CurrentAnthemPolicy N/A

Cytokine and CAM Antagonist Appendix A — Coverage and Utilization Management

Coverage and utilization management rules for cytokine and cell adhesion molecule (CAM) antagonist drugs for Anthem HealthKeepers Medicaid products in Virginia; defines FDA indications, quantity limits, and initial approval criteria for listed agents.

Policy Summary

PayerAnthem

PolicyCytokine and CAM Antagonist Appendix A — Coverage and Utilization Management

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionPlace agents on the Routine PDL and document required prior therapy trials and weight- or indication-specific dosing to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~20+agents cataloged

Most agentsRoutine PDL required

SpecifiedQuantity limits

MultipleWeight-based dosing

Coverage Criteria for Cytokine and CAM Antagonists

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Typical biologic approval criteria (example: Actemra)

Covered when ALL of the following are met (common template used for several agents such as tocilizumab/Actemra):

PDL and prior therapy: Placement on the Routine PDL AND tried and failed methotrexate; OR medication will be used in conjunction with methotrexate; OR member has a contraindication to methotrexate (examples: alcohol abuse, cirrhosis, chronic liver disease)

Additional DMARD failure: Member has tried and failed another DMARD (other than methotrexate) such as azathioprine, d-penicillamine, cyclophosphamide, cyclosporine, gold salts, hydroxychloroquine, leflunomide, sulfasalazine, or tacrolimus

used as a required element for some RA and juvenile arthritis approvals

IBD biologic criteria (Entyvio, Cimzia)

Covered when ALL of the following are met:

Routine PDL: Placement on the Routine PDL

Corticosteroid failure: Trial and failure of a compliant regimen of oral corticosteroids for moderate-to-severe disease (or IV corticosteroids for severe/fulminant disease or failure of oral corticosteroids), unless corticosteroids are contraindicated

Thiopurine trial: Trial and failure of azathioprine or mercaptopurine for three consecutive months3 months

Parenteral methotrexate trial: Trial and failure of parenteral methotrexate for three consecutive months3 months

Enspryng (satralizumab) NMOSD criteria

Covered when ALL of the following are met:

Seropositive AQP4: Member was found to be seropositive for aquaporin-4 (AQP4) IgG antibodies

Core clinical characteristic: Member has ≥ 1 core clinical characteristic (examples: optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy/diencephalic syndrome with typical MRI lesions, or symptomatic cerebral syndrome with NMOSD-typical brain lesions)>=1

Exclude alternative diagnoses: Alternative diagnoses have been excluded (examples: multiple sclerosis, sarcoidosis, cancer, chronic infection)

Infliximab product prior-to requirement

Covered when ALL of the following are met:

Routine PDL: Placement on the Routine PDL

Infliximab generic first: Trial and failure of infliximab (generic Remicade) prior to use of any other infliximab product

Zymfentra has pediatric dosing exceptions noted

Vedolizumab (Entyvio) initial approval criteria

Vedolizumab (Entyvio) covered when ALL of the following are met:

Routine PDL placement: Placement on the Routine PDL

Prior corticosteroid trial and failure: Trial and failure of a compliant regimen of oral corticosteroids for moderate-to-severe disease (or IV corticosteroids for severe/fulminant disease or failure of oral corticosteroids), unless contraindicated

Prior thiopurine trial: Trial and failure of azathioprine or mercaptopurine for three consecutive months3 months

Prior parenteral methotrexate trial: Trial and failure of parenteral methotrexate for three consecutive months3 months

Adalimumab class coverage criteria

Adalimumab products (Humira and biosimilars) covered when ALL of the following are met (product- and indication-specific):

PDL requirement: Placement on the Routine PDL for the specific adalimumab product

FDA-approved indication: Requested use matches an FDA-approved indication for the product (examples include rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, juvenile idiopathic arthritis, hidradenitis suppurativa, non-infectious uveitis)

Quantity limits and dosing: Adhere to induction and maintenance quantity limits per product PI, including pediatric weight-based dosing where specified

Ilumya (tildrakizumab) coverage criteria

Ilumya (tildrakizumab-asmn) covered when ALL of the following are met:

Routine PDL: Placement on the Routine PDL

Disease duration and severity: Moderate-to-severe plaque psoriasis for at least 6 months PLUS at least one of: BSA ≥10% OR PASI ≥10 OR incapacitating plaque location6 months; BSA >=10% or PASI >=10

Prior topical/systemic/phototherapy trials: Failed a 3-month trial of topical agents AND failed a 3-month trial of at least one systemic agent AND failed a 3-month trial of phototherapy (or documented not a candidate)3 months each

Specialist and prior therapy requirements for selected rheumatology agents

Rheumatology and JAK/IL-targeted agents covered with specialist involvement and prior therapy trials:

Specialist prescribing: Prescribed by or in consultation with a rheumatologist where specified

Prior non-biologic DMARD failure: History of failure, contraindication, or intolerance to one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine) required for certain agents

Combination therapy restriction: Use in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine, cyclosporine) is not recommended

Canakinumab coverage criteria

Canakinumab (Ilaris) coverage when diagnosis confirmed:

Periodic fever syndromes: Coverage approvable with confirmation of diagnosis for CAPS (FCAS, MWS), TRAPS, HIDS/MKD, and FMF

Weight-based dosing: Adhere to weight-based dosing and possible dose escalation if inadequate response (examples: >40 kg: 150 mg q8w; 15–40 kg: 2 mg/kg q8w; may increase to 3 mg/kg)weight-based

Mirikizumab (Omvoh) criteria

Mirikizumab (Omvoh) coverage:

Routine PDL: Placement on the Routine PDL

Adhere to induction and maintenance dosing: Follow specified induction intravenous dosing for UC/CD and maintenance subcutaneous dosing per product PI

JAK inhibitors / selected systemic agents

Example: Rinvoq (upadacitinib) and similar JAK inhibitors — covered when ALL of the following are met

Routine edits and prior therapy: Placement on the Routine PDL AND if TNF inhibitors are clinically inadvisable, member must try and fail at least one other systemic therapy for the relevant condition; AND use in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (e.g., azathioprine or cyclosporine) is not recommended.

applies across multiple indications (RA, AS, UC, CD)

Ustekinumab (Stelara and biosimilars)

Ustekinumab products — covered when ALL of the following are met

Preferred product and TNF trial: Preferred ustekinumab products (Pyzchiva, Starjemza) may be approved after trial and failure of a preferred TNF-alpha inhibitor; other ustekinumab products require Routine PDL edits including trial and failure of preferred ustekinumab products

applies to psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis

Dosing per weight/age: Weight- and indication-based dosing required (IV weight-based induction then maintenance subcutaneous dosing at specified intervals)specific weight bands as listed

see quantity limit entries for exact doses

Golimumab (Simponi, Simponi Aria)

Golimumab products — covered when ALL of the following are met

Routine PDL and prior trials for UC: Placement on the Routine PDL; for ulcerative colitis, trial and failure of oral or rectal aminosalicylates for two consecutive months, trial and failure of corticosteroids (unless contraindicated) or IV corticosteroids, and trial and failure of azathioprine or mercaptopurine for three consecutive months may be required

dosing and quantity limits per indication

Spesolimab — GPP flares

Spesolimab for generalized pustular psoriasis (GPP) flares — covered when ALL of the following are met

Specialist prescriber and clinical presentation: Prescribed by or in consultation with a dermatologist, rheumatologist, or other psoriasis specialist; AND member is presenting with primary, sterile, macroscopically visible pustules on non-acral skin (excluding pustulation restricted to psoriatic plaques); AND has at least one of documented genetic mutation (IL36RN/CARD14/AP1S3), skin biopsy with Kogoj's pustules, systemic symptoms or lab abnormalities (fever, elevated CRP, leukocytosis/neutrophilia), OR a GPP flare of moderate-to-severe intensity (for example, ≥5% BSA with pustules or GPPPGA ≥3)GPPPGA ≥ 3 or ≥5% BSA in examples

Single 900 mg IV dose; may repeat once if symptoms persist after one week

Risankizumab (Skyrizi) coverage logic

Risankizumab — covered when ALL of the following are met (psoriasis/psoriatic arthritis/Crohn's/UC as applicable)

Psoriasis criteria: Placement on the Routine PDL AND diagnosis of moderate-to-severe plaque psoriasis ≥6 months with at least one of: BSA ≥10% OR PASI ≥10 OR incapacitating plaque location; AND failed adequate trials of topical therapy (≥3 months), at least one systemic agent (≥3 months), and phototherapy (≥3 months) unless not candidates; AND not receiving risankizumab in combination with another biologic or non-biologic immunomodulator

Dosing: 150 mg at weeks 0 and 4 then every 12 weeks; quantity limits specified

Crohn's/UC criteria: Placement on the Routine PDL AND induction/maintenance dosing per label; trial and failure of conventional agents required for UC (one conventional agent for ≥3 months) and for Crohn's trial and failure of corticosteroids (unless contraindicated); not used in combination with another biologic or non-biologic immunomodulator

IV loading and SC maintenance dosing specified

Deucravacitinib (Sotyktu) psoriasis

Deucravacitinib (Sotyktu) — covered when ALL of the following are met

Specialist prescriber and disease severity: Placement on the Routine PDL AND prescribed by or in consultation with a dermatologist/rheumatologist/other specialist; AND symptoms persistent ≥6 months with at least one of: BSA ≥3% OR PASI ≥10 OR incapacitating plaque location; AND trial and failure (≥3 months) of at least one conventional therapy (DMARD such as methotrexate, immunosuppressant like cyclosporine, or oral retinoid); AND not used in combination with any other biologic agentBSA ≥3% or PASI ≥10

Dosing: 6 mg orally once daily

Ixekizumab (Taltz)

Ixekizumab — covered when ALL of the following are met

Psoriasis prior therapy: Placement on the Routine PDL AND member has tried and failed at least two topical treatments (examples listed); for systemic indications follow Routine PDL provisions and indication-specific dosing/age/weight guidance

Quantity limits per PI with induction and maintenance dosing specified

Guselkumab (Tremfya) coverage logic

Guselkumab — covered when ALL of the following are met

Psoriasis criteria: Placement on the Routine PDL AND diagnosis of moderate-to-severe plaque psoriasis ≥6 months with at least one of: BSA ≥10% OR PASI ≥10 OR incapacitating plaque location; AND failed topical (≥3 months), systemic (≥3 months), and phototherapy (≥3 months) trials as applicable; AND member is not receiving guselkumab in combination with another biologic agent or non-biologic immunomodulator

Dosing: 100 mg at weeks 0 and 4 then every 8 weeks

UC and Crohn's criteria: Placement on the Routine PDL AND induction and maintenance dosing per label; trial and failure of one conventional agent for UC after at least 3 months required; for Crohn's trial and failure of corticosteroids (unless contraindicated); AND member is not receiving guselkumab in combination with another biologic or non-biologic immunomodulator

IV or SC induction regimens described

Initial therapy — Guselkumab (plaque psoriasis)

Guselkumab (Tremfya) for moderate-to-severe plaque psoriasis — Covered when ALL of the following are met:

psoriasis_diagnosis_and_severity: Diagnosis of moderate-to-severe plaque psoriasis for ≥6 months with at least one of: BSA ≥10% OR PASI ≥10 OR incapacitation due to plaque locationBSA ≥10% OR PASI ≥10

prior_topical_trial: Member did not respond adequately (or is not a candidate) to a 3-month minimum trial of topical agents3 months

prior_systemic_trial: Member did not respond adequately (or is not a candidate) to a 3-month minimum trial of at least one systemic agent (examples: immunosuppressives, retinoids, methotrexate)3 months

prior_phototherapy_trial: Member did not respond adequately (or is not a candidate) to a 3-month minimum trial of phototherapy (examples: PUVA or UVB with coal tar or dithranol)3 months

no_concomitant_therapies: Member is not receiving guselkumab in combination with another biologic agent for psoriasis or a non-biologic immunomodulator (examples: apremilast, tofacitinib, baricitinib)

Guselkumab — PsA, UC, Crohn's criteria

Guselkumab for psoriatic arthritis, ulcerative colitis, Crohn's disease — Covered when routine PDL and disease-specific prior therapy criteria are met:

PsA_indication: FDA‑approved indication for active psoriatic arthritis (adults and pediatric ≥6 years and ≥40 kg where specified) with dosing per label

UC_prior_therapy: For ulcerative colitis: Trial and failure of ONE conventional agent used in UC after at least 3 months (examples: azathioprine, mesalamine, corticosteroids); Routine PDL required

Crohns_prior_therapy: For Crohn's disease: Trial and failure of a compliant regimen of oral or IV corticosteroids (unless contraindicated); Routine PDL required

no_concomitant_therapy_GI: Member is not receiving guselkumab in combination with another biologic agent for GI indications or a non-biologic immunomodulator (example: upadacitinib)

Inebilizumab (Uplizna) — NMOSD initial criteria

Inebilizumab (Uplizna) for NMOSD — Covered when ALL of the following are met:

AQP4-positive NMOSD indication: Treatment of NMOSD in adult members who are anti-AQP4 antibody positive

Dosing schedule: Initial: 300 mg IV then 300 mg IV at 2 weeks; subsequent single 300 mg IV every 6 months starting 6 months from first infusion

Infection screening attestation: Prescriber attests member has been screened for hepatitis B virus (HBV) and tuberculosis (TB) prior to initiating treatment and member does not have an active infection

Concomitant immunosuppressant restriction: Prescriber attests member is not concomitantly receiving other immunosuppressant-type drugs and will not use in combination with complement-inhibitor or anti-CD20 antibody therapies

Relapse history: Documentation of either (a) one or more relapses requiring rescue therapy within the previous 12 months OR (b) two or more relapses requiring rescue therapy in the prior 2 years

Baseline measures: Documentation that member has a baseline Expanded Disability Status Scale (EDSS) score ≤ 8 and documentation of baseline relapse

Inebilizumab — Myasthenia gravis criteria

Inebilizumab (or related dosing entries) for Myasthenia Gravis and other immune conditions — Covered when ALL of the following are met:

gMG indication: Treatment of generalized myasthenia gravis in adults who are AChR- or MuSK-antibody positive

Prescriber specialty: Prescribed by or in consultation with a neurologist or other myasthenia gravis specialist

Infection screening: Prescriber attests member has been screened for HBV and TB and does not have active infection

MG severity: Member has MG-ADL score between 6 and 10 with >50% non-ocular contribution OR MG-ADL ≥11; AND MGFA clinical classification II–IVb

Prior immunosuppressive trials: Member has tried and had inadequate response to at least two immunosuppressive therapies (examples: azathioprine, mycophenolate) OR inadequate response to one immunosuppressive therapy plus chronic IVIG or plasmapheresis/plasma exchange

Etrasimod (Velsipity) — UC criteria

Etrasimod (Velsipity) for ulcerative colitis — Covered when Routine PDL criteria are met:

Indication: Treatment of moderately to severely active ulcerative colitis in adults

Quantity limit: 30 tablets per 30 days

Routine PDL: Placement on the Routine PDL required for approval

Tofacitinib (Xeljanz/XR) — RA, PsA, UC criteria

Tofacitinib (Xeljanz/XR) — Covered when Routine PDL and prior therapy requirements met:

RA indication: Moderate-to-severely active rheumatoid arthritis in adults with inadequate response or intolerance to one or more TNF blockers; trial and failure of methotrexate and at least one other DMARD required

PsA indication: Active psoriatic arthritis in adults and pediatric members ≥2 years with prior TNF blocker failure/intolerance; dosing and quantity limits differ by age

UC indication: Moderately to severely active ulcerative colitis in adults after inadequate response or intolerance to TNF blockers; induction and maintenance dosing specified with maximum induction duration limits

Quantity limits: Typical quantity limits: Xeljanz 5 mg BID (60 tabs/30d) or Xeljanz XR 11 mg QD (30 tabs/30d); induction dosing: 10 mg BID or XR 22 mg QD for limited duration per indication

Renal/hepatic adjustment: Members with moderate/severe renal impairment or moderate hepatic impairment: Xeljanz 5 mg once daily dosing specified

For neuromyelitis optica spectrum disorder (NMOSD) approvals, the policy requires confirmation that alternative diagnoses have been excluded. Examples explicitly listed include multiple sclerosis, sarcoidosis, cancer, and chronic infection as conditions that must be ruled out when establishing the NMOSD diagnosis.

The policy restricts combination use of certain agents. Specifically, it states that use in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (for example, azathioprine or cyclosporine) is not recommended and may be excluded from coverage; this restriction is included in the approval language for multiple JAK and systemic agents.

For JAK inhibitors and selected systemic agents the policy consistently states that concurrent use with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (such as azathioprine or cyclosporine) is not recommended. This combination restriction is applied across indications and is a basis for denying or not approving requests that propose such concomitant regimens.

Several agents — including guselkumab — have explicit combination exclusions. The criteria state that members must not be receiving guselkumab in combination with another biologic agent or certain non-biologic immunomodulators (examples cited include apremilast, tofacitinib, baricitinib, and upadacitinib), and similar concurrent-biologic restrictions are applied for guselkumab across dermatologic and GI indications.

The policy reiterates that use of JAK inhibitors in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants is considered clinically inappropriate and is not recommended. Requests proposing such combination therapy are subject to non-approval per the documented criteria.

Coverage is contingent on meeting the specific prior-trial and indication requirements for each agent. The policy makes clear that therapy without documentation of required prior trials or without meeting the indication-specific criteria (severity measures, specialty prescriber, or prior failure of specified agents) is not consistent with the coverage criteria and may be considered not medically necessary.

Requests for guselkumab will be reviewed against the listed criteria and may be denied when the member is receiving guselkumab in combination with another biologic agent or a listed non-biologic immunomodulator (for example, apremilast, tofacitinib, baricitinib, or upadacitinib). The approval language explicitly requires that guselkumab not be used concurrently with these agents.

Coding and Dosing Thresholds

Medication listing (no billing codes in this extract)mixed

no codes listed

Document provides medication names, indications and limits but does not list CPT/HCPCS/NDC codes in this section.

Psoriasis severity criteria — inv-36: BSA ≥10% OR PASI ≥10 OR incapacitating plaque location

Psoriasis severity criteriaBody surface area (BSA) ≥ 10% OR Psoriasis Area and Severity Index (PASI) score ≥ 10 OR incapacitation due to plaque location (for example, head and neck, palms, soles, or genitalia)

Required disease durationSymptoms present ≥ 6 months where specified (eg, for IL‑23 and related agents)

Prior therapy trialsDocumentation of inadequate response (or not candidate) to topical, systemic, and/or phototherapy trials as specified (commonly 3‑month minimums)

Canakinumab dosing thresholds — inv-37

Canakinumab dosing — adults/large childrenWeight > 40 kg: 150 mg every 8 weeks (variable by indication; some indications list 150 mg every 4 weeks with possible escalation)

Canakinumab dosing — pediatric/weight‑basedWeight ≥ 15 kg and < 40 kg: 2 mg/kg every 8 weeks (can increase to 3 mg/kg for inadequate response)

Dose escalation guidanceFor certain indications and inadequate response, doses may be increased (examples: up to 3 mg/kg in children or up to 300 mg every 4 weeks for some adult indications)

Body Surface Area (BSA) / PASI — inv-38

BSA thresholdBody surface area (BSA) ≥ 10%

PASI thresholdPsoriasis Area and Severity Index (PASI) score ≥ 10

ApplicationUsed as a disease‑severity threshold for multiple psoriasis agents (eg, Ilumya, Sotyktu where applicable)

Weight bands for ustekinumab and others — inv-39

Adult weight bands (ustekinumab example)Weight <60 kg, 60–100 kg, and >100 kg dosing/quantity distinctions apply (IV induction then maintenance SC dosing at weight‑based amounts)

Pediatric weight bandsPediatric dosing frequently uses bands such as 15–40 kg with mg/kg dosing or specific syringe counts per weight band

Implication for authorizationApproval and quantity limits reference these weight bands; prescriber must document weight for dosing verification

Body surface area / PASI — inv-40

BSA ≥ 10% OR PASI ≥ 10For plaque psoriasis, moderate‑to‑severe disease defined as BSA ≥ 10% OR PASI ≥ 10 OR incapacitation due to plaque location

Therapy duration requirementMany psoriasis agent entries require disease duration ≥ 6 months where noted

Prior trial expectationsDocumentation of failed topical, systemic, and/or phototherapy trials (commonly 3 months each) when specified

Weight for pediatric guselkumab — inv-41

Pediatric weight threshold for guselkumabEligible pediatric members for guselkumab are ≥ 6 years of age and weighing ≥ 40 kg

Adult dosing noteGuselkumab dosing for adults is 100 mg SC at weeks 0 and 4 then every 8 weeks; weight ≥40 kg is an eligibility threshold for pediatric dosing

Documentation requirementPrescriber must document age and weight to confirm appropriate pediatric dosing band

EDSS — inv-42

EDSS baseline requirement for inebilizumabBaseline Expanded Disability Status Scale (EDSS) score must be ≤ 8

Context of useRequired as part of initial documentation for Uplizna (inebilizumab) in NMOSD approvals

Related documentationPrescriber must also document baseline relapse history and meet other NMOSD criteria (eg, AQP4 positivity)

MG-ADL score — inv-43

MG‑ADL severity thresholdsMyasthenia Gravis-Activities of Daily Living (MG‑ADL) score 6–10 with >50% from non‑ocular items, OR MG‑ADL ≥ 11

MGFA class requirementMGFA clinical classification class II–IVb is required in conjunction with MG‑ADL thresholds for inebilizumab in gMG

Prior therapy requirementDocumentation of inadequate response to at least two immunosuppressive therapies (or alternative combos) is required

Provider Actions, Prior Authorization & Documentation

Documentation Required

Provider Actions & Required Documentation (high‑level)

Many products in this appendix require prior authorization and specific supporting documentation. For pediatric approvals, include weight-based induction and maintenance dosing. For biologics and targeted therapies (e.g., guselkumab, vedolizumab, inebilizumab, tofacitinib), document prior trials, failures, contraindications, prescriber specialty, and any required screening/attestations.

Pediatric dosing: Document weight-based induction and maintenance doses for all pediatric requests (include weight, dose, schedule, and dates of administration).
Guselkumab (PsA/UC/Crohn’s): For approvals in psoriatic arthritis, ulcerative colitis, or Crohn’s disease, include disease‑specific induction/maintenance dosing, documentation of trials/failures of conventional agents (e.g., azathioprine, 6‑mercaptopurine, corticosteroids), and confirm member is not receiving guselkumab in combination with another biologic or a non‑biologic immunomodulator (e.g., upadacitinib).
Tofacitinib (Xeljanz): Prior authorization requires documentation of trial and failure (or contraindication/intolerance) to methotrexate plus at least one other DMARD (e.g., sulfasalazine, hydroxychloroquine, minocycline) and trial and failure or intolerance to TNF blocker(s) where indicated (RA, PsA, JIA, UC).
Vedolizumab (Entyvio): Document trial and failure of a compliant corticosteroid regimen (oral or IV as appropriate), trial and failure of azathioprine or mercaptopurine for three consecutive months, AND trial and failure of parenteral methotrexate for three consecutive months for Crohn’s or ulcerative colitis as applicable.
Infliximab products: A trial and failure of infliximab (generic Remicade) is required prior to approval of other infliximab biosimilars/products unless contraindicated or documented intolerance.
Step therapy/Trial-failure requirements: Many agents require step therapy including trial and failure of preferred TNF‑alpha inhibitor or conventional agents (aminosalicylates, corticosteroids, immunomodulators) prior to approval of non‑preferred biologics or newer agents. Document duration and adherence to prior regimens.
Specialty-prescribing: When specialty prescriber consultation is required (for example, rheumatologist, dermatologist, neurologist, gastroenterologist), include the consultant’s name, specialty, consultation date, and relevant notes supporting the request.
Diagnosis confirmation: Provide confirmatory diagnostic evidence when specified (for example, seropositivity for AQP4 IgG and core clinical characteristics for NMOSD; MG‑ADL, MGFA class for myasthenia gravis; biopsy/genetic testing or GPP severity scores for pustular psoriasis).
Required clinical documentation: Include baseline disease severity measures (e.g., PASI, BSA for psoriasis; EDSS and relapse history for NMOSD; MG‑ADL and MGFA for myasthenia gravis), prior therapy dates/doses, and objective lab/imaging when applicable.
Required documentation for inebilizumab (Uplizna): Prescriber must attest that HBV and TB screening occurred prior to initiation and that member does not have an active infection; include documentation of relapse history (one or more relapses requiring rescue therapy in prior 12 months OR two or more relapses in prior 2 years) and baseline EDSS score (≤ 8) and baseline relapse documentation.
Required documentation for myasthenia gravis: Must be prescribed by or in consultation with a neurologist/MG specialist; include MG‑ADL score (6–10 with >50% non‑ocular items or ≥11), MGFA clinical classification (II–IVb), and documentation of inadequate response to at least two immunosuppressive therapies (or alternative pathway per criteria).
Combination therapy exclusion: Requests may be denied if member is receiving the requested product in combination with another biologic or prohibited non‑biologic immunomodulator unless combination is specifically allowed by the FDA indication and documented rationale is provided.
Infection screening and concomitant therapy: For agents with infection risk (for example, inebilizumab, other B‑cell depleting or immunosuppressive therapies), prescriber must attest to HBV and TB screening and absence of active infection; deny if screening/attestation is not documented or if active infection is present.
Failure to meet trial-of-therapy requirements: Requests missing required prior trials (for example, methotrexate, azathioprine/mercaptopurine, infliximab/Remicade, appropriate corticosteroid regimens, or preferred TNF agents) or lacking documentation of inadequate response, intolerance, or contraindication may be denied.

Step Therapy

Step Therapy and Prior Therapy Requirements

Prior authorization is required for many appendix products and approvals depend on meeting step‑therapy and trial/failure criteria. Provide explicit prior therapy timelines, doses, responses, and reason for discontinuation (lack of efficacy, intolerance, or contraindication).

Step therapy: Document trials of required prior agents in sequence, including durations (e.g., azathioprine/mercaptopurine for ≥3 months; corticosteroids per indication; trial of a preferred TNF‑alpha inhibitor when required).
Vedolizumab specific: For Crohn’s and UC, include documentation of trial and failure of oral (or IV if indicated) corticosteroids, azathioprine/mercaptopurine for 3 months, and parenteral methotrexate for 3 months; failure must be described (no response, loss of response, or intolerance).
Guselkumab (UC/CD): For GI indications, document failure of one conventional agent (e.g., 6‑MP, azathioprine, mesalamine, corticosteroids) for at least 3 months where specified; for PsA/psoriasis, document trials of topical, phototherapy, systemic agents and preferred TNF where required.
Tofacitinib (Xeljanz): For RA/PsA/JIA/UC, include prior DMARD (methotrexate plus one other DMARD) and prior TNF blocker failure or intolerance documentation as applicable.

Denial Risk

Denial Risks & Specialty Documentation

Denial risk increases when required specialty prescriber input, diagnosis confirmation, or specific attestations are missing. Confirm all required attestations and specialty consultations are present before submission.

Specialty prescriber and consultation: Where required (e.g., rheumatology for abatacept, dermatology for Spevigo/Stelara guidance, neurology for Uplizna and myasthenia gravis), include prescriber specialty and consultation notes.
Indication/diagnosis mismatch: Prescriptions outside the specified indication or without required clinical presentation (for example, Spevigo requests not for GPP flares) can be denied.
Documentation completeness: Missing baseline scores (PASI, BSA, EDSS, MG‑ADL/MGFA), missing prior trial dates/doses, or absent infection screening attestations (HBV/TB) are common causes for denial.
Infliximab step requirement: Requests for infliximab biosimilars/products require prior trial and documented failure of infliximab (generic Remicade) unless contraindicated.

Prior Authorization

Provider Submission Checklist (practical)

Actionable checklist for submission to maximize approval likelihood: include specialty consult, confirmatory diagnostics, prior therapy details, pediatric weight/dosing, infection screening attestations, and statements about lack of concomitant prohibited therapies.

Checklist: Specialty prescriber name/specialty, diagnosis confirmation (labs/antibodies/biopsy/PGA/PASI/MG‑ADL/EDSS as applicable), complete prior therapy history with dates/doses/duration and reason for discontinuation, pediatric weight and planned dosing schedule, HBV and TB screening attestations where required, and statement that the member is not receiving prohibited concomitant biologic or immunomodulator therapy.
Guselkumab combination exclusion: Explicitly state member is not on another biologic or specified immunomodulator when submitting for psoriasis, PsA, UC, or Crohn’s.
Inebilizumab (Uplizna): Include relapse history, baseline EDSS, HBV/TB screening attestation, and prescriber attestations re: concomitant therapies and contraindicated combinations (complement inhibitors or anti‑CD20 agents).
Myasthenia gravis: Include neurologist consultation, MG‑ADL and MGFA scores, and documentation of prior immunosuppressive therapy trials and outcomes.

Background and Scope

This appendix lists FDA‑approved indications and quantity limits for cytokine and CAM antagonist agents (biologics, biosimilars, and JAK inhibitors). It also defines utilization management expectations used for Anthem HealthKeepers Medicaid in Virginia, including prior authorization via the Routine PDL, indication-specific diagnostic confirmation (for example, AQP4 seropositivity for NMOSD), quantity limits per product prescribing information, and combination-therapy exclusions that affect coverage determinations.

Definitions and Abbreviations

Routine PDL — inv-70

Routine PDL pathwayAuthorization pathway commonly applied across appendix entries; many products require placement on the Routine Preferred Drug List (Routine PDL) for approval

Prior authorization expectationProducts in the appendix require prior authorization with documentation of FDA indication and required prior therapy trials where specified

Used across specialtiesRoutine PDL applies to dermatology, rheumatology, gastroenterology, and neurology indications listed in the appendix

Confirmed NMOSD diagnosis — inv-71

NMOSD confirmation — serologyMember must be seropositive for aquaporin‑4 (AQP4) IgG antibodies

Core clinical characteristicMember must have at least one core clinical characteristic (eg, optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy/diencephalic syndrome with typical MRI lesions, or symptomatic cerebral syndrome with NMOSD‑typical brain lesions)

Exclude alternative diagnosesAlternative diagnoses (eg, multiple sclerosis, sarcoidosis, cancer, chronic infection) must be excluded

Routine PDL — inv-72

Routine PDL placementPlacement on the Routine Preferred Drug List (Routine PDL) is a repeated criterion for approval across entries

Effect on authorizationRoutine PDL requirement often triggers prior‑authorization review and documentation of prior trials/failures

Applies to multiple agentsReferenced for biologics, biosimilars, JAK inhibitors, and similar agents in the appendix

Quantity limit per PI — inv-73

Quantity limit per PI definitionQuantity limits are specified per the product prescribing information (PI), often expressed per induction/maintenance intervals or per 28/30 days

Common expressionLimits are frequently expressed as syringe/vial counts per 28 days or specified induction vs maintenance schedules

Used to enforce dosingAuthorization and refill quantity checks reference these PI limits for approvals

Sotyktu dosing — inv-74

Sotyktu dosingDeucravacitinib 6 mg orally once daily; 1 tablet per day (30 tablets per 30 days)

Administration routeOral dosing with or without food

Authorization noteRoutine PDL and specialist prescribing/consultation often required per product criteria

Spevigo acute dosing — inv-75

Spesolimab acute dosingSingle 900 mg intravenous infusion once; may be given again if symptoms persist after one week

IndicationTreatment of generalized pustular psoriasis (GPP) flares in members ≥12 years and ≥40 kg

Authorization requirementRoutine PDL and specialist prescriber consultation required per criteria

PASI / BSA criteria — inv-76

PASI/BSA criteria for plaque psoriasisModerate‑to‑severe plaque psoriasis defined as BSA ≥ 10% OR PASI ≥ 10 OR incapacitating plaque location; often requires ≥ 6 months disease duration where noted

Prior therapy trials requiredMany agents require documented inadequate response to topical (≥3 months), systemic (≥3 months), and phototherapy (≥3 months) trials when specified

Not used in combinationSeveral agents require that member is not receiving combination therapy with another biologic or specified immunomodulator

EDSS / MG-ADL / MGFA — inv-77

EDSS definition and thresholdEDSS = Expanded Disability Status Scale; baseline EDSS score requirement ≤ 8 for inebilizumab (Uplizna) in NMOSD

MG‑ADL and MGFA useMG‑ADL and MGFA are clinical scales used to document myasthenia gravis severity for authorization decisions

Documentation expectationsPrescribers must attest to infection screening (HBV/TB) and provide baseline scores/relapse history where required

Policy Summary

PayerAnthem

PolicyCytokine and CAM Antagonist Appendix A — Coverage and Utilization Management

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionPlace agents on the Routine PDL and document required prior therapy trials and weight- or indication-specific dosing to support prior authorization.

SourceLink

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