ModifiedPremera Blue Cross of WashingtonPolicy 5.01.645

Pharmacologic Treatment of Psoriatic Arthritis

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This policy governs medical-necessity, prior-authorization, step-therapy, and site-of-service review for biologic and other pharmacologic treatments of active psoriatic arthritis. It applies to members of all ages for specified intravenous and injectable drugs, with site-of-service review generally applying to members age 13 and older; Alaska fully insured members are exempt from the site-of-service criteria.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyPharmacologic Treatment of Psoriatic Arthritis

Policy CodePolicy 5.01.645

Change TypeModified

Effective DateJanuary 1, 2027

Next Review DateNot specified

Key ActionDocument the requested administration setting and any clinical, geographic, access, or safety rationale for drugs subject to site-of-service review.

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

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Policy Summary

PayerPremera Blue Cross of Washington

PolicyPharmacologic Treatment of Psoriatic Arthritis

Policy CodePolicy 5.01.645

Change TypeModified

Effective DateJanuary 1, 2027

Next Review DateNot specified

Key ActionDocument the requested administration setting and any clinical, geographic, access, or safety rationale for drugs subject to site-of-service review.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria were added or expanded for multiple ustekinumab products and biosimilars, including Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Steqeyma, Yesintek, and Wezlana.

The policy updated drug-specific age and weight requirements for Tremfya, Otezla, Otezla XR, Xeljanz, Simponi Aria, and Tremfya.

The policy updated preferred alternatives and formulary-specific coverage rules for several drugs, including Otezla XR as a preferred alternative for Cimzia, Simponi, Bimzelx, Cosentyx, and Orencia.

The policy clarified that site-of-service medical necessity criteria can apply to injection drugs and limits site-of-service review to individuals older than 13 years.

Additional HCPCS codes were added for newer ustekinumab biosimilars and related products.

Idacio (adalimumab-aacf) was removed from the policy because it was removed from the market.

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

Added tofacitinib and tofacitinib extended-release with criteria matching Xeljanz and Xeljanz XR.

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

Added adalimumab-bwwd with criteria matching Hadlima and second-line adalimumab products.

Updated Skyrizi coverage criteria to include individuals aged 6 years or older for psoriatic arthritis.

Updated Tremfya criteria to include individuals aged 6 years or older who weigh at least 40 kg.

Updated Otezla criteria to include individuals aged 6 years or older and added Otezla XR to preferred alternatives for selected drugs.

Updated Xeljanz criteria to include individuals aged 2 years or older.

Updated Simponi Aria criteria to include individuals aged 2 years or older.

Removed Idacio and Yuflyma from the policy because the products were removed from the market or discontinued.

Updated product preference assignments for selected adalimumab and infliximab products, including Renflexis becoming preferred and certain products becoming non-preferred.

Removed Stelara as a preferred alternative for all non-preferred agents.

Clarified that site-of-service medical-necessity criteria may apply to injection drugs.

12 monthsMaximum initial authorization

12 monthsMaximum reauthorization

13+Site-of-service review age

50 milesInfusion-center distance threshold

2 yearsLowest stated age for selected agents

30+HCPCS codes listed

Coverage Criteria

Site-of-service medical necessity

Hospital-based outpatient administration is medically necessary only when one of the following conditions is met:

Hospital-based outpatient criteria

Increased complication risk: Known cardiac or pulmonary condition; unstable renal function limiting response to fluids; difficult or unstable vascular access; acute mental-status or cognitive condition affecting treatment safety; or history of severe adverse drug reaction or anaphylaxis to a related or similar drug.At least 1 listed condition
Grade 3 or 4 cytokine release syndrome: Temperature at least 38 °C; hypotension requiring 1 or more vasopressors; hypoxia requiring high-flow nasal cannula, face mask, non-rebreather mask, Venturi mask, CPAP, BiPAP, intubation, or mechanical ventilation; and admission to an inpatient setting as soon as possible.All listed findings

Preferred medically necessary sites: Physician office, infusion center, home infusion, hospital-based outpatient setting, or outpatient hospital IV infusion department.

The applicable site is medically necessary for the first 90 days of an initial course or re-initiation after 6 months or longer following discontinuation. This does not include therapies whose standard dosing interval is itself 6 months or longer.

Active psoriatic arthritis drug coverage

Coverage is available for active psoriatic arthritis when the common and applicable drug-specific requirements are met.

Common active-disease requirements: The individual has active psoriatic arthritis; the medication is prescribed by or in consultation with a rheumatologist or dermatologist; and the applicable product-specific age and step-therapy requirements are met.

First-line or preferred therapies: The requested agent meets the applicable criteria for adalimumab products, Avsola, Inflectra, Renflexis, Enbrel, Simponi Aria or Immgolis IV, Taltz, Steqeyma, Yesintek, Tremfya, Skyrizi, Rinvoq, Rinvoq LQ, tofacitinib, or Xeljanz products.

Second-line therapies: The requested agent meets the applicable criteria for Cimzia, Immgolis SC, Simponi SC, Janssen-unbranded infliximab, Remicade, specified ustekinumab products, Bimzelx, Cosentyx, or Orencia.

Noncovered uses

The listed drugs are covered only for uses outlined in this policy or related medical policies.

Investigational or not medically necessary uses: Combination use with other listed agents or use for conditions not outlined in this policy or related medical policies is investigational. All other uses for approved conditions listed in the policy are not medically necessary.

The medication must be used according to the product's U.S. Food and Drug Administration dosage and administration prescribing information.

General coverage requirements

Coverage is subject to the applicable drug-specific criteria.

General drug coverage: The drug is used for a condition and indication outlined in this policy or a related medical policy, meets the applicable drug-specific coverage criteria, and is prescribed according to the product's FDA dosage and administration information.

Continuation therapy

Continuation therapy requires all applicable requirements.

Continuation therapy: The drug-specific coverage criteria continue to be met and chart notes demonstrate that the individual continues to show a positive clinical response to therapy.Approval up to 12 months

Combination use of the listed agents with one another, or use for conditions not outlined in this policy or a related medical policy, is considered investigational and is not covered under these criteria.

The listed agents must not be used in combination with one another or for conditions not outlined in this policy or related medical policies. Such use is considered investigational.

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 provided at a site that does not meet the applicable site-of-service criteria is considered not medically necessary.

Uses of the drugs for approved conditions that do not satisfy the applicable drug-specific coverage criteria are considered not medically necessary.

Initial Therapy Criteria

Preferred adalimumab products

Preferred adalimumab products may be medically necessary for active psoriatic arthritis when:

Adalimumab-aaty, adalimumab-adaz, or adalimumab-adbm with NDCs starting 00597: The individual is aged 18 years or older and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Age 18+

Does not apply to Formulary ID 6062, Rx Plan F1; consult policy 5.01.647 for that custom open formulary.

Avsola, Inflectra, and Renflexis infliximab biosimilars

Avsola, Inflectra, and Renflexis may be medically necessary for active psoriatic arthritis when:

Preferred IV infliximab biosimilars: The individual is aged 18 years or older and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Age 18+

Continuation and Reauthorization

Continuation authorization

Reauthorization requires continued satisfaction of drug-specific coverage criteria and evidence of ongoing benefit.

Reauthorization: The drug-specific coverage criteria continue to be met and chart notes demonstrate that the individual continues to show a positive clinical response to therapy.Approval up to 12 months

Continuation and reauthorization for all listed drugs

All listed drugs may be reauthorized when the following requirements are met:

Continuation and reauthorization: The drug-specific criteria continue to be met and chart notes demonstrate that the individual continues to show a positive clinical response to therapy.Approval up to 12 months

Step-Therapy Requirements

Requested therapy	Required prior therapy
Cimzia; Immgolis SC; or Simponi SC	Inadequate response or intolerance to 2 of the following: Enbrel; adalimumab-aaty, adalimumab-adaz, or adalimumab-adbm with NDCs starting 00597; Otezla or Otezla XR; Rinvoq or Rinvoq LQ; Skyrizi; Sotyktu; Steqeyma or Yesintek; or Taltz.

Requested therapy	Required prior therapy
Infliximab (Janssen-unbranded) or Remicade	Documented trial and treatment failure with Avsola, Inflectra, and Renflexis. Applies to individuals not previously treated with the requested therapy.

Requested therapy	Required prior therapy
Imuldosa; Otulfi; Pyzchiva; Selarsdi; Starjemza; Stelara; ustekinumab; ustekinumab-aauz; ustekinumab-aekn; ustekinumab-ttwe; or Wezlana	Inadequate response or intolerance to both Steqeyma and Yesintek.

Requested therapy	Required prior therapy
Bimzelx	Inadequate response or intolerance to 1 of the following: Enbrel; adalimumab-aaty, adalimumab-adaz, or adalimumab-adbm with NDCs starting 00597; Otezla or Otezla XR; Skyrizi; Sotyktu; Steqeyma or Yesintek; Taltz; or Tremfya.

Requested therapy	Required prior therapy or qualifying pathway
Cosentyx	Inadequate response or intolerance to 2 of the specified agents: Enbrel; qualifying 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.
Adult Orencia	Inadequate response or intolerance to 2 of the specified agents, or heart failure, a previously treated lymphoproliferative disorder, a previous serious infection, or a demyelinating disorder.

Requested therapy	Required prior therapy
Rinvoq or Rinvoq LQ	Inadequate response or intolerance to at least 1 TNF blocker.
Tofacitinib extended-release or Xeljanz XR	Inadequate response or intolerance to all of adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm with NDCs starting 00597.

Tier	Agents
Tier 1	Enbrel; Rinvoq or Rinvoq LQ; and subcutaneous Steqeyma or Yesintek.

Requested therapy	Required prior therapy
Stelara	For individuals not previously treated with Stelara, trial of both Steqeyma and Yesintek is required.

Non-preferred therapy	Preferred alternatives
Selected non-preferred agents	Use the applicable formulary's preferred alternatives before the requested agent, including specified adalimumab products and Sotyktu.

Non-preferred therapy	Preferred alternatives
Xeljanz or Xeljanz XR	Tofacitinib or tofacitinib extended-release.

Non-preferred therapy	Preferred alternative
Non-preferred infliximab products	Renflexis.

Site-of-Service Requirements

Note

Preferred Medically Necessary Sites

For specified IV infusion and injection drugs, treatment is covered in the most appropriate, safe, and cost-effective setting. Preferred medically necessary sites are the physician's office, an infusion center, home infusion, or a hospital-based outpatient setting.

Drugs subject to site-of-service review include Avsola, Cosentyx IV, Inflectra, unbranded infliximab, Orencia, Remicade, Renflexis, and Simponi Aria.
The hospital-based outpatient setting includes an outpatient hospital IV infusion department.

Prior Authorization

Initial Course and Re-Initiation

The hospital-based outpatient setting is medically necessary for the first 90 days when it is the initial course of infusion or injection therapy or when therapy is re-initiated after the individual has been off treatment for at least 6 months.

The 6-month rule does not apply when standard dosing between infusions or injections is 6 months or longer.

Coding and Operational Thresholds

Referenced NDC prefixNDC

00597

NDCs starting with 00597; referenced for adalimumab-adbm

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

1–10 of 13

1/2

HCPCSHCPCS

Q5103	Injection, infliximab-dyyb, biosimilar (Inflectra), 10 mg
Q5104	Injection, infliximab-abda, biosimilar (Renflexis), 10 mg
Q5121	Injection, infliximab-axxq, biosimilar (Avsola), 10 mg
Q5137	Injection, ustekinumab-auub, subcutaneous injection (Wezlana), biosimilar, 1 mg
Q5138	Injection, ustekinumab-auub, intravenous (Wezlana), biosimilar, 1 mg
Q5140	Injection, adalimumab-fkjp (Hulio), biosimilar, 1 mg
Q5141	Injection, adalimumab-aaty (Yuflyma), biosimilar, 1 mg
Q5142	Injection, adalimumab-ryvk biosimilar (Simlandi), 1 mg
Q5143	Injection, adalimumab-adbm, biosimilar (Cyltezo), 1 mg
Q5144	Injection, adalimumab-aacf (Idacio), biosimilar, 1 mg

1–10 of 16

1/2

Added HCPCS codesHCPCS

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

Outpatient infusion-center distance

Distance thresholdNo outpatient infusion center within 50 miles of the individual's home

Additional access conditionNo contracted home infusion agency will travel to the individual's home

Covered setting when conditions are metHospital-based outpatient setting or outpatient hospital IV infusion department

Initial or re-initiation site-of-service period

Applicable periodFirst 90 days

Initial treatmentInitial course of infusion or injection of a pharmacologic or biologic agent

Authorization, Documentation, and Denial Risks

Prior Authorization

Submit medical-benefit and site review information

Specific IV and injectable drugs are reviewed for medical necessity for all ages. For members age 13 and older, the administration site is also reviewed; applicable sites include a physician office, infusion center, home infusion, and hospital-based outpatient settings.

Prior Authorization

Track authorization periods

Initial authorization may be approved for up to 12 months. Reauthorization may also be approved for up to 12 months when drug-specific criteria remain met and chart notes show continued positive clinical response.

Prior Authorization

Confirm specialist prescribing or consultation

The requested medication must be prescribed by or in consultation with a rheumatologist or dermatologist unless a more specific criterion applies.

Clinical Background

Psoriatic arthritis is an inflammatory disease affecting the joints and the areas where tendons and ligaments attach to bone. Common manifestations include joint pain and stiffness, skin rashes, and fingernail or toenail changes. This policy addresses when biologic and other pharmacologic treatments may be medically necessary for active psoriatic arthritis.

Definitions

Definition

ConditionPsoriatic arthritis

Disease typeInflammatory disease

Affected areasJoints and areas where tendons and ligaments connect to bone

Definition

MeaningThe location where a drug is administered

Example settingHospital-based outpatient setting

Other settingsInfusion center, physician's office, or home

Biosimilar and Product Preference Rules

Step Therapy

Document biosimilar failure before brand infliximab

For individuals not previously treated with the requested therapy, brand infliximab products require a documented trial and treatment failure with Avsola, Inflectra, and Renflexis.

Step Therapy

Try both ustekinumab biosimilars first

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

Step Therapy

Apply Stelara’s updated prerequisite

For individuals not previously treated, Stelara coverage requires a trial with Steqeyma and Yesintek.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyPharmacologic Treatment of Psoriatic Arthritis

Policy CodePolicy 5.01.645

Change TypeModified

Effective DateJanuary 1, 2027

Next Review DateNot specified

Key ActionDocument the requested administration setting and any clinical, geographic, access, or safety rationale for drugs subject to site-of-service review.

SourceLink

On This Page

These products are subject to site-of-service review.

Enbrel criteria

Enbrel may be medically necessary for active psoriatic arthritis when:

Enbrel: The individual is aged 18 years or older and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Age 18+

Simponi Aria and Immgolis IV criteria

Simponi Aria and Immgolis IV may be medically necessary for active psoriatic arthritis when:

IV golimumab: The individual is aged 2 years or older and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Age 2+

Simponi Aria is subject to site-of-service review.

Taltz criteria

Taltz may be medically necessary for active psoriatic arthritis when:

Taltz: The individual is aged 18 years or older and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Age 18+

Steqeyma and Yesintek criteria

Steqeyma and Yesintek may be medically necessary for active psoriatic arthritis when:

Ustekinumab biosimilars: The individual is aged 6 years or older and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Age 6+

Tremfya and Skyrizi IL-23 inhibitor criteria

Tremfya and Skyrizi may be medically necessary for active psoriatic arthritis when:

IL-23 inhibitors: For Tremfya, the individual is aged 6 years or older and weighs at least 40 kg. For Skyrizi, the individual is aged 6 years or older. The medication is prescribed by or in consultation with a rheumatologist or dermatologist.Tremfya: age 6+ and weight at least 40 kg; Skyrizi: age 6+

Rinvoq and Rinvoq LQ criteria

Rinvoq and Rinvoq LQ may be medically necessary for active psoriatic arthritis when:

Upadacitinib: The individual is aged 2 years or older, has had an inadequate response or intolerance to 1 or more TNF blockers, and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Age 2+; inadequate response or intolerance to at least 1 TNF blocker

Tofacitinib and immediate-release Xeljanz criteria

Tofacitinib and immediate-release Xeljanz may be medically necessary for active psoriatic arthritis when:

Tofacitinib immediate-release: The individual is aged 2 years or older, has had an inadequate response or intolerance to 1 or more TNF blockers, and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Age 2+; inadequate response or intolerance to at least 1 TNF blocker

Tofacitinib extended-release and Xeljanz XR criteria

Tofacitinib extended-release and Xeljanz XR may be medically necessary for active psoriatic arthritis when:

Tofacitinib extended-release: The individual is aged 18 years or older, has had an inadequate response or intolerance to all of adalimumab-aaty, adalimumab-adaz, and adalimumab-adbm with NDCs starting 00597, and the medication is prescribed by or in consultation with a dermatologist or rheumatologist.Age 18+; inadequate response or intolerance to all 3 specified adalimumab products

Does not apply to Formulary ID 6062, Rx Plan F1; consult policy 5.01.647.

Cimzia, Immgolis SC, and Simponi SC criteria

Cimzia, Immgolis SC, and Simponi SC may be medically necessary for active psoriatic arthritis when:

SC TNF inhibitors requiring 2 prior agents: The individual is aged 18 years or older and has had an inadequate response or intolerance to 2 of the following: Enbrel; one of adalimumab-aaty, adalimumab-adaz, or adalimumab-adbm with NDCs starting 00597; 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.Age 18+; inadequate response or intolerance to 2 listed agents

Janssen-unbranded infliximab and Remicade criteria

Janssen-unbranded infliximab and Remicade may be medically necessary for active psoriatic arthritis when:

Brand infliximab: The individual is aged 18 years or older, has a documented trial and treatment failure with Avsola, Inflectra, and Renflexis, and the medication is prescribed by or in consultation with a rheumatologist or dermatologist.Age 18+; failure of all 3 specified biosimilars

The failure requirement applies only to individuals not previously treated with the requested therapy. Products are subject to site-of-service review.

Specified ustekinumab products criteria

The specified ustekinumab products may be medically necessary for active psoriatic arthritis when:

Ustekinumab products requiring biosimilar trials: The individual is aged 6 years or older, has had an inadequate response or intolerance to both Steqeyma and Yesintek, and the medication is prescribed by or in consultation with a dermatologist or rheumatologist.Age 6+; inadequate response or intolerance to both Steqeyma and Yesintek

Applies to Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara, ustekinumab, ustekinumab-aauz, ustekinumab-aekn, ustekinumab-ttwe, and Wezlana.

Bimzelx criteria

Bimzelx may be medically necessary for active psoriatic arthritis when:

Bimzelx: The individual is aged 18 years or older, has had an inadequate response or intolerance to 1 of the following: Enbrel; one of the specified adalimumab products; Otezla or Otezla XR; Skyrizi; Sotyktu; Steqeyma or Yesintek; Taltz; or Tremfya, and the medication is prescribed by or in consultation with a dermatologist or rheumatologist.Age 18+; inadequate response or intolerance to 1 listed agent

Does not apply to Formulary ID 6062, Rx Plan F1; consult policy 5.01.647.

Cosentyx criteria

Cosentyx may be medically necessary for active psoriatic arthritis when:

Cosentyx: The individual has had an inadequate response or intolerance to 2 of the following: Enbrel; one of the 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, and the medication is prescribed by or in consultation with a dermatologist or rheumatologist.Inadequate response or intolerance to 2 listed agents

Cosentyx IV is subject to site-of-service review. Does not apply to Formulary ID 6062, Rx Plan F1; consult policy 5.01.647.

Orencia criteria for adults and pediatric individuals

Orencia may be medically necessary for active psoriatic arthritis when one of the applicable adult or pediatric pathways is met:

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

Orencia IV is subject to site-of-service review. The criteria do not apply to Formulary ID 6062, Rx Plan F1; consult policy 5.01.647.

Initial therapy authorization subject to drug-specific criteria

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

Initial authorization: The requested drug meets its drug-specific coverage criteria, is used for a condition outlined in this policy or a related medical policy, and is used according to FDA dosage and administration prescribing information.Approval up to 12 months

Authorization must reflect the applicable initial-course or re-initiation duration and any ongoing review requirements.

Unsupported block type: info

Prior Authorization

Hospital Outpatient Setting

A hospital-based outpatient setting may be medically necessary when a preferred lower-cost site is not appropriate and the applicable site-of-service criteria are met.

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.
The hospital is the only place that offers infusions or injections of the drug.
The individual has a qualifying increased risk of complications, including an applicable cardiac or pulmonary condition, unstable renal function, difficult or unstable vascular access, acute mental-status or cognitive conditions affecting safety, or a history of severe adverse drug reactions or anaphylaxis to a related or similar drug.
For cytokine release syndrome, grade 3 or 4 criteria and planned admission to an inpatient setting must be met.

Documentation Required

Infusion Center Setting

An infusion center is a preferred medically necessary site when the drug can be safely administered there and the applicable medical-necessity and authorization requirements are met.

The infusion center is generally preferred over a hospital outpatient setting when no qualifying exception supports hospital administration.
Document the requested drug, dose, frequency, administration site, and clinical rationale.

Billing Rule

Physician Office Setting

A physician office is a preferred medically necessary site for eligible infusion therapy when the office can safely administer the drug and the site-of-service requirements are satisfied.

The office must have the appropriate personnel, equipment, monitoring, emergency-response capability, and medication-specific resources.
Injection drugs administered in an office may also be subject to site-of-service medical-necessity review.

Documentation Required

Home Setting

Home infusion is a preferred medically necessary site when a contracted home infusion agency is available and the individual can safely receive the therapy at home.

A home setting may be considered when there is no outpatient infusion center within 50 miles and a contracted home infusion agency will travel to the individual's home.
Document home safety, clinical stability, caregiver support when applicable, and the agency's ability to provide the requested therapy.

Prior Authorization

Office-Administered Injection Drugs

Site-of-service medical-necessity criteria may apply to injection drugs administered in a physician office, in addition to the underlying drug medical-necessity criteria.

Confirm whether the request is reviewed under the medical benefit and whether the member is age 13 or older.
Do not assume that an injection drug is exempt from site-of-service review.

Documentation Required

Infusion-Center Injection Drugs

Site-of-service medical-necessity criteria may apply to injection drugs administered in an infusion center. The requested setting must be supported by the member's clinical needs and the applicable benefit rules.

Submit medical records supporting the requested site, including prior treatment response, adverse reactions, comorbidities, access limitations, and safety-monitoring needs.
Coverage may be denied when the preferred setting is not medically necessary or when required records are absent.

Denial Risk

Authorization and Coverage Controls

Site-of-service medical-necessity criteria may apply to injection drugs administered in a hospital outpatient setting. Providers must satisfy all applicable authorization, formulary, and medical-necessity requirements before administration.

Authorization may be limited to the approved duration; request extensions or renewals before the authorization expires.
Unlisted use, combination therapy, non-FDA-concordant use, unmet drug-specific requirements, incorrect formulary criteria, benefit-plan limitations, missing medical records, therapeutic-tier requirements, prerequisite therapy, and preferred-product sequencing can affect approval.
For tofacitinib, document that covered alternatives and applicable prerequisite therapies were considered or tried.
For infliximab, follow the plan's preference hierarchy and document why a preferred product is not appropriate when requesting another product.
Stelara is no longer a preferred alternative; apply the current preferred-product requirements, including applicable ustekinumab alternatives.

Applicable siteThe applicable medically necessary site of service

Therapy re-initiation

Re-initiation thresholdAfter 6 months or longer following discontinuation of therapy

Applicable periodThe applicable site is considered medically necessary for the first 90 days

ExceptionDoes not include cases in which the standard dosing interval between infusions or injections is 6 months or longer

Cytokine release syndrome temperature

Temperature thresholdAt least 38 °C

CRS severityGrade 3 or 4 cytokine release syndrome

RequirementTemperature finding must be present with the other specified CRS findings

Cytokine release syndrome vasopressor requirement

Vasopressor threshold1 or more vasopressors

Associated findingHypotension requiring 1 or more vasopressors

CRS severityGrade 3 or 4 cytokine release syndrome

Site-of-service review age

Review ageOlder than 13 years

Review scopeSite-of-service medical necessity review

Younger individualsPediatric individuals are not subject to this site-of-service review criterion

Otezla weight requirement

ProductOtezla (apremilast)

Minimum weightAt least 20 kg

Covered conditionPsoriatic arthritis

Tremfya weight requirement

ProductTremfya (guselkumab)

Minimum weightAt least 40 kg

Covered conditionActive psoriatic arthritis

Tremfya weight requirement in updated criteria

Updated productTremfya (guselkumab)

Updated minimum weightAt least 40 kg

Age criterionIndividuals aged 6 years or older

Prior Authorization

Meet criteria for initial authorization

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

Documentation Required

Document continued benefit for reauthorization

Reauthorization may be approved for up to 12 months when drug-specific coverage criteria continue to be met and chart notes demonstrate a positive clinical response to therapy.

Step Therapy

Follow the therapeutic tiers

Apply the policy’s first-line and second-line therapeutic classes when selecting and requesting treatment. Classes include TNF-alpha, IL-17, IL-12/23, IL-23, Janus kinase, PDE-4, and T-cell costimulation modulators.

Step Therapy

Document prerequisite therapy

Before requesting a second-line agent, document the required inadequate response or intolerance to the specified prior agents. Requirements vary by product and may require one agent, two agents, or all specified biosimilar or preferred products.

Step Therapy

Sequence brand infliximab after biosimilars

For individuals not previously treated with the requested therapy, brand infliximab products require a documented trial and treatment failure with Avsola, Inflectra, and Renflexis.

Step Therapy

Consider tier 1 agents first

Tier 1 agents listed in the policy include Enbrel, Rinvoq or Rinvoq LQ, and subcutaneous Steqeyma or Yesintek.

Step Therapy

Use formulary-preferred alternatives

Use the preferred alternatives identified by the applicable formulary before selected non-preferred agents. Listed preferred alternatives include specified adalimumab products and Sotyktu.

Step Therapy

Recognize tofacitinib alternatives

Use tofacitinib or tofacitinib extended-release as preferred alternatives where Xeljanz or Xeljanz XR are listed as preferred alternatives.

Step Therapy

Use the infliximab preference hierarchy

Renflexis is preferred and is listed as a preferred alternative for non-preferred infliximab products. Select and document the preferred product when applicable.

Step Therapy

Do not use Stelara as a preferred alternative

Do not rely on Stelara as a preferred alternative for non-preferred agents; Stelara was removed from that preferred-alternative logic.

Documentation Required

Submit complete medical records

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

Documentation Required

Document prior therapy and response

Document prior treatment failures, inadequate responses, or intolerances when required by the requested drug’s criteria. For reauthorization, include chart notes demonstrating continued positive clinical response.

Documentation Required

Document the site-of-service rationale

For drugs subject to site-of-service review, document the requested administration setting and the clinical, geographic, access, or safety rationale supporting that setting.

Documentation Required

Include required clinical records

Submit office visit notes documenting the diagnosis, relevant history, physical evaluation, and medication history. Records must support that medical-necessity criteria are met.

Denial Risk

Avoid an unsupported administration site

Infusion or injectable therapy may be considered not medically necessary when the requested site of service does not meet the applicable site-of-service criteria.

Denial Risk

Avoid unlisted or combination use

Combination use of the listed agents with each other, or use for conditions not outlined in this policy or related medical policies, is considered investigational.

Denial Risk

Satisfy the approved-condition criteria

All other uses of the drugs for approved conditions listed in the policy are considered not medically necessary unless the applicable drug-specific criteria are met.

Denial Risk

Document every drug-specific requirement

Coverage may be denied when required age, prescriber specialty, inadequate-response or intolerance history, prior-agent trials, or formulary-specific requirements are not documented.

Denial Risk

Avoid investigational use

Use of a listed drug in combination with other listed agents or for a condition not outlined in this policy or related medical policies is considered investigational.

Denial Risk

Meet the drug-specific coverage criteria

Uses of the drugs for approved conditions that do not meet the drug-specific coverage criteria are considered not medically necessary.

Billing Rule

Follow FDA dosage and administration

Use each medication according to the product’s U.S. Food and Drug Administration dosage and administration prescribing information.

Billing Rule

Use the correct formulary policy

For members whose plans use custom formulary criteria, apply policy 5.01.647 rather than this policy when directed by the member’s plan.

Billing Rule

Verify member benefit limitations

Coverage remains subject to the limits and conditions of the member benefit plan. Consult the member benefit booklet or a customer service representative for applicable benefit limitations.

Definition

TemperatureAt least 38 °C

Blood pressure supportHypotension requiring one or more vasopressors

Respiratory supportHypoxia requiring specified high-flow oxygen, positive pressure, intubation, or mechanical ventilation

Definition

MeaningThe location where the drug is administered

Facility locationsHospital-based outpatient setting or infusion center

Other locationsPhysician's office or home

Site-of-service age criterion and pediatric limitation

Age criterionSite-of-service review is limited to individuals older than 13 years

Pediatric limitationPediatric individuals may require smaller doses, lower infusion rates, appropriately sized equipment, age-appropriate venipuncture, and behavioral management

Reason for limitationSpecialty infusion training is necessary for pediatric IV insertions and therapy

Documentation Required

Document Stelara prerequisite therapy

For individuals not previously treated with Stelara, document a trial with Steqeyma and Yesintek before requesting Stelara coverage.

Step Therapy

Select preferred Renflexis when applicable

Renflexis was updated from non-preferred to preferred status and is listed as a preferred alternative for non-preferred infliximab products.