Defines Cigna's prior authorization requirements, coverage criteria, and exclusions for Cosentyx (secukinumab) subcutaneous for inflammatory conditions across FDA-approved indications; affects prescribers, reviewers, and members under Cigna-administered plans.
Change TypeCriteria added and revisions (Hidradenitis Suppurativa addedtimeframe and age criteria updated)
Effective DateN/A
Next Review DateN/A
Key ActionObtain prior authorization with indication‑specific documentation and prescriber specialty verification before coverage of Cosentyx subcutaneous.
Policy name was updated to specify this is for the subcutaneous formulation of Cosentyx.
For a patient currently receiving Cosentyx, it was clarified this applies to the subcutaneous formulation for Enthesitis-Related Arthritis and Plaque Psoriasis.
For Psoriatic Arthritis, Ankylosing Spondylitis, and Non-Radiographic Axial Spondyloarthritis, for patients currently receiving Cosentyx it was clarified this applies to the subcutaneous or intravenous formulation.
Hidradenitis Suppurativa condition and criteria for approval was added to the policy.
Timeframe for established on-therapy for Cosentyx subcutaneous was changed from 90 days to 3 months for Hidradenitis Suppurativa and Plaque Psoriasis.
For initial approvals, requirement that patient is ≥ 18 years of age was added for Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis.
For Plaque Psoriasis initial therapy, a 3-month trial or prior intolerance to Otezla XR (apremilast ER) or Sotyktu (deucravacitinib) was added as an exception to the requirement for trial of one traditional systemic agent.
The appendix was updated to add Otezla XR under Oral Therapies/Targeted Synthetic Oral Small Molecular Drugs.
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FDA‑approved indications listed
6 moInitial approval (several indications)
3 moInitial approval (HS & psoriasis)
1 yrRenewal duration
Concurrent biologicNot medically necessary
11/15/2023Selected revision (HS added)
Coverage Criteria by Indication
Ankylosing Spondylitis
Covered when ONE of the following is met
Ankylosing Spondylitis A or B: A) Initial Therapy: approve for 6 months if BOTH: (i) patient is ≥ 18 years of age; AND (ii) the medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous or Intravenous: approve for 1 year if BOTH: (i) patient has been established on Cosentyx subcutaneous or intravenous for at least 6 months; AND (ii) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR (b) compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, or improvement in function or activities of daily living).
Examples of objective measures listed (ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and/or serum markers such as CRP or ESR).
Enthesitis-Related Arthritis
Covered when ONE of the following is met
Enthesitis-Related Arthritis A or B: A) Initial Therapy: approve for 6 months if BOTH: (i) patient is ≥ 4 years of age; AND (ii) the medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous: approve for 1 year if BOTH: (i) patient has been established on Cosentyx subcutaneous for at least 6 months; AND (ii) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR (b) compared with baseline, patient experienced an improvement in at least one symptom (e.g., improved limitation of motion, less joint pain or tenderness, decreased duration of morning stiffness or fatigue, improved function or activities of daily living).
Examples of objective measures listed (JADAS, MD global, PGA, PDA, JDAS, cJDAS, JSpADA, serum markers such as CRP or ESR, and/or reduced corticosteroid dose).
Hidradenitis Suppurativa
Covered when ONE of the following is met
Hidradenitis Suppurativa A or B: A) Initial Therapy: approve for 3 months if ALL: (i) patient is ≥ 18 years of age; AND (ii) patient has tried at least one other therapy (examples include intralesional or oral corticosteroids, systemic antibiotics such as clindamycin, dicloxacillin, erythromycin, and isotretinoin); AND (iii) the medication is prescribed by or in consultation with a dermatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous: approve for 1 year if ALL: (i) patient has been established on Cosentyx subcutaneous for at least 3 months; AND (ii) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; AND (iii) compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or drainage of lesions, nodules, or cysts).
Examples of objective measures listed (Hurley staging, Sartorius score, Physician Global Assessment, Hidradenitis Suppurativa Severity Index).
Non-Radiographic Axial Spondyloarthritis
Covered when ONE of the following is met
Non-Radiographic Axial Spondyloarthritis A or B: A) Initial Therapy: approve for 6 months if ALL: (i) patient is ≥ 18 years of age; AND (ii) patient has objective signs of inflammation defined as at least ONE: (a) C-reactive protein elevated beyond the upper limit of normal for the reporting laboratory; OR (b) sacroiliitis reported on magnetic resonance imaging; AND (iii) the medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous or Intravenous: approve for 1 year if BOTH: (i) patient has been established on Cosentyx subcutaneous or intravenous for at least 6 months; AND (ii) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR (b) compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, or improvement in function or activities of daily living).
Plaque Psoriasis A or B: A) Initial Therapy: approve for 3 months if ALL: (i) patient is ≥ 6 years of age; AND (ii) patient meets ONE of the following: (a) patient has tried at least one traditional systemic agent for at least 3 months unless intolerant (examples include methotrexate, cyclosporine, acitretin) OR (b) according to the prescriber, the patient has a contraindication to methotrexate; AND (iii) the medication is prescribed by or in consultation with a dermatologist. Note: an exception to the trial of a traditional systemic agent may be made if the patient has had a 3-month trial or prior intolerance to a biologic, Otezla/Otezla XR (apremilast), or Sotyktu (deucravacitinib). OR B) Patient is Currently Receiving Cosentyx Subcutaneous: approve for 1 year if ALL: (i) patient has been established on Cosentyx subcutaneous for at least 3 months; AND (ii) patient experienced a beneficial clinical response, defined as improvement from baseline in at least one of the following: estimated body surface area, erythema, induration/thickness, and/or scale; AND (iii) compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, itching, and/or burning).
Exceptions and examples (prior biologic, Otezla XR, Sotyktu, biosimilars) provided in policy; prescriber specialty requirement: dermatologist.
Psoriatic Arthritis
Covered when ONE of the following is met
Psoriatic Arthritis A or B: A) Initial Therapy: approve for 6 months if BOTH: (i) patient is ≥ 2 years of age; AND (ii) the medication is prescribed by or in consultation with a rheumatologist or a dermatologist. OR B) Patient is Currently Receiving Cosentyx Subcutaneous or Intravenous: approve for 1 year if BOTH: (i) patient has been established on Cosentyx subcutaneous or intravenous for at least 6 months; AND (ii) patient meets at least ONE of the following: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC enthesitis score, Leeds Dactylitis Instrument Score, MDA, PsAID-12, and/or serum markers such as CRP or ESR); OR (b) compared with baseline, patient experienced an improvement in at least one symptom (e.g., less joint pain, morning stiffness, or fatigue; improved function; decreased soft tissue swelling).
Standardized measures of disease activity examples provided in policy.
Cosentyx (secukinumab subcutaneous) is considered not medically necessary for any uses not specifically listed as covered in this policy. Notable exclusions include: concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition, due to increased adverse event risk and lack of controlled data supporting additive benefit; Crohn's disease, where trials showed exacerbations and lack of efficacy; rheumatoid arthritis, where clinical trials did not demonstrate consistent or superior efficacy compared with available therapies; and uveitis, where Phase III studies did not show statistically significant benefit versus placebo.
Requests for Cosentyx in combination with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition are not medically necessary and will be denied. The policy language clarifies this exclusion as “Concurrent Use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug (as listed),” reflecting the revision history that updated how these agents are referenced.
Concurrent administration of Cosentyx with another biologic or a targeted synthetic oral small molecule drug carries a coverage denial risk: combination therapy is not recommended because of a potentially higher rate of adverse events and insufficient controlled clinical data demonstrating additive efficacy; therefore such requests are considered not medically necessary.
Use of Cosentyx for Crohn's disease and rheumatoid arthritis is considered not medically necessary. Clinical trial data for Crohn's disease showed exacerbations and a terminated Phase II study with no meaningful reduction in disease activity, and rheumatoid arthritis trials did not demonstrate consistent or superior efficacy compared with available treatments.
Use of Cosentyx for uveitis is considered not medically necessary. Multiple Phase III studies (SHEILD, INSURE, and ENDURE) did not show a statistically significant difference between Cosentyx subcutaneous and placebo for uveitis outcomes.
Prior Authorization, Documentation, and Prescriber Requirements
Prior authorization is recommended for prescription benefit coverage of Cosentyx subcutaneous; approvals are provided for the durations specified in the policy (months = 30 days).
Initial approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (see indication-specific prescriber requirements below).
Prior Authorization
Indication-specific PA criteria
Indication-specific PA criteria must be met for initial and continuation approvals. Initial-therapy approvals require meeting age, prior therapy, objective inflammation, and prescriber criteria where specified by indication. Continuation/renewal approvals require documentation of established use and evidence of clinical benefit versus baseline.
Ankylosing spondylitis: Initial — patient ≥18 years and prescribed by or in consultation with a rheumatologist; Initial approvals = 6 months. Continuation — established on therapy ≥6 months and documentation of benefit by ≥1 objective measure or symptom improvement; continuation approvals = 1 year.
Background and Indication Overview
Cosentyx (secukinumab) is an interleukin‑17A (IL‑17A) antagonist indicated for several inflammatory conditions. The policy covers Cosentyx subcutaneous for FDA‑approved indications including enthesitis‑related arthritis, hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non‑radiographic axial spondyloarthritis, with indication‑specific age limits, trial requirements, objective inflammation measures, and approval durations defined in the criteria. Pivotal trials supporting certain axial disease indications required objective signs of inflammation (for example, elevated C‑reactive protein beyond the laboratory upper limit of normal or sacroiliitis on MRI) as part of enrollment and response assessment.
Definitions and Clinical Terms
inv-24: Objective signs of inflammation — definitions and examples
DefinitionObjective signs of inflammation: elevated C-reactive protein beyond the laboratory upper limit of normal and/or sacroiliitis on magnetic resonance imaging (MRI)
Context — pivotal trial requirementIn the pivotal trial for non‑radiographic axial spondyloarthritis, patients were required to have objective signs of inflammation (elevated CRP and/or sacroiliitis on MRI).
Examples of objective measures for assessmentAdditional objective measures referenced for axial disease and response assessment include ASDAS, BASDAI, BASFI, BAS‑G, BASMI, ASQoL, DFI, HAQ‑S, and serum markers (CRP, ESR).
Change TypeCriteria added and revisions (Hidradenitis Suppurativa addedtimeframe and age criteria updated)
Effective DateN/A
Next Review DateN/A
Key ActionObtain prior authorization with indication‑specific documentation and prescriber specialty verification before coverage of Cosentyx subcutaneous.
Enthesitis-related arthritis: Initial — patient ≥4 years and prescribed by or in consultation with a rheumatologist; Initial approvals = 6 months. Continuation — established on Cosentyx subcutaneous ≥6 months with documented objective response; continuation approvals = 1 year.
Hidradenitis suppurativa: Initial — patient ≥18 years, tried ≥1 other therapy, prescribed by or in consultation with a dermatologist; Initial approvals = 3 months. Continuation — established on Cosentyx subcutaneous ≥3 months with documented objective response; continuation approvals = 1 year.
Non-radiographic axial spondyloarthritis: Initial — patient ≥18 years, objective signs of inflammation (elevated CRP or sacroiliitis on MRI), prescribed by or in consultation with a rheumatologist; Initial approvals = 6 months. Continuation — established on therapy ≥6 months with documented objective response; continuation approvals = 1 year.
Plaque psoriasis: Initial — patient ≥6 years and tried ≥1 traditional systemic agent for ≥3 months (examples: methotrexate, cyclosporine, acitretin) unless intolerant or has prescriber-determined contraindication to methotrexate; a prior 3-month trial or intolerance to a biologic (non-tablet), Otezla/Otezla XR (apremilast), or Sotyktu (deucravacitinib tablets) is an exception to the traditional systemic agent requirement; medication must be prescribed by or in consultation with a dermatologist; Initial approvals = 3 months. Continuation — established on Cosentyx subcutaneous ≥3 months with documented improvement in body surface area, erythema, induration/thickness, and/or scale and symptom improvement; continuation approvals = 1 year.
Psoriatic arthritis: Initial — patient ≥2 years and prescribed by or in consultation with a rheumatologist or dermatologist; Initial approvals = 6 months. Continuation — established on Cosentyx subcutaneous or intravenous ≥6 months with documented clinical benefit; continuation approvals = 1 year.
Prior Authorization
Prior authorization requirements updated
Policy updated to specify formulation and to clarify indication-specific criteria and timeframes for established therapy and continuation.
Policy now applies specifically to the subcutaneous formulation of Cosentyx for most indications; where noted, criteria reference subcutaneous or intravenous formulations for patients currently receiving therapy.
Timeframe changes: Hidradenitis suppurativa and plaque psoriasis established-on-therapy timeframe for continuation changed to 3 months; other indications generally require ≥6 months of established therapy for continuation.
Plaque psoriasis initial-therapy notes updated to add that a 3-month trial or prior intolerance to Otezla/Otezla XR or Sotyktu is an exception to the requirement to trial a traditional systemic agent, and prescriber wording for methotrexate contraindication was modified to 'according to the prescriber, the patient has a contraindication to methotrexate.'
Documentation Required
Prescriber specialty requirement
Prescriber specialty and documentation requirements for initiation and continuation of therapy.
Initial approvals require the medication to be prescribed by or in consultation with a specialist appropriate to the condition (e.g., rheumatologist for ankylosing spondylitis, enthesitis-related arthritis, non-radiographic axial spondyloarthritis, and psoriatic arthritis; dermatologist for plaque psoriasis and hidradenitis suppurativa).
Continuation/renewal requests must document established use on Cosentyx for the required timeframe (typically ≥6 months or ≥3 months where specified) and provide objective evidence of response compared with baseline (examples: disease activity scores, validated clinical indices, serum inflammatory markers, or documented symptom improvement).
For patients currently receiving Cosentyx, the formulation to be documented is clarified (subcutaneous for most indications; subcutaneous or intravenous where explicitly noted).
Usage in policy
Listed in the appendix as the abbreviation for Non‑radiographic axial spondyloarthritis (nr-axSpA).
Related termsAppears alongside other abbreviations such as SC (Subcutaneous) and IV (Intravenous) in the appendix.
inv-26: SC — abbreviation expansion: Subcutaneous
AbbreviationSC = Subcutaneous
Context — formulation'SC' is used in the appendix to denote the subcutaneous formulation; Cosentyx subcutaneous is the formulation addressed throughout the policy.
Related abbreviationsListed in the appendix with other route abbreviations such as IV = Intravenous.