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Pharmacologic Treatment of Psoriasis
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Medical necessity and site-of-service criteria for systemic, biologic, and infusion/injectable pharmacologic treatments for psoriasis for Premera Bluecross members; intended for providers seeking coverage requirements and prior authorization guidance.
Added coverage criteria for Otezla XR (apremilast extended release) for the treatment of psoriasis in individuals aged 6 years and older and weighing at least 50 kg.
Added Otezla XR to list of preferred alternatives for multiple biologics (Bimzelx, Siliq, Cosentyx, Cimzia, Ilumya).
Updated coverage criteria for Tremfya (guselkumab) to include individuals weighing at least 40 kg.
Updated coverage criteria for Tremfya (guselkumab) to include individuals weighing at least 40 kg and updated age requirement to 6 years or older in a later revision.
Added coverage criteria for Icotyde (icotrokinra) for treatment of psoriasis in individuals aged 12 years or older and weighing at least 40 kg.
Added coverage criteria for Spesolimab (Spevigo) IV and SC for generalized pustular psoriasis and included safety data from GPP and PPP trials.
Added coverage criteria for Otezla XR to preferred alternative lists for multiple biologics and updated Skyrizi age requirement to 6 years or older.
Coverage Criteria and Medical Necessity
Site of Service (SOS) Medical Necessity
Covered when ALL of the following are met (site-of-service logic):
SOS general
- Preferred sites: Physician's office OR Infusion center OR Home infusion OR Hospital-based outpatient setting
Preferred medically necessary sites (chunks 2-3)
- Initial-course coverage: Hospital-based outpatient site is considered medically necessary for first 90 days for initial course or re-initiation after >=6 months (not when standard dosing interval is >=6 months)90 days
chunk 2
- Exceptions requiring hospital setting: No outpatient infusion center within 50 miles and no contracted home infusion agency OR hospital is only place offering the drug50 miles
chunk 2
- High-risk clinical conditions: Known cardiac condition, unstable renal function, difficult vascular access, acute mental status changes affecting safety, or history of severe adverse drug reactions/anaphylaxis
chunk 3
- CRS requirement: If cytokine release syndrome (CRS) grade 3 or 4 (temperature >=38°C AND hypotension requiring >=1 vasopressor AND hypoxia requiring high-flow oxygen or positive pressure) AND individual will be admitted to inpatient settingCRS grade 3 or 4
chunk 3
Agent-specific Medical Necessity for Plaque Psoriasis
Covered when ALL of the following are met (common agent-level logic repeated across agents unless otherwise noted):
chunks 6-16
chunks 6,8,9,11,12
chunk 8
chunks 13-16
Step Therapy / Line-of-Therapy Groupings
Agents are grouped into first-line and second-line tiers; approval may require prior failure of agents in earlier tiers.
chunks 4-6
chunks 4-5,18
Second-line TNF-α antagonists (adalimumab products)
Covered when ALL of the following are met
chunk 18
Exceptions: extensive recalcitrant facial involvement OR pustular involvement of hands/feet OR genital involvement interfering with sexual function
AND inadequate response or intolerance to specified adalimumab agents listed in policy
chunk 18
Cimzia (certolizumab pegol) criteria
Covered when ALL of the following are met
chunk 20
Exceptions: facial, pustular hands/feet, genital interference
chunk 20
chunk 20
chunk 20
Infliximab products (Remicade, Janssen unbranded, Renflexis)
Covered when ALL of the following are met (moderate to severe plaque psoriasis)
chunk 21
Exceptions: facial, pustular hands/feet, genital interference
For Renflexis: documented trial and treatment failure with Avsola and Inflectra required for individuals not previously treated with requested therapy
chunk 21
Ustekinumab (IL-12/23) and IL-23 inhibitor class and Ilumya/Icotyde
Covered when ALL of the following are met (agent-specific age thresholds apply)
chunks 23-24
Exceptions: facial, pustular hands/feet, genital interference
Plus documented inadequate response or intolerance to specified comparator biologics or agents as required by drug-specific criteria
chunk 25
chunk 23
Emergent use of infliximab for severe psoriasis variants
Covered when ANY of the following severe conditions are present (emergent treatment)
May be eligible for infliximab without prior use or failure of first-line agents
Coverage criteria and evidence-linked thresholds
Covered when ALL specified program-specific benefit and clinical criteria are met (examples and trial-defined eligibility shown in evidence):
chunks 36-37
2026 Update; chunk 55
chunk 55
chunks 51-52
General agent coverage with age/weight and step therapy requirements
Covered when all plan-specific medical necessity and step-therapy criteria are met as detailed in the policy sections for each agent.
Also requires adherence to step therapy/preferred product sequencing and prior authorization rules where applicable (chunks 55,66,71)
Spevigo (spesolimab) coverage and safety
Spesolimab (Spevigo) — pustular psoriasis coverage notes
Trial data: Grade 3/4 AEs <10% in GPP; SAEs 6% at Week 1 and 12% at Week 12; no deaths reported (chunk 54)
For Alaska fully-insured members the site-of-service medical necessity criteria do not apply. For those members, only the infusion/injection drug Medical Necessity criteria apply; check the member's plan booklet or ID card and refer to the applicable infusion and injection drug medical necessity policy for coverage determinations.
This policy does not address intravenous (IV) and injectable therapy services for individuals who are receiving inpatient services; inpatient administration is outside the scope of the site-of-service provisions in this document.
All uses of the drugs listed for conditions that are approved in their product labeling but that do not meet the specific drug-level coverage criteria in this policy are considered not medically necessary.
Use of agents listed in this policy in combination with one another, or use for conditions not described in this policy or related medical policies, is considered investigational and therefore not medically necessary.
The manufacturer is not pursuing FDA approval of spesolimab for palmoplantar pustulosis (PPP). A Phase 2a PPP trial did not meet the primary endpoint (no difference in PPPASI-50 at Week 16 versus placebo), and therefore use of spesolimab for PPP is not supported by the pivotal evidence cited in this policy.
Topical agents and several other drugs were migrated out of this policy into policy 5.01.652 (Miscellaneous Pharmacologic Treatments of Psoriasis). Examples moved include Vtama (tapinarof), Zoryve cream (roflumilast), Duobrii, Enstilar, Taclonex, Wynzora, brand calcipotriene formulations, Dovonex, Sorilux, Vectical, Soriatane, and Spevigo (spesolimab-sbzo).
Infusion and injectable therapy services administered at sites that do not meet the site-of-service criteria in this policy are considered not medically necessary and may be denied; additionally, IV-administered drugs described in this policy must be billed through the medical benefit (not pharmacy).
All other uses of the drugs listed in this policy that do not meet the drug-specific coverage criteria are considered not medically necessary.
In the PPP trial, spesolimab did not demonstrate a statistically significant difference versus placebo for the primary endpoint of PPPASI-50 at Week 16; accordingly, use of spesolimab for PPP would be considered unsupported by the pivotal evidence presented and is not covered under this policy segment.
Site-of-service medical necessity criteria and pharmacy benefit exclusions apply depending on the member's plan and formulary. Coverage rules and site-of-service review may not apply to certain custom formularies or to some Medicare Advantage plans; confirm plan-specific applicability before requesting services.
Coding, Codes and Key Clinical Thresholds
| NDCs starting with 82009 | Adalimumab-adbm [NDCs starting with 82009] (listed in policy) |
| NDCs starting with 00597 | Adalimumab-adbm (specific NDC block noted in policy) |
| J0139 | Injection, adalimumab, 1 mg |
| J0717 | Injection, certolizumab pegol (Cimzia), 1 mg |
| J1628 | Injection, guselkumab (Tremfya), 1 mg (note: J1628 also referenced for etanercept entries in policy) |
| J1745 | Injection, infliximab, excludes biosimilar (Remicade or Janssen unbranded), 10 mg |
| J3245 | Injection, tildrakizumab (Ilumya), 1 mg |
| J3357 | Injection, ustekinumab, subcutaneous injection (Stelara), 1 mg |
| J3590 | Unclassified biologics (use only to report listed unclassified biologics) |
| Q5098 | Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg |
| Q5099 | Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg |
| Q5100 | Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg |
| Q5103 | Injection, infliximab-dyyb (Inflectra), biosimilar, 10 mg |
| Q5104 | Injection, infliximab-abda (Renflexis), biosimilar, 10 mg |
| Q5121 | Injection, infliximab-axxq (Avsola), biosimilar, 10 mg |
| Q5137 | Injection, ustekinumab-auub (Wezlana), biosimilar, subcutaneous, 1 mg |
| Q5140 | Injection, adalimumab-fkjp, biosimilar, 1 mg |
| Q5141 | Injection, adalimumab-aaty, biosimilar, 1 mg |
| Q5142 | Injection, adalimumab-ryvk, biosimilar, 1 mg |
| Avsola | infliximab-axxq |
| Inflectra | infliximab-dyyb |
| Infliximab (Janssen) | unbranded infliximab |
| Remicade | infliximab |
| Renflexis | infliximab-abda |
| Abrilada | adalimumab-afzb |
| adalimumab-adbm | Cyltezo unbranded |
| adalimumab-aacf | Idacio unbranded |
| adalimumab-adaz | Hyrimoz unbranded |
| adalimumab-bwwd | biosimilar adalimumab |
| J3590 | Unspecified biologics (parentheticals used in policy for some agents) |
| Q5164 | HCPCS code added for Icotyde effective July 1, 2026 |
| Q5098 | HCPCS code (Imuldosa) listed in policy |
| Q5099 | HCPCS code (Steqeyma) listed in policy |
| Q5100 | HCPCS code (Yesintek) listed in policy |
| Q5137 | HCPCS code (Wezlana) listed in policy history |
| Q9996 | HCPCS code (Pyzchiva) listed in policy history |
| Q9998 | HCPCS code (Selarsdi) listed in policy history |
| Q9999 | HCPCS code (Otulfi) listed in policy history |
Actions Required by Ordering/Prescribing Providers
Prior authorization required — demonstrate age, BSA, and prior systemic therapy trial
Many biologic and systemic psoriasis therapies require prior authorization. Approval generally requires documentation of the patient’s age meeting agent-specific thresholds, disease extent (commonly ≥10% BSA unless an exception applies), and prior trial and inadequate response, intolerance, or contraindication to at least one approved systemic therapy (e.g., methotrexate, cyclosporine, acitretin, or PUVA). Medication must be prescribed by or in consultation with a dermatologist.
- Document age per agent-specific thresholds (e.g., many biologics ≥6 years; some agents 18+; Tremfya weight requirement updated to ≥40 kg).
- Document disease extent (commonly ≥10% BSA) or exception criteria (extensive recalcitrant facial, pustular hand/foot, or genital involvement).
- Document prior trial and failure/intolerance of at least one approved systemic therapy unless contraindicated.
- Prescriptions must be by or in consultation with a dermatologist.
Prior authorization plus site-of-service review for biologic/infused agents
Prior authorization and a site-of-service review are required for listed biologic and infused agents; applicable HCPCS/J-codes and Q-codes are provided in the policy and site-of-service medical necessity rules apply for IV-administered drugs and for individuals aged 13 and older.
- Site-of-service medical necessity applies to medical benefit reviews and is reviewed for individuals aged 13 and older.
- IV-administered drugs are subject to site-of-service review and associated HCPCS/J-code listings in the policy.
Prior authorization must follow medical vs pharmacy benefit routing
Certain agents are managed under the medical benefit, pharmacy benefit, or both; prior authorization must follow the benefit routing for the specific agent (e.g., infliximab products are medical-benefit managed; many adalimumab and other biologics may be managed through pharmacy and/or medical benefits). Otezla XR coverage routing was added with pediatric age/weight criteria.
- Confirm whether the requested agent is medical-benefit managed (e.g., Avsola, Inflectra, Remicade, Renflexis) or pharmacy/medical managed per the policy lists.
- Ensure prior authorization request is submitted to the correct benefit (medical vs pharmacy) to avoid routing denials.
- Otezla XR was added to preferred alternatives and has coverage for individuals ≥6 years and ≥50 kg.
Prior authorization required for listed HCPCS/J/Q codes
Prior authorization is required for specific HCPCS/J/Q codes listed in the policy; requests for drugs represented by those codes must meet the policy’s medical necessity criteria to be approved.
Follow defined step-therapy tiers and document prior failures
Step therapy tiers are defined and providers must document required prior failures per the step hierarchy; some agents require failure of listed first-line agents before approval for second-line agents.
- Step tiers include TNF-α antagonists, IL-17 inhibitors, IL-23 inhibitors, TYK2 inhibitors, PDE-4 inhibitors and others.
- Approval for many second-line agents requires prior inadequate response or intolerance to specified first-line agents as detailed in the policy.
Document prior inadequate response/intolerance to systemic therapy
Coverage generally requires documentation of prior inadequate response, intolerance, or contraindication to at least one approved systemic therapy (e.g., methotrexate, cyclosporine, acitretin, or PUVA); for some agents additional specified biologic/oral agent failures are required.
- Document prior trial(s) and reason for discontinuation (inadequate response, intolerance, or contraindication).
- Some agents require failure/intolerance of specified biologics or multiple agents (refer to agent-specific sections).
Otezla XR added to preferred alternatives — document alternative therapy use
Otezla XR was added to the list of preferred alternatives for several biologic agents; providers should document use or contraindication of preferred alternatives when step-therapy rules reference them.
- Otezla XR is now listed as a preferred alternative for Bimzelx, Siliq, Cosentyx, Cimzia, and Ilumya per the 2026 update.
- If a preferred alternative is tried, document trial dates, dose, and clinical response or intolerance.
Adhere to updated preferred-product sequencing for step therapy
Providers must follow updated preferred-product sequencing and step requirements; multiple policies revisions updated preferred adalimumab biosimilars and infliximab sequencing that affect authorization prerequisites.
- Verify member’s formulary and preferred-product lists in the policy history before submitting authorization.
- Document trials of preferred biosimilars or infliximab products if required by the step sequence.
Submit clinical documentation of diagnosis, BSA, and prior treatments
Documentation submitted for authorization must support the diagnosis (e.g., chronic plaque psoriasis), BSA involvement, prior trials and failures/intolerance of listed systemic agents, and that the medication is prescribed by or in consultation with a dermatologist.
- Include documentation of BSA percent or description of special-site disease if <10% (extensive facial, pustular hands/feet, genital involvement).
- Include medication history noting agents tried, dates, doses, and reasons for discontinuation.
Include office visit notes with authorization request
Submit office visit notes that contain the diagnosis, relevant history, physical evaluation, and medication history to demonstrate that medical necessity criteria are met.
- Attach office visit notes showing current disease activity, prior therapies, and clinician rationale for the requested agent.
Provide clinical severity documentation (e.g., GPPGA, BSA) for pustular disease
Document clinical severity metrics where relevant (trial-defined thresholds such as GPPGA pustulation subscores or BSA) for severe variants like generalized pustular psoriasis; these data are relevant to medical necessity determinations for agents used in pustular disease.
- For GPP flare requests, document GPPGA pustulation subscore and BSA involvement consistent with trial inclusion (e.g., pustulation subscore ≥2 and ≥5% BSA when applicable).
- Provide objective severity measures (GPPASI, GPPGA, BSA) when available.
Follow FDA prescribing information and document dosing/monitoring
Prescribing must follow FDA dosage and administration; policy notes medications are subject to product prescribing information and monitoring requirements and member benefit limitations.
- Ensure dosing, frequency, and administration route align with FDA-approved prescribing information.
- Be aware of member-specific benefit limitations or custom formulary exceptions referenced in the policy.
Bill IV-administered drugs through the medical benefit
Claims for IV-administered drugs described in this policy must be processed through the medical benefit; submitting IV drugs through the pharmacy benefit or incorrect billing route may trigger denial.
- Submit IV-administered drug claims through the medical benefit only per policy instruction.
- Verify benefit routing prior to claim submission to avoid billing-route denials.
Site-of-service denials — ensure SOS criteria are met
Use of a non-preferred or non-medically necessary site of service when the site-of-service criteria are not met is considered not medically necessary and may be denied; initial course hospital-based outpatient infusion is medically necessary for first 90 days when indicated.
- If site-of-service criteria are not met (e.g., no clinical justification for hospital-based infusion), expect possible denial for site-of-service.
- Hospital-based outpatient site is considered medically necessary for the initial 90 days for initial course or re-initiation after ≥6 months when criteria are met.
Denial risk if required prior systemic or comparator trials are not documented
Requests for biologic agents may be denied if required prior trials of approved systemic therapies (e.g., methotrexate, cyclosporine, acitretin, PUVA) or specified comparator biologics are not documented.
- For many agents, document at least one prior systemic therapy trial unless contraindicated.
- Some agents require documented failure of specified biologics or multiple agents per agent-specific criteria.
Benefit routing can trigger denials — verify medical vs pharmacy management
Benefit routing (medical vs pharmacy) affects authorization; requests may be managed under different benefits depending on the agent, and routing to the incorrect benefit could result in denial or delayed approval.
- Confirm whether the agent is managed through the medical benefit (e.g., infliximab products) or pharmacy/medical benefit before submitting authorization.
- If routed incorrectly, resubmit to the correct benefit to avoid denial.
Denial triggers — unmet coverage, SOS, or formulary requirements
Coverage denials commonly occur when coverage criteria, site-of-service medical necessity criteria, or formulary-specific requirements (such as trials of preferred agents or step therapy) are not met; review policy details and member plan exceptions before submission.
- Check for plan-specific exceptions (custom open/preferred formularies) referenced in policy history and related policies.
- Document compliance with step-therapy, preferred-product sequencing, and SOS rules to reduce denial risk.
Background and Safety Evidence
Psoriasis is a chronic inflammatory skin disease that most commonly presents as plaque psoriasis, characterized by well-demarcated, erythematous, scaly plaques. Pustular forms of psoriasis are much less common but can be more severe and systemic in presentation.
Definitions and Clinical Terms
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