CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cosentyx (secukinumab) — Coverage Criteria

Defines medical necessity, authorization duration, dosing limits, and documentation requirements for Cosentyx (secukinumab) for Medicaid members of Neighborhood Health Plan of Rhode Island across FDA-approved indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCosentyx (secukinumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization with member chart documenting indication, baseline objective measures, prior therapy trials or intolerance, and pretreatment TB screening.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6covered indications listed

6 moinit auth length (most)

12 mocont. auth length (when response)

qty limitsformulary pack limits

Coverage Criteria for Cosentyx (secukinumab)

Initial therapy criteria (per indication)

Covered when ALL of the following per-indication criteria are met

General preconditions: Member has documentation submitted; pretreatment TB screening performed (unless exempt); up-to-date vaccinations; physician assessment of baseline disease severity with objective measure; will not receive live vaccines concurrently; not used concomitantly with other injectable biologic response modifiers; no active infection

General safety and documentation requirements apply to all indications

Indication-specific criteria

Plaque Psoriasis: Prescribed by or in consultation with a dermatologist or rheumatologist; member is >=6 years old; at least 10% body surface area affected OR involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas); inadequate response or intolerance to at least a 3-month trial of methotrexate, cyclosporine, or acitretin OR inadequate response/intolerance to at least a 3-month trial of phototherapy unless intolerant; inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab and at least a 6-month trial of ustekinumab biosimilar at maximum tolerated doses; trial of topical roflumilast (Zoryve) within last 12 months required if BSA <=20% unless exceptions apply
Initial authorization 6 months; pediatric dosing variations apply
Psoriatic Arthritis: Prescribed by or in consultation with a dermatologist or rheumatologist; member is >=2 years old; documented moderate to severe active disease; if axial-predominant disease— inadequate response or intolerance to at least a 4-week trial of one NSAID unless contraindicated; if peripheral arthritis/dactylitis/active enthesitis— inadequate response to at least a 3-month trial of an oral DMARD (e.g., methotrexate, azathioprine, sulfasalazine) unless intolerant; inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab and at least a 6-month trial of ustekinumab biosimilar at maximum tolerated doses; new patients must initiate at 150 mg before increasing to 300 mg unless coexistent plaque psoriasis
Initial authorization 6 months
Ankylosing Spondylitis: Prescribed by or in consultation with a rheumatologist; member is >=18 years old; documented active disease; inadequate response or intolerance to at least two NSAIDs over a total of 4 weeks unless contraindicated; inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses; new patients must initiate at 150 mg before increasing to 300 mg
Initial authorization 6 months
Non-radiographic axial spondyloarthritis (nr-axSpA): Prescribed by or in consultation with a rheumatologist; member is >=18 years old; objective signs of inflammation (elevated CRP above the upper limit of normal and/or sacroiliitis on MRI); inadequate response or intolerance to at least two NSAIDs over a total of 4 weeks unless contraindicated; without definitive radiographic sacroiliac joint structural damage; inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses
Initial authorization 6 months
Enthesitis-related arthritis (ERA): Prescribed by or in consultation with a rheumatologist; member is >=4 years old; active disease demonstrated by at least three active joints and at least one site of active enthesitis at baseline or documented by history; inadequate response or intolerance to NSAIDs, sulfasalazine, or methotrexate
Initial authorization 6 months; pediatric dosing described
Hidradenitis Suppurativa (HS): Prescribed by or in consultation with a dermatologist; moderate to severe HS with inadequate response to or intolerance/contraindication to oral antibiotics (or at least 90 days of oral antibiotics); inadequate response/intolerance/contraindication to at least a 3-month trial of adalimumab at maximum tolerated doses and at least a 6-month trial of ustekinumab at maximum tolerated doses; escalation to every-2-week dosing requires medical rationale after at least 16 weeks of therapy and documented incremental benefit
Initial authorization 6 months; escalation criteria for q2w dosing

Continuation/renewal criteria

Continuation (renewal) criteria — Covered when ANY of the following treatment response measures are met

Plaque Psoriasis response: Reduction in body surface area (BSA) affected from baseline OR improvement in signs and symptoms (e.g., itching, redness, flaking, scaling, burning, cracking, pain)

Authorization of 12 months may be granted when response documented

Psoriatic Arthritis response: Improvement from baseline in number of swollen joints, number of tender joints, enthesitis, dactylitis, and/or skin and/or nail involvement

Authorization of 12 months may be granted when response documented

Ankylosing Spondylitis and axial spondyloarthritis response: Improvement from baseline in functional status, total spinal pain, or measures of inflammation (e.g., morning stiffness)

Authorization of 12 months may be granted when response documented

ERA response: Improvement from baseline in number of flares, number of joints with limited movement, dactylitis, or enthesitis

Authorization of 12 months may be granted when response documented

Hidradenitis Suppurativa response: Reduction in abscess and inflammatory nodule count, decreased frequency of inflammatory lesions, reduced formation of new sinus tracts/scarring, reduction in pain, reduction in suppuration, fewer relapses, improved quality of life, or improvement on a disease severity assessment tool from baseline; for q2w dosing, documented rationale and incremental benefit after >=16 weeks

Authorization of 6 months for HS continuation; response criteria enumerated

Product Coding, Dosing, and Clinical Thresholds

Product dosing strengths and pack sizesmixed

75 mg	0.5 ml per 28 with post-limit for loading dose of 375 mg (2.5 ml) per 35 days
150 mg	2 ml per 56 with post-limit for loading dose of 900 mg (6 ml) per 60 days
300 mg	2 ml per 28 with post-limit for loading dose of 1500 mg (10 ml) per 35 days

Plaque psoriasis BSA — clinical threshold

Threshold>= 10% body surface area (BSA) affected OR involvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Age requirementMember >= 6 years of age

Prior topical/systemic/phototherapyInadequate response to >=3 months of methotrexate, cyclosporine, or acitretin OR >=3 months phototherapy unless intolerant

Biologic stepInadequate response/intolerance/contraindication to >=3 months adalimumab AND >=6 months ustekinumab biosimilar at maximum tolerated doses

Zoryve exceptionIf BSA > 20%, trial of Zoryve (roflumilast) cream not required; if BSA <= 20%, inadequate response or intolerance to Zoryve within last 12 months must be documented

nr-axSpA inflammation criteria

Objective inflammation criteriaElevation of C-reactive protein (CRP) above the upper limit of normal and/or sacroiliitis on MRI

Age requirementMember >= 18 years of age

NSAID trial requirementInadequate response or intolerance to at least two NSAIDs over 4 weeks total unless contraindicated

Radiographic statusNo definitive radiographic evidence of structural sacroiliac joint damage (non-radiographic)

Biologic stepInadequate response/intolerance/contraindication to >=3 months of adalimumab at maximum tolerated doses

ERA disease activity — clinical threshold

Disease activity thresholdActive disease demonstrated by >= 3 active joints and at least 1 site of active enthesitis at baseline or documented by history

Age requirementMember >= 4 years of age

Prior therapy requirementInadequate response or intolerance to NSAIDs, sulfasalazine, or methotrexate

Authorization lengthInitial authorization of 6 months (pediatric dosing described)

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation of the clinical indication, prior therapy trials/failures or intolerance/contraindication, and the requested dosing regimen. Authorizations are typically for up to 6 months for initial therapy (12 months for continuation in plaque psoriasis when response is documented).

Prior authorization required for all indications
Include indication-specific prior therapy trials (document duration, dose, response, or intolerance)
Specify requested dose and whether loading doses are needed

Step Therapy

Step Therapy Requirements

Step therapy requirements vary by indication. Prior trials (and minimum durations) are required as specified for each condition (examples below). Documented inadequate response, intolerance, or contraindication to the listed therapies is required to meet step requirements.

Plaque psoriasis: ≥3-month trials of methotrexate, cyclosporine, or acitretin; ≥3-month phototherapy trial unless intolerant; trials of adalimumab and ustekinumab biosimilar at specified durations
Psoriatic arthritis: trial of NSAID for axial disease (≥4 weeks) or 3-month trial of an oral DMARD for peripheral disease
Ankylosing spondylitis / nr-axSpA: inadequate response to ≥2 NSAIDs over 4 weeks; trial of adalimumab required

Documentation Required

Required Documentation

Submit the member's chart or medical record. Required documentation must demonstrate baseline disease severity, objective measures, prior treatment history (including dates, doses, and reasons for discontinuation), and safety screening results.

Baseline disease severity using objective measures/tools (e.g., BSA for psoriasis, active joint count for JIA, CRP or MRI for nr-axSpA)
Pretreatment TB screening (TB skin test or IGRA) unless member previously received a biologic/targeted synthetic DMARD
Vaccination status up to date per guidelines prior to initiation
Documentation of concurrent medication exclusions (e.g., not to be used with live vaccines or concurrent injectable biologic response modifiers)
Prior therapy trials with duration and outcome (inadequate response, intolerance, or contraindication)

Denial Risk

Documentation and Safety Triggers for Denial

Failure to submit required records, missing objective baseline or response data, or absence of documented prior therapy trials/intolerances may result in denial. Therapy may also be denied if safety screenings (e.g., TB testing, active infection assessment, vaccination status) are incomplete or if the requested regimen conflicts with formulary quantity limits.

Omission of member chart/medical record or incomplete clinical notes is a common denial trigger
Lack of pretreatment TB screening (when required) or evidence of active infection may lead to denial
Missing objective baseline severity measures or absence of documented prior trials/intolerance will risk denial
Requests exceeding formulary quantity limits or without medical rationale for exceptions may be denied

Objective Signs, Response Measures, and Clinical Definitions

Objective signs of inflammation / response measures

Examples of objective inflammation measuresElevation of CRP above the upper limit of normal and/or sacroiliitis on MRI (nr-axSpA)

Psoriasis response measureReduction in body surface area (BSA) affected from baseline or improvement in signs/symptoms (itching, redness, flaking, scaling, burning, cracking, pain)

Arthritis/joint countsImprovement in number of swollen joints, number of tender joints, enthesitis, and dactylitis for PsA; counts of active joints for ERA

Axial disease measuresImprovement in functional status, total spinal pain, or inflammation (e.g., morning stiffness) for AS/axial spondyloarthritis

HS response measuresReduction in abscess/inflammatory nodule count, decreased frequency of inflammatory lesions, reduced formation of new sinus tracts/scarring, reduced pain or suppuration, improved quality of life

OpenPayer

Cosentyx (secukinumab) — Coverage Criteria

Coverage Criteria for Cosentyx (secukinumab)

Product Coding, Dosing, and Clinical Thresholds

Prior Authorization, Documentation, and Step Therapy Requirements

Objective Signs, Response Measures, and Clinical Definitions

Background on Secukinumab