CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cosentyx (secukinumab) (Intravenous) — Coverage Criteria

Policy governs medical benefit coverage, authorization, dosing limits, and clinical criteria for intravenous Cosentyx (secukinumab) for adult and pediatric indications across Medicaid, Commercial, and Medicare-Medicaid Plan members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCosentyx (secukinumab) (Intravenous) — Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor / No material change

Effective DateJul 1, 2024

Next Review DateMay 1, 2024

Key ActionPrior authorization required with documentation of indication-specific criteria, prior therapy trials/failures, specialist prescribing or consultation, baseline assessments, and planned IV dosing consistent with Cosentyx dosing and quantity limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial length of authorization

12 monthspossible renewal duration

J3247HCPCS billing code

6 mg/kg → 1.75 mg/kg q4wdosing regimen (IV)

Coverage & Clinical Criteria

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Initial therapy general and dosing criteria

Covered when ALL of the following general conditions are met and the indication-specific criteria below are satisfied.

General requirements: Patient is at least 18 years of age unless otherwise specified by indication; AND physician has assessed baseline disease severity using an objective measure/tool; AND patient is up to date with age-appropriate vaccinations and will not receive live vaccines concurrently; AND no active infection is present; AND patient has been evaluated and screened for latent tuberculosis prior to initiation and will receive ongoing TB monitoring during treatment; AND Cosentyx will not be used concomitantly with another injectable biologic response modifier (including TNF inhibitors and IL inhibitors) or specified oral non-biologic agents; AND MMP members with prior receipt of this medication within the past 365 days are exempt from Step Therapy Requirements.

general prerequisites

Dose and quantity limits: Quantity limits: Loading = 6 vials (125 mg vials) at week 0; Maintenance = 3 vials every 28 days. Max per-dose (IV): Loading 6 mg/kg (up to 750 mg loading described), Maintenance 1.75 mg/kg every 4 weeks (equates to 375 mg maintenance described); total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in adults.

see HCPCS J3247 for unit billing

Adult and pediatric Psoriatic Arthritis

Covered for Psoriatic Arthritis when ALL of the following are met:

PsA criteria: Patient is 2 years of age or older; AND documented moderate to severe active psoriatic arthritis; AND Cosentyx is prescribed by, or in consultation with, a specialist in dermatology or rheumatology; AND baseline objective disease assessment is documented; AND for predominantly axial disease, trial and failure of at least a 4-week trial of one NSAID unless contraindicated; OR for peripheral arthritis, dactylitis, or active enthesitis, trial and failure of at least a 3-month trial of one oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine); AND member has had inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab and at least a 6-month trial of ustekinumab at maximum tolerated doses; AND vaccination, infection, and TB screening/monitoring prerequisites as specified in general requirements.

Authorization of 12 months may be granted if positive clinical response; dose escalation rules apply

Ankylosing Spondylitis

Covered for Ankylosing Spondylitis when ALL of the following are met:

AS criteria: Documented active ankylosing spondylitis; AND Cosentyx is prescribed by, or in consultation with, a specialist in rheumatology; AND patient had an adequate trial and failure of at least two NSAIDs over a total of 4 weeks unless contraindicated; AND member has had inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses; AND vaccination, infection, and TB screening/monitoring prerequisites as specified in general requirements.

Authorization of 12 months may be granted with demonstrated clinical response; dose escalation rules apply

Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

Covered for Active Non-Radiographic Axial Spondyloarthritis when ALL of the following are met:

nr-axSpA criteria: Cosentyx is prescribed by, or in consultation with, a specialist in rheumatology; AND patient has objective signs of inflammation (elevated CRP above the upper limit of normal and/or sacroiliitis on MRI); AND patient lacks definitive radiographic sacroiliac structural damage; AND documented active disease; AND patient had an adequate trial and failure of at least two NSAIDs over a total of 4 weeks unless contraindicated; AND member has had inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses; AND vaccination, infection, and TB screening/monitoring prerequisites as specified in general requirements.

Authorization of 12 months may be granted with demonstrated clinical response; dose escalation rules apply

Continuation / Renewal criteria

Renewal (12 months) may be granted when ALL of the following are met:

Renewal criteria for PsA: Member is using Cosentyx for active psoriatic arthritis and achieves or maintains a positive clinical response demonstrated by improvement from baseline in measures such as number of swollen joints, number of tender joints, dactylitis, enthesitis, or skin and/or nail involvement; AND patient showed initial improvement or response to therapy and responded by treatment week 8, followed by subsequent loss of response or continued active disease; AND patient has received the loading dose plus at least one maintenance dose at the specified dose and interval OR at least two maintenance doses at the specified dose and interval.

Allows dose escalation up to the maximum dose and frequency specified upon clinical review

Renewal criteria for AS and axial SpA: Member is using Cosentyx for active ankylosing spondylitis or active axial spondyloarthritis and achieves or maintains a positive clinical response demonstrated by improvement from baseline in functional status, total spinal pain, or inflammation (e.g., morning stiffness); AND patient showed initial improvement or response to therapy and responded by treatment week 8, followed by subsequent loss of response or continued active disease; AND patient has received the loading dose plus at least one maintenance dose at the specified dose and interval OR at least two maintenance doses at the specified dose and interval.

Allows dose escalation up to the maximum dose and frequency specified upon clinical review

Cosentyx IV must not be administered concurrently with another injectable biologic response modifier (including TNF inhibitors and other interleukin inhibitors) or with specified oral non-biologic immunomodulatory agents. Examples of prohibited concurrent therapies include, but are not limited to, anti-TNF agents such as adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade); IL-targeted biologics such as ustekinumab (Stelara), guselkumab (Tremfya), risankizumab (Skyrizi), bimekizumab (Bimzelx); and oral agents such as apremilast (Otezla), tofacitinib (Xeljanz), baricitinib (Olumiant), and upadacitinib (Rinvoq).

Maintenance dosing that results in total doses exceeding the recommended per-infusion thresholds is not supported. For IV Cosentyx the dosing framework is loading 6 mg/kg at Week 0, then maintenance 1.75 mg/kg every 4 weeks (or 1.75 mg/kg q4w without a loading dose). For billing/administration limits this corresponds to a loading dose of 750 mg and a maintenance dose of 375 mg every 28 days. The policy specifies that total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in adults and may be considered outside recommended dosing.

Provider Requirements & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Submit documentation of indication-specific criteria, prior therapy trials/failures, and specialist prescribing or consultation as applicable. Members who have received this medication within the past 365 days are exempt from step therapy requirements.

Prior authorization is required for Cosentyx (secukinumab IV) with supporting clinical documentation.
Members who received Cosentyx within the past 365 days: not subject to step therapy.

Step Therapy

Step Therapy Requirements

Step therapy applies unless the member received this medication within the past 365 days or has documented contraindication/intolerance. Members must have trialed and had inadequate response, intolerance, or contraindication to the required first-line agents prior to approval.

Adult Psoriatic Arthritis: trial and inadequate response, intolerance, or contraindication to at least a 3-month trial of ONE oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine) for peripheral disease OR a 4-week trial of ONE NSAID for predominantly axial disease.
Ankylosing Spondylitis and nr-axSpA: trial and inadequate response, intolerance, or contraindication to at least TWO NSAIDs over 4 weeks (total) unless contraindicated.
PsA/AS/nr-axSpA: Member must have had inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses; some PsA criteria also reference a 6-month trial of ustekinumab when applicable.

Denial Risk

Concurrent Biologic or Specified Oral Therapy — Not Permitted

Concurrent use of Cosentyx with other injectable biologic response modifiers or specified oral non-biologic immunomodulatory agents is not permitted.

Do not administer concurrently with injectable biologic response modifiers (e.g., adalimumab, etanercept, infliximab, ustekinumab, guselkumab, risankizumab, bimekizumab, etc.).
Do not use concomitantly with specified oral non-biologic agents (e.g., apremilast, tofacitinib, baricitinib, upadacitinib).
Ensure documentation confirms absence of concurrent biologic or listed oral therapies prior to approval.

Documentation Required

Documentation Requirements

Required documentation must be provided with the prior authorization request to support approval.

Patient age and indication-specific age criteria.
Baseline disease severity documented using an objective measure/tool (e.g., CRP elevation, MRI evidence for nr-axSpA).
Vaccination status (up to date) and confirmation Cosentyx will not be given with live vaccines.
Evaluation and screening for latent tuberculosis prior to initiation and plan for ongoing TB monitoring.
Details of prior therapy trials: agents used, dose, duration, and reason for discontinuation (inadequate response, intolerance, or contraindication).
Specialist prescribing or consultation note (dermatology or rheumatology as applicable).

OpenPayer

Cosentyx (secukinumab) (Intravenous) — Coverage Criteria

Coverage & Clinical Criteria

Provider Requirements & Prior Authorization

Billing Codes & Dosing Limits

Definitions & Background