ModifiedPremera BluecrossPolicy N/A

Pharmacologic Treatment of Psoriasis — Medical necessity and site-of-service criteria for systemic, biologic, and topical therapies

Medical necessity and site-of-service criteria for pharmacologic (including biologic and oral) treatments of moderate to severe plaque psoriasis for Premera members, with plan-specific formulary sections and infusion site-of-service rules.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Psoriasis

Policy CodePolicy N/A

Change TypeMaterial updates (added agents, biosimilar placements, HCPCS/NDC updates)

Effective DateJan 2, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documented age, ≥10% BSA (or qualifying exception), and prior trial/failure of required systemic therapies; include dermatology consultation notes.

SourceLink

POLICY UPDATE CHANGES

Added coverage for the topical drugs Vtama (tapinarof) and Zoryve (roflumilast) for the treatment of plaque psoriasis.

Added coverage for Spevigo (spesolimab-sbzo) for the treatment of generalized pustular psoriasis flares in adults.

Added coverage for Sotyktu (deucravacitinib) for the treatment of plaque psoriasis.

Added multiple adalimumab biosimilars and clarified preferred vs non-preferred biosimilars with identical coverage criteria.

Clarified that the medications listed are subject to the product's FDA dosage and administration prescribing information.

Updated re-authorization duration of approval from 3 years to 12 months.

≥10% BSAMinimum BSA often required

Step therapyStep therapy tiers

Required

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Dermatologist involvement

12 moRe-authorization duration

Applies (selected IVs)Site-of-service review

Coverage Criteria and Medical Necessity

Initial (First-line) Biologic/Systemic Therapy Criteria

Covered when ALL of the following are met (agent/class-specific):

Age: Individual meets the age requirement specified for the agent (examples: Enbrel age 4+, Taltz age 6+, many agents 18+)agent-specific

See agent-specific lines

Diagnosis and severity: Diagnosis of chronic plaque psoriasis involving at least 10% BSA>=10% BSA

Exceptions allowed for extensive recalcitrant facial, pustular hands/feet, or genital involvement

Prior therapy: History of an adequate trial and treatment failure with at least 1 approved systemic therapy (eg, methotrexate, cyclosporine, acitretin, or PUVA), unless contraindicated or not toleratedtrial and failure of >=1 systemic

Some agents require failure of additional specific agents per second-line rules

Prescriber: Medication is prescribed by or in consultation with a dermatologistconsultation documented

Applies to many biologic approvals

Second-line/Biologic Switch Criteria

Covered as second-line when ALL of the following are met:

Age: Individual meets agent-specific age requirement (usually 18+)agent-specific

Diagnosis and severity: Chronic plaque psoriasis involving at least 10% BSA (exceptions as above)>=10% BSA

Prior therapy: Inadequate response or intolerance to specified prior biologic(s) or therapies as listed (e.g., failure of TNF inhibitors, IL-12/23 inhibitors, Skyrizi, Sotyktu, Otezla, etc., depending on agent)agent-specific list

Some second-line agents require failure of 1 or 2 listed agents

Site-of-Service Medical Necessity Criteria

Site-of-service (SOS) review applies for IV/injectable drugs for medical benefit reviews (ages 13+ SOS review):

Applicable members: SOS criteria apply to medical benefit reviews for IV/injectable drugs; for site-of-service review specifically, ages 13 and older are reviewedage-specific

SOS criteria does NOT apply to Alaska fully-insured members

Medically necessary sites: Physician office, infusion center, home infusion, or hospital-based outpatient setting are considered medically necessary sites when criteria are metsite-specific

Hospital-based outpatient setting considered medically necessary for initial course or re-initiation after specified intervals or when no other option within 50 miles or specific clinical risks

Clinical conditions requiring hospital outpatient site: Known cardiac condition, significant respiratory disease (eg, FVC <=40%), unstable renal function, difficult vascular access, acute mental status changes, history of severe adverse drug reactions/anaphylaxis, or grade 3–4 cytokine release syndrome meeting listed features

General medical necessity

Covered when ALL of the following are met

General coverage criteria: 1) Age requirement per agent (commonly >=18 years; some agents >=6 years). 2) Diagnosis of chronic plaque psoriasis with >=10% BSA involvement (exceptions allowed). 3) History of an adequate trial and treatment failure with >=1 approved systemic therapy (eg, methotrexate; cyclosporine; acitretin; or PUVA) unless contraindicated or not tolerated. 4) Inadequate response or intolerance to specified prior agents as required per drug (number varies by agent). 5) Medication is being prescribed by or in consultation with a dermatologist.see nodes

Exceptions permit coverage for extensive/recalcitrant facial, pustular hands/feet, or genital involvement affecting function.

Infliximab emergent treatment

Covered when ANY of the following are met

Infliximab emergent use: Infliximab products (Avsola, Inflectra, Remicade, Renflexis) may be considered medically necessary as emergent treatment for severe pustular, exfoliative, or inflammatory psoriasis without prior use or failure/intolerance of a first-line agent.none

Applies to severe clinical presentations; otherwise standard prior therapy rules apply.

Essentials formulary coverage

Plan-specific first-line designations (Essentials Plans only)

Essentials plan first-line: Section 2 lists first-line systemic choices for Essentials Plans (Rx Plan E1, E3, E4) including specified TNF-alpha inhibitors, IL-17, IL-12/23, IL-23 inhibitors, TYK2 inhibitor Sotyktu, PDE-4 inhibitor Otezla, and infliximab IV products. Step therapy tiers are defined in Section 2.none

Providers must follow Section 2 sequencing for Essentials plans.

Agent general medical necessity criteria

Covered when ALL of the following are met (agent-specific variations noted):

Age: Patient meets agent-specific minimum age (commonly >=18 years; some agents >=6 years)see coding.thresholds

chunks 37,39,51

Diagnosis/BSA: Diagnosis of chronic plaque psoriasis with >=10% body surface area involvement>=10% BSA

exceptions allowed for specific anatomic/severe disease

Exceptions to BSA requirement: Coverage may be granted if ANY of: extensive recalcitrant facial involvement OR pustular involvement of hands and feet OR genital involvement interfering with sexual functionN/A

Infliximab (Remicade, biosimilars) criteria

Infliximab (brands and biosimilars) coverage rules

Age and diagnosis: Individual is aged 18 years or older with chronic plaque psoriasis involving >=10% BSA (exceptions apply)>=18 years, >=10% BSA

chunk 36,48

Emergent indication: May be considered medically necessary as emergent treatment for severe pustular, exfoliative, or inflammatory psoriasis without prior-line failureN/A

chunk 50

Biosimilar trial requirement for some plans: For certain formulations, documentation of trial and treatment failure with Avsola and Inflectra is required prior to coverage (plan-specific); Renflexis may require documented trial/failure with Avsola and Inflectra for individuals not previously treated with the requested therapydocumented trial/failure with specified infliximab biosimilars

Agent-specific step therapy/failed agent requirements

Agent-specific additional requirements (examples preserved from document):

Bimzelx (bimekizumab) prerequisites: Patient is >=18 and meets general criteria and has had inadequate response or intolerance to at least 1 of a listed set of agents (including TNF, IL, oral agents) as specified>=1 failed listed agent

chunk 41

Cosentyx (secukinumab) prerequisites: Patient >=6 years, meets general criteria, and has had inadequate response or intolerance to 2 of listed agents (eg, Enbrel, adalimumab variants, Otezla, Skyrizi, Sotyktu, Steqeyma/Yesintek, Taltz, Tremfya)failed 2 listed agents

chunks 43,44

Cimzia (certolizumab) prerequisites: Patient >=18, meets general criteria, and has had inadequate response or intolerance to 2 of the listed agents (eg, Enbrel, adalimumab variants, Otezla, Skyrizi, Sotyktu, Steqeyma/Yesintek, Taltz, Tremfya)

General medical necessity criteria

Covered when ALL of the following are met (agent-specific variations noted):

Age requirement: Patient meets the age threshold required for the specified agent (examples: Enbrel ≥4 years; some agents ≥6 years; many agents ≥18 years)agent-specific

see agent entries

Disease severity: Diagnosis of chronic plaque psoriasis involving at least 10% BSA>=10% BSA

Exceptions allowed for extensive recalcitrant facial, genital involvement affecting function, or pustular involvement of hands/feet

Prior therapy requirement: History of an adequate trial and treatment failure with at least 1 approved systemic therapy (e.g., methotrexate, cyclosporine, acitretin, or PUVA) unless contraindicated or not tolerated≥1 systemic agent tried and failed unless contraindicated

Agent/class-specific coverage

Agent- or class-specific coverage and step-therapy logic (examples extracted):

IL-17 inhibitors (first-line example): Taltz (ixekizumab) may be considered medically necessary for ages ≥6 with ≥10% BSA and prior trial/failure of ≥1 systemic therapy unless contraindicated; other IL-17 agents have similar criteriaagent-specific

Some IL-17 agents appear in first-line and second-line tiers depending on plan

IL-23 inhibitors and other biologics: Skyrizi (risankizumab) and Tremfya (guselkumab) generally require age ≥18 and ≥10% BSA and prior trial/failure of ≥1 systemic therapy unless contraindicatedagent-specific

Plan-specific formulary tiers (M1, M2, M4) apply

PDE4 and TYK2 oral agents: Otezla (apremilast) and Sotyktu (deucravacitinib) have age and weight requirements (Otezla ≥6 yrs and ≥20 kg; Sotyktu ≥18 yrs) plus prior systemic therapy trial/failure

Typical agent-specific medical necessity criteria (Initial therapy / step requirements)

Covered when ALL of the following are met (examples vary by agent/formulary):

Age criteria per agent (e.g., 18+ for many biologics; some IL-12/23 agents 6+)see agent-specific

Diagnosis of chronic plaque psoriasis involving at least 10% BSA (exceptions allowed for extensive facial, pustular palmar-plantar, or genital involvement)>=10% BSA or exception

Prior systemic therapy: History of trial and inadequate response or intolerance to at least one approved systemic therapy (methotrexate, cyclosporine, acitretin, or PUVA) unless contraindicated>=1 systemic tried

Prior biologic failures:

Infliximab and biosimilar medical necessity

Infliximab (Remicade, Janssen, Renflexis) may be considered medically necessary when:

Age: Individual is aged 18 years or older>=18

Diagnosis: Chronic plaque psoriasis involving at least 10% BSA (exceptions for severe/pustular/exfoliative disease)>=10% BSA or exception

Exception for severe disease: Emergent treatment for severe pustular, exfoliative or inflammatory psoriasis may be allowed without prior first-line failure

Prior biosimilar trial: Documented trial and treatment failure with Avsola and Inflectra may be required prior to other infliximab products in some tiers

IL-12/23 and IL-23 inhibitor medical necessity

IL-12/23 and IL-23 inhibitors may be considered medically necessary when ALL of the following apply:

Age: IL-12/23: aged 6 years or older; IL-23 agents often 18+agent-specific

Diagnosis: Chronic plaque psoriasis involving >=10% BSA (exceptions for facial, palm/sole, genital)>=10% BSA or exception

Prior systemic therapy: History of trial and failure with >=1 approved systemic therapy (methotrexate, cyclosporine, acitretin, or PUVA) unless contraindicated>=1 systemic tried

Covered therapies and criteria

Covered treatments and clinical indications described in this document include the following.

Topical therapy (usually corticosteroids) is recommended as first-line treatment for psoriasis; Vtama (tapinarof) and Zoryve (roflumilast) were added to coverage for plaque psoriasis.

Chunks 90; 108

Phototherapy (UVB, narrowband UVB, PUVA) is used for individuals who fail topical therapy or have disease too extensive for topicals; home units may be available under DME benefits.

Chunk 91

Traditional systemic agents: Approved systemic agents (methotrexate, cyclosporine, acitretin) are effective but have significant toxicities and monitoring requirements; systemic corticosteroids generally avoided.

Chunk 90

Biologic agents for plaque psoriasis: Multiple biologics (eg, infliximab, adalimumab, etanercept, ustekinumab, guselkumab, risankizumab, tildrakizumab, bimekizumab, etc.) are discussed with trial evidence supporting efficacy; coverage includes newer agents per policy updates.

Policy-level coverage updates

Policy history records additions, formulary placement changes, age and site-of-service updates, and step therapy/precedent agent requirements.

Additions: Multiple topical and systemic agents were added to coverage (eg, Vtama, Zoryve, Spevigo, Sotyktu, Bimzelx)

See specific drug sections for detailed criteria

Formulary placement changes: Numerous adalimumab and infliximab biosimilars and branded products were moved between preferred and non-preferred lists; some products now require prior trial and failure of preferred agents; HCPCS/J-code updates were added (eg, J1747, J0139, Q5140–Q5143).

Applies to new starts; see policy drug lists

Site-of-service exceptions: Site-of-service medical necessity criteria does not apply to Alaska fully-insured members; exceptions for cytokine release syndrome treatment apply and non-formulary exception approvals may be granted up to 12 months.

90-day provider notifications applied for many changes

The Site-of-Service (SOS) Medical Necessity criteria described in this policy do not apply to Alaska fully-insured members. For those members, separate infusion and injection drug medical necessity criteria—per Alaska-specific guidance—should be used; providers are instructed to contact Customer Service or refer to the member's plan booklet/ID card for the applicable infusion/injection drug criteria.

Certain custom Open and Preferred formularies are governed by alternate medical necessity criteria and therefore have different coverage rules. Specifically, the custom Open formulary (Formulary ID: 6062; Rx Plan F1) and the custom Preferred formulary (Formulary ID: 6064; Rx Plan G3) follow the separate criteria outlined in policy 5.01.647. Providers should check the member plan booklet or ID card to confirm whether these alternate formulary rules apply.

There are plan-specific formulary exceptions for which the standard medical necessity criteria in this document do not apply. Members enrolled in the custom Open formulary (Formulary ID: 6062; Rx Plan F1) or the custom Preferred formulary (Formulary ID: 6064; Rx Plan G3) are subject to the coverage rules set forth in policy 5.01.647; confirm eligibility by reviewing the member's plan booklet or ID card prior to authorization.

This policy reiterates that the medical necessity criteria described herein are not applicable for two specified custom formularies: Formulary ID 6062 (Rx Plan F1) and Formulary ID 6064 (Rx Plan G3). For members on these plans, providers must use the alternate criteria published in policy 5.01.647.

Certain medical necessity rules listed in this policy are explicitly excluded for members enrolled in the custom Open and Preferred formularies (Formulary ID: 6062; Rx Plan F1 and Formulary ID: 6064; Rx Plan G3). These members are governed by the separate criteria found in policy 5.01.647, and the provider should verify plan assignment before applying the standard rules.

The custom Open and Preferred formularies (Formulary ID: 6062; Rx Plan F1 and Formulary ID: 6064; Rx Plan G3) are excluded from some of the medical necessity criteria detailed in this policy; these members must follow the alternate rules in policy 5.01.647. Always confirm the member's formulary and plan before initiating prior authorization or site-of-service review.

Systemic corticosteroids are generally avoided in psoriasis management because they may be associated with severe exacerbations during and after treatment. This advisory reflects the drugs' risk profile and supports use of approved systemic and biologic therapies when indicated.

This medical policy does not apply to Medicare Advantage plans. Providers should verify the member's benefit type and consult the applicable Medicare Advantage rules or the member's plan booklet for coverage determinations.

When the site-of-service criteria in this policy are not met, the outpatient location for infusion or injectable therapy is considered not medically necessary. Claims for IV-administered drugs must be billed through the medical benefit (not pharmacy), and administration at a nonapproved site may result in denial.

Members enrolled in the custom Open and Preferred formularies identified (Formulary ID: 6062; Rx Plan F1 and Formulary ID: 6064; Rx Plan G3) must follow the alternate medical necessity criteria referenced in policy 5.01.647. Use of this policy's criteria for those members may be inapplicable and should be avoided without prior verification.

Use of a biologic or systemic agent for stable plaque psoriasis without documentation that the member meets the BSA threshold (typically ≥10% BSA) or the required prior systemic therapy trials (or a qualifying exception) would not meet the medical necessity criteria in this policy and may be denied.

Coverage is not supported when required clinical elements are missing, including documentation of the member's age, the specified BSA threshold (commonly ≥10% BSA), or evidence of required prior systemic therapy trials and treatment failures. Additionally, members on custom formularies excluded from this policy require alternate criteria; failure to verify eligibility may lead to denial.

All other uses of the agents listed in this policy that are not explicitly described (including combination use of listed agents) or indications outside those outlined are considered investigational or not medically necessary. For example, evidence does not support routine coverage of spesolimab for palmoplantar pustulosis (PPP), and the manufacturer is not pursuing FDA approval for PPP.

In a Phase 2 trial of spesolimab for palmoplantar pustulosis (PPP), no significant efficacy advantage over placebo was demonstrated on the primary endpoint; consequently, the manufacturer is not seeking FDA approval for PPP. Use of spesolimab for PPP is therefore not supported by positive trial evidence.

Codes, Age/Weight/BSA Thresholds, and Key Values

HCPCS (selected)HCPCS

J0135	Injection, adalimumab (Humira), 20 mg (code terminated 01/01/25)
J0139	Injection, adalimumab, mg (new code effective 01/01/25)
J0717	Injection, certolizumab pegol (Cimzia), 1 mg (may be used for Medicare when drug administered under direct supervision of a physician; not for self-administered use)
J1438	Injection, etanercept (Enbrel), 25 mg (may be used for Medicare when drug administered under direct supervision of a physician; not for self-administered use)
J1628	Injection, guselkumab (Tremfya), mg

HCPCS (additional / biosimilars)HCPCS

J1745	Injection, infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg
J1747	Injection, spesolimab-sbzo (Spevigo), mg
J2327	Injection, risankizumab-rzaa, intravenous (Skyrizi), mg
J3245	Injection, tildrakizumab (Ilumya), mg
J3357	Injection, ustekinumab (Stelara), mg
J3590	Injection; miscellaneous; may be used for multiple biologics including Cyltezo, Hyrimoz HCF, Adalimumab-adaz HCF (Sandoz - unbranded), Abrilada, Hadlima, Hulio, Hyrimoz LCF, Starjemza, Yuflyma, Yusimry and Bimzelx

Q-codes / Biosimilar HCPCS (selected)HCPCS

Q5098	Injection, ustekinumab-srlf (Imuldosa), biosimilar, mg (new code effective 07/01/25)
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, mg (new code effective 07/01/25)
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar, mg (new code effective 07/01/25)
Q5103	Injection, infliximab-dyyb (Inflectra), biosimilar, 10 mg
Q5104	Injection, infliximab-abda (Renflexis), biosimilar, 10 mg
Q5121	Injection, infliximab-axxq (Avsola), biosimilar, 10 mg

Q-codes / Adalimumab biosimilars (new codes effective 01/01/25)HCPCS

Q5140	Injection, adalimumab-fkjp (Hulio), biosimilar, mg
Q5141	Injection, adalimumab-aaty (Yuflyma), biosimilar, mg
Q5142	Injection, adalimumab-ryvk biosimilar, mg
Q5143	Injection, adalimumab-adbm (Cyltezo), biosimilar, mg
Q5144	Injection, adalimumab-aacf (Idacio), biosimilar, mg
Q5145	Injection, adalimumab-afzb (Abrilada), biosimilar, mg

Q-codes / Ustekinumab (additional)HCPCS

Q9996	Injection, ustekinumab-ttwe (Pyzchiva), subcutaneous, mg
Q9998	Injection, ustekinumab-aekn (Selarsdi), mg
Q9999	Injection, ustekinumab-aauz (Otulfi), biosimilar, mg

Prior Authorization, Documentation, and Billing Guidance

Billing Rule

Site-of-service prior authorization for specified IV/injectable drugs

Site-of-service prior authorization is required for specified IV and injectable therapies listed in this policy (for example: Avsola, Inflectra, Infliximab [Janssen unbranded], Remicade, Renflexis, Spevigo). Claims for drugs administered via an intravenous route must be billed through the medical benefit (not pharmacy). Site-of-service medical necessity criteria applies to medical-benefit reviews for most members (does not apply to Alaska fully-insured members — contact Customer Service or check member plan booklet).

Affected products include IV infliximab products (Avsola, Inflectra, Infliximab [Janssen unbranded], Remicade, Renflexis) and specified injectable agents (eg, Spevigo).
SOS criteria apply to location of administration (hospital outpatient, infusion center, physician office, home infusion).
SOS exception for cytokine release syndrome (CRS) and other emergent/medical-condition-based scenarios is described in the policy.

Clinical Background and Rationale

Plaque psoriasis is characterized by well-demarcated, scaly plaques on the skin and may require escalation from topical therapy to phototherapy, traditional systemic agents, or biologic therapies when disease is moderate to severe. Other forms include pustular psoriasis, which can be more severe. Initial treatment typically begins with topical agents; individuals with widespread or refractory disease may require systemic or biologic therapy per the clinical criteria in this policy.

Definitions and Exception Criteria

Plaque psoriasis — Definition and treatment pathway

DefinitionPlaque psoriasis: chronic immune-mediated disease with scaly plaques; treatment escalates from topical agents to phototherapy, systemic agents, and biologics

Treatment pathwayFirst-line: topical therapies (eg, corticosteroids); escalate to phototherapy or systemic/biologic therapies for extensive or refractory disease

Policy additionsPolicy recently added coverage for topical Vtama (tapinarof) and Zoryve (roflumilast) for plaque psoriasis

Site of service — Definition

DefinitionSite of service: the location where the drug is administered (hospital outpatient, infusion center, physician office, or at home)

SOS review age limitFor site-of-service medical necessity review, individuals aged 13 years and older are reviewed

Policy Revision History

2022-11-01added

Added coverage for topical agents Vtama (tapinarof) and Zoryve (roflumilast) for plaque psoriasis and added Spevigo (spesolimab‑sbzo) for generalized pustular psoriasis flares in adults.

2022-12-01added

Added coverage for Sotyktu (deucravacitinib) for the treatment of plaque psoriasis.

2023-02-01added

Added the adalimumab biosimilar Amjevita (adalimumab‑atto) as a covered prerequisite with identical coverage criteria to Humira.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Psoriasis

Policy CodePolicy N/A

Change TypeMaterial updates (added agents, biosimilar placements, HCPCS/NDC updates)

Effective DateJan 2, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documented age, ≥10% BSA (or qualifying exception), and prior trial/failure of required systemic therapies; include dermatology consultation notes.

SourceLink

On This Page

Prescriber: Medication prescribed by or in consultation with a dermatologistconsult documented

clinical criteria listed

All listed features for CRS must be documented

allows coverage even if BSA criterion not met

Prior therapy: History of an adequate trial and treatment failure with at least 1 approved systemic therapy (eg, methotrexate, cyclosporine, acitretin, PUVA) unless contraindicated or not tolerated; some agents require failure of additional named biologics (1 or 2 specific agents) as listed per agent>=1 prior systemic; agent-specific additional failures

see agent-specific nodes in document

Prescriber: Medication is being prescribed by or in consultation with a dermatologistN/A

required for coverage

failed 2 listed agents

Some agents require failure/intolerance to multiple specific agents or classes before approval (see second-line/step therapy rules)

Exceptions for emergent severe disease: Certain IV agents (e.g., infliximab products) may be considered medically necessary emergently for severe pustular, exfoliative, or inflammatory psoriasis without prior use or failure of a first-line agentN/A

Site-of-service review applies to some IV products

See individual agent criteria

Second-line biologics and step requirements: Certain agents (e.g., Bimzelx, Siliq, Cosentyx second-line rules) require inadequate response or intolerance to specified lists of prior agents (may require failure of 2 listed agents or intolerance to multiple adalimumab biosimilars/agents) before approvalfailure/intolerance to specified agents (often 2)

Detailed agent lists and permutations provided per tier

TNF-alpha antagonists: Various adalimumab products and other TNF-a agents have first- and second-line placement depending on plan; coverage requires age and BSA criteria plus prior therapy trials as specifiedagent- and plan-specific

Multiple biosimilars and branded products listed

In many tiered requirements, inadequate response or intolerance to specified other biologics (lists vary by agent) is required (e.g., failure of listed adalimumab biosimilars or specific biologics)

agent-specific number

See policy for exact agent lists and step order

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

documented trial of listed biosimilars

Site-of-service review applies

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

Prior biologic trials:

Inadequate response or intolerance to specified agents (often requires failure of 1-2 listed biologics depending on tier)

Prescriber requirement: Prescribed by or in consultation with a dermatologist

Sotyktu (deucravacitinib) step criteria: Policy requires trial of three agents among specified list prior to Sotyktu (updated from two): Enbrel, Humira, Amjevita, Otezla, Skyrizi, Stelara, Taltz, Tremfya (note: later updates modified this requirement per history).

Chunk 109

Spesolimab for GPP flares: Spesolimab (Spevigo) is covered for generalized pustular psoriasis flares in adults based on trial evidence showing rapid reduction in pustulation (GPPGA pustulation subscore 0 at Week 1: 54% vs 6% for placebo).

Chunks 101, 108

Prior Authorization

Prior authorization requirement

Prior authorization is required per the medical necessity criteria for many systemic and biologic agents included in this policy (including biologics, infliximab products, IL-12/23 and IL-23 inhibitors, TYK2 inhibitors, IL-17 inhibitors, PDE-4 inhibitors, and others). Authorization decisions are contingent on the member’s specific formulary and the plan section that applies.

Check the member’s plan booklet or ID card to determine whether this policy’s criteria apply (custom Open/Preferred formularies may follow policy 5.01.647).
Non-formulary exception reviews may be approved up to 12 months when criteria are met.

Prior Authorization

Prior authorization for biologics and biosimilars

Certain biologic agents and biosimilars are specifically included in the policy and subject to prior authorization and step-therapy rules; updates have added or reclassified biosimilars and HCPCS/J-codes over time. Verify preferred vs non-preferred biosimilar status and NDC-based distinctions when selecting agents.

Policy history documents multiple updates to biosimilar coverage and preferred product lists (e.g., Amjevita, Cyltezo, Hyrimoz, Abrilada, Hulio, Yusimry, etc.).
New HCPCS/J-codes (eg, J1747, J0139, Q5140–Q5143) were added and should be used as applicable.
Preferred vs non-preferred status may change over time; check NDC prefixes noted in policy (examples: NDCs starting with 55513, 72511, 83457, 00074, 61314).

Denial Risk

Incomplete medical records — risk of denial if required documentation is missing

Incomplete medical records or missing documentation will jeopardize approval. Submit complete office visit notes and supporting records demonstrating that medical necessity criteria are met.

Required records include office visit notes with diagnosis, relevant history, physical exam, and medication history.
Incomplete or missing documentation (eg, absence of documentation of trials, BSA, or dermatologist consultation) may lead to denial or delay.

Billing Rule

Biosimilar coverage distinctions

Biosimilar coverage distinctions and step/brand-preference changes affect which products must be tried first. The policy includes NDC-based distinctions and product-specific preferred/non-preferred designations that impact step therapy and prior authorization requirements.

Some adalimumab biosimilars are preferred (eg, Cyltezo LCF, Hyrimoz HCF, Sandoz unbranded [NDCs starting with 55513]) while others are non-preferred (examples: Amjevita [NDCs starting with 55513 previously non-preferred updates], Humira [various NDC prefixes]).
Policy history documents periodic reclassification of preferred status — always verify current status prior to prescribing.

Note

Plan applicability — verify member’s formulary/plan

This policy’s medical necessity criteria do not apply to certain custom Open and Preferred formularies (see Formulary IDs noted in the policy). Providers must verify plan applicability prior to requesting authorization.

Check the member’s Plan booklet or ID card or contact Member Services to determine whether this policy applies. If member is on a custom formulary (e.g., Formulary ID 6062 or 6064), refer to policy 5.01.647 for criteria.
Site-of-service criteria does not apply to Alaska fully-insured members per Alaska HB 226 — verify member’s state and insurance type.

Documentation Required

Required documentation to support prior authorization

Documentation required to support prior authorization includes age, diagnosis, extent of disease (BSA ≥10% or qualifying exception), prior therapy trials and failures (or contraindication/intolerance), and prescriber specialty. Medication must be prescribed by or in consultation with a dermatologist unless otherwise specified.

Age thresholds vary by agent (eg, some agents have pediatric age limits such as 4, 6, 12, or 18 years).
Document body surface area (BSA) involvement ≥10% or a qualifying exception (extensive facial involvement, pustular hands/feet, genital disease interfering with function, or other specified exceptions).
Provide documentation of prior adequate trial and treatment failure with required systemic therapies (eg, methotrexate, cyclosporine, acitretin, PUVA) or documented contraindication/intolerance.
Medication should be prescribed by or in consultation with a dermatologist; include documentation of specialist involvement.

Documentation Required

Clinical documentation required — submit office notes and objective measures

Submit office visit notes that document diagnosis, relevant history, physical exam findings, medication history, and objective disease severity measures when applicable (eg, PASI, sPGA, GPPGA pustulation subscore, PPPASI). These records substantiate medical necessity for initial and continuation therapy.

Include objective severity measures used in trials or criteria (PASI, sPGA, GPPGA, GPPASI, PPPASI) when relevant to the indication.
For pustular psoriasis or generalized pustular psoriasis flares, include disease-specific scores and documentation of flare severity per the policy definitions.

Note

Benefit verification — confirm coverage and applicable criteria

Before submitting a prior authorization request, verify member benefits and formulary coverage. Contact Member Services or consult the member benefit booklet/ID card to confirm whether the policy and its step therapy requirements apply to the member.

Benefit verification determines if the policy criteria apply, whether SOS review is required, and which formulary section (Section 1, 2, or 3) is relevant.
If coverage is governed by a custom formulary, follow the directions in the member’s plan materials or policy 5.01.647.

Step Therapy

Policy defines step therapy tiers (first-line and second-line)

The policy defines step-therapy tiers (first-line and second-line agents) and requires prior trials of specified first-line/systemic therapies before approving later-line agents. Tier placement varies by formulary section (Sections 1–3) and by specific agent class.

Step therapy tiers are organized by plan section — verify which section applies to the member (Open/Preferred/Select, Essentials, or ISHIP Metallic).
Examples: TNF-alpha antagonists, IL-17 inhibitors, IL-12/23 and IL-23 inhibitors, TYK2 inhibitor (Sotyktu), and PDE-4 inhibitor (Otezla) have defined tier placements that affect required prior trials.

Step Therapy

Step therapy — failed agents required prior to approval

Many agents require documented inadequate response or intolerance to specified other biologic or systemic agents (step therapy). The number and identity of required failed agents varies by drug class, patient age, and formulary section — include dates, doses, and clinical response in the record.

Some second-line biologics require failure of one preferred biologic; others require failure of two or more listed agents.
Provide documentation of trials (dates, duration, reason for discontinuation) and objective evidence of inadequate response or intolerance.

Step Therapy

Sotyktu step-therapy requirement — confirm current required prior agents

Sotyktu (deucravacitinib) has specific step-therapy requirements that have changed historically; the current policy requires trying a set of specified agents before Sotyktu depending on formulary and date of policy revision. Verify the current step requirement for Sotyktu at time of request.

Provider should document trials of the agents specified by the policy effective date (historically required 2 agents, later 3 agents, with subsequent adjustments; recent updates changed brand preferred product step therapy from three agents to one agent for certain settings).
Confirm which agents (eg, Enbrel, Humira, Amjevita, Otezla, Skyrizi, Stelara, Taltz, Tremfya, etc.) must be tried and failed for the member’s plan and date of service.

Step Therapy

Step therapy and preferred product requirements — verify current product hierarchy

Step-therapy and preferred product requirements are frequently updated; prior authorization for non-preferred agents often requires documentation of trial and inadequate response to preferred products. Verify current preferred-product lists and NDC-based distinctions before requesting non-preferred agent coverage.

Recent updates moved Avsola/Inflectra/other infliximab products between first- and second-line tiers and changed preferred adalimumab biosimilar lists; Humira and other adalimumab products have been reclassified in several updates.
When a non-preferred adalimumab product is requested, document trials of all required preferred adalimumab products per the policy (including NDC-specified preferred products).

SOS applicabilitySOS medical necessity applies to medical benefit reviews for IV/injectable drugs; check member plan for custom formulary exceptions

Exception criteria — Coverage exceptions

Exception scenariosCoverage exceptions may be granted for extensive/recalcitrant facial disease, pustular involvement of hands/feet, or genital disease interfering with sexual function

Effect on BSA requirementThese exceptions permit coverage even when documented BSA is <10%

Documentation neededClinical documentation must describe the extent and functional impact of facial, palmar/plantar, or genital involvement

Exception conditions — When BSA/prior-therapy rules may be waived

Conditions permitting exceptionExtensive recalcitrant facial involvement; pustular involvement of hands and feet; genital involvement interfering with sexual function may allow coverage despite BSA <10% or without prior systemic therapy

Applies to multiple agentsException conditions are referenced across biologic and systemic agent criteria in the policy

Documentation requirementProvider must document the specific anatomic severity and functional impact to justify exception-based coverage

Emergent treatment — Infliximab exceptions

Emergent infliximab useInfliximab and biosimilars may be used emergently for severe pustular, exfoliative, or inflammatory psoriasis without prior-line failure

ContextEmergent allowance contrasts with standard prior-therapy requirements for stable plaque psoriasis

Site-of-service noteInfliximab IV products are subject to site-of-service review and medical-benefit administration rules

Moderate to severe plaque psoriasis — Definition

Moderate-to-severe definitionChronic plaque psoriasis involving at least 10% BSA or disease that is extensive/recalcitrant in critical areas (face, palms/soles, genital) constitutes moderate-to-severe disease

Clinical impactEven with <10% BSA, disease in critical areas or affecting function may meet moderate-to-severe definition for coverage

Treatment implicationPatients meeting this definition are candidates for systemic or biologic therapies per policy criteria

Moderate to severe plaque psoriasis — Typical thresholds

Typical BSA threshold>= 10% BSA commonly used to define moderate-to-severe disease for biologic/infusion criteria

Alternate phrasingSome policy statements reference >3% for moderate disease context, but >=10% is used for many biologic approvals

Exceptions and functionExtensive/recalcitrant involvement of face/palms/soles/genitalia can substitute for BSA threshold when function is affected

Site of service — Definition and limits

Site-of-service definitionLocation where the drug is administered (hospital outpatient, infusion center, physician office, or home)

Limits on administration sitesSite-of-service medical necessity review applies to certain IV/injectable drugs; check member plan for custom formulary exceptions

Age applicabilityFor SOS review age threshold is 13 years and older

PASI — Definition

PASI definitionPsoriasis Area and Severity Index (PASI) measures extent/severity; scores range 0–72 and are used in trials

Severe PASI cutoff>= 11 (policy references >=11 as severe)

Clinical usePASI may be referenced as an objective disease severity measure supporting medical necessity decisions

GPP — Generalized pustular psoriasis

GPP definitionGeneralized pustular psoriasis (GPP) is a rare, potentially life-threatening subtype characterized by sterile pustules and systemic inflammation

Clinical severityGPP can cause systemic illness and requires distinct management compared with plaque psoriasis

Policy coverageSpesolimab (Spevigo) is included for GPP flares per policy updates based on trial evidence

Open/Preferred/Select formularies — Applicability and exceptions

Formulary exception noteCustom Open and Preferred formularies (eg, Formulary ID: 6062, Rx Plan F1; Formulary ID: 6064, Rx Plan G3) may have different criteria — see policy 5.01.647

ApplicabilityProviders should check the member plan booklet or ID card to determine whether this policy applies

Medicare Advantage exclusionThis medical policy does not apply to Medicare Advantage (see policy exclusions/history for details)

2023-04-01revised

Added HCPCS code J1747 and clarified NDC‑based distinctions for Amjevita (55513 vs 72511); updated Sotyktu step requirement from two to three agents (interim change noted later).

2024-01-01added/revised

Added coverage for Bimzelx (bimekizumab‑bkzx) and updated Zoryve age/coverage details; added Bimzelx to HCPCS J3590; removed Stelara SC site‑of‑service requirement.

2024-05-01added/revised

Added Spevigo (spesolimab‑sbzo) SC injection coverage criteria and updated Spevigo age requirement (to 12 years or older); updated Otezla age requirement for pediatric use.

2024-12-01updated

Clarified that medications listed are subject to FDA dosage/administration information and added multiple new HCPCS codes (including J0139, Q5140–Q5143).

2025-02-01updated

Clarified that Site‑of‑Service medical necessity criteria does not apply to Alaska fully‑insured members; added that non‑formulary exception authorizations may be approved up to 12 months.

2025-05-01revisedLatest

Updated re‑authorization duration of approval from 3 years to 12 months.