CurrentUnitedHealthcarePolicy 2024 P 2196-15

Cosentyx (secukinumab) prior authorization / medical necessity

UnitedHealthcare prior authorization / medical necessity program for Cosentyx (secukinumab) prefilled syringe or Sensoready pen covering multiple indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, enthesitis-related arthritis, hidradenitis suppurativa). Defines initial authorization and reauthorization clinical criteria, prescriber requirements, concomitant therapy exclusions, documentation requirements, and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyCosentyx (secukinumab) prior authorization / medical necessity

Policy CodePolicy 2024 P 2196-15

Change TypeRevised / Clarified (step therapy removed; HS added)

Effective DateJan 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapy trials (drug, date, duration), and claims history or medical records to support current Cosentyx use; document positive clinical response for reauthorization.

POLICY UPDATE CHANGES

Effective 1/1/2025 program updated; P&T approvals listed through 10/2024 and step therapy requirements removed effective 10/2024.

Clarified that patients established on therapy via manufacturer samples must meet initial authorization criteria as if new to therapy.

Added coverage criteria for hidradenitis suppurativa (HS) (1/2024).

6Covered Indications

12Excluded concomitant agents (examples)

P&T / change entries

Coverage Summary

UnitedHealthcare's prior authorization/medical necessity program for Cosentyx (secukinumab) prefilled syringe or Sensoready pen covers multiple FDA indications including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, enthesitis-related arthritis, and hidradenitis suppurativa. The policy defines both initial authorization and reauthorization clinical criteria, requires documentation of prior therapy trials and prescriber specialty (e.g., dermatologist or rheumatologist as specified by indication), and includes a concomitant targeted immunomodulator exclusion. Authorization is issued for 12 months unless otherwise specified; coverage stance is covered_with_criteria and policy status is CURRENT.

Clinical thresholds

Body Surface Area psoriasis>= 3% BSA (or palmoplantar, facial, genital involvement, or severe scalp psoriasis)

Methotrexate trial3 month trial at maximally indicated dose unless contraindicated or intolerant

NSAID trial for AS/ERAHistory of failure to two NSAIDs, each used >= 4 weeks at maximally indicated doses

Antibiotic trial for HSHistory of failure to at least 1 oral antibiotic at maximally indicated dose unless contraindicated or intolerant

Initial Therapy Criteria

General Program

Authorization will be issued for 12 months unless otherwise specified; state mandates may modify requirements.

Medication: Cosentyx (secukinumab) prefilled syringe or Sensoready pen

Program: Prior Authorization / Medical Necessity

Plaque Psoriasis - Initial Authorization

Cosentyx will be approved based on ALL of the following criteria:

Diagnosis of moderate to severe plaque psoriasis

One of the following

A. Disease extent/severity
- Greater than or equal to 3% body surface area involvement, OR palmoplantar, facial, genital involvement, OR severe scalp psoriasis

Continuation / Reauthorization Criteria

Plaque Psoriasis - Reauthorization

Cosentyx reauthorization criteria (ALL):

Documentation of positive clinical response to Cosentyx therapy

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

Psoriatic Arthritis - Reauthorization

Cosentyx reauthorization criteria (ALL):

Documentation of positive clinical response to Cosentyx therapy

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

Concomitant Therapy Exclusion & Not Covered

The policy explicitly requires that the patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed such as etanercept, certolizumab, golimumab, abatacept, adalimumab, ustekinumab, risankizumab, guselkumab, ixekizumab, brodalumab, tildrakizumab, tofacitinib, baricitinib, upadacitinib, apremilast). Combination targeted immunomodulator therapy is a coverage exclusion and may result in authorization denial if documented.

Concomitant targeted immunomodulator examples (must not be used in combination)mixedNot Covered

adalimumab	Examples: Humira/adalimumab and similar products
etanercept	Enbrel (etanercept)
certolizumab	Cimzia (certolizumab)
golimumab	Simponi (golimumab)
abatacept	Orencia (abatacept)
ustekinumab	Stelara (ustekinumab)
risankizumab	Skyrizi (risankizumab)
guselkumab	Tremfya (guselkumab)
ixekizumab	Taltz (ixekizumab)
brodalumab	Siliq (brodalumab)

1–10 of 15

1/2

Applicable Codes

Drug - NDCNDCCovered

No codes listed

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Initial and reauthorization require prior authorization with documentation of diagnosis, prior therapy trials (drug, date, duration), current therapy claim history or medical records to bypass step, and documentation of positive clinical response for reauthorization.

Documentation Required

Document trials and contraindications

Provider must document dates and durations of topical, systemic, NSAID, methotrexate, antibiotic, or biologic therapy trials and any contraindications or intolerances when claiming failure of prior therapies.

Clinical Evidence & References

Evidence: Cosentyx [package insert], October 2023. The policy criteria align with FDA indications and age-specific approvals (e.g., plaque psoriasis ≥6 years, PsA ≥2 years, ERA ≥4 years) as noted in the background and references.

Background & Definitions

Background: Cosentyx (secukinumab) is a human interleukin-17A (IL-17A) antagonist. It is FDA-indicated for moderate to severe plaque psoriasis (ages ≥6 years), active psoriatic arthritis (ages ≥2 years), adult ankylosing spondylitis, adult non-radiographic axial spondyloarthritis with objective inflammation, enthesitis-related arthritis (ages ≥4 years), and moderate to severe hidradenitis suppurativa (adults). UnitedHealthcare prior authorization criteria are aligned with these age- and indication-specific requirements, including required prior therapy trials, documentation of treatment history or current use, and prescriber specialty requirements.

Current user bypassPatient is currently on Cosentyx as documented by claims history or medical records AND has NOT used manufacturer-supplied samples or Novartis assistance to establish use

Targeted immunomodulatorBiologic or targeted synthetic DMARD examples (e.g., TNF inhibitors, IL inhibitors, JAK inhibitors, apremilast); listed examples include adalimumab, etanercept, certolizumab, golimumab, ustekinumab, risankizumab, guselkumab, ixekizumab, brodalumab, tildrakizumab, tofacitinib, baricitinib, upadacitinib, apremilast

Revision History

2024-10policy_change

Material: 10/2024 removed all step therapy requirements through preferred products and removed the adalimumab footnote; program update effective 1/1/2025 per P&T change history.

2024-10/2025-01-01effective_date_noteLatest

Effective note: P&T approvals listed through 10/2024 and program effective date 1/1/2025.

2024-01policy_change

Material: 1/2024 added coverage criteria for hidradenitis suppurativa (HS) requiring diagnosis of moderate to severe HS (Hurley Stage II or III) and a history of failure to at least one oral antibiotic trial at maximally indicated doses (or documentation of current therapy) as part of initial authorization.

Policy Summary

PayerUnitedHealthcare

PolicyCosentyx (secukinumab) prior authorization / medical necessity

Policy CodePolicy 2024 P 2196-15

Change TypeRevised / Clarified (step therapy removed; HS added)

Effective DateJan 1, 2025

Next Review Date

On This Page

B. Topical therapy failure (unless contraindicated)

History of failure to one of the following topical therapies: corticosteroids (e.g., betamethasone, clobetasol, desonide), tazarotene, vitamin D analogs (e.g., calcitriol, calcipotriene), calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), anthralin, coal tar

C. Prior systemic therapy

History of failure to a 3 month trial of methotrexate at maximally indicated dose unless contraindicated or intolerant3 months at maximally indicated dose
Patient has been previously treated with a targeted immunomodulator FDA-approved for plaque psoriasis as documented by claims history or medical records
Document date and duration

Current user bypass conditions (both required to bypass step therapy if claim history absent)

Patient is currently on Cosentyx therapy as documented by claims history or submission of medical records (document date and duration of therapy)
Patient has NOT received a manufacturer-supplied sample at no cost in prescriber's office or any form of assistance from Novartis Cosentyx Connect to establish current use

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

Prescribed by or in consultation with a dermatologist

Psoriatic Arthritis - Initial Authorization

Cosentyx will be approved based on ALL of the following:

Diagnosis of active psoriatic arthritis (PsA)

One of the following

History of failure to a 3 month trial of methotrexate at maximally indicated dose unless contraindicated or intolerant3 months at maximally indicated dose
Document date and duration of trial
Patient has been previously treated with a targeted immunomodulator FDA-approved for PsA as documented by claims history or medical records
Document date and duration

Current user bypass conditions

Patient is currently on Cosentyx therapy as documented by claims history or submission of medical records (document date and duration of therapy)
Patient has NOT received a manufacturer-supplied sample at no cost in prescriber's office or any form of assistance from the Novartis Cosentyx Connect to establish current use

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

Prescribed by or in consultation with a rheumatologist or dermatologist

Ankylosing Spondylitis (AS) - Initial Authorization

Cosentyx will be approved based on ALL of the following:

Diagnosis of active ankylosing spondylitis

One of the following

History of failure to two NSAIDs (e.g., ibuprofen, naproxen) at maximally indicated doses, each used for at least 4 weeks unless contraindicated or intolerant2 NSAIDs each used >= 4 weeks
Document drug, date, duration
Patient has been previously treated with a targeted immunomodulator FDA-approved for AS as documented by claims history or medical records
Document date and duration
Current user bypass
- Patient is currently on Cosentyx therapy as documented by claims history or submission of medical records (document date and duration of therapy)
- Patient has NOT received a manufacturer-supplied sample at no cost in prescriber's office or any form of assistance from the Novartis Cosentyx Connect to establish current use

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

Prescribed by or in consultation with a rheumatologist

Non-radiographic axial spondyloarthritis (nr-axSpA) - Initial Authorization

Cosentyx will be approved based on ALL of the following:

Diagnosis of active non-radiographic axial spondyloarthritis

One of the following

History of failure to two NSAIDs at maximally indicated doses, each used for at least 4 weeks unless contraindicated or intolerant2 NSAIDs each used >= 4 weeks
Document date and duration of trial
History of failure to Cimzia (certolizumab) or other specified agents when required by criteria, or prior treatment with a targeted immunomodulator FDA-approved for nr-axSpA as documented by claims/medical records
Document date and duration
Current user bypass
- Patient is currently on Cosentyx therapy as documented by claims history or submission of medical records (document date and duration)
- Patient has NOT received a manufacturer-supplied sample at no cost in prescriber's office or any form of assistance from the Novartis Cosentyx Connect to establish current use

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

Prescribed by or in consultation with a rheumatologist

Enthesitis-related arthritis (ERA) - Initial Authorization

Cosentyx will be approved based on ALL of the following:

Diagnosis of active enthesitis-related arthritis

One of the following

History of failure to two NSAIDs at maximally indicated doses, each used for at least 4 weeks unless contraindicated or intolerant2 NSAIDs each used >= 4 weeks
Document date and duration of trial
Current user bypass
- Patient is currently on Cosentyx therapy as documented by claims history or submission of medical records (document date and duration)
- Patient has NOT received a manufacturer-supplied sample at no cost in prescriber's office or any form of assistance from the Novartis Cosentyx Connect to establish current use

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

Prescribed by or in consultation with a rheumatologist

Hidradenitis Suppurativa (HS) - Initial Authorization

Cosentyx will be approved based on ALL of the following:

Diagnosis of moderate to severe hidradenitis suppurativa (Hurley Stage II or III)Hurley Stage II or III

One of the following

History of failure to at least one oral antibiotic (e.g., doxycycline, clindamycin, rifampin) at maximally indicated doses unless contraindicated or intolerantAt least 1 oral antibiotic trial
Document date and duration of trial
Current user bypass
- Patient is currently on Cosentyx therapy as documented by claims history or submission of medical records (document date and duration)
- Patient has NOT received a manufacturer-supplied sample at no cost in prescriber's office or any form of assistance from a Novartis sponsored program to establish current use

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

Prescribed by or in consultation with a dermatologist

AS / Non-radiographic axial spondyloarthritis - Reauthorization

Cosentyx reauthorization criteria (ALL):

Documentation of positive clinical response to Cosentyx therapy

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

ERA - Reauthorization

Cosentyx reauthorization criteria (ALL):

Documentation of positive clinical response to Cosentyx therapy

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

HS - Reauthorization

Cosentyx reauthorization criteria (ALL):

Documentation of positive clinical response to Cosentyx therapy

Patient is NOT receiving Cosentyx in combination with another targeted immunomodulator (examples listed)

Billing Rule

Claims history acceptable for current user bypass

Claims history demonstrating current Cosentyx therapy may be used to bypass prior therapy requirements; if samples or manufacturer assistance were used to establish current use, initial authorization criteria must still be met.

Step Therapy

Step therapy removed (10/2024)

As of 10/2024, all step therapy requirements through preferred products were removed; prior versions included preferred adalimumab products and other preferred biologics.

Denial Risk

Combination therapy exclusion

Authorization may be denied if patient is receiving Cosentyx in combination with another targeted immunomodulator.

2024-01-2024-10clarification

Material clarification: Across indications, patients established on therapy via manufacturer-supplied samples or Novartis assistance must meet initial authorization criteria as if new to therapy; claims history documenting current Cosentyx use may be used to bypass prior therapy requirements when available.