CurrentNeighborhood Health Plan of Rhode IslandPolicy 2017-A

Secukinumab (Cosentyx) prior authorization and coverage criteria

Defines prior authorization, documentation, prescriber requirements, and coverage criteria for Cosentyx (secukinumab) for indicated dermatologic and rheumatologic conditions; applies to members of Neighborhood Health Plan of Rhode Island as implemented by CVS Caremark. (This file is Part 1 of 2.)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySecukinumab (Cosentyx) prior authorization and coverage criteria

Policy CodePolicy 2017-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of indication-specific criteria, prior therapy history or reasons to avoid prior agents, and TB testing within 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration commonly granted for approvals

6+min age: plaque psoriasis

2+min age: psoriatic arthritis

4+min age: enthesitis-related arthritis

12 monthsTB test valid interval

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2017-Areference number

Coverage Criteria

Plaque psoriasis (Initial therapy eligibility)

Authorization of 12 months may be granted for members 6 years of age or older for moderate to severe plaque psoriasis when ANY of the following are met:

Plaque psoriasis qualifying conditions: Crucial body areas affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas).age >=6

Applies to members 6 years and older

Plaque psoriasis qualifying conditions: At least 10% of body surface area (BSA) affected.BSA >=10%

Applies to members 6 years and older

Plaque psoriasis qualifying conditions: At least 3% of body surface area (BSA) affected AND either: inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) or methotrexate, cyclosporine, or acitretin; OR a clinical reason to avoid methotrexate, cyclosporine, and acitretin.BSA >=3% with qualifiers

Applies to members 6 years and older

Psoriatic arthritis (Initial therapy eligibility)

Authorization of 12 months may be granted for members 2 years of age or older for treatment of active psoriatic arthritis when ONE of the following is met:

PsA qualifying conditions: Member has mild to moderate disease and has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic DMARD administered at adequate dose and duration; OR intolerance/contraindication to methotrexate, leflunomide, or another conventional synthetic DMARD; OR member has enthesitis or predominantly axial disease.age >=2

Prior biologic history may affect authorization length

PsA qualifying conditions: Member has severe disease.age >=2

Applies regardless of prior conventional therapy

Ankylosing spondylitis and non-radiographic axial spondyloarthritis (Initial therapy eligibility)

Authorization of 12 months may be granted for adult members for treatment of active ankylosing spondylitis or active non-radiographic axial spondyloarthritis when ANY of the following is met:

AS/nr-axSpA qualifying conditions: Member has had an inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs).adult

Must have trialed ≥2 NSAIDs

AS/nr-axSpA qualifying conditions: Member has an intolerance or contraindication to two or more NSAIDs.adult

Documented intolerance/contraindication to ≥2 NSAIDs

Enthesitis-related arthritis (Initial therapy eligibility)

Authorization of 12 months may be granted for members 4 years of age or older for treatment of active enthesitis-related arthritis when ALL of the following are met:

ERA qualifying conditions: Member has active disease demonstrated by at least three active joints involved and at least one site of active enthesitis at baseline or documented by history.age >=4

Required baseline disease activity

ERA qualifying conditions: Member has had an inadequate response to NSAIDs, sulfasalazine, or methotrexate; OR member has an intolerance or contraindication to NSAIDs, sulfasalazine, or methotrexate.age >=4

Must meet either prior therapy failure or documented intolerance/contraindication

Hidradenitis suppurativa (Initial therapy eligibility)

Authorization of 12 months may be granted for adult members for treatment of moderate to severe hidradenitis suppurativa when ONE of the following is met:

HS qualifying conditions: Member has had an inadequate response to an oral antibiotic used for hidradenitis suppurativa for at least 90 days (e.g., clindamycin, metronidazole, moxifloxacin, rifampin, tetracyclines).adult

Prior antibiotic trial ≥90 days required

HS qualifying conditions: Member has an intolerance or contraindication to oral antibiotics used for hidradenitis suppurativa.adult

Documented intolerance/contraindication to oral antibiotics

Continuation/maintenance therapy criteria (all indications)

Authorization of 12 months may be granted for continuing therapy when the member demonstrates clinical improvement or maintenance of low disease activity as evidenced by ANY of the following relevant measures from baseline:

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).improvement from baseline

Applies to members ≥6 years using therapy for PsO

Psoriatic arthritis response: Improvement in number of swollen joints, number of tender joints, dactylitis, enthesitis, axial disease, skin and/or nail involvement, functional status, or C-reactive protein (CRP) from baseline.improvement from baseline

Applies to members ≥2 years using therapy for PsA

AS/nr-axSpA response: Improvement in functional status, total spinal pain, inflammation (e.g., morning stiffness), swollen or tender joints, or C-reactive protein (CRP) from baseline.

Enthesitis-related arthritis (ERA) — Initial or continuation authorization (4 years and older)

Authorization of 12 months may be granted for members 4 years of age or older using secukinumab for active enthesitis-related arthritis who achieve or maintain a positive clinical response as evidenced by improvement in any of the following from baseline:

ERA response criteria: Improvement in any of: number of flares; number of joints with active arthritis (e.g., swelling, pain); number of joints with limited movement; dactylitis; enthesitis.improvement from baseline

Used to justify 12-month authorization for ERA

Hidradenitis suppurativa — Initial or continuation authorization (adult members)

Authorization of 12 months may be granted for adult members using secukinumab for moderate to severe hidradenitis suppurativa who achieve or maintain a positive clinical response as evidenced by any of the following:

Hidradenitis suppurativa response criteria: Improvement in any of: reduction in abscess and inflammatory nodule count from baseline; reduced formation of new sinus tracts and scarring; decrease in frequency of inflammatory lesions; reduction in pain; reduction in suppuration; improvement in frequency of relapses; improvement in quality of life; improvement on a disease severity assessment tool.improvement from baseline

Used to justify 12-month authorization for HS

Universal safety prerequisites

General safety and dosing considerations applicable to all indications

TB screening and concomitant therapy: Member has documented negative TB test (TST or IGRA) within 12 months prior to initiating therapy if biologic/targeted-synthetic naive; if TB test is positive, further testing (e.g., chest x-ray) must confirm no active disease before treatment; do not administer the requested medication to members with active TB infection; if latent TB, TB treatment must be started before initiation. Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug for the same indication.TB negative within 12 months or documented management if positive

Applies to all indications

All uses of secukinumab outside the FDA‑approved indications listed in this policy are considered experimental/investigational and not medically necessary. Requests for such indications may be denied.

Do not administer secukinumab to members with active tuberculosis (TB) infection. Prior to initiating therapy, document a negative TB test (TST or IGRA) within 12 months for biologic/targeted‑synthetic naïve patients; if TB screening is positive, obtain confirmatory evaluation (e.g., chest x‑ray) to exclude active disease and treat latent TB prior to starting therapy.

Use of secukinumab for indications not included among the FDA‑approved conditions listed in this policy (and any compendial uses noted) is considered not medically necessary.

Coding

DrugNDC|mixed

secukinumab

Cosentyx (brand and generic name listed; all dosage forms and strengths)

Body surface area (BSA) — thresholds used in coverage rules

Primary BSA thresholdAt least 10% of body surface area (BSA) affected.

Conditional lower BSA thresholdAt least 3% BSA affected plus one of: inadequate response or intolerance to phototherapy or methotrexate/cyclosporine/acitretin, or clinical reason to avoid those drugs.

Application contextBSA thresholds apply to plaque psoriasis initial therapy eligibility for members 6 years and older.

TB test recency — TB test within specified interval prior to initiation

Required TB test timingDocumented negative TB test (TST or IGRA) within 12 months prior to initiating therapy for biologic/targeted-synthetic–naïve persons.

If TB test positive

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the requested medication. Typical authorizations may be issued for up to 12 months when criteria are met. Do not administer the medication concomitantly with another biologic or targeted synthetic drug for the same indication.

Authorization duration: up to 12 months for approved indications when criteria are satisfied.
Concomitant therapy: not permitted with other biologic or targeted synthetic drugs for same indication.

Prior Authorization

12-Month Authorization, Clinical Response, and TB Screening Requirements

Authorization may be granted for 12 months for eligible members (age varies by indication) when initial criteria are met and for continuation/renewal when there is documentation of positive clinical response or maintenance of low disease activity. For members naïve to biologic or targeted synthetic drugs associated with increased TB risk, a negative TB test (TST or IGRA) within 12 months prior to initiation is required. If TB screening is positive, further evaluation (e.g., chest x-ray) to rule out active disease is required; do not start therapy with active TB. If latent TB is identified, TB treatment must be started prior to initiation.

Background

Secukinumab (Cosentyx) is an IL‑17A inhibitor indicated for multiple immune‑mediated dermatologic and rheumatologic conditions, including moderate to severe plaque psoriasis (age ≥6 years), active psoriatic arthritis (age ≥2 years), adult ankylosing spondylitis and non‑radiographic axial spondyloarthritis, enthesitis‑related arthritis (age ≥4 years), and moderate to severe hidradenitis suppurativa (adults). Coverage under this policy is limited to those FDA‑approved indications.

Definitions

Crucial body areas — anatomical areas considered crucial for BSA/coverage decisions

Listed crucial areasHands, feet, face, neck, scalp, genitals/groin, and intertriginous areas.

RelevanceInvolvement of these areas can qualify plaque psoriasis for coverage even with lower overall BSA.

UsageUsed as an alternative qualifying criterion to numeric BSA thresholds for initial therapy eligibility.

Body surface area (BSA) definition — measurement and thresholds used

DefinitionPercent of body surface area (BSA) affected by psoriasis — used as a quantitative measure to determine coverage eligibility.

Primary threshold≥10% BSA affected qualifies for coverage.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySecukinumab (Cosentyx) prior authorization and coverage criteria

Policy CodePolicy 2017-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of indication-specific criteria, prior therapy history or reasons to avoid prior agents, and TB testing within 12 months.

SourceLink

On This Page

improvement from baseline

Applies to adult members using therapy for AS/nr-axSpA

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

Applies to members ≥4 years using therapy for ERA

HS response: Reduction in abscess and inflammatory nodule count from baseline; reduced formation of new sinus tracts and scarring; decrease in frequency of inflammatory lesions; reduction in pain; reduction in suppuration; improvement in frequency of relapses; improvement in quality of life; or improvement on a disease severity assessment tool from baseline.improvement from baseline

Applies to adult members using therapy for HS

Further testing (e.g., chest x-ray) required to exclude active disease before initiation; if latent TB, TB treatment must be started before therapy.

Absolute contraindicationDo not administer the requested medication to members with active tuberculosis infection.

Renewals: require documented improvement or low disease activity versus baseline (examples below vary by indication).
TB screening: negative TST or IGRA within 12 months for biologic/targeted-synthetic–naïve patients; positive screens require further testing and management before starting therapy.

Denial Risk

Indication Limitations

Uses of the medication outside the listed FDA‑approved indications (e.g., any indication not included under FDA-approved Indications) are considered experimental/investigational and not medically necessary.

Denial Risk

Infection and Concomitant Therapy Risks

Do not administer the medication to members with active tuberculosis. If TB screening is positive, obtain confirmatory testing (such as chest x-ray) to exclude active disease. If latent TB is present, initiate TB treatment before starting the medication. Also ensure the member is not receiving another biologic or targeted synthetic agent for the same indication.

Active TB: contraindication to administration.
Latent TB: begin appropriate treatment prior to initiation.
Concomitant biologic/targeted synthetic therapy: not allowed.

Documentation Required

Required Documentation for Prior Authorization

Submit supporting documentation to initiate prior authorization and for renewals: medical record chart notes documenting affected body area(s) and body surface area (BSA) when applicable; prior medication history with responses; documentation of any prior phototherapy; and for renewals, objective documentation of clinical response or decreased BSA/improvement in signs and symptoms.

Initial requests: chart notes or medical record documentation of affected area(s) and BSA (if applicable).
Initial requests: prior medication history, including responses to prior therapies; if a therapy is not advisable, provide clinical reason to avoid.
Continuation requests: chart notes documenting decreased BSA and/or improvement in signs and symptoms or other evidence of positive clinical response.

Documentation Required

Required Clinical Response and TB Documentation for Renewal

For authorization (initial and renewal), document objective evidence of clinical response compared to baseline. Examples by indication include reduced number of flares, fewer joints with active arthritis, decreased abscess and inflammatory nodule counts, reduced pain or suppuration, improved frequency of relapses, or improvement on disease severity assessment tools.

Psoriatic arthritis/ERA: improvements in number of flares, active joints, limited movement, dactylitis, or enthesitis.
Hidradenitis suppurativa: reduction in abscess/inflammatory nodule counts, decreased formation of sinus tracts/scarring, reduced pain or suppuration, improved lesion frequency, quality of life, or disease severity scores.

Step Therapy

Required Prior Therapies or Documentation of Intolerance

Initial therapy often requires documentation of prior inadequate response to specified systemic or non-biologic treatments or documented intolerance/contraindication. Examples by indication include prior biologic or targeted synthetic use for some age groups, inadequate response to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin), inadequate response to conventional synthetic DMARDs (methotrexate, leflunomide, sulfasalazine) for PsA, or inadequate response to at least two NSAIDs for AS/nr-axSpA. For hidradenitis suppurativa, document at least 90 days of an appropriate oral antibiotic with inadequate response or intolerance/contraindication.

Plaque psoriasis: prior biologic/targeted synthetic therapy OR inadequate response/intolerance to phototherapy or methotrexate/cyclosporine/acitretin, or clinical reason to avoid these agents.
Psoriatic arthritis: inadequate response to methotrexate, leflunomide, or another conventional synthetic agent, or documented intolerance/contraindication.
Ankylosing spondylitis/nr-axSpA: inadequate response to ≥2 NSAIDs or intolerance/contraindication to ≥2 NSAIDs.
Hidradenitis suppurativa: inadequate response to an oral antibiotic for ≥90 days or documented intolerance/contraindication.

Documentation Required

Clinical Reasons to Avoid Prior Systemic Agents

If systemic non-biologic agents are to be avoided, provide a clinical reason from accepted examples such as chronic liver disease or alcohol use disorder, drug interactions, high risk of treatment-related toxicity, pregnancy or planning pregnancy, breastfeeding, significant comorbidity (e.g., liver/kidney disease, blood dyscrasias, uncontrolled hypertension), hypersensitivity, or history of intolerance/adverse event.

Clinical reasons to avoid methotrexate, cyclosporine, acitretin, or leflunomide may include: alcohol use disorder or chronic liver disease, drug interactions, high toxicity risk, pregnancy or breastfeeding, significant comorbidities, hypersensitivity, or prior intolerance.

Lower-threshold pathway≥3% BSA affected may qualify when accompanied by inadequate response or intolerance to phototherapy or methotrexate/cyclosporine/acitretin, or a documented clinical reason to avoid those drugs.

Positive clinical response / low disease activity definition — measures used for continuation/renewal

General definitionPositive clinical response or low disease activity = improvement or maintenance evidenced by indication‑specific measures from baseline.

ERA measuresImprovement in any of: number of flares; number of joints with active arthritis (e.g., swelling, pain); number of joints with limited movement; dactylitis; enthesitis.

HS measuresImprovement in any of: reduction in abscess and inflammatory nodule count; reduced new sinus tracts/scarring; decreased frequency of inflammatory lesions; reduced pain; reduced suppuration; fewer relapses; improved quality of life; improved disease severity tool score.