ModifiedPremera BluecrossPolicy N/A

Site-of-service review and formulary prior authorization for selected biologic and injectable drugs

Defines prior authorization, step therapy, and site-of-service medical necessity criteria for selected IV and injectable biologic drugs for members on two custom Premera formularies (Open Formulary ID 6062; Preferred Formulary ID 6064). Applies to medical benefit IV/SC administration reviews and specific formularies.

Policy Summary

PayerPremera Bluecross

PolicySite-of-service review and formulary prior authorization for selected biologic and injectable drugs

Policy CodePolicy N/A

Change TypeMultiple additions & formulary updates

Effective DateN/A

Next Review DateN/A

Key ActionSubmit office visit notes documenting diagnosis, relevant history, physical exam and medication history to support prior authorization requests.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Abrilada (adalimumab-afzb) and multiple other adalimumab biosimilars/unbranded products and listed them by brand and NDC prefixes.

Updated age requirements for several adalimumab products to include ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and pyoderma gangrenosum.

Added numerous biologic agents (rituximab products, tocilizumab products, vedolizumab SC, anakinra, sarilumab, bimekizumab, tildrakizumab, baricitinib, ozanimod, abatacept, certolizumab pegol, golimumab) and associated HCPCS/J-codes into coverage criteria.

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

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

Updated product formulary status for several infliximab and adalimumab biosimilars (preferred/non-preferred changes).

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.

formulary IDs covered

90hospital outpatient initial days

50distance threshold (miles)

12mreauthorization max

5adalimumab Q-codes listed

20+distinct products listed

Coverage Criteria

Second-line CD20-directed antibodies

Second-line CD20-directed antibodies (e.g., Riabni, Ruxience, Truxima, Rituxan) — coverage and site-of-service review.

ALL of the following

The requested agent is one of the following CD20-directed antibodies: Riabni (rituximab-arrx) IV; Ruxience (rituximab-pvvr) IV; Truxima (rituximab-abbs) IV; or Rituxan (rituximab) IV (including Rituxan Hycela SC).
Indication: Treatment of moderately to severely active rheumatoid arthritis (e.g., approximately 28 swollen and 28 tender joint assessment).
Concomitant therapy: The agent will be administered in combination with methotrexate.
Step therapy / prior trials
- The individual has tried and failed any ONE of the first-line therapies (e.g., a preferred adalimumab product such as Humira [adalimumab] or an approved biosimilar/alternatives listed in policy; etanercept [Enbrel]; a preferred infliximab product; Actemra [tocilizumab]; tofacitinib [Xeljanz/Xeljanz XR]; upadacitinib [Rinvoq]) as documented in the chart.
- OR the individual has had an inadequate response to methotrexate or other conventional synthetic DMARD and is NOT a suitable candidate for TNF inhibitors due to a recent (e.g., within 5 years) history of lymphoma or other malignancy; latent tuberculosis with contraindication to chemoprophylaxis; or a prior serious adverse event that precludes TNF inhibitor use.
Site-of-service: IV administrations are subject to site-of-service review per policy. Medically necessary sites include physician office, infusion center, or contracted home infusion when appropriate. Hospital-based outpatient infusion is considered medically necessary for the initial course or re-initiation after >=6 months, or when clinical risk factors (e.g., significant cardiac or pulmonary disease, unstable renal function, difficult/unstable vascular access, acute mental status changes, known history of severe infusion reactions/anaphylaxis, or grade 3–4 cytokine release syndrome) are present, or when no outpatient/home infusion option exists within 50 miles.
Administration and benefit: These agents are managed through the medical benefit; ensure appropriate billing to the medical benefit as specified by the plan.
Length of approval: Initial authorization may be granted consistent with policy (up to 12 months) if coverage criteria are met and documentation demonstrates clinical response on therapy.

Initial Therapy Criteria

Initial therapy preferences

Initial therapy preferences — high‑level placement of drug classes for first‑line use:

First-line TNF-alpha inhibitors: Preferred adalimumab products and other TNF inhibitors may be first‑line for multiple indications when age and specialist prescriber criteria are met

First-line IL-6 inhibitors: Actemra (tocilizumab) and tocilizumab biosimilars may be considered first‑line for RA/PJIA when criteria are met (eg age >=18 for adults; prior DMARDs failed/intolerant for adults)

Initial therapy requirements

Initial therapy requirements (summary):

Specialist prescriber: Medication must be prescribed by or in consultation with an appropriate specialist (eg dermatologist, rheumatologist, gastroenterologist)

Continuation / Re-authorization Criteria

Re-authorization

Re-authorization (continuation) — summary:

Re-authorization criteria: May be approved for up to 12 months provided drug‑specific coverage criteria are met and chart notes demonstrate ongoing positive clinical response12 months

Maintenance/continuation evidence

Maintenance / continuation evidence (context for continued coverage):

Maintenance response observed: In trials (eg CLASSIC‑II, CHARM), maintenance dosing sustained remission in randomized responders through up to 56 weeks; withdrawal led to flares in a proportion of subjects

Dose escalation/escape rules described in trials

Continuation / re-authorization — re-authorization duration and rules updated

Step Therapy Rules

Step requirement	Required prior agents / preferred examples	Supporting note
Must try preferred first-line agents before second-line biologics
Preferred adalimumab products (Humira and listed biosimilars) and specified preferred infliximab biosimilars (eg, Avsola/Inflectra as listed) — trial of these agents is required prior to second-line agents such as CD20-directed antibodies or certain IL‑6 inhibitors
Exemption allowed when TNF inhibitors are contraindicated or not a candidate (eg recent malignancy, latent TB not amenable to prophylaxis) — see product-specific criteria

Requirement	Examples of required failed agents	Count required / context
Failure of 1 or more specified agents before approval
Adalimumab products (Humira and listed biosimilars), etanercept (Enbrel), other biologics such as Taltz, Rinvoq, Simponi, Skyrizi depending on indication
Often 1 agent required (eg AS, HS) or 2 agents required for some indications (eg certain psoriasis, psoriatic arthritis, ankylosing spondylitis) as enumerated per indication

Prior therapy category	Specific conventional/systemic or biologic agents to try	Indication-specific notes
Conventional systemic therapies
Corticosteroid (eg prednisone, methylprednisolone), azathioprine, 6‑mercaptopurine, methotrexate, mesalamine (Pentasa) — as applicable to Crohn's and other disease-specific lists
Examples: Crohn's disease may require trial of one corticosteroid or one other agent (eg azathioprine, methotrexate) prior to biologic

Benefit routing	Examples (managed benefit)	Effect on step requirements
Benefit assignment determines management pathway
Some agents are managed through the medical benefit (IV infusions: Actemra IV, Orencia IV, rituximab products), some through pharmacy or both (listed adalimumab biosimilars, Entyvio SC), and some exclusively via pharmacy (Olumiant, Zeposia)
Follow benefit-specific step therapy and prior authorization rules — route (IV vs SC vs oral) and NDC/HCPCS determine whether pharmacy or medical step rules apply

Coverage label	Product examples	Requirement before non-preferred product
covered_with_criteria
Preferred adalimumab products (Humira and designated biosimilars such as Yuflyma when listed as preferred), preferred infliximab products (eg Avsola where listed preferred) — see policy product lists
Policy may require trial of the listed preferred product(s) prior to coverage of non-preferred products; formulary status updates (effective dates noted) affect which agent must be tried first

Coding

Document header referencesmixed

No codes listed

Product-specific NDC prefixes mentionedNDC

NDCs starting with 00074	Humira (adalimumab) (AbbVie) — preferred adalimumab product referenced with NDC prefix
NDCs starting with 83457	Humira (adalimumab) (Cordavis) referenced with NDC prefix

HCPCS and Q-codes (selected)HCPCS

J0129	Injection, abatacept (Orencia), 10 mg.
J0135	Injection, adalimumab (Humira) 20 mg (code terminated effective 01/01/25).
J0139	Injection, adalimumab (Humira) mg (new code effective 01/01/25).
J0717	Injection, certolizumab pegol (Cimzia), mg.
J3245	Injection, tildrakizumab (Ilumya) , mg.
J3247	Injection, secukinumab (Cosentyx) , IV, mg.
J3262	Injection, tocilizumab (Actemra), 1 mg.
J3590	Unclassified biologics (use to report: Amjevita, Bimzelx; Cyltezo, Hadlima, Hulio, Hyrimoz, Kevzara, Kineret; Siliq, Simlandi, Yuflyma and Yusimry).
J9311	Injection, rituximab 10 mg and hyaluronidase (Rituxan Hycela).
J9312	Injection, rituximab (Rituxan), 10 mg.

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Q-codes for adalimumab biosimilarsHCPCS

Q5141	Injection, adalimumab-aaty, biosimilar (Yuflyma), mg.
Q5142	Injection, adalimumab-ryvk biosimilar (Simlandi), mg.
Q5143	Injection, adalimumab-adbm; biosimilar (Cyltezo), mg.
Q5144	Injection, adalimumab-aacf (Idacio), biosimilar, mg.
Q5145	Injection, adalimumab-afzb (Abrilada) , biosimilar, mg.

Adalimumab biosimilar HCPCS Q-codesHCPCS

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

HCPCS/J/Q Codes added or referencedHCPCS

J0135	Injection, adalimumab, 20 mg/0.4 mL (example HCPCS added)
J3590	Unclassified biologics
Q5131	Adjunct code added (Q-code)
Q5132	Adjunct code added (Q-code)
Q5119	Ruxience IV (Q-code) per history
Q5115	Truxima IV (Q-code)
J3262	Actemra (tocilizumab) J-code
Q5133	Tofidence IV (Q-code)
Q5135	Tyenne (tocilizumab) Q-code
J3247	Cosentyx J-code

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inv-43: Hospital-based outpatient initial course duration

Hospital-based outpatient initial course duration90 days (hospital outpatient site considered medically necessary for the initial course of infusion)

Re-initiation after discontinuationHospital-based outpatient setting medically necessary for re-initiation after ≥6 months off therapy

Exception when standard dosing ≥6 monthsNot considered initial/re-initiation if standard dosing interval between infusions is 6 months or longer

inv-44: Distance without outpatient infusion center

Distance threshold for no outpatient infusion/home infusion50 miles (hospital outpatient site may be used when no outpatient infusion center or contracted home infusion agency will travel within 50 miles)

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization and step therapy are required for many of the drugs listed in this policy. Prior authorization (PA) is required when the drug is managed under the medical or medical/pharmacy benefit and when an HCPCS Q‑code or J‑code is billed for administration. Step therapy (failure of specified prior therapies) must be documented where listed in the clinical criteria.

Prior authorization required for medical‑benefit administered IV/ injectable agents
HCPCS Q‑codes (see Coding) may trigger prior authorization when billed
Step‑therapy requirements (trial and failure of specified agents) are required where described in the drug‑specific criteria

Billing Rule

HCPCS Q‑codes: Prior Authorization Note

Site-of-Care Rules

Note

Preferred sites of care

Preferred medically necessary sites include physician office, infusion center, and home infusion; hospital outpatient is limited to initial courses (first 90 days), re‑initiation after ≥6 months, or when other site exceptions apply.

Note

Multiple agents subject to SOS review

Several products (for example Entyvio IV vs SC and Cosentyx IV) and multiple adalimumab formulations are explicitly subject to site‑of‑service review; provider must note product formulation and intended administration site on requests.

Note

SOS review applies to infusion center, office, specialty clinic

Site‑of‑service review rules apply to infusion center, office, and specialty clinic settings; many indications require specialist involvement and appropriate documentation to justify site selection.

Biosimilar & Product Preference Notes

Billing Rule

Infliximab preferred products listed first‑line

Preferred infliximab products (for example Avsola, Inflectra) are listed as first‑line options for certain indications; follow the policy's preferred product listing when documenting prior trials.

Billing Rule

Humira and multiple biosimilars listed

Humira (adalimumab) and multiple biosimilars (Simlandi, Yuflyma, Hyrimoz, Cyltezo, Abrilada, Hulio, Amjevita, etc.) are listed across indications and may serve as preferred trial agents per the policy.

Billing Rule

Yuflyma (Q5141) — managed via pharmacy/medical benefit

Yuflyma (adalimumab-aaty) is listed among adalimumab biosimilars with HCPCS Q‑code Q5141 and may be managed through pharmacy and/or medical benefit depending on NDC/HCPCS.

Billing Rule

Definitions

inv-71: Site of Service (SOS) definition

Site of Service (SOS) definitionThe location where a drug is administered (physician's office, infusion center, home infusion, or hospital-based outpatient setting)

Preferred medically necessary sitesPhysician office, infusion center, home infusion

Hospital outpatient roleHospital-based outpatient setting considered medically necessary for initial course (first 90 days) or re-initiation after ≥6 months, or when no outpatient/home infusion is available within 50 miles, or patient has specific clinical risk factors

inv-72: Body surface area (BSA) definition

Body surface area (BSA) definitionPercent of body surface involved by chronic plaque psoriasis; policy threshold for consideration is >= 10% BSA

Use in criteria

Quantity Limits

inv-92: Humira and biosimilars — quantity limit references

Humira and biosimilars — quantity limit referenceHumira and listed adalimumab biosimilars are included in the policy's quantity limits section (product grouping referenced in history and coding updates)

Coding and benefit routingAdalimumab products and biosimilars are managed through pharmacy and/or medical benefit depending on NDC/HCPCS (see coding/Q‑codes)

Formulary updatesPolicy history notes addition of multiple adalimumab biosimilars (Abrilada, Yuflyma, Cyltezo, etc.) and HCPCS/Q‑code changes relevant to prior authorization and quantity management

Background

This policy governs intravenous and injectable biologic therapies used to treat autoimmune and inflammatory diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and related conditions. It establishes prior authorization and step therapy requirements, specialist prescriber expectations, site-of-service medical necessity rules, and product-specific coverage criteria for IV and SC biologic agents administered under the medical or pharmacy benefit.

Policy Summary

PayerPremera Bluecross

PolicySite-of-service review and formulary prior authorization for selected biologic and injectable drugs

Policy CodePolicy N/A

Change TypeMultiple additions & formulary updates

Effective DateN/A

Next Review DateN/A

Key ActionSubmit office visit notes documenting diagnosis, relevant history, physical exam and medication history to support prior authorization requests.

SourceLink

On This Page

Prior therapy: Documented inadequate response or intolerance to specified conventional/systemic therapies and one or more biologics as enumerated per indicationas specified

Initial therapy general rules

Initial therapy general rules (summary):

General initial therapy requirements: Age within specified indication limits; prescriber specialty consultation as specified; documented trials of conventional therapies and/or biologics as listed for each indication; documentation of intolerance or inadequate response to required prior agents

Specific prior agents and counts vary by indication and are enumerated in the policy

Hidradenitis suppurativa — induction

Hidradenitis suppurativa — induction regimen used in trials (context for initial dosing):

HS induction dosing (trial): Humira induction in HS trials: 160 mg at Week 0, 80 mg at Week 2, then 40 mg weekly beginning Week 4 through Week 11

Used in HS‑I and HS‑II trials

Crohn's disease — induction/maintenance

Crohn's disease — induction and maintenance regimens studied (context for initial therapy expectations):

Crohn's dosing (trial examples): Induction regimens in CLASSIC and GAIN included larger initial doses (eg 160 mg/80 mg) with maintenance dosing of 40 mg QOW or 40 mg QW as studied; maintenance benefit observed in responders through up to 56 weeks

Response differs by TNF‑naive vs prior TNF exposure

Initial biologic therapy considerations

Initial biologic therapy considerations — when to escalate to biologic therapy:

When to escalate to biologic: Moderate to severe disease or failure of NSAIDs/corticosteroids/traditional DMARDs may prompt use of TNF inhibitors or other biologics; early initiation of DMARDs is recommended to prevent joint damage

Clinical judgment and FDA labeling guide agent selection

Continuation / re‑authorization — updated rules:

Re-authorization duration update: Re‑authorization duration of approval changed from 3 years to 12 months per interim review; continued coverage requires meeting drug‑specific criteria and documentation of ongoing clinical benefit12 months

Interim review noted in policy history

Alternative requiredNo contracted home infusion agency available to travel to the member's home

Applies to site-of-service determinationUsed to determine when hospital outpatient infusion is medically necessary versus outpatient/home infusion

inv-45: Psoriasis BSA threshold

Psoriasis BSA threshold>= 10% body surface area (chronic plaque psoriasis involving at least 10% BSA required for biologic consideration)

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

Prescriber contextPrescribed by or in consultation with a dermatologist for psoriasis indications

inv-46: Cosentyx age for plaque psoriasis

Minimum age — Cosentyx for plaque psoriasis>= 6 years (Cosentyx SC may be considered medically necessary for chronic plaque psoriasis in individuals aged 6 years or older)

BSA requirement>= 10% BSA or qualifying exception (see policy)

PrescriberMust be prescribed by or in consultation with a dermatologist

inv-47: Cosentyx age for psoriatic arthritis (IV/SC)

Minimum age — Cosentyx for psoriatic arthritis (IV/SC)>= 2 years (Cosentyx IV/SC may be considered medically necessary for active psoriatic arthritis in individuals aged 2 years or older)

Prior therapy requirementInadequate response or intolerance to 2 specified agents for pediatric/adult PsA indications

PrescriberPrescribed by or in consultation with a rheumatologist

inv-48: CDAI remission threshold

CDAI remission thresholdCDAI < 150 (induction of remission defined as CDAI <150)

Study contextUsed as primary efficacy endpoint in CLASSIC-I/II and GAIN trials for Crohn's disease induction/maintenance evaluations

ApplicationThreshold used to define remission for coverage/evidence rationale in Crohn's disease criteria

inv-49: CRP threshold

CRP predictive threshold>= 24.1 mg/dL (identified as a predictive risk factor associated with a subset of RA patients)

Clinical relevanceCRP level used in RA context to help determine aggressive disease and DMARD choice

Source guidanceReferenced in rheumatoid arthritis clinical context within policy rationale

Some HCPCS Q‑codes listed in the Coding section correspond to specific biosimilars and will trigger prior authorization when submitted on medical claims. When billing Q‑codes or J‑codes for the agents in this policy, ensure the prior authorization is obtained and the code matches the drug dispensed/ administered.

Examples: Q5141–Q5145 (adalimumab biosimilar Q‑codes)
Newly added HCPCS per history: Q5119 (Ruxience), Q5115 (Truxima), Q5133 (Tofidence)

Denial Risk

Denial Triggers

Denials may occur if the site‑of‑service is not supported by the policy’s medical necessity SOS criteria, if required prior authorization is not obtained, or if age or specialty prescriber requirements are not met.

No PA or SOS review — possible denial when site does not meet medical necessity SOS criteria (e.g., using hospital‑based outpatient beyond allowed initial/reinitiation period without clinical justification)
Missing or incomplete prior authorization documentation
Prescriber not specialty‑required where policy mandates specialty consultation or prescribing

Prior Authorization

Site‑of‑Service Review Triggers

Site‑of‑service (SOS) review is performed for specified IV/ injectable agents to determine the most appropriate, safe and cost‑effective location (physician office, infusion center, home infusion, or hospital outpatient). SOS review applies for members aged 13 and older (per policy) and only for medical benefit reviews; Alaska fully‑insured members are excluded from SOS criteria.

SOS review applies to listed IV agents (Actemra IV, Orencia IV, rituximab products, tocilizumab products, etc.)
Hospital‑based outpatient setting may be medically necessary for the initial course or re‑initiation after ≥6 months, or when no infusion center/home infusion is available within 50 miles
SOS review is triggered when administration site billed or when clinical documentation indicates hospital outpatient use

Denial Risk

Age‑Based Denial Risk

Some denials are age‑based when the requested use falls outside FDA‑approved or policy‑specified age indications. Age limits in this policy follow FDA‑approved indications where applicable.

Examples: Pediatric age minimums for ulcerative colitis, Crohn’s, hidradenitis, etc., as specified in drug criteria may cause denial if member is younger than policy age requirement

Documentation Required

Specialist Prescriber / Consultation Requirement

Where the policy requires a specialist prescriber or consultation (e.g., rheumatologist for many biologics; gastroenterologist for Entyvio/Zeposia; dermatologist for certain psoriasis agents), the prescription must be written or the request must include documentation of specialist consultation.

Entyvio (vedolizumab) SC and Zeposia (ozanimod) — prescriber or consultation with a gastroenterologist required
Bimzelx, other psoriasis agents — prescriber or consultation with dermatologist required
Many RA and related agent approvals require rheumatology prescriber or consultation

Documentation Required

Required Documentation

Documentation must be submitted with PA requests and will be required for medical necessity review. At minimum include office visit notes with diagnosis, relevant history, physical exam, prior medication trials and responses, and rationale for the chosen site of service. Chart notes should show ongoing clinical benefit for reauthorization.

Office visit notes with diagnosis, relevant history and physical exam
Medication history showing trials and failures as required by step‑therapy criteria
For reauthorization: documentation of positive clinical response and ongoing benefit

Note

Prescribing Compliance and FDA Dosing

Prescribing and dosing must follow the product’s FDA‑approved dosing and administration information. Uses or combinations not described in this policy are considered investigational and are not medically necessary per the policy.

All uses must follow FDA dosing/administration; off‑label combinations not specified in policy are investigational
Chart documentation should support adherence to FDA dosing when relevant

Step Therapy

Step / Failed Therapy Requirements

Step therapy and failed‑therapy requirements in the drug‑specific criteria must be met and documented. Many agents require a trial and treatment failure with one or more preferred adalimumab products or other listed agents before second‑line agents will be authorized.

Examples: Rituximab products may be second‑line after failure of specified first‑line agents (adalimumab preference listed)
Entyvio SC requires trial and failure with TWO listed agents for ulcerative colitis
Bimzelx requires trial/failure of at least one biologic (e.g., Enbrel, Humira, Taltz) and specialist prescribing

Step Therapy

Prior / Trial Requirements

Prior or trial requirements (trial of standard systemic therapies, corticosteroids, or other disease‑specific agents) specified in the drug criteria must be documented prior to approval. Exceptions (e.g., contraindication or intolerance) must be clearly documented.

Psoriasis agents often require prior trial of methotrexate, cyclosporine, acitretin or PUVA unless contraindicated
Hidradenitis suppurativa: trial of intralesional/oral corticosteroids or systemic antibiotics required before biologic approval
Documented intolerance or contraindication must be included to waive trial requirements

Billing Rule

IV formulations managed under medical benefit

IV formulations are managed under the medical benefit and should be administered in appropriate infusion settings (infusion center, office, or hospital outpatient when criteria met).

Billing Rule

SC formulations — home or clinic per benefit

SC formulations may be managed under the pharmacy or medical benefit depending on product and NDC/HCPCS; they may be administered in the office or at home per benefit routing.

Note

Site‑of‑care rules depend on product and codes

Coverage and coding include both IV and SC products; specific site‑of‑care rules and benefit routing depend on the product formulation and HCPCS/NDC coding on the request.

Simlandi (Q5142) — managed via pharmacy/medical benefit

Simlandi (adalimumab-ryvk) is listed with HCPCS Q‑code Q5142 and may be managed through pharmacy and/or medical benefit depending on NDC/HCPCS.

Billing Rule

Adalimumab products updated to non‑preferred (effective Jan 2, 2026)

Certain adalimumab products were updated to non‑preferred effective January 2, 2026 (90‑day provider notification) — verify current product preference before submitting a request.

Example: Cyltezo (adalimumab‑adbm) updated from preferred to non‑preferred effective Jan 2, 2026.

Billing Rule

Adalimumab products updated to preferred

Other adalimumab products have been updated to preferred status per interim reviews — confirm product status at time of submission.

Example: Yuflyma (adalimumab‑aaty) updated from non‑preferred to preferred.

Billing Rule

Infliximab products updated to preferred in some criteria

Infliximab products (e.g., Avsola) were updated from non‑preferred to preferred in certain criteria sets; document which infliximab product was used for prior therapy trials.

Example: Avsola (infliximab‑axxq) updated to preferred in specified criteria.

Applied to determine eligibility for biologic therapy in plaque psoriasis indications

Exceptions noteCertain limited but recalcitrant areas may qualify despite <10% BSA (see policy exceptions)

inv-73: HiSCR definition for hidradenitis suppurativa

HiSCR definitionHidradenitis Suppurativa Clinical Response (HiSCR): ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to baseline

Assessment timingHiSCR evaluated at Week 12 in HS clinical trials (HS‑I and HS‑II)

Clinical useUsed as primary efficacy endpoint to evaluate response to biologic therapy in HS studies

inv-74: Clinical remission (CD) definition

Clinical remission (CD) definitionInduction of remission in Crohn's disease defined as CDAI < 150

Trial endpointPrimary efficacy endpoint at Week 4 in CLASSIC‑I and GAIN trials was induction of remission (CDAI <150)

Use in coverage rationaleCDAI <150 used to define remission for clinical/evidence assessments in Crohn's disease criteria

inv-75: Psoriatic Arthritis (PsA) definition/context

Psoriatic Arthritis (PsA) definition/contextPsoriatic arthritis is a spondyloarthropathy associated with psoriasis, featuring peripheral and spinal inflammation, dactylitis, enthesitis, and potential joint destruction

Clinical implicationsModerate to severe disease may require DMARDs or biologic therapy to prevent joint damage; specialist involvement recommended

Treatment contextNSAIDs for mild disease; traditional DMARDs and anti‑TNF agents for moderate to severe disease

inv-76: Spondyloarthropathies (SpAs) definition/context

Spondyloarthropathies (SpAs) definition/contextA heterogeneous group of disorders with axial skeletal involvement and frequent HLA‑B27 association, including ankylosing spondylitis

Clinical featuresMay include sacroiliitis, peripheral arthritis, and enthesitis; treatment ranges from NSAIDs to biologics depending on severity

Overlap with PsAApproximately 20–40% of individuals with PsA may have some degree of sacroiliitis; SpA features inform therapy selection

inv-77: Pyoderma gangrenosum definition/context

Pyoderma gangrenosum definition/contextAn inflammatory dermatologic condition with painful ulcerations, presumed autoimmune; biologic therapy (eg TNF inhibitors) used when refractory to topical/systemic immunosuppressants

Clinical courseLesions often develop at sites of minor skin injury and can become necrotic; treatment is empiric and individualized

Treatment sequencingFirst‑line: topical/systemic corticosteroids and immunosuppressants; biologics considered when these fail