Blue Cross Blue Shield - Iowa Cosentyx Prior Auth

Coverage Criteria

Plaque psoriasis (Initial Therapy)

Covered when ALL of the following are met:

Plaque psoriasis initial approval: Member is age 6 years or older and is a candidate for systemic therapy or phototherapy; authorization of 12 months (subcutaneous formulations only) may be granted when the member has previously received a biologic or targeted synthetic drug for plaque psoriasis OR when any of the following apply: crucial body areas are affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); at least 10% body surface area (BSA) is affected; OR at least 3% BSA is affected AND the member has had inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin, or has a clinical reason to avoid those agents.

Psoriatic arthritis (Initial Therapy)

Covered when ALL of the following are met:

Psoriatic arthritis initial approval: Member meets at least ONE of: (a) documented inadequate response or intolerable adverse event to each of Avsola, Inflectra, Simponi Aria, and Skyrizi; OR (b) documented clinical reason to avoid TNF inhibitors AND documented inadequate response or intolerable adverse event with Skyrizi. AND member has a documented reason where self-administration is not appropriate (patient or caregiver unable to perform subcutaneous injections with proper technique OR unable to adhere to the prescribed dosing regimen).

Ankylosing spondylitis (Initial Therapy)

Covered when ALL of the following are met:

Ankylosing spondylitis initial approval: Member meets at least ONE of: (a) documented inadequate response or intolerable adverse event with each of Avsola, Inflectra, and Simponi Aria; OR (b) documented clinical reason to avoid TNF inhibitors. AND member has a documented reason where self-administration is not appropriate (patient or caregiver unable to perform subcutaneous injections with proper technique OR unable to adhere to the prescribed dosing regimen).

Non-radiographic axial spondyloarthritis (Initial Therapy)

Covered when ALL of the following are met:

nr-axSpA initial approval: Member has a documented reason where self-administration is not appropriate due to inability of the patient or caregiver to perform subcutaneous injections with proper technique or inability to adhere to the prescribed dosing regimen.

Enthesitis-related arthritis (Initial Therapy)

Covered when ALL of the following are met:

ERA initial approval: Member is age 4 years or older with active disease demonstrated by three active joints and at least one site of active enthesitis, AND member has either an inadequate response or intolerance to NSAIDs, sulfasalazine, or methotrexate, OR has an intolerance or contraindication to NSAIDs, sulfasalazine, or methotrexate.

Hidradenitis suppurativa (Initial Therapy)

Covered when ANY of the following are met:

HS initial approval: Member has experienced an inadequate response to an oral antibiotic used for hidradenitis suppurativa for at least 90 days; OR member has an intolerance or contraindication to oral antibiotics used for HS.90 days

Continuation Therapy

Covered when ALL of the following are met:

Continuation therapy general: Member currently using the requested medication may receive continuation authorization when documentation demonstrates clinical improvement from baseline or maintenance of low disease activity as defined by indication-specific measures (e.g., decreased BSA or improvement in signs/symptoms for psoriasis; improvement in swollen/tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP for PsA; improvement in functional status, total spinal pain, or inflammation for AS/axSpA; reduction in abscess/inflammatory nodule count, pain, suppuration, or improved quality of life for HS; improvement in number of flares, joints with active arthritis, limited movement, dactylitis, or enthesitis for ERA).

Psoriatic arthritis (PsA)

Authorization of 12 months may be granted when ALL of the following are met:

PsA continuation/12 months: Member is using the requested medication for active psoriatic arthritis and achieves or maintains positive clinical response evidenced by improvement from baseline in any of: number of swollen joints; number of tender joints; dactylitis; enthesitis; axial disease; skin and/or nail involvement; functional status; C-reactive protein (CRP).

Ankylosing spondylitis (AS) and axial spondyloarthritis (axSpA)

Authorization of 12 months may be granted when ALL of the following are met:

AS/axSpA continuation/12 months: Member is using the requested medication for active ankylosing spondylitis or active axial spondyloarthritis and achieves or maintains positive clinical response evidenced by low disease activity or improvement from baseline in any of: functional status; total spinal pain; inflammation (e.g., morning stiffness).

Enthesitis-Related Arthritis (ERA)

Authorization of 12 months (Cosentyx subcutaneous formulations only) may be granted when ALL of the following are met:

ERA continuation/12 months (subcutaneous): Member is using the requested medication for enthesitis-related arthritis and achieves or maintains positive clinical response evidenced by improvement from baseline in any of: number of flares; number of joints with active arthritis; number of joints with limited movement; dactylitis; enthesitis.

Moderate to severe hidradenitis suppurativa

Authorization of 12 months (Cosentyx subcutaneous formulations only) may be granted when ALL of the following are met:

HS continuation/12 months (subcutaneous): Member is using the requested medication for moderate to severe hidradenitis suppurativa and achieves or maintains positive clinical response as evidenced by one or more of: reduction in abscess and inflammatory nodule count; reduced formation of new sinus tracts/scarring; decrease in frequency of inflammatory lesions; reduction in pain; reduction in suppuration; improvement in relapse frequency; improvement in quality of life; improvement on a disease severity assessment tool from baseline.

TB screening and concomitant therapy

Covered when ALL of the following are met:

TB screening and concomitant therapy: For persons naïve to biologic or targeted synthetic drugs, member must have documented negative TB testing (TST or IGRA) within 12 months prior to initiating therapy; if TB screening is positive, further evaluation to exclude active TB (e.g., chest x-ray) is required and latent TB must be treated prior to initiation. Member may not use the requested medication concomitantly with any other biologic or targeted synthetic drug for the same indication. Do not administer the medication to members with active TB infection.

Intravenous requests for Cosentyx (secukinumab) are subject to the plan’s preferred product requirements. When a requested indication is FDA‑approved for a preferred IV agent, the preferred products — Avsola, Inflectra, Skyrizi, and Simponi Aria — will apply and IV Cosentyx will be denied absent documentation of a clinical exception. Coverage of IV Cosentyx may be considered only when documentation demonstrates clinical circumstances that exclude the use of those preferred agents or supports prior use of a preferred product and a clinical exception.

Approval of IV Cosentyx also requires documentation that self-administration of subcutaneous Cosentyx pens or prefilled syringes by the patient or caregiver is not appropriate when the request is based on inability to self-administer (see policy for acceptable documentation).

Before initiating Cosentyx, a negative TB screening test (TST or IGRA) within 12 months is required for persons naïve to biologic or targeted synthetic therapies. If TB screening is positive, further evaluation (for example, chest x‑ray) must be completed to rule out active disease. Do not administer the requested medication to members with active tuberculosis infection. If latent TB is identified, treatment for latent tuberculosis must be started prior to initiating Cosentyx.

In addition, members may not receive Cosentyx concomitantly with any other biologic or targeted synthetic therapy for the same indication; documentation must confirm absence of concurrent biologic/targeted synthetic treatment.

Cosentyx is considered not medically necessary when the member does not meet the policy’s specified coverage criteria. This includes failure to provide required TB screening or follow-up, use in the presence of active TB infection, concomitant use with another biologic/targeted synthetic drug for the same indication, or absence of documentation that the indication‑specific clinical and prior‑therapy criteria are satisfied.

Members currently receiving Cosentyx via samples or manufacturer assistance programs must meet the same initial approval criteria to continue coverage; lack of documentation meeting the policy requirements is grounds for denial as not medically necessary.

Initial Therapy Criteria and Dosing

Initial therapy criteria

Covered when ALL of the following indication-specific initial approval criteria are met:

Initial therapy summary: See indication-specific criteria: Psoriasis (age and BSA/crucial area/treatment history stipulations), Psoriatic arthritis (failure or avoidance of listed agents and self-administration constraint), Ankylosing spondylitis (failure or avoidance of listed agents and self-administration constraint), Non-radiographic axSpA (self-administration constraint), Enthesitis-related arthritis (age >=4, active joint/enthesitis criteria and failure/intolerance to conventional agents), Hidradenitis suppurativa (inadequate response to oral antibiotics >=90 days or intolerance/contraindication).

Initial therapy and dosing

Covered when ALL of the following dosing and quantity limits are applied:

Initiation and maintenance dosing summary: Initiation and maintenance dosing and quantity limits vary by formulation, indication, age and weight (examples: PsO adult initiation 10 x 150 mg per first 28 days with maintenance 2 x 150 mg per 28 days; pediatric and weight-based regimens specified for PsO and PsA; UnoReady 300 mg pen initiation and maintenance schedules provided). For inadequate responders, consider escalation to 300 mg every 2 weeks (specified as 4 x 150 mg per 28 days or 2 x 300 mg per 28 days) where applicable. Approvals may be subject to these limits and to FDA labeling and guideline-based dosing adjustments.

Continuation Therapy Criteria

Continuation therapy criteria

Covered when ALL of the following are met:

Continuation therapy criteria summary: Continuation approvals require evidence of clinical improvement from baseline. Acceptable evidence varies by indication and may include decreased BSA or improvement in signs/symptoms for psoriasis; improvement in swollen/tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP for PsA; improvement in functional status, total spinal pain, or inflammation for AS/axSpA.

Continuation therapy

Covered when ALL of the following are met:

12-month continuation authorization: Member currently using the medication may receive 12-month authorization if there is maintenance of positive clinical response or low disease activity as defined by indication-specific measures (improvement from baseline). This includes new members currently using the medication; documentation must show maintained benefit for the requested indication.maintenance of response

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cosentyx. Submit a completed prior authorization request with all required documentation; initial requests must include chart notes or medical record documentation supporting diagnosis, affected body surface area (BSA) when applicable, prior medication history and responses (or clinical reasons to avoid), and baseline measures. Prescriber specialty requirements apply for initial approvals (see specialty list).

A completed prior authorization request form
Initial requests: chart notes documenting diagnosis, affected area(s) and BSA (if applicable), prior medications tried and response or clinical reason to avoid prior therapies
Continuation requests: chart notes documenting clinical improvement or maintenance of low disease activity (examples below)
Documented negative TB test within 12 months for biologic-naïve patients (TST or IGRA) and follow-up evaluation if positive
Documentation that self-administration (pen or prefilled syringe) is not appropriate when relevant

Procedures and Billing Codes

Procedures and billing codesmixed

C9166	Injection, secukinumab, intravenous, 1 mg (cancelled 7/1/2024)
J3247	Injection, secukinumab, intravenous, 1 mg (effective 7/1/2024)
J3490	Unclassified drugs (when specified as [Cosentyx] (secukinumab) (intravenous))
J3590	Unclassified biologics (when specified as [Cosentyx] (secukinumab) (intravenous))

Covered HCPCS/J-codesHCPCSCovered

J3247

Injection, secukinumab, intravenous, 1 mg (effective 7/1/2024)

Historic/Cancelled CodesHCPCS

C9166

Injection, secukinumab, intravenous, 1 mg (cancelled 7/1/2024)

Unclassified billing codes (when specified for Cosentyx intravenous)HCPCS

J3490	Unclassified drugs (when specified as [Cosentyx] (secukinumab) (intravenous))
J3590	Unclassified biologics (when specified as [Cosentyx] (secukinumab) (intravenous))

Dose escalation for inadequate response

Dose escalation optionIncrease to 300 mg every 2 weeks (specified equivalently as 4 x 150 mg syringes/pens per 28 days)

When to considerIf patient does not adequately respond to standard dosing

Related formulationsApplies to 150 mg syringe/pen regimens and UnoReady 300 mg pens per policy guidance

Quantity Limits and Packaging

Cosentyx prefilled syringe / SensoReady pen (75 mg, 150 mg)

Adult Psoriasis initiation10 x 150 mg syringes/pens per first 28 days

Adult Psoriasis maintenance2 x 150 mg syringes/pens per 28 days

Pediatric Psoriasis initiation<50 kg: 5 x 75 mg syringes per first 28 days; >=50 kg: 4 x 150 mg syringes/pens per first 28 days

Pediatric Psoriasis maintenance<50 kg: 1 x 75 mg syringe per 28 days; >=50 kg: 2 x 150 mg syringes/pens per 56 days

Cosentyx (150 mg) adult/indication limits

Psoriatic arthritis (adult) initiation4 x 150 mg syringes/pens per first 28 days

Step Therapy Requirements

Indication / Formulation	Step therapy requirement
Intravenous Cosentyx (IV formulation)
For IV Cosentyx requests: member must have documented inadequate response or intolerable adverse event to the preferred intravenous products Avsola, Inflectra, Simponi Aria (and Skyrizi when applicable for PsA) OR a documented clinical reason to avoid those agents before approval of IV Cosentyx for indications where the preferred products are FDA‑approved.

Appendix	Clinical reasons / examples
Appendix A: Clinical reasons to avoid TNF‑inhibitors
Examples listed include: history of demyelinating disorder; history of congestive heart failure; history of hepatitis B infection; autoantibody formation or lupus‑like syndrome; risk of lymphoma.
Appendix B: Examples of clinical reasons to avoid systemic agents (methotrexate, cyclosporine, acitretin, leflunomide)
Examples listed include: clinical diagnosis of alcohol use disorder or chronic liver disease; breastfeeding; drug interactions; risk of treatment‑related toxicity; pregnancy or planning pregnancy; significant comorbidity (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension); hypersensitivity; history of intolerance or adverse event.

Site of Care and Infusion Requirements

Note

Infusion center (IV) requests subject to preferred IV product rules; SC assumed self-administration

Intravenous formulation requests are subject to the preferred IV product requirement; subcutaneous formulations are assumed to be self‑administered unless documentation shows self‑administration is not appropriate.

If self-administration is not appropriate, document the reason (e.g., patient/caregiver unable to perform injections or unable to adhere to dosing).
IV requests will be reviewed for clinical exceptions to preferred product rules.

Biosimilar and IV Formulation Notes

Step Therapy

Preferred IV alternatives (Avsola, Inflectra, Skyrizi, Simponi Aria) apply when FDA‑approved options exist

When FDA‑approved alternative IV agents exist for the indication, the policy designates Avsola, Inflectra, Skyrizi, and Simponi Aria as preferred products that must be tried and shown inadequate or intolerable (or a documented clinical reason to avoid) before approving IV Cosentyx.

Coverage for IV Cosentyx may be granted only if a clinical exception is documented or prior use of preferred product(s) is demonstrated.

Definitions

Self-administration not appropriate

DefinitionPatient or caregiver is unable to perform subcutaneous injections with Cosentyx pen or prefilled syringe with proper technique or unable to adhere to the prescribed dosing regimen

Documentation neededChart notes must support why self-administration is not appropriate

ImplicationRequired for approval of intravenous formulation or when subcutaneous administration is not feasible

Positive clinical response / low disease activity

DefinitionImprovement from baseline in indication-specific measures (examples include number of swollen/tender joints, dactylitis, enthesitis, axial pain/morning stiffness, decreased BSA or skin/nail involvement, reduction in abscess/inflammatory nodule counts, decreased pain or suppuration, fewer relapses, improved functional status or quality of life, and reduced CRP)

Use for continuation

Background

Cosentyx (secukinumab) is covered for multiple immune‑mediated inflammatory conditions when the policy’s indication‑specific criteria and general requirements are met. The policy emphasizes appropriate patient selection aligned with FDA labeling, clinical guidelines, and prior use of preferred or alternative therapies.

For IV formulation requests the policy enforces a preferred intravenous product requirement (Avsola, Inflectra, Skyrizi, Simponi Aria) and allows IV Cosentyx only when a documented clinical exception exists. Across all indications, prior authorization is required and coverage is contingent on meeting required documentation, including TB screening and the absence of concomitant biologic or targeted synthetic therapy for the same indication.

OpenPayer

Cosentyx (secukinumab) drug coverage — prior authorization criteria

Coverage Criteria

Initial Therapy Criteria and Dosing

Continuation Therapy Criteria

Provider Actions and Documentation Requirements

Procedures and Billing Codes

Quantity Limits and Packaging

Step Therapy Requirements

Site of Care and Infusion Requirements

Biosimilar and IV Formulation Notes

Definitions

Background