors — First Line

Rinvoq, Rinvoq LQ, tofacitinib, and the listed Xeljanz products may be considered medically necessary for active psoriatic arthritis when the applicable criteria are met.

Applicable Janus kinase inhibitor criteria

Rinvoq (upadacitinib) or Rinvoq LQ (upadacitinib)
- The individual is aged 2 years or older.
- The individual has had an inadequate response or intolerance to one or more TNF blockers.
- The medication is prescribed by or in consultation with a rheumatologist or dermatologist.
Tofacitinib or Xeljanz (tofacitinib)
- The individual is aged 2 years or older.

TNF Inhibitors — Later Line

The applicable TNF inhibitors may be considered medically necessary for active psoriatic arthritis when all drug-specific criteria are met.

Applicable later-line TNF inhibitor

Cyltezo, Hadlima, or Hulio
- The individual has had an inadequate response or intolerance to all of adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm with NDCs starting with 00597.
- The medication is prescribed by or in consultation with a dermatologist or rheumatologist.
Hyrimoz, Simlandi, or Yusimry
- The individual has had an inadequate response or intolerance to all of adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm with NDCs starting with 00597.
- The medication is prescribed by or in consultation with a dermatologist or rheumatologist.

Later-Line IL-17 and Ustekinumab Therapy

The listed later-line IL-17 and ustekinumab products may be considered medically necessary for active psoriatic arthritis when the applicable criteria are met.

Applicable later-line therapy

Bimzelx (bimekizumab-bkzx)
- The individual is aged 18 years or older.
- The individual has had an inadequate response or intolerance to one of the following: Enbrel; specified adalimumab products; Otezla or Otezla XR; Skyrizi; Sotyktu; Steqeyma or Yesintek; Taltz; or Tremfya.
- The medication is prescribed by or in consultation with a dermatologist or rheumatologist.
Ustekinumab products, including Stelara and listed biosimilars
- The individual is aged 6 years or older.

Cosentyx and Orencia

Cosentyx and Orencia may be considered medically necessary for active psoriatic arthritis when the applicable criteria are met.

Applicable agent

Cosentyx (secukinumab) IV/SC
- The individual has had an inadequate response or intolerance to two of the following: Enbrel; specified adalimumab products; Otezla or Otezla XR; Rinvoq or Rinvoq LQ; Skyrizi; Sotyktu; Steqeyma or Yesintek; Taltz; Tremfya; or tofacitinib, tofacitinib extended-release, Xeljanz, or Xeljanz XR.
- The medication is prescribed by or in consultation with a dermatologist or rheumatologist.
Orencia (abatacept) IV/SC — adults
- The individual is aged 18 years or older.
- ANY of the following

Initial Authorization

Initial authorization may be approved for up to 12 months when the drug-specific coverage criteria are met.

ALL of the following

The requested drug is listed in this policy and is being used for active psoriatic arthritis or another covered indication described in this policy.
All applicable drug-specific medical-necessity criteria are met.
The medication is used according to FDA dosage and administration prescribing information.

Continuation Therapy

Reauthorization may be approved for up to 12 months when continued coverage requirements are met.

ALL of the following

The applicable drug-specific coverage criteria continue to be met.
Chart notes demonstrate that the individual continues to show a positive clinical response to therapy.

Initial Stelara Therapy

For an individual who has not previously been treated with the requested Stelara or ustekinumab therapy, initial Stelara therapy may be considered medically necessary when all of the following are met.

ALL of the following

The individual is aged 6 years or older.
The individual has active psoriatic arthritis.
The individual has had an inadequate response or intolerance to both Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce).
Stelara (ustekinumab) or the requested ustekinumab product is prescribed by or in consultation with a dermatologist or rheumatologist.

The medications listed in this policy are subject to the product's U.S. Food and Drug Administration dosage and administration prescribing information. All other uses of the above-named agents when used in combination with each other or for conditions not outlined in this policy or related medical policies are considered investigational.

Coverage under this policy is limited to the indications and criteria described in the policy. Combination use of the listed agents with each other is not covered unless specifically addressed by this policy or a related medical policy.

This medical policy does not apply to Medicare Advantage.

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

Infusion and injectable therapy services provided at a site that does not meet the applicable site-of-service criteria are considered not medically necessary.

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

Initial Therapy Requirements

Initial therapy is covered when the requested product's age, specialist, active-disease, and step-therapy criteria are met.

Active disease and product-specific eligibility: The requested drug is being used for active psoriatic arthritis and all product-specific age and prior-treatment requirements are satisfied.Product-specific

Specialist requirement: The medication is prescribed by or in consultation with a rheumatologist or dermatologist, as required by the applicable product criteria.Rheumatologist or dermatologist

Initial Authorization

Initial authorization is subject to the applicable drug-specific coverage criteria.

Continuation and Reauthorization

Reauthorization Criteria

Reauthorization is available when continuation requirements are met.

Continued coverage: The drug-specific coverage criteria remain met and chart notes demonstrate that the individual continues to show a positive clinical response to therapy.

Applies to all drugs listed in the policy. Reauthorization may be approved for up to 12 months.

Reauthorization

All drugs listed in the policy may be reauthorized when drug-specific criteria remain satisfied and clinical response continues.

Continuation therapy: Drug-specific coverage criteria remain satisfied and chart notes demonstrate a continued positive clinical response to therapy.

Approval may be granted for up to 12 months.

Product-Specific Step Therapy

Step	First-line category	Product options identified in the policy
1
TNF-alpha inhibitors
Avsola (IV); Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Simlandi, and Yusimry (SC)
1
IL-17 inhibitors
Taltz (ixekizumab)
1
IL-12/23 inhibitors
Brand ustekinumab-aauz and brand ustekinumab-ttwe (SC)
1
IL-23 inhibitors
Skyrizi (SC)
1
Janus kinase inhibitors
Rinvoq, Rinvoq LQ, Xeljanz, and Xeljanz XR
1
PDE-4 inhibitors
Otezla and Otezla XR

Step 2 product	Prior-treatment or qualifying requirement	Additional requirement
Cimzia, Immgolis SC, and Simponi SC
Inadequate response or intolerance to 2 specified agents, including eligible TNF inhibitors, adalimumab products, Otezla or Otezla XR, Rinvoq or Rinvoq LQ, Skyrizi, Sotyktu, Steqeyma or Yesintek, or Taltz
Age 18 years or older; prescribed by or in consultation with a dermatologist or rheumatologist
Bimzelx
Inadequate response or intolerance to 1 specified agent, including Enbrel, specified adalimumab products, Otezla or Otezla XR, Skyrizi, Sotyktu, Steqeyma or Yesintek, Taltz, or Tremfya
Age 18 years or older; prescribed by or in consultation with a dermatologist or rheumatologist
Cosentyx
Inadequate response or intolerance to 2 specified agents, including Enbrel, specified adalimumab products, Otezla or Otezla XR, Rinvoq or Rinvoq LQ, Skyrizi, Sotyktu, Steqeyma or Yesintek, Taltz, Tremfya, or tofacitinib/Xeljanz products
Prescribed by or in consultation with a dermatologist or rheumatologist
Adult Orencia
Inadequate response or intolerance to 2 specified agents, or heart failure, a previously treated lymphoproliferative disorder, a previous serious infection, or a demyelinating disorder
Age 18 years or older; prescribed by or in consultation with a dermatologist or rheumatologist
Pediatric Orencia
Inadequate response or intolerance to Enbrel, Rinvoq or Rinvoq LQ, or Steqeyma or Yesintek; alternatively, a qualifying condition may satisfy the requirement
Age 2 years or older; prescribed by or in consultation with a dermatologist or rheumatologist

Step 3 reference product	Required prior treatment	Eligibility details
Infliximab Janssen-unbranded and Remicade
Documented trial and treatment failure with Avsola, Inflectra, and Renflexis
Age 18 years or older; requirement applies to individuals not previously treated with the requested therapy; rheumatologist or dermatologist involvement required
Ustekinumab products and Wezlana
Inadequate response or intolerance to both Steqeyma and Yesintek
Age 6 years or older; prescribed by or in consultation with a dermatologist or rheumatologist

Tier	Product options	Coverage pathway
1
Enbrel
Tier 1 option
1
Rinvoq or Rinvoq LQ
Tier 1 options
1
Steqeyma or Yesintek, subcutaneous
Tier 1 options
1
Enbrel, Rinvoq or Rinvoq LQ, or Steqeyma or Yesintek
Pediatric Orencia may use inadequate response or intolerance to 1 of these agents, or a qualifying condition, before coverage

Requested product	Required trial before coverage	Applies to
Stelara (ustekinumab)
Steqeyma (ustekinumab-aauz) and Yesintek (ustekinumab-kfce)
Individuals not previously treated with Stelara

Sequence	Product	Requirement
Before Stelara
Steqeyma (ustekinumab-aauz)
Trial required for individuals not previously treated with Stelara
Before Stelara
Yesintek (ustekinumab-kfce)
Trial required for individuals not previously treated with Stelara
After required trials
Stelara (ustekinumab)
May be considered after trials with both Steqeyma and Yesintek, subject to the applicable coverage criteria

Selected product	Preferred alternatives identified	Notes
Bimzelx, Cimzia, Cosentyx, Orencia, and Simponi SC
Adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm with NDCs beginning 00597; Sotyktu; Otezla XR
Alternatives were updated in the policy history
Products with Xeljanz or Xeljanz XR listed
Tofacitinib or tofacitinib extended-release
Criteria match Xeljanz and Xeljanz XR, respectively
Non-preferred infliximab products
Renflexis (infliximab-abda)
Updated from non-preferred to preferred

Site-of-Service Requirements

Prior Authorization

Preferred Sites of Care and Hospital Exceptions

Use the most appropriate, safe, and cost-effective site for covered IV infusion or injection therapy. Physician offices, infusion centers, and home infusion are preferred; hospital-based outpatient administration requires applicable medical-necessity support.

Hospital-based outpatient administration is medically necessary for the first 90 days of an initial infusion or injection course or when therapy is re-initiated after at least 6 months of discontinuation, except when standard dosing is itself 6 months or longer.
It may also be medically necessary when no outpatient infusion center is within 50 miles and no contracted home infusion agency will travel to the individual's home, or when the hospital is the only location offering the drug.
Document qualifying increased risk, such as a cardiac or pulmonary condition, unstable renal function affecting response to fluids, difficult or unstable vascular access, acute mental-status or cognitive conditions affecting safety, or a history of severe adverse reactions or anaphylaxis to a related drug.
For cytokine release syndrome, hospital-based outpatient administration requires grade 3 or 4 CRS, including temperature at least 38 °C, hypotension requiring one or more vasopressors, and qualifying hypoxia, with admission to an inpatient setting as soon as possible.

Product Identification and Coding

NDC-specific product identificationNDC

NDCs starting with 00597

Adalimumab-adbm products identified by National Drug Code numbers beginning with 00597

HCPCSHCPCS

J0129	Injection, abatacept (Orencia), 10 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered)
J0139	Injection, adalimumab (Humira), 1 mg
J0717	Injection, certolizumab pegol (Cimzia), 1 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered)
J1438	Injection, etanercept (Enbrel), 25 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered)
J1602	Injection, golimumab (Simponi Aria), 1 mg, for intravenous use
J1628	Injection, guselkumab (Tremfya), 1 mg
J1745	Injection, infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J3247	Injection, secukinumab, intravenous (Cosentyx), 1 mg
J3357	Injection, ustekinumab, subcutaneous injection (Stelara), 1 mg
J3590	Unclassified biologics (use to report: Abrilada, Adalimumab-adaz HCF, Amjevita, Bimzelx, Cyltezo, Hadlima, Hulio, Hyrimoz LCF, Hyrimoz HCF, Immgolis, Imgolis Intri, Imuldosa, Kevzara, Kineret, Sandoz unbranded, Simponi, Skyrizi, Starjemza, Taltz, Yuflyma, Yusimry)

1–10 of 29

1/3

Added HCPCS codesHCPCS

Q9999	HCPCS code added to the policy; product description not specified in the document window
Q5137	Wezlana
Q5138	Wezlana
Q9996	Steqeyma
Q9998	Steqeyma
Q5098	Imuldosa
Q5099	Otulfi
Q5100	Yesintek
Q5164	New HCPCS code; product description not specified in the document window

Site-of-Service Age

Threshold13 years of age or older

Applies toSite-of-service medical necessity review

Administration locationsHospital-based outpatient setting, infusion center, physician's office, or home

Otezla Minimum Weight

Minimum weightAt least 20 kg

ProductOtezla (apremilast)

Condition

Authorization, Documentation, and Denial Risks

Prior Authorization

Submit medical-necessity and site review requests

Specific IV and injectable drugs are reviewed for medical necessity at all ages. For individuals aged 13 years and older, the administration site is also reviewed for medical necessity.

Prior Authorization

Request authorization for up to 12 months

All drugs listed in the policy may be approved for up to 12 months initially. Reauthorization may also be approved for up to 12 months when drug-specific criteria remain met and records show a positive clinical response.

Plan authorization requests around the maximum 12-month initial and reauthorization periods.

Prior Authorization

Confirm active disease and specialist involvement

Document active psoriatic arthritis, the applicable age and prior-treatment requirements, and prescribing by or consultation with a rheumatologist or dermatologist when required by the product criteria.

Biosimilar and Reference Product Sequencing

Step Therapy

Complete the infliximab biosimilar trials

For individuals not previously treated with the requested therapy, infliximab Janssen-unbranded and Remicade require a documented trial and treatment failure with Avsola, Inflectra, and Renflexis.

Document failure with all three products.
These products are also subject to site-of-service review.

Step Therapy

Document failure or intolerance to both products

The listed ustekinumab products require inadequate response or intolerance to both Steqeyma and Yesintek before coverage may be considered.

Step Therapy

Use Steqeyma as a tier 1 option before Stelara

Subcutaneous Steqeyma is listed as a tier 1 option. For individuals not previously treated with Stelara, coverage requires a trial with Steqeyma and Yesintek.

Condition Overview

Psoriatic arthritis is an inflammatory disease affecting the joints and the areas where tendons and ligaments attach to bone. It is associated with psoriasis and may involve inflammatory joint and spine symptoms, joint destruction, dactylitis, enthesitis, and psoriatic skin plaques. Common symptoms include joint pain and stiffness, skin rashes, and fingernail or toenail changes.

Key Definitions

Site of Service

DefinitionThe location where a drug is administered

ExamplesHospital-based outpatient setting, infusion center, physician's office, or home

Review scopeFor individuals age 13 and older, the administration site is reviewed for medical necessity

Reauthorization

DefinitionApproval following the initial authorization period

Continuation requirementDrug-specific coverage criteria must continue to be met

Clinical evidence

Policy Summary

PayerPremera Blue Cross of Washington

PolicyPharmacologic Treatment of Psoriatic Arthritis

Policy CodePolicy 5.01.645

Change TypeModified

Effective DateJanuary 1, 2027

Last ReviewSep 8, 2026

Next Review DateNot specified

Key ActionFor previously untreated individuals seeking Stelara coverage, document trials with Steqeyma and Yesintek.

SourceLink

On This Page

Difficult or unstable vascular access.

Acute mental status changes or cognitive conditions affecting the safety of infusion or injection therapy.

Known history of severe adverse drug reactions or anaphylaxis to a related or similar drug.

Cytokine release syndrome (CRS)

CRS is grade 3 or 4.
ALL of the following
- Temperature at least 38 °C.
- Hypotension requiring one or more vasopressors.
- Hypoxia requiring high-flow nasal cannula, face mask, non-rebreather mask, Venturi mask, or positive pressure such as CPAP, BiPAP, intubation, or mechanical ventilation.
The individual will be admitted to an inpatient setting as soon as possible.

Tremfya (guselkumab) SC

The individual is aged 6 years or older and weighs at least 40 kg.
The medication is prescribed by or in consultation with a rheumatologist or dermatologist.

Skyrizi (risankizumab-rzaa) SC

The individual is aged 6 years or older.
The medication is prescribed by or in consultation with a dermatologist or rheumatologist.

The individual has had an inadequate response or intolerance to one or more TNF blockers.

The medication is prescribed by or in consultation with a rheumatologist or dermatologist.

Tofacitinib extended-release or Xeljanz XR (tofacitinib extended-release)

The individual is aged 18 years or older.
The individual has had an inadequate response or intolerance to one or more TNF blockers.
The medication is prescribed by or in consultation with a rheumatologist or dermatologist.

Cimzia, Immgolis, or Simponi SC

The individual is aged 18 years or older.
The individual has had an inadequate response or intolerance to two of the following: Enbrel; specified adalimumab products; Otezla or Otezla XR; Rinvoq or Rinvoq LQ; Skyrizi; Sotyktu; Steqeyma or Yesintek; or Taltz.
The medication is prescribed by or in consultation with a dermatologist or rheumatologist.

Infliximab (Janssen-unbranded) or Remicade

The individual is aged 18 years or older.
The individual has a documented trial and treatment failure with Avsola, Inflectra, and Renflexis.
The medication is prescribed by or in consultation with a rheumatologist or dermatologist.

The individual has had an inadequate response or intolerance to both Steqeyma and Yesintek.

The medication is prescribed by or in consultation with a dermatologist or rheumatologist.

The individual has had an inadequate response or intolerance to two of the following: Enbrel; specified adalimumab products; Otezla or Otezla XR; Rinvoq or Rinvoq LQ; Skyrizi; Sotyktu; Steqeyma or Yesintek; Taltz; Tremfya; or tofacitinib, tofacitinib extended-release, Xeljanz, or Xeljanz XR.

The individual has heart failure, a previously treated lymphoproliferative disorder, a previous serious infection, or a demyelinating disorder.

The medication is prescribed by or in consultation with a dermatologist or rheumatologist.

Orencia (abatacept) SC — pediatric individuals

The individual is aged 2 years or older.
ANY of the following
- The individual has had an inadequate response or intolerance to Enbrel, Rinvoq or Rinvoq LQ, or Steqeyma or Yesintek.
- The individual has heart failure, a previously treated lymphoproliferative disorder, a previous serious infection, or a demyelinating disorder.
The medication is prescribed by or in consultation with a dermatologist or rheumatologist.

Initial authorization: The requested medication satisfies its drug-specific coverage criteria and the submitted documentation establishes medical necessity.

Initial authorization may be approved for up to 12 months.

Stelara Initial Therapy

For previously untreated individuals seeking Stelara coverage:

Required trials before Stelara: The individual has a trial with Steqeyma (ustekinumab-aauz) and Yesintek (ustekinumab-kfce) before coverage of Stelara.

Applies to individuals not previously treated.

Billing Rule

Drugs Subject to Site-of-Service Review

Site-of-service review applies to the following IV products. Services delivered at a nonpreferred site are not medically necessary when the applicable site-of-service criteria are not met.

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

Note

Age Limitation for Site-of-Service Review

For site-of-service medical-necessity review, the individual must be 13 years of age or older. The review concerns the location where the drug is administered, including a hospital-based outpatient setting, infusion center, physician office, or home.

Pediatric individuals may require age-appropriate doses, infusion rates, equipment, venipuncture, behavioral management, and specialty infusion training.
Site-of-service review is limited to individuals 13 years of age or older because pediatric physiology and developmental needs differ from those of adults.

Documentation Required

Injection Drugs and Ustekinumab Documentation

Site-of-Service Medical Necessity criteria can apply to injection drugs as well as IV drugs. When requesting coverage for ustekinumab products or other injectable therapy, submit complete clinical documentation and apply the applicable formulary and benefit rules.

Document active disease and involvement of the appropriate treating specialist, along with the drug-specific clinical history supporting the requested product.
Document required ustekinumab product trials, including sequencing through Steqeyma (ustekinumab-aauz) and Yesintek (ustekinumab-kfce) for individuals not previously treated before requesting Stelara (ustekinumab).
Describe product-specific step therapy and the Tier 1 drug options considered or tried; if a Tier 1 option is not appropriate, document the clinical exception and its rationale.
Record prior and current ustekinumab exposure, response, intolerance, contraindication, or other relevant history to support the required sequencing.
These ustekinumab coverage criteria do not apply to Medicare Advantage plans; verify the member's benefit-specific requirements before submitting.
Injection services remain subject to the applicable site-of-service medical-necessity criteria and may be denied when those criteria are not met.

Tremfya Minimum Weight

Minimum weightAt least 40 kg

ProductTremfya (guselkumab)

ConditionPsoriatic arthritis

Skyrizi Minimum Age

Minimum age6 years or older

ProductSkyrizi (risankizumab-rzaa)

ConditionPsoriatic arthritis

Tremfya Minimum Weight

Minimum weightAt least 40 kg

ProductTremfya (guselkumab)

ConditionPsoriatic arthritis

Prior Authorization

Support the initial authorization request

Initial authorization may be approved for up to 12 months when the applicable drug-specific coverage criteria are met and the medical record documents medical necessity.

Submit records establishing the requested drug’s medical necessity.
Include the applicable product-specific age, specialist, disease, and prior-treatment information.

Prior Authorization

Document continued eligibility for reauthorization

Reauthorization may be approved for up to 12 months only when the drug-specific coverage criteria remain met and chart notes document continued positive clinical response.

Step Therapy

Document both ustekinumab product trials

For individuals who have not previously been treated with Stelara, document a trial with Steqeyma (ustekinumab-aauz) and Yesintek (ustekinumab-kfce) before requesting Stelara coverage.

Record the trial history for both products.

Step Therapy

Follow product-specific step therapy

Apply the product-specific step-therapy tiers across TNF-alpha, IL-17, IL-12/23, IL-23, Janus kinase, PDE-4, and T-cell costimulation agents. Requirements range from first-line eligibility to documented inadequate response or intolerance to specified agents.

Verify the requested product’s tier before submitting authorization.
Document the applicable prior-treatment failures or intolerance.

Step Therapy

Document required second-line failures

Certain second-line products require inadequate response or intolerance to two specified agents. Pediatric Orencia requires inadequate response or intolerance to one specified agent or a qualifying condition.

Use the product-specific eligible-agent list when documenting failures.
For Orencia, a qualifying condition may substitute for the required treatment failure as specified.

Step Therapy

Complete the ustekinumab sequence

Before specified reference ustekinumab products are considered, document inadequate response or intolerance to both Steqeyma and Yesintek.

The requirement applies to the listed ustekinumab products and Wezlana criteria.

Step Therapy

Use tier 1 options or document an exception

The tier 1 options are Enbrel, Rinvoq or Rinvoq LQ, and subcutaneous Steqeyma or Yesintek. A clinical exception involves heart failure, a previously treated lymphoproliferative disorder, a previous serious infection, or a demyelinating disorder, with prescribing by or consultation with an appropriate clinician.

Document the qualifying condition when relying on the clinical exception.
Document specialist prescribing or consultation.

Step Therapy

Trial Steqeyma and Yesintek before Stelara

Previously untreated individuals seeking Stelara coverage must first trial Steqeyma and Yesintek.

Documentation Required

Submit complete medical records

Submit medical records documenting that medical-necessity criteria are met, including office visit notes with the diagnosis, relevant history, physical evaluation, and medication history.

Documentation Required

Record the drug-specific clinical history

Document the individual’s age, active psoriatic arthritis diagnosis, prescribing or consulting specialist, prior therapies, inadequate response or intolerance, treatment failures, and any qualifying comorbidities required by the requested drug’s criteria.

Documentation Required

Document the requested administration site

For medical-benefit IV or injectable drugs subject to site-of-service review, document the requested administration setting and any applicable clinical, geographic, access, or safety reason supporting that setting.

Documentation Required

Include required office visit records

Submit office visit notes documenting the diagnosis, relevant history, physical evaluation, and medication history.

Documentation Required

Show a positive response at continuation

For reauthorization, submit chart notes demonstrating that the individual continues to show a positive clinical response to therapy.

Denial Risk

Avoid an unqualified administration site

Infusion or injectable therapy is not medically necessary when the requested site of service does not meet the policy’s site-of-service criteria.

Use the physician’s office, infusion center, or home infusion unless a documented hospital outpatient exception applies.

Denial Risk

Avoid excluded combinations and uses

Uses of the listed drugs in combination with each other, for conditions not outlined in this policy or related medical policies, or for other uses not meeting the policy criteria are investigational or not medically necessary.

Denial Risk

Prevent reauthorization denial

Reauthorization requires the drug-specific coverage criteria to remain met and chart notes to demonstrate a continued positive clinical response. Missing continuation evidence creates a denial risk.

Denial Risk

Do not request unapproved combinations or conditions

Use of the listed drugs in combination with each other, or for conditions not outlined in this policy or related medical policies, is considered investigational.

Denial Risk

Meet all coverage criteria

Uses of the drugs for approved conditions that do not meet the policy’s coverage criteria are considered not medically necessary.

Documentation Required

Document continued response

Reauthorization requires drug-specific criteria to remain satisfied and chart notes to demonstrate continued positive clinical response to therapy.

Include current response documentation with each reauthorization request.

Note

Use the applicable Medicare Advantage policy

This medical policy does not apply to Medicare Advantage plans. Evaluate coverage under the applicable Medicare Advantage benefit and policy requirements.

Step Therapy

Use Yesintek as a tier 1 option before Stelara

Subcutaneous Yesintek is listed as a tier 1 option. For individuals not previously treated with Stelara, coverage requires a trial with Steqeyma and Yesintek.

Billing Rule

Consider preferred Renflexis alternatives

Renflexis (infliximab-abda) was updated from a non-preferred product to a preferred product and added as a preferred alternative for non-preferred infliximab products.

Billing Rule

Account for Stelara trial and preference status

For previously untreated individuals seeking Stelara coverage, Steqeyma is a required trial. Stelara was later identified as a non-preferred product.

Step Therapy

Complete both required Stelara trials

Previously untreated individuals seeking Stelara coverage must trial Steqeyma and Yesintek before Stelara may be covered.

Chart notes must demonstrate that the individual continues to show a positive clinical response to therapy

Site of Service

DefinitionThe location where the drug is administered

Included settingsHospital-based outpatient setting, infusion center, physician's office, or the individual's home

Age for site reviewSite-of-service medical necessity review is limited to individuals 13 years of age or older

Psoriatic Arthritis

Disease classificationA spondyloarthropathy associated with psoriasis

Inflammatory featuresPeripheral and spine inflammation and pain, dactylitis, and enthesitis

Other characteristicsJoint deformities related to joint destruction and psoriatic skin plaques