Viva Health secukinumab Prior Auth & Coverage

Initial Therapy — Covered when ALL of the following universal criteria AND the indication-specific criteria are met

Covered when ALL of the following universal criteria AND the indication-specific criteria are met

Universal requirements: Member age meets indication-specific minimum; physician documented baseline objective disease severity using an objective measure/tool; HBV screening completed prior to initiation; member is up to date with age-appropriate vaccinations; latent TB screening prior to initiation and ongoing TB monitoring during treatment; member will not receive live vaccines during therapy; member does not have an active infection; member is not on concurrent biologic or targeted synthetic therapy

Applies to all indications unless otherwise specified

Plaque Psoriasis initial criteria: Member is at least 6 years of age; documented moderate-to-severe plaque psoriasis for ≥6 months with ≥3% BSA involvement OR PASI ≥10 OR incapacitating location/impact or intractable pruritus; and prior inadequate response (or not a candidate) to a 4-week topical trial, a 3-month trial of at least one non-biologic systemic agent, and a 3-month trial of phototherapy unless member is already established on biologic/targeted therapy or has >10% BSA (in which case prior trials are not required)

Prior trials not required for members established on biologic/targeted therapy or >10% BSA

Adult Psoriatic Arthritis initial criteria: Documented moderate-to-severe active PsA; for predominantly axial disease or enthesitis: failure of ≥4-week trial of one NSAID unless contraindicated; for peripheral arthritis or dactylitis: failure of ≥3-month trial of one csDMARD unless contraindicated; OR member already established on biologic/targeted therapy; may be used alone or with methotrexate

Members new to subcutaneous therapy should initiate at 150 mg before increasing unless coexistent plaque psoriasis

Juvenile Psoriatic Arthritis initial criteria: Member is at least 2 years of age; documented moderate-to-severe active polyarticular disease; prior 1-month trial and failure (unless contraindicated/intolerant) of NSAID OR a csDMARD OR member already established on biologic/targeted therapy; may be used alone or with methotrexate

Ankylosing Spondylitis initial criteria: Member is at least 12 years of age; documented active disease; failure of at least two NSAIDs over a total of 4 weeks unless contraindicated; OR member already established on biologic/targeted therapy

New subcutaneous users should start at 150 mg before increasing

Non-radiographic Axial Spondyloarthritis initial criteria: Objective signs of inflammation (elevated CRP above ULN and/or sacroiliitis on MRI), absence of definitive radiographic sacroiliac structural damage, documented active disease; failure of at least two NSAIDs unless contraindicated; OR member already established on biologic/targeted therapy

Enthesitis-Related Arthritis initial criteria: Member is 4 to <18 years of age; documented moderate-to-severe active polyarticular disease; prior 1-month trial and failure (unless contraindicated/intolerant) of NSAID OR oral csDMARD; OR member already established on biologic/targeted therapy

Pediatric weight-tier dosing applies per dosing section

Hidradenitis Suppurativa initial criteria: Member is at least 12 years of age; moderate-to-severe HS; at least 5 inflammatory lesions (abscesses and/or inflammatory nodules); lesions involve at least 2 distinct anatomic areas

Continuation/Renewal Therapy — Renewal covered when ALL of the following are met

Renewal covered when ALL of the following are met

Renewal universal: Member continues to meet the universal and indication-specific criteria and has no unacceptable toxicity to the drug (examples: new/worsening inflammatory bowel disease, severe infections including TB or HBV reactivation, hypersensitivity reactions)

Absence of unacceptable toxicity required for renewal

Plaque Psoriasis renewal response: Documented improvement in signs/symptoms compared to baseline such as redness, thickness, scaliness, and reduction in BSA to ≤1% and/or PASI ≤3 or PGA ≤1

Adult Psoriatic Arthritis renewal response: Improvement in tender/swollen joint counts, reduction in CRP, improvement in patient global assessment or imaging, or improvement on a disease activity scoring tool; dose escalation may be considered case-by-case if member showed initial response by week 8 then loss of response and has received required prior dosing

Dose escalation requires initial improvement and appropriate prior dosing (loading + ≥1 maintenance or ≥2 maintenance doses)

Response-based coverage — Covered when evidence of disease response is documented for the relevant indication.

Covered when evidence of disease response is documented for the relevant indication.

General response requirements: For each treated indication, clinical response must be demonstrated by improvement in signs/symptoms from baseline using specified measures; examples include ASDAS, BASDAI, ASAS40 for axial disease; JADAS or ACR‑Pedi for juvenile indications; HiSCR or ≥50% reduction in abscess/inflammatory nodule count for HSsee children nodes

Documentation should include baseline and follow-up measures per indication

HS escalation (adult) — Coverage for HS dose escalation (to up to 300 mg every 2 weeks) is allowed only when ALL of the following are met:

Coverage for HS dose escalation (to up to 300 mg every 2 weeks) is allowed only when ALL of the following are met:

HS dose escalation criteria: Member is an adult; has shown an initial improvement/response to secukinumab; responded by treatment week 8 with subsequent loss of response or continued active disease; and has received the required loading and maintenance dosing (either loading plus at least one maintenance dose at the specified dose/interval, or at least two maintenance doses at the specified dose/interval)

Dose escalation to 300 mg every 2 weeks is considered upon clinical review on a case-by-case basis

Loading dose and maintenance dosing options — Coverage allows administration with or without loading dose and may permit increasing to 300 mg every 4 weeks for select adult indications

Coverage allows administration with or without loading dose and may permit increasing to 300 mg every 4 weeks for select adult indications if active disease persists.

Loading dose options: For certain adult indications (e.g., PsA, AS, nr‑axSpA), secukinumab may be administered with or without a loading dose; both regimens are described for coverage and dosing verification

If active disease continues, increasing to 300 mg every 4 weeks may be considered as described in renewal/dose escalation criteria

Concurrent use of secukinumab with any other biologic therapy or targeted synthetic therapy is not permitted. This is a universal requirement that must be met prior to initiation and maintained during treatment; failure to confirm absence of concurrent biologic or targeted synthetic therapy may result in denial or non-renewal of prior authorization.

Formulation and route are strictly defined: solution in vials (Cosentyx 125 mg/5 mL) is intended for intravenous use in adult members only; UnoReady pens, Sensoready pens, and prefilled syringes are for subcutaneous use only. Prior authorization requests should specify the formulation requested (IV vs SQ) and billing should use the appropriate HCPCS/NDC identifiers for the selected presentation.

Use of secukinumab is contraindicated in the presence of an active infection, including clinically important localized infections. Members must be evaluated and screened for infections (including latent TB and viral hepatitis as required) prior to initiation and monitored during therapy; treatment in the setting of active infection would be considered not medically necessary.

For intravenous dosing in adults receiving the 1.75 mg/kg maintenance regimen (nr-axSpA/AS context), total IV doses exceeding 300 mg per infusion are not recommended. Additionally, intravenous infusion products and administration are restricted to adult members and must be administered by healthcare professionals in a healthcare setting; exceeding formulation-specific dosing guidance or using IV presentations in pediatric members is outside the stated recommendations.

Coding, Dosing Units, and Diagnosis Codes

Max Units (per dose and over time)mixed

Enthesitis-Related Arthritis (ERA)	Loading: 150 mg at weeks 0,1,2,3,4; Maintenance: 150 mg every 28 days (subcutaneous)
Plaque Psoriasis and Adult Psoriatic Arthritis with co-existent Plaque Psoriasis	Loading: 300 mg at weeks 0,1,2,3,4; Maintenance: 300 mg every 28 days (subcutaneous)
Psoriatic Arthritis and Ankylosing Spondylitis	Subcutaneous: Loading 150 mg weeks 0-4; Maintenance 300 mg every 28 days. Intravenous: Loading 750 billable units at week 0; Maintenance 375 billable units every 28 days.
Non-Radiographic Axial Spondyloarthritis	Subcutaneous: Loading 150 mg weeks 0-4; Maintenance 150 mg every 28 days. Intravenous: Loading 750 billable units at week 0; Maintenance 375 billable units every 28 days.
Hidradenitis Suppurativa	Loading: 300 mg at weeks 0,1,2,3,4; Maintenance: 300 mg every 28 days (may increase to 300 mg every 2 weeks if inadequate response)

HCPCS CodesHCPCS

J3247	Injection, secukinumab, intravenous, 1 mg; IV formulation ONLY
J3590	Unclassified biologics (SQ formulation ONLY)
C9399	Unclassified drugs or biologicals (SQ formulation ONLY)

Product identifiers / packaging (NDC placeholders)NDC

00078-1070-xx	Cosentyx 300 mg/2 mL single-dose UnoReady Pen; single-dose prefilled syringe 300 mg/2 mL (carton of 1)
00078-0639-xx	Cosentyx 150 mg/mL single-dose Sensoready Pen; single-dose prefilled syringe 150 mg/mL (carton of 1 or 2)
00078-1056-xx	Cosentyx 75 mg/0.5 mL single-dose prefilled syringe (pediatric <50 kg; carton of 1)
00078-1168-xx	Cosentyx 125 mg/5 mL solution in a single-dose vial for dilution prior to IV injection (carton of 1)

Subcutaneous ICD-10 Codes (partial)ICD-10

L40.0	Psoriasis vulgaris
L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.54	Psoriatic juvenile arthropathy
L40.59	Other psoriatic arthropathy
L73.2	Hidradenitis suppurativa
M08.80	Other juvenile arthritis, unspecified site
M08.811	Other juvenile arthritis, right shoulder

1–10 of 18

1/2

Subcutaneous ICD-10 Codes (continued)ICD-10

M08.841	Other juvenile arthritis, right hand
M08.842	Other juvenile arthritis, left hand
M08.849	Other juvenile arthritis, unspecified hand
M08.851	Other juvenile arthritis, right hip
M08.852	Other juvenile arthritis, left hip
M08.859	Other juvenile arthritis, unspecified hip
M08.861	Other juvenile arthritis, right knee
M08.862	Other juvenile arthritis, left knee
M08.869	Other juvenile arthritis, unspecified knee
M08.871	Other juvenile arthritis, right ankle and foot

1–10 of 16

1/2

Subcutaneous ICD-10 Codes (continued)ICD-10

M08.911	Juvenile arthritis, unspecified, right shoulder
M08.912	Juvenile arthritis, unspecified, left shoulder
M08.919	Juvenile arthritis, unspecified, unspecified shoulder
M08.921	Juvenile arthritis, unspecified, right elbow
M08.922	Juvenile arthritis, unspecified, left elbow
M08.929	Juvenile arthritis, unspecified, unspecified elbow
M08.931	Juvenile arthritis, unspecified, right wrist
M08.932	Juvenile arthritis, unspecified, left wrist
M08.939	Juvenile arthritis, unspecified, unspecified wrist
M08.941	Juvenile arthritis, unspecified, right hand

1–10 of 12

1/2

Subcutaneous ICD-10 Codes / Axial spondyloarthritis (continued)ICD-10

M08.951	Juvenile arthritis, unspecified, right hip
M08.952	Juvenile arthritis, unspecified, left hip
M08.959	Juvenile arthritis, unspecified, unspecified hip
M08.961	Juvenile arthritis, unspecified, right knee
M08.962	Juvenile arthritis, unspecified, left knee
M08.969	Juvenile arthritis, unspecified, unspecified knee
M08.971	Juvenile arthritis, unspecified, right ankle and foot
M08.972	Juvenile arthritis, unspecified, left ankle and foot
M08.979	Juvenile arthritis, unspecified, unspecified ankle and foot
M08.98	Juvenile arthritis, unspecified, vertebrae

1–10 of 15

1/2

Subcutaneous ICD-10 Codes (continued)ICD-10

M45.4	Ankylosing spondylitis of thoracic region
M45.5	Ankylosing spondylitis of thoracolumbar region
M45.6	Ankylosing spondylitis of lumbar region
M45.7	Ankylosing spondylitis of lumbosacral region
M45.8	Ankylosing spondylitis of sacral and sacrococcygeal region
M45.9	Ankylosing spondylitis of unspecified sites in spine
M45.AB	Non-radiographic axial spondyloarthritis of multiple sites in spine
M45.A0	Non-radiographic axial spondyloarthritis of unspecified sites in spine
M45.A1	Non-radiographic axial spondyloarthritis of occipito-atlanto-axial region
M45.A2	Non-radiographic axial spondyloarthritis of cervical region

1–10 of 15

1/2

Intravenous ICD-10 CodesICD-10Covered

L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.54	Psoriatic juvenile arthropathy
L40.59	Other psoriatic arthropathy

Intravenous ICD-10 Codes (continued)ICD-10

M45.0	Ankylosing spondylitis of multiple sites in spine
M45.1	Ankylosing spondylitis of occipito-atlanto-axial region
M45.2	Ankylosing spondylitis of cervical region
M45.3	Ankylosing spondylitis of cervicothoracic region
M45.4	Ankylosing spondylitis of thoracic region
M45.5	Ankylosing spondylitis of thoracolumbar region

Medicare Part B covered diagnosis codesICD-10

N/A	Medicare Part B Covered Diagnosis Codes: N/A

Provider Requirements, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required and Billing/Formulation Guidance

Prior authorization is required. Initial approvals are for 180 days (6 months); renewals are for 365 days (12 months). The PA must specify the formulation requested (intravenous vs subcutaneous) and the appropriate billing code(s) for the formulation being billed.

Prior authorization initial length: 180 days; renewal length: 365 days.
PA must specify formulation (IV vs SQ) on the request.
HCPCS codes: J3247 for IV secukinumab (1 mg units); J3590 or C9399 may be used for SQ formulations as unclassified biologic/drug codes — ensure correct billing pathway per payer guidance.

Step Therapy

Dose Escalation / Step-up Requirements

Dose escalation (step-up) is conditionally permitted for certain indications but requires documentation of prior response and dosing history.

Hidradenitis Suppurativa (HS) adults: standard maintenance 300 mg every 4 weeks; if inadequate response, escalation to 300 mg every 2 weeks may be considered after documented initial improvement and appropriate loading/maintenance doses.
Ankylosing Spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA): if active disease persists, increasing to 300 mg every 4 weeks may be considered per criteria.
Dose-escalation requests must document: initial improvement/response, timing of response (e.g., by week 8 for HS when applicable), that loading doses and minimum maintenance dosing were given (or two maintenance doses were administered) before escalation.

Denial Risk

Potential Triggers for Denial

Potential triggers for denial include failure to meet required PA prerequisites, lack of documentation of baseline disease severity, missing required screening or vaccination status, unsupported dosing escalation, and use of contraindicated concurrent therapies.

Age eligibility not met (e.g., below indication-specific minimum age).
No documented baseline objective disease severity assessment using an accepted tool (e.g., PASI, BSA, ASDAS, BASDAI, HiSCR, JADAS/ACR-Pedi where applicable).
No documented HBV screening or latent TB screening prior to initiation, or failure to confirm up-to-date age-appropriate vaccinations; live vaccines during therapy.
Concurrent treatment with another biologic or targeted synthetic therapy without justification.
Dose escalation for HS or other indications without documentation of initial response, required prior doses, or appropriate timing as specified in the policy.

Note

NQTL and Utilization Management Note

Utilization management considerations: prior authorization is applied due to drug cost as indicated by the NQTL assessment. The utilization management NQTL is intended to be applied comparably across MH/SUD and M/S prescription drugs and should not be more stringent for MH/SUD.

NQTL checklist identified cost of drug as a reason to consider PA.
Apply utilization management (PA) comparably and not more stringently between MH/SUD and M/S prescription drugs.

Billing Rule

Billing Code and Formulation PA Requirements

Billing providers must indicate which formulation is being requested on the PA and bill with the appropriate HCPCS or unclassified codes. Use the IV-specific HCPCS for intravenous administration and the payer’s instructed unclassified codes for subcutaneous formulations.

IV formulation (vial solution) — bill J3247 (Injection, secukinumab, intravenous, 1 mg).
SQ formulation (pens, prefilled syringes) — bill using payer-designated unclassified codes such as J3590 or C9399 per payer billing guidance; include NDC and product description on claim when required.
Note: Only vials/solution are for intravenous use (adult IV only); UnoReady/Sensoready pens and prefilled syringes are SQ only — ensure code chosen matches the actual product/formulation administered.

Definitions and Clinical Measures

Moderate to severe plaque psoriasis — initial documentation and prior therapy

Minimum disease durationDocumented for at least 6 months

Activity threshold≥3% BSA involvement OR PASI ≥10 OR disabling location/impact

Prior therapyPrior inadequate response to topical, non-biologic systemic, and phototherapy required unless exempt (established biologic or >10% BSA)

Non-radiographic axial spondyloarthritis (nr-axSpA)

Objective inflammationElevation of CRP above ULN and/or sacroiliitis on MRI

Radiographic requirementAbsence of definitive radiographic structural damage of sacroiliac joints

Prior therapy requirementFailure of at least two NSAIDs unless contraindicated (or already on biologic/targeted therapy)

ASDAS-MI — Ankylosing Spondylitis Disease Activity Score - Major Improvement

ASDAS-MI exampleImprovement of ≥2.0 in ASDAS and/or reaching the lowest possible ASDAS (Major Improvement)

Other measuresASDAS improvement ≥1.1, BASDAI improvement ≥2, or ASAS40 response may be used

UseMeasures used to document disease response for renewal and treatment decisions

HiSCR — Hidradenitis Suppurativa Clinical Response

HiSCR definition≥50% reduction in abscess and inflammatory nodule count with no increase in abscesses or draining fistulas compared with baseline

ContextUsed to document response in Hidradenitis Suppurativa for renewal and escalation decisions

Alternate responseReduction in skin pain or total abscess/inflammatory nodule count may also indicate response

ACR-Pedi / JADAS — Pediatric composite response measures

ACR‑Pedi 30≥30% improvement in 3 of 6 variables (example threshold for pediatric response)

Tool examplesJADAS or ACR‑Pedi composite scores used to document improvement in juvenile arthritis/ERA

ContextRequired documentation for renewal to show clinical response compared to baseline

Non-Quantitative Treatment Limitations (NQTLs)

DefinitionMethods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan

ExamplesUtilization review, prior authorization, and other administrative processes

Policy applicationCost of the drug was identified as a factor considered when applying prior authorization (NQTL checklist)

Policy Revision History

2026-05-05policy_reviewLatest

Policy last reviewed and updated (Last Review Date: 05/05/2026); document reflects multiple prior review dates and current policy status.

2015-02-24policy_origin

Policy originated (Date of Origin: 02/24/2015).

2016-01-01review

Documented date reviewed (01/2016) included in policy review history.

2017-01-01review

Documented date reviewed (01/2017) included in policy review history.

2018-01-01review

Documented date reviewed (01/2018) included in policy review history.

2018-08-01review

Documented date reviewed (08/2018) included in policy review history.

2019-08-01review

Documented date reviewed (08/2019) included in policy review history.

2020-03-01review

Documented date reviewed (03/2020) included in policy review history.

2020-07-01review

Documented date reviewed (07/2020) included in policy review history.

2021-07-01review

Documented date reviewed (07/2021) included in policy review history.

2021-08-01review

Documented date reviewed (08/2021) included in policy review history.

2022-01-01review

Documented date reviewed (01/2022) included in policy review history.

2022-08-01review

Documented date reviewed (08/2022) included in policy review history.

2023-06-01review

Documented date reviewed (06/2023) included in policy review history.

2023-08-01review

Documented date reviewed (08/2023) included in policy review history.

2023-11-01review

Documented date reviewed (11/2023) included in policy review history.

2023-12-01review

Documented date reviewed (12/2023) included in policy review history.

2024-08-01review

Documented date reviewed (08/2024) included in policy review history.

2025-03-01review

Documented date reviewed (03/2025) included in policy review history.

2026-03-01review

Documented date reviewed (03/2026) included in policy review history.

2026-04-01review

Documented date reviewed (04/2026) included in policy review history.

OpenPayer

Cosentyx (secukinumab) prior authorization and coverage

Coverage Criteria for Secukinumab (Cosentyx)

Coding, Dosing Units, and Diagnosis Codes

Provider Requirements, Prior Authorization, and Billing Guidance

Background and Indications

Definitions and Clinical Measures

Policy Revision History