Cosentyx (secukinumab) prior authorization and medical necessity
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Defines Colorado Rocky Mountain Health Plans' prior authorization and medical necessity requirements for Cosentyx (secukinumab) prefilled syringe or Sensoready pen across indicated dermatologic and rheumatologic conditions for members; applies to prescribers seeking coverage for this medication.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial Therapy — Plaque Psoriasis
Covered when ALL of the following are met
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Reauthorization — Plaque Psoriasis
Covered when ALL of the following are met
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Initial Therapy — Psoriatic Arthritis
Covered when ALL of the following are met
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Reauthorization — Psoriatic Arthritis
Covered when ALL of the following are met
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Initial Therapy - Ankylosing Spondylitis
Covered when ALL of the following are met
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Reauthorization - Ankylosing Spondylitis
Covered when ALL of the following are met
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Initial Therapy - Non-radiographic Axial Spondyloarthritis
Covered when ALL of the following are met
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chunks 29-32
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Reauthorization - Non-radiographic Axial Spondyloarthritis
Covered when ALL of the following are met
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Initial Therapy - Enthesitis-Related Arthritis
Covered when ALL of the following are met
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Initial Therapy - Enthesitis-Related Arthritis
Covered when ALL of the following are met:
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Reauthorization - Enthesitis-Related Arthritis
Covered when ALL of the following are met:
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Initial Therapy - Hidradenitis Suppurativa
Covered when ALL of the following are met:
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Reauthorization - Hidradenitis Suppurativa
Covered when ALL of the following are met:
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Requests for Cosentyx will be denied if the patient is receiving Cosentyx in combination with another systemic targeted immunomodulator for treatment of the same indication. Examples listed in the policy include adalimumab, bimekizumab (Bimzelx), certolizumab (Cimzia), etanercept (Enbrel), tildrakizumab (Ilumya), apremilast (Otezla), risankizumab (Skyrizi), brodalumab (Siliq), deucravacitinib (Sotyktu), ixekizumab (Taltz), guselkumab (Tremfya), ustekinumab and other targeted immunomodulators.
Use of Cosentyx in combination with another systemic targeted immunomodulator for treatment of the same indication is explicitly excluded. The policy states that patients must not be receiving Cosentyx together with other systemic targeted immunomodulators (examples include adalimumab, bimekizumab, certolizumab, etanercept, abatacept, apremilast, upadacitinib, golimumab, risankizumab, ixekizumab, guselkumab, tofacitinib, and ustekinumab) for the same treated condition.
Combination therapy for the same indication is not permitted. For multiple indications the policy reiterates that patients must not receive Cosentyx in combination with another systemic targeted immunomodulator (examples include adalimumab, bimekizumab and other biologic or targeted agents) when seeking coverage for the same disease.
The change history documents administrative updates including addition of Mississippi to the state mandate footnote and multiple revisions to step therapy and combination-therapy example lists. Those entries do not introduce new clinical exclusion conditions beyond the policy's standing prohibition on concurrent use of Cosentyx with another systemic targeted immunomodulator for the same indication.
Initial Therapy — General — Initial therapy requirements vary by indication but generally require diagnosis plus prior therapy trials or prior biologic exposure.
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Initial Therapy Requirements — Initial authorization requirements by indication
Initial authorization requirements by indication
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Initial Therapy — Initial authorization requires meeting indication-specific prior therapy or current-user documentation plus prescriber specialty and comb...
Initial authorization requires meeting indication-specific prior therapy or current-user documentation plus prescriber specialty and combination therapy exclusion.
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What Providers Must Do
Prior authorization required for Cosentyx (initial approval)
Prior authorization is required for Cosentyx. For initial approvals, include the diagnosis and documentation of prior therapy trials (topical therapies and/or a 3‑month methotrexate trial at maximally indicated dose unless contraindicated) or documentation of prior systemic targeted immunomodulator therapy or current use as specified by indication.
- Document diagnosis of the indicated condition.
- Document prior topical therapy trial(s) (drug, date, duration) or methotrexate 3‑month trial (date, duration) unless contraindicated.
- If prior biologic/systemic targeted immunomodulator was used, provide claims history or medical records (drug, date, duration).
Prior authorization required — AS / nr‑axSpA initial use
Prior authorization is required for initial use of Cosentyx for ankylosing spondylitis and related axial spondyloarthropathies; include the diagnosis and meet indication‑specific prior therapy or current‑user documentation (e.g., failure of two NSAIDs each ≥4 weeks, prior targeted therapy, or documented current Cosentyx use).
- Provide diagnosis of active ankylosing spondylitis or non‑radiographic axial spondyloarthritis.
- If relying on current‑use status, submit claims history or medical records documenting date and duration of Cosentyx therapy.
Initial authorization: diagnosis plus indication‑specific prior therapy or current‑user documentation
Initial authorization requires confirmation of the diagnosis and meeting the indication‑specific prior therapy or current‑user documentation. For example, ERA requires failure of two NSAIDs each ≥4 weeks unless contraindicated, while HS initial approvals require documented current Cosentyx therapy (claims/records) and Hurley II/III diagnosis.
- Confirm diagnosis per indication.
- Provide documentation of prior therapy trials (drug name, dates, duration) or claims/medical records showing current Cosentyx use.
- For HS, document Hurley Stage II or III and date/duration of therapy; manufacturer samples/assistance do not qualify as establishing current use.
Prior authorization and step therapy change history
The policy change log records multiple revisions to step therapy and prior authorization requirements over time, including additions and removals of step agents and prescriber requirement updates; recognize that step and PA expectations have evolved and may affect current submission requirements.
- Historical changes include adding Tremfya, Skyrizi, Rinvoq, Xeljanz to step lists and later removal of some preferred‑product step requirements.
- Clarifications to documentation and bypass rules were added over multiple change‑control entries.
Step therapy expectations — topical therapies and methotrexate
Step therapy expectations: document failure of specified prior therapies before initial approval. For plaque psoriasis, require history of failure to at least one topical therapy (document drug/date/duration) and either a 3‑month methotrexate trial at maximally indicated dose unless contraindicated or prior systemic targeted immunomodulator use.
- Document topical therapy failure (e.g., corticosteroids, vitamin D analogs, tazarotene — include drug, date, duration).
- If methotrexate is used as the step, document a 3‑month trial at maximally indicated dose (date, duration) unless contraindicated.
NSAID step requirement — two NSAID trials ≥4 weeks each
NSAID step requirement: initial authorization for AS, nr‑axSpA, and ERA generally requires failure of two NSAIDs at maximally indicated doses, each used for at least 4 weeks, unless contraindicated.
- Document each NSAID trial (drug name, dates, duration) showing at least 4 weeks of therapy at maximally indicated dose.
- If contraindicated or adverse effects preclude NSAID use, document rationale.
Step therapy for ERA — two NSAID trials or documented current use
For enthesitis‑related arthritis initial requests, document either failure of two NSAIDs (each ≥4 weeks at maximally indicated doses) or provide claims/medical records showing current Cosentyx therapy; current‑user status cannot be established solely by manufacturer samples/Cosentyx Connect assistance.
- Provide drug name, dates, and duration for each NSAID trial.
- If relying on current use to bypass steps, submit claims history or medical records documenting date and duration; note samples/assistance do not qualify.
Step therapy history and revisions — verify current requirements
Change log documents numerous step therapy modifications (adding/removing agents and preferred‑product updates); be aware prior step sequences have changed and verify current step requirements before submission.
- Recent historical updates include preferred adalimumab product changes, addition of Tremfya/Skyrizi/Rinvoq/Xeljanz, and removal of preferred‑product step requirements in 10/2024.
- Confirm current step sequence via drug coverage tools as noted in change history.
Required documentation — drug names, dates, durations
Required documentation — providers must submit diagnosis and detailed prior therapy information: drug name, dates, and duration for topical therapies, methotrexate, NSAIDs, antibiotics, or prior systemic targeted immunomodulators.
- Document drug name, exact dates, and duration of each prior trial.
- For prior biologic or targeted immunomodulator therapy, submit claims history or medical records listing drug, date, and duration.
Prior therapy documentation — NSAIDs and systemic targeted therapy
Prior therapy documentation: when prior NSAID trials are required, document each NSAID (name, dates, duration) showing use at maximally indicated doses for at least 4 weeks, or provide claims/records of prior systemic targeted therapy.
- Include the NSAID name, start and end dates, and duration for each trial.
- If prior systemic targeted immunomodulator was used, include claims or medical records documenting therapy (drug, date, duration).
Current user documentation and sample exclusion
If the member is a current Cosentyx user, provide claims history or medical records documenting the date and duration of therapy; note that manufacturer‑supplied samples or Cosentyx Connect assistance cannot be used to establish current user status without supporting records.
- Submit claims history or medical records showing dates and durations for Cosentyx therapy.
- If the member was established via manufacturer samples or Cosentyx Connect, they must meet initial authorization criteria as new to therapy unless full documentation is provided.
Documentation — prior therapies and current Cosentyx use
Required documentation for prior therapies and current use: always include drug name, date, and duration for prior NSAID, antibiotic, methotrexate, or targeted immunomodulator trials; for current Cosentyx users provide claims/medical records with date and duration and document absence of manufacturer sample reliance if applicable.
- Provide drug, date, and duration for each required prior therapy trial.
- For current users, submit claims or medical records and indicate whether manufacturer samples or assistance were used.
Documentation clarifications — medical records may be required
Documentation clarifications in the change log require submission of medical records in certain cases (for example, to document current Cosentyx therapy if claim history is unavailable) — ensure medical records are attached when relying on current‑use bypasses.
- When bypassing step therapy based on current Cosentyx use and claims history is unavailable, attach medical records documenting date and duration of therapy.
- Review change log clarifications which state submission of medical records may be required.
Common triggers for denial — combination therapy, missing prior trials, lack of response
Common triggers for denial include concurrent use of Cosentyx with another systemic targeted immunomodulator for the same indication, missing documentation of required prior trials, or insufficient evidence of positive clinical response at reauthorization.
- Do not request coverage for Cosentyx in combination with another systemic targeted immunomodulator for the same indication (examples listed in policy).
- Ensure prior trials and dates/durations are fully documented to avoid denial.
- For reauthorization, document positive clinical response to therapy.
Concurrent systemic targeted immunomodulator exclusion
Concurrent targeted immunomodulator exclusion: requests will be denied if the patient is receiving Cosentyx in combination with another systemic targeted immunomodulator for the same indication (examples provided in the policy).
- Verify the patient is not concurrently treated with agents such as adalimumab, etanercept, certolizumab, bimekizumab, ixekizumab, or other listed targeted immunomodulators.
- If combination therapy is present, do not submit for Cosentyx coverage for that same indication.
Prescriber specialty and combination‑therapy denial risk
Denial may occur if prescriber specialty requirements are not met or if Cosentyx is used concurrently with another systemic targeted immunomodulator for the same indication; ensure prescriptions are from or in consultation with the required specialist (dermatologist for psoriasis/HS; rheumatologist for AS/ERA/nr‑axSpA).
- Confirm prescriber is a dermatologist for plaque psoriasis and HS, or a rheumatologist for ankylosing spondylitis, nr‑axSpA, and ERA, or document appropriate consultation.
- Do not combine Cosentyx with another systemic targeted immunomodulator for the same indication.
Verify current step/PA requirements (change‑log noted)
Not explicitly stated in these chunks — change‑history notes reference step therapy and documentation requirements which have, in other parts of the program, altered authorization pathways; verify current PA and step requirements against the latest formulary/coverage tools.
- Because step therapy and PA requirements have changed historically, confirm the current step sequence and PA code lists before submission.
- Use the plan's drug coverage tools for the most up‑to‑date step and preferred‑product requirements.
Initial Authorization Criteria by Indication
inv-01: Initial Therapy — Plaque Psoriasis — Covered when ALL of the following are met
Continuation or current-user documentation requirements
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inv-03: Initial Therapy — Psoriatic Arthritis — Covered when ALL of the following are met
Covered when ALL of the following are met
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inv-05: Initial Therapy - Ankylosing Spondylitis — Covered when ALL of the following are met
Covered when ALL of the following are met
chunks 20-23
inv-07: Initial Therapy - Non-radiographic Axial Spondyloarthritis — Covered when ALL of the following are met
Covered when ALL of the following are met
chunks 28-33
inv-09: Initial Therapy - Enthesitis-Related Arthritis — Covered when ALL of the following are met
Covered when ALL of the following are met
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inv-10: Initial Therapy - Enthesitis-Related Arthritis — Covered when ALL of the following are met:
Covered when ALL of the following are met:
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inv-12: Initial Therapy - Hidradenitis Suppurativa — Covered when ALL of the following are met:
Covered when ALL of the following are met:
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Reauthorization and Continuation Requirements
inv-43: Current Users / Continuation — Continuation or current-user documentation requirements
Continuation or current-user documentation requirements
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inv-44: Reauthorization / Continuation — Reauthorization/continuation conditions
Reauthorization/continuation conditions
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inv-45: Reauthorization/Continuation — Reauthorization requirements for continuation therapy
Reauthorization requirements for continuation therapy
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Reauthorization for plaque psoriasis requires documentation of a positive clinical response to Cosentyx therapy and confirmation that the patient is not receiving Cosentyx in combination with another systemic targeted immunomodulator for the same indication. Authorization, when criteria are met, is issued for 12 months.
inv-08: Reauthorization - Non-radiographic Axial Spondyloarthritis — Covered when ALL of the following are met
Covered when ALL of the following are met
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inv-06: Reauthorization - Ankylosing Spondylitis — Covered when ALL of the following are met
Covered when ALL of the following are met
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inv-11: Reauthorization - Enthesitis-Related Arthritis — Covered when ALL of the following are met:
Covered when ALL of the following are met:
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inv-13: Reauthorization - Hidradenitis Suppurativa — Covered when ALL of the following are met:
Covered when ALL of the following are met:
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Step Therapy Requirements and History
| Step requirement | Details |
|---|---|
| Documented methotrexate trial | |
| History of failure to a 3-month trial of methotrexate at maximally indicated dose, unless contraindicated or clinically significant adverse effects are experienced (document date and duration of trial). |
| What to document | Required elements |
|---|---|
| Drug name | |
| Document the specific prior therapy agent used (e.g., topical corticosteroid, methotrexate, NSAID, etc.). | |
| Date of trial | |
| Document start and end dates or date and duration of the prior therapy trial. | |
| Duration of trial | |
| For methotrexate: 3 months at maximally indicated dose; for NSAIDs: each NSAID used at maximally indicated dose for at least 4 weeks (when required). |
| Required prior therapies | Condition / Notes |
|---|---|
| Two NSAID trials | |
| History of failure to two NSAIDs (e.g., ibuprofen, naproxen) at maximally indicated doses, each used for at least 4 weeks, unless contraindicated or clinically significant adverse effects are experienced (document drug, date, and duration). | |
| Methotrexate trial | |
| History of failure to a 3-month trial of methotrexate at maximally indicated dose unless contraindicated (document date and duration). | |
| Specified topical therapies (psoriasis) | |
| History of failure to one topical therapy (e.g., corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) unless contraindicated; document drug, date, and duration of trial. | |
| Other prior systemic targeted immunomodulator | |
| Prior treatment with a systemic targeted immunomodulator FDA‑approved for the indication may satisfy step (document via claims or medical records). |
| History entry | Notes |
|---|---|
| Preferred adalimumab products requirement (historical) | |
| Policy change history documents updates to step therapy requiring trials of Humira/Amjevita or preferred adalimumab products in prior editions; refer to change log for dates and revisions. | |
| Addition/removal of specific agents | |
| Change log notes addition of agents (e.g., Tremfya, Skyrizi, Rinvoq, Xeljanz) and later removal of step therapy through preferred products (10/2024) with ongoing updates referenced in the history. | |
| Step therapy revisions over time | |
| Multiple historical entries record modifications to step therapy sequence and preferred product lists across 2020–2026; consult change-control history for specifics relevant to a given request date. |
Definitions and Clinical Terms
Background and Rationale
Cosentyx (secukinumab) is a human interleukin-17A antagonist with FDA-approved indications across dermatologic and rheumatologic conditions, including plaque psoriasis (pediatric and adult age ranges per indication), psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, enthesitis-related arthritis, and hidradenitis suppurativa. The policy change history shows iterative updates to indications, step therapy examples, and state mandate footnotes but maintains the clinical intent and coverage criteria for these indications.
Policy Change Log
Removed all step therapy requirements through preferred products and removed adalimumab footnote.
Annual review completed (policy administrative review noted in change log for 10/2025).
Updated combination therapy examples and language with no change to clinical intent during administrative update.
Updated background and reference only (no material clinical changes documented).
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