Viva Health Cosentyx Prior Auth Policy Update

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

Covered when ALL of the following universal criteria are met and the relevant indication-specific criteria are met:

Universal initial criteria: Member meets age requirement (>=18 unless otherwise specified); physician has assessed baseline disease severity using an objective measure; member screened for hepatitis B virus (HBV) prior to initiating treatment; provider confirms member is up to date with age-appropriate vaccinations

Chunk 3

Universal safety criteria: Member screened for latent tuberculosis (TB) prior to initiating treatment and will receive ongoing TB monitoring; 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

Chunk 4

Plaque Psoriasis (PsO): Member >=6 years with documented moderate to severe plaque psoriasis >=6 months AND at least one of: >=3% BSA OR PASI >=10 OR incapacitating/serious emotional consequences due to location/intractable pruritus; AND member failed or is not candidate for a 4-week topical trial, a 3-month non-biologic systemic trial, and a 3-month phototherapy trial unless exceptions apply or member is established on biologic/has >10% BSABSA >=3% or PASI >=10

Chunk 5

Adult Psoriatic Arthritis (PsA): Documented moderate to severe active disease; AND either failure of a 4-week NSAID trial for predominant axial disease/enthesitis OR failure of a 3-month csDMARD trial for peripheral arthritis/dactylitis OR already established on biologic/targeted therapy; may be used alone or with methotrexate; new subcutaneous users should start at 150 mg before increasing to 300 mg unless co-existent plaque psoriasis

Chunk 6

Juvenile Psoriatic Arthritis (JPsA): Member >=2 years with documented moderate to severe active polyarticular disease; AND failure of at least a 1-month trial of NSAID OR csDMARD unless contraindicated OR already established on biologic/targeted therapy; may be used alone or with methotrexate

Chunk 7

Ankylosing Spondylitis (AS): Member >=12 years with documented active disease; AND either failure of at least TWO NSAIDs over 4 weeks total unless contraindicated OR already established on biologic/targeted therapy; new subcutaneous users should start at 150 mg before increasing to 300 mg

Chunk 8

Non-radiographic axial spondyloarthritis (nr-axSpA): Objective signs of inflammation (elevated CRP and/or MRI sacroiliitis), absence of definitive radiographic sacroiliac joint damage, documented active disease; AND failure of at least TWO NSAIDs unless contraindicated OR already established on biologic/targeted therapy

Chunk 9

Enthesitis-Related Arthritis (ERA): Member aged 4 to <18 with documented moderate to severe active polyarticular disease; AND failure of at least a 1-month trial of NSAID OR csDMARD unless contraindicated OR already established on biologic/targeted therapy

Chunk 10

Hidradenitis Suppurativa (HS): Member >=12 years with moderate to severe disease; at least 5 inflammatory lesions (abscesses/inflammatory nodules); lesions affect at least 2 distinct anatomic areas>=5 inflammatory lesions

Chunk 11

Renewal Therapy — Renewal approval provided when ALL of the following are met:

Renewal approval provided when ALL of the following are met:

Ongoing universal renewal criteria: Member continues to meet universal and indication-specific criteria; absence of unacceptable toxicity (examples: new or severe inflammatory bowel disease, severe infections including TB or HBV reactivation, hypersensitivity reactions)

Chunk 13

Plaque Psoriasis renewal response: Improvement compared to baseline such as total BSA involvement ≤ 1% and/or PASI ≤ 3 and/or PGA ≤ 1BSA <=1; PASI <=3; PGA <=1

Chunk 14

Adult Psoriatic Arthritis renewal response: Improvement in joint counts, CRP, patient global assessment, imaging, or disease activity tool; dose escalation permitted on case-by-case review if member showed initial improvement and responded by week 8 with subsequent loss of response and after receiving required loading/maintenance dosingresponse by week 8 when applicable

Response-based coverage criteria — Covered when disease response is demonstrated per indication-specific measures

Covered when disease response is demonstrated per indication-specific measures

General disease response requirement

nr-axSpA responses: Examples include: ≥1.1 improvement on ASDAS; ASDAS-Major Improvement (e.g., ≥2.0); ≥2 improvement on BASDAI; ASAS40ASDAS >=1.1; ASDAS-MI >=2.0; BASDAI >=2
Chunk 18
Enthesitis-Related Arthritis responses: Examples include improvement in tender/swollen joint counts, CRP, patient global, or composite indices such as JADAS or ACR-Pedi30 with ≥30% improvement in 3 of 6 variablesACR-Pedi30
Chunk 19
Hidradenitis Suppurativa responses:

Dosing-linked coverage — Dosing and administration conditions for coverage

Dosing and administration conditions for coverage

Dose must match indication-specific regimen: Dosing must follow indication-specific loading and maintenance schedules and age/weight-based pediatric doses; use the specified subcutaneous or intravenous regimens for each indication and observe maximum per-infusion recommendations (e.g., total IV doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in adults with AS)See dosing per indication in Section V

Chunks 21-24

Diagnosis documentation requirement — Coverage references and diagnosis code linkage

Coverage references and diagnosis code linkage

Diagnosis requirement: Documentation of an applicable ICD-10 diagnosis code from the provided subcutaneous or intravenous lists is required when requesting coverage; select the code that corresponds to the intended route and indicationnone

Codes listed across chunks 42-49; Medicare Part B codes: N/A (chunk 51-52)

Requests for Cosentyx will be denied if the member is receiving concurrent treatment with another biologic therapy or targeted synthetic therapy. The policy requires that the member not be on any other biologic or targeted synthetic agent at the time of Cosentyx initiation or while receiving therapy.

For pediatric members, self-administration is not permitted. Pediatric dosing must be prepared and injected by an adult caregiver after appropriate training. Additionally, intravenous infusion is restricted to administration by a healthcare professional in a healthcare setting; IV vials are for adult use only, while UnoReady/Sensoready pens and prefilled syringes are for subcutaneous use only.

This policy extract does not list any Medicare Part B covered diagnosis codes (stated as N/A). When billing Medicare Part B or assessing Medicare coverage, consult applicable CMS National Coverage Determinations (NCD), Local Coverage Determinations (LCD), Local Coverage Articles (LCA), and contractor guidance for jurisdiction-specific requirements.

For intravenous administration in adults using the 1.75 mg/kg maintenance dosing for axial disease, the policy notes that total IV doses exceeding 300 mg per infusion are not recommended. Requests for IV dosing that exceed this recommendation are not supported by the documented dosing guidance in this extract.

Coding and Clinical Thresholds

Dosing/HCPCS units referencedmixed

150 mg	subcutaneous dosing unit referenced in max units per dose
300 mg	subcutaneous dosing unit referenced in max units per dose
750 billable units	intravenous loading dose (HCPCS billable units)
375 billable units	intravenous maintenance dose (HCPCS billable units)

HCPCS CodesHCPCS

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

Product presentations / NDC examplesNDC

NDC (examples listed)

Product NDC patterns listed for UnoReady pens, Sensoready pens, prefilled syringes, and IV vial (full NDCs shown as 00078-1070-xx; 00078-0639-xx; 00078-1056-xx; 00078-1168-xx)

Subcutaneous ICD-10 diagnosis codesICD-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 diagnosis 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

Axial spondyloarthritis / ankylosing spondylitis ICD-10 codesICD-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.
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.

1–10 of 20

1/2

Intravenous ICD-10 diagnosis codesICD-10

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.

Medicare Part B coding noteICD-10

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

Plaque Psoriasis BSA — Coverage Threshold

Threshold>= 3% body surface area

Age requirementMember is at least 6 years of age

ContextPart of plaque psoriasis initial coverage criteria requiring moderate to severe disease ≥6 months and prior trials of topical, systemic, and phototherapy unless exempt

PASI score for plaque psoriasis — Coverage Threshold

Threshold (PASI)>= 10

Indication contextUsed as one of the qualifying measures for moderate to severe plaque psoriasis (≥6 months)

Alternative to BSAPASI ≥10 may be used instead of ≥3% BSA or incapacitating location/emotional impact

Hidradenitis Suppurativa lesion count — Coverage Threshold

Threshold>= 5 inflammatory lesions (abscesses and/or inflammatory nodules)

Age requirementMember is at least 12 years of age

Anatomic requirementLesions must affect at least 2 distinct anatomic areas

ASDAS improvement — Example thresholds and ASDAS-MI

Example improvement threshold≥1.1 improvement on ASDAS

ASDAS-Major Improvement (ASDAS-MI)Defined as improvement ≥2.0 in ASDAS and/or reaching the lowest possible ASDAS

Context of useApplied for nr-axSpA and AS to demonstrate response in renewal/response criteria

HiSCR — HS Response Definition

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

ContextUsed to define clinical response for hidradenitis suppurativa; ties to dose-escalation rules for adults

Measurement focusReduction in total abscess and inflammatory nodule count and/or reduction in skin pain

ACR‑Pedi / JADAS — Pediatric Response Measures

Example pediatric measureACR‑Pedi30: ≥30% improvement from baseline in three of six variables

Alternative pediatric toolJADAS (Juvenile Arthritis Disease Activity Score) may be used to demonstrate response

ContextApplied for enthesitis-related arthritis / juvenile psoriatic arthritis in renewal and response documentation

NQTL factor counts — Prior Authorization Considerations

Indication considerationYes (consider for prior authorization)

Safety/efficacy considerationNo (PA not prioritized for safety/efficacy)

Misuse/abuse considerationNo (PA not prioritized for misuse/abuse)

Cost considerationYes (consider for prior authorization due to drug cost)

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required. Initial approval will be provided for 6 months (180 days). Renewals may be authorized every 12 months (365 days).

Initial prior authorization duration: 6 months (180 days).
Renewal prior authorization duration: every 12 months (365 days).

Documentation Required

Required Documentation

Required documentation and baseline assessments. Provider must document member age and an objective baseline disease severity assessment using an appropriate validated tool; confirm HBV screening completed prior to initiation; confirm latent TB screening completed prior to initiation and ongoing TB monitoring during treatment; and confirm member is up to date on age-appropriate vaccinations and will not receive live vaccines during therapy.

Document member age (meets indication-specific minimum age).
Objective baseline disease severity assessment (e.g., PASI, BSA, ASDAS, BASDAI, JADAS, HiSCR, etc.).
HBV screening completed prior to initiating therapy.
Latent TB screening completed prior to initiating therapy and plan for ongoing TB monitoring.
Vaccination status documented and member will not receive live vaccines during therapy.

Step Therapy

Required Prior Therapy per Indication

Indication-specific prior therapy requirements. Providers must document prior treatment trials or reasons why trials are not appropriate as specified by indication (trial durations and agents below). For members already established on biologic or targeted synthetic therapy, prior trials may not be required as noted in indication-specific criteria.

Plaque Psoriasis (≥6 y): 4-week trial of topical agents AND 3-month trial of at least one non-biologic systemic agent AND 3-month trial of phototherapy (unless member is already on biologic/targeted therapy or has >10% BSA involvement).
Adult Psoriatic Arthritis: for axial disease or enthesitis, failure of ≥4-week trial of one NSAID (unless contraindicated); for peripheral arthritis/dactylitis, failure of ≥3-month trial of one csDMARD; OR already established on biologic/targeted synthetic therapy.
Juvenile Psoriatic Arthritis (≥2 y): ≥1-month trial and failure of NSAID OR csDMARD unless contraindicated/intolerant; OR already established on biologic/targeted therapy.
Ankylosing Spondylitis (≥12 y): failure of ≥2 NSAIDs over 4 weeks total unless contraindicated; OR already established on biologic/targeted therapy.
Non-radiographic Axial Spondyloarthritis: objective signs of inflammation (elevated CRP and/or MRI sacroiliitis) AND failure of ≥2 NSAIDs unless contraindicated; OR already established on biologic/targeted therapy.
Enthesitis-Related Arthritis (4 y to <18 y): ≥1-month trial and failure of NSAID OR oral csDMARD unless contraindicated/intolerant; OR already established on biologic/targeted therapy.
Hidradenitis Suppurativa (≥12 y): document moderate to severe disease with ≥5 inflammatory lesions affecting ≥2 distinct areas (no specific non-biologic trial required in extract).

Denial Risk

Triggers for Denial

Triggers for denial. Requests may be denied if required elements are missing or not met.

Member does not meet the minimum age requirement for the requested indication.
No objective baseline disease severity assessment documented using an appropriate tool.
HBV screening not completed prior to initiating therapy.
Latent TB screening not completed prior to initiating therapy or lack of plan for TB monitoring during treatment.
Vaccination status not documented or live vaccine planned during therapy.
Concurrent use of another biologic or targeted synthetic therapy without documentation supporting combination use where allowed.
Required prior therapy trials (per indication) not documented and no justification for why trials are not appropriate, where applicable.

Documentation Required

Diagnosis Code Documentation

Diagnosis code documentation and route-specific coding. Providers must document an appropriate ICD-10 diagnosis code from the enumerated lists corresponding to the intended route of administration (subcutaneous or intravenous). Ensure the diagnosis code aligns with the clinical indication submitted.

Use one of the listed ICD-10 codes corresponding to the indication and route (subcutaneous vs intravenous) as documented in the medical necessity criteria (e.g., L40.* series for psoriasis, L73.2 for hidradenitis suppurativa, M45.* and M45.A* for axial spondyloarthritis/non-radiographic axSpA, M08.* series for juvenile arthritis, etc.).
Ensure submitted ICD-10 code reflects the clinical documentation and objective measures provided in the request.

Documentation Required

NQTL-Informed Documentation

NQTL-informed documentation. Prior authorization was applied considering indication and drug cost per the NQTL checklist; therefore documentation should support medical necessity for the indication and justify need given cost considerations.

Include clinical rationale linking objective disease severity, prior therapy trials (or exceptions), and documented treatment response to support PA approval.
Because indication and cost were identified as relevant NQTL factors, provide clear documentation that the requested therapy is appropriate for the member's condition and consistent with clinical criteria.

Billing Rule

Billing / Prior Authorization Codes

Billing / Prior Authorization Codes. Prior authorization applies to both IV and SQ formulations; include appropriate HCPCS/NDC information on the request as applicable.

IV formulation HCPCS: J3247 (secukinumab injection, IV, 1 mg).
SQ formulation HCPCS: J3590 or C9399 (unclassified biologic/drug) — include NDC for the specific presentation when available.
Provide NDC and product description for subcutaneous presentations (e.g., Cosentyx 300 mg/2 mL, 150 mg/mL, 75 mg/0.5 mL) or IV vial (125 mg/5 mL) when submitting the PA.

Definitions

Contraindications to Phototherapy — Examples

Example contraindicationXeroderma pigmentosum

Photosensitive genodermatosesExamples: trichothiodystrophy, Cockayne syndrome, Bloom syndrome, Rothmund‑Thomson syndrome

Pregnancy/lactation (PUVA)Pregnancy or lactation contraindicate PUVA

Other examplesLupus erythematosus; history of photosensitivity diseases or skin cancer; severe organ disease; photosensitizing medications

ASDAS‑MI / ASDAS — Definition and Major Improvement

ASDAS descriptionAnkylosing Spondylitis Disease Activity Score (ASDAS) used to quantify axial spondyloarthritis disease activity

ASDAS improvement example≥1.1 improvement on ASDAS is cited as an example threshold for response

ASDAS‑MI definitionASDAS‑Major Improvement defined as improvement ≥2.0 in the ASDAS and/or reaching the lowest possible ASDAS

HiSCR — Hidradenitis Suppurativa Clinical Response Definition

HiSCR core definitionHiSCR = ≥50% reduction in abscess and inflammatory nodule count with no increase in abscesses or draining fistulas

Use casePrimary HS clinical response endpoint referenced for coverage and dose‑escalation decisions

Timing/contextResponse assessment informs adult dose escalation rules (response by week 8 and subsequent loss of response)

ACR‑Pedi / JADAS — Pediatric Composite Measures

ACR‑Pedi exampleACR‑Pedi30: ≥30% improvement in three of six variables

JADASJuvenile Arthritis Disease Activity Score can be used as an alternative composite pediatric disease activity measure

ContextApplied for enthesitis‑related arthritis and juvenile psoriatic arthritis to document response for renewal

Non‑Quantitative Treatment Limitations (NQTLs) — Definition and Application

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 and prior authorization are types of NQTLs

Application to this policyNQTL checklist informed PA design; indication and cost were marked as considerations while safety/efficacy and misuse/abuse were not prioritized

Revision History

2026-05-05last_reviewLatest

Policy last reviewed on 05/05/2026.

2015-02-24date_of_origin

Policy originally issued on 02/24/2015.

2015-02dates_reviewed

Document reviewed in February 2015.

2016-01dates_reviewed

Document reviewed in January 2016.

2017-01dates_reviewed

Document reviewed in January 2017.

2018-01dates_reviewed

Document reviewed in January 2018.

2018-08dates_reviewed

Document reviewed in August 2018.

2019-08dates_reviewed

Document reviewed in August 2019.

2020-03dates_reviewed

Document reviewed in March 2020.

2020-07dates_reviewed

Document reviewed in July 2020.

2021-07dates_reviewed

Document reviewed in July 2021.

2021-08dates_reviewed

Document reviewed in August 2021.

2022-01dates_reviewed

Document reviewed in January 2022.

2022-08dates_reviewed

Document reviewed in August 2022.

2023-06dates_reviewed

Document reviewed in June 2023.

2023-08dates_reviewed

Document reviewed in August 2023.

2023-11dates_reviewed

Document reviewed in November 2023.

2023-12dates_reviewed

Document reviewed in December 2023.

2024-08dates_reviewed

Document reviewed in August 2024.

2025-03dates_reviewed

Document reviewed in March 2025.

2026-03dates_reviewed

Document reviewed in March 2026.

2026-04dates_reviewed

Document reviewed in April 2026.

OpenPayer

Cosentyx (secukinumab) (Subcutaneous/Intravenous)

Coverage Criteria

Coding and Clinical Thresholds

Provider Actions and Authorization

Background

Definitions

Revision History