Inflammatory Conditions Preferred Specialty Management Policy for Employer Plans: Legacy Prescription Drug Lists
Defines preferred and non-preferred specialty drug management, prior authorization, continuation, and step therapy requirements for multiple biologic and oral therapies used to treat inflammatory conditions for employer legacy prescription drug lists.
Policy Summary
PayerCigna
PolicyInflammatory Conditions Preferred Specialty Management Policy for Employer Plans: Legacy Prescription Drug Lists
Policy CodePolicy PSM017
Change TypeMultiple preferred-product and step updates (adds/removals/clarifications)
Effective Date03/01/2026
Next Review DateN/A
Key ActionProvide prior authorization documentation showing required trials of Step 1/Preferred products or claims verification (90‑day supply within a 130‑day look‑back) when requesting initiation or continuation.
Tremfya subcutaneous was added as a Preferred Product for Ulcerative Colitis.
Hyrimoz (NDCs starting with 61314) was removed from Preferred Products across multiple indications.
Cimzia was added as an agent that counts toward a trial of a Preferred Product for juvenile idiopathic arthritis (and other specific indications).
Preferred Product lists were updated for multiple indications (examples: added Bimzelx to Step 2a for certain conditions; Cosentyx/Bimzelx added as agents counting toward preferred product trial for adults with psoriatic arthritis).
Omvoh subcutaneous moved from Step 2a to Preferred (Step 1) for Crohn's Disease and Ulcerative Colitis; Omvoh subcutaneous/IV added in various gastroenterology preferred listings.
Velsipity was added as a Preferred Product for Ulcerative Colitis (and to other relevant agents' preferred lists).
A general note was added that a trial of multiple ustekinumab products counts as one product and examples of ustekinumab products were clarified/expanded (Stelara, Wezlana, Otufli, Pyzchiva, ustekinumab-ttwe, Selarsdi, Steqeyma, Yesintek, etc.).
Adalimumab-ryvk NDCs starting with 82009 specified as the Preferred adalimumab product for rheumatology, dermatology, and gastroenterology.
Otezla XR was added to Step 1 Preferred Products for Psoriatic Arthritis and Plaque Psoriasis and counts collectively with Otezla.
PSM017coverage policy identifier
65pages
6 monthstypical initial approval
1 yearcontinuation approval
130 daysclaims look-back
2prior product trials
Coverage Criteria and Indication-specific Rules
Step therapy criteria (Rheumatology examples)
Covered when meeting the step therapy sequence according to indication-specific Step 1, Step 2a/2b, Step 3a rules
Rheumatology - RA Step 1: Step 1 Preferred agents for RA: Enbrel; Adalimumab products (Cyltezo/adalimumab-adbm, Simlandi/adalimumab-ryvk (NDCs starting with 82009), Humira (NDCs starting with 00074)).
[documentation required for prescriber-supported trial of Preferred Products when noted]
Rheumatology - RA Step 2a: Step 2a Non-Preferred (directed to ONE Step 1 Product): Tocilizumab SC products (Actemra SC, Tyenne SC) directed to adalimumab specifically; Rinvoq; Xeljanz (tablets/XR) as listed.
Directed to specific Step 1 product as noted
Rheumatology - RA Step 3a: Step 3a Non-Preferred (directed to TWO Step 1 or 2a Products) [documentation required]: Cimzia; Kevzara; Kineret; Olumiant; Orencia SC; Simponi SC.
Non-preferred products are considered medically necessary when the following indication-specific exception criteria are met.
Cimzia - Rheumatoid Arthritis Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cimzia PA criteria; AND (ii) patient has tried TWO of: a tocilizumab SC product (e.g., Actemra SC, Tyenne SC), Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR [documentation required].6 months
Multiple products of same class count as ONE product where noted; examples listed in policy.
Cimzia - Ankylosing Spondylitis Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cimzia PA criteria; AND (ii) patient has tried TWO of: Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR [documentation required].6 months
Multiple products of same class count as ONE product where noted.
Approve for 6 months if ALL of the following are met
Simponi standard criteria: Patient meets the standard Inflammatory Conditions - Simponi Subcutaneous Prior Authorization Policy criteria.
See referenced standard policy
Prior therapy requirement: Patient has tried TWO of the listed products specific to the indication (examples provided) OR other listed allowance (e.g., established therapy).2 products or specified alternatives
Examples and grouping rules provided in policy (multiple products of same group count as one)
Simponi Subcutaneous - Continuation / Established Patients
Approve for 1 year if ALL of the following are met
Standard criteria: Patient meets the standard Inflammatory Conditions - Simponi Subcutaneous Prior Authorization Policy criteria.
See referenced standard policy
Established therapy or prior trials: Patient meets one of the specified conditions (e.g., has tried required prior therapies per indication; or has been established on product for ≥90 days with claims verification or prescriber attestation).90 days established therapy
Verification in claims history required or prescriber attestation if unavailable
Approve for 6 months if ALL of the following are met
Standard criteria: Patient meets the standard Inflammatory Conditions - Tocilizumab Subcutaneous Prior Authorization Policy criteria.
See referenced standard policy
Additional requirements: Patient has tried one adalimumab product OR, per prescriber, has heart failure or a previously treated lymphoproliferative disorder.1 adalimumab product or prescriber‑stated contraindication
A trial of Cimzia, Enbrel, an infliximab product, or Simponi Aria also counts
Cimzia - Crohn's Disease / Other Conditions
Approvals and established therapy rules
Prior therapy for Crohn's: Patient has tried one of: an adalimumab product, Omvoh subcutaneous, Skyrizi subcutaneous (on‑body injector), an ustekinumab subcutaneous product, Tremfya subcutaneous, or Zymfentra; trials of certain IV products (infliximab IV, Entyvio IV, Omvoh IV, Skyrizi IV, Tremfya IV, ustekinumab IV) may also count as specified.1 product
Examples listed in policy
Established Cimzia therapy: Patient has been established on Cimzia for at least 90 days with prescription claims showing at least a 90‑day supply dispensed within the past 130 days, or prescriber verification if claims not available.90 days
Prescriber verification allowed when claims not available; samples/coupons do not satisfy requirement
Initial and continuation therapy criteria (Cosentyx/Bimzelx/Siliq)
Initial therapy approvals by indication with required criteria and durations
Ankylosing Spondylitis - Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cosentyx SC PA criteria; AND (ii) patient has tried TWO of: Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR [documentation required]. Trials of Cimzia, infliximab products, Simponi, or Bimzelx also count.6 months
Alternate Step 1/Step 2 products may be reviewed if criterion ii not met.
nr-axSpA - Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cosentyx SC PA criteria; AND (ii) patient has tried TWO of: Cimzia, Taltz, or Rinvoq [documentation required]. Trials of other specified TNFi or IL‑17 agents also count.6 months
Step 1/2 products may be reviewed if criterion ii not met.
Plaque Psoriasis - Initial Therapy:
Plaque Psoriasis - Patient Currently Receiving Siliq
Approve for 1 year when ALL of the following are met
Siliq continuation: i. Patient meets the standard Inflammatory Conditions - Siliq PA criteria; AND ii. Patient has either: (a) tried TWO of: Enbrel, an adalimumab product, Otezla/Otezla XR, Skyrizi SC, Sotyktu, an ustekinumab SC product, Taltz, or Tremfya SC [documentation required]; OR (b) has been established on Siliq ≥90 days with prescription claims indicating at least a 90‑day supply dispensed within the past 130 days (or prescriber verification if claims unavailable).
Samples/coupons do not satisfy claims‑verification unless prescriber verifies paid claims; multiple products of same molecule count as one.
Plaque Psoriasis - Ilumya
Initial: Approve for 3 months when ALL of the following are met; Continuation: Approve for 1 year when ALL met
Ilumya initial: i. Patient meets the standard Inflammatory Conditions - Ilumya PA criteria; AND ii. Patient has tried TWO of: Enbrel, an adalimumab product, Otezla/Otezla XR, Skyrizi SC, Sotyktu, an ustekinumab SC product, Taltz, or Tremfya SC [documentation required].3 months
Multiple products of same molecule count as one.
Ilumya continuation: i. Patient meets the standard Inflammatory Conditions - Ilumya PA criteria; AND ii. Patient has either: (a) tried two specified agents; OR (b) been established on Ilumya ≥90 days with claims verification of a 90‑day supply within past 130 days (or prescriber verification if claims unavailable).1 year
Prescriber verification allowed when claims unavailable; samples/coupons do not satisfy verification.
Crohn's Disease and Ulcerative Colitis - Entyvio
Approve for 6 months (initial) or 1 year (continuation) when ALL of the following are met
Entyvio initial Crohn's: i. Patient meets the standard Inflammatory Conditions - Entyvio SC PA criteria; AND ii. For Crohn's, patient has tried TWO of: an adalimumab product, Skyrizi SC, Tremfya SC, an ustekinumab SC product, Zymfentra, Omvoh SC, Cimzia, or Rinvoq [documentation required]; OR prescriber indicates patient has started/undergoing Entyvio IV induction therapy.6 months
Trials of infliximab IV or other IV agents may count if documented.
Entyvio continuation established use: Patient has been established on Entyvio SC for ≥90 days and claims show ≥90‑day supply dispensed within past 130 days (verification required), or prescriber verification if claims unavailable.>=90 days; 90‑day supply in past 130 days
If continuation criteria not met, Step 1/Step 2 products may be considered per referenced policies.
Kineret and Orencia
Initial approvals typically for 6 months; continuation approvals for 1 year when criteria met
Kineret initial RA: i. Patient meets the standard Inflammatory Conditions - Kineret PA criteria; AND ii. Patient has tried TWO of: a tocilizumab SC product, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR [documentation required].6 months
Trials of listed IV or other products may count as specified.
Kineret continuation: i. Patient meets the standard Inflammatory Conditions - Kineret PA criteria; AND ii. Patient either has tried two specified agents or has been established on Kineret ≥90 days with claims verification of a 90‑day supply within past 130 days (or prescriber verification if claims unavailable).>=90 days; 90‑day supply in past 130 days
Prescriber verification allowed when claims unavailable.
Orencia initial/continuation: Patient meets the standard Inflammatory Conditions - Orencia SC PA criteria; for initiation patient must have tried TWO of: tocilizumab SC, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR [documentation required], or have prescriber‑reported contraindication (heart failure, prior lymphoproliferative disorder, prior serious infection, demyelinating disorder). Continuation approvals commonly for 1 year when continuation verification met.
Rheumatoid Arthritis - Initial Therapy
Approve for 6 months if ALL of the following are met:
RA Initial: i. Patient meets the standard Inflammatory Conditions - Orencia Subcutaneous PA criteria; AND ii. Patient meets ONE of: (a) has tried TWO of: a tocilizumab SC product, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR [documentation required]; OR (b) per prescriber has heart failure, a previously treated lymphoproliferative disorder, a previous serious infection, or a demyelinating disorder.6 months
Trial counting rules apply; examples listed in policy.
Juvenile Idiopathic Arthritis - Initial Therapy
Approve for 6 months if ALL of the following are met:
JIA Initial: i. Patient meets the standard Inflammatory Conditions - Orencia Subcutaneous PA criteria; AND ii. Patient meets ONE of: (a) has tried TWO of: a tocilizumab SC product, Enbrel, an adalimumab product, Rinvoq/Rinvoq LQ, or Xeljanz [documentation required]; OR (b) per prescriber has heart failure, a previously treated lymphoproliferative disorder, a previous serious infection, or a demyelinating disorder.6 months
Examples and trial counting rules provided; alternative products listed that count toward trials.
Psoriatic Arthritis - Initial Therapy
Approve for 6 months if ALL of the following are met:
PsA Initial: i. Patient meets the standard Inflammatory Conditions - Orencia Subcutaneous PA criteria; AND ii. Patient meets ONE of the following (options vary by age and prior trials; includes trials of specified alternative agents or prescriber‑reported contraindications).6 months
Detailed age‑based prior trial lists and exceptions included in policy.
Continuation Therapy - Orencia
Approve for 1 year if ALL of the following are met:
Currently Receiving Orencia: i. Patient meets the standard Inflammatory Conditions - Orencia Subcutaneous PA criteria; AND ii. Patient either has tried required prior products per indication or has been established on Orencia (IV or SC) for ≥90 days with prescription claims indicating at least a 90‑day supply dispensed within past 130 days (or prescriber verification if claims unavailable).1 year
Claims verification exceptions described in policy.
Other Conditions
Other inflammatory conditions
Other Conditions: Approve Orencia subcutaneous (initial therapy for a duration as directed or 1 year for continuation) if the patient meets the standard Inflammatory Conditions - Orencia Subcutaneous PA criteria.
Applies to other conditions not specifically enumerated.
Olumiant RA Initial: i. Patient meets the standard Inflammatory Conditions - Olumiant PA criteria; AND ii. Patient has tried TWO of: a tocilizumab SC product, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR [documentation required].6 months
Mirrors Orencia prior‑trial structure; step product review if not met.
Olumiant continuation: i. Patient meets the standard Inflammatory Conditions - Olumiant PA criteria; AND ii. Patient either has tried two specified agents or has established use per claims/prescriber verification (≥90 days with 90‑day supply within past 130 days).1 year
Rinvoq Ankylosing Spondylitis Initial: i. Patient meets the standard Inflammatory Conditions - Rinvoq/LQ PA criteria; AND ii. Patient has tried one of Enbrel or an adalimumab product (a trial of Cimzia, an infliximab product, or Simponi also counts).6 months
Preferred product review pathway if prior trial not met.
Rinvoq RA Initial: i. Patient meets the standard Inflammatory Conditions - Rinvoq/LQ PA criteria; AND ii. Patient has tried one of Enbrel or an adalimumab product (a trial of Cimzia, infliximab, or Simponi also counts).6 months
If prior trial not met, request may be reviewed under Preferred Product criteria.
Rheumatoid Arthritis - Initial Therapy
Approve for 6 months if ALL of the following are met
ALL of the following
criterion i: Patient meets the standard Inflammatory Conditions - Rinvoq/LQ PA criteria
criterion ii: Patient has tried one of Enbrel or an adalimumab product (a trial of Cimzia, an infliximab product, or Simponi also counts)
Examples of adalimumab products listed in document
Psoriatic Arthritis - Initial Therapy
Approve for 6 months if ALL of the following are met
ALL of the following
criterion i: Patient meets the standard Inflammatory Conditions - Rinvoq/LQ PA criteria
criterion ii: Patient has tried one of Enbrel or an adalimumab product (a trial of Cimzia, infliximab, or Simponi variants also counts)
Ulcerative Colitis - Initial Therapy and Indication-specific prior therapy list
Approve for 6 months if ALL of the following are met
ALL of the following
criterion i: Patient meets the standard Inflammatory Conditions - Rinvoq/LQ PA criteria
criterion ii: Patient has tried one adalimumab product (trials of infliximab products, Cimzia, or Simponi subcutaneous also count)
Examples of adalimumab products listed
alternative prior therapy per indication: For patients meeting continuation criteria but lacking required prior trial, requests for specified Preferred Products for each indication may be reviewed using standard Inflammatory Conditions PA criteria.
Lists of preferred alternative products provided by indication
Continuation Therapy for patients currently receiving Rinvoq/Rinvoq LQ
Approve for 1 year if ALL of the following are met
ALL of the following
criterion i: Patient meets the standard Inflammatory Conditions - Rinvoq/LQ PA criteria
criterion ii: Patient meets ONE of the indication-specific prior therapy conditions OR has been established on Rinvoq/Rinvoq LQ for at least 90 days with claims verification (90‑day supply within past 130 days) or prescriber verification if claims unavailable
Options a‑h enumerate prior therapy per condition (see policy)
Initial therapy approvals generally for 6 months when standard Xeljanz/XR PA criteria are met plus prior biologic trials
ALL of the following
criterion i: Patient meets the standard Inflammatory Conditions - Xeljanz/XR PA criteria
criterion ii: Patient has tried one of Enbrel or an adalimumab product (trials of Cimzia, infliximab, or Simponi variants also count)
Juvenile Idiopathic Arthritis - Initial Therapy
Juvenile Idiopathic Arthritis - Initial Therapy: Approve for 6 months when ALL of the following are met
JIA initial therapy: i. Patient meets the standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND ii. Patient has tried one of Enbrel or an adalimumab product (a trial of Cimzia or an infliximab product also counts).6 months
If criterion ii not met, requests for a Preferred Product may be reviewed under respective standard PA policy.
Psoriatic Arthritis - Initial Therapy
Psoriatic Arthritis - Initial Therapy: Approve for 6 months when ALL of the following are met
PsA initial therapy: i. Patient meets the standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND ii. Patient has tried one of Enbrel or an adalimumab product (a trial of Cimzia, an infliximab product, or Simponi also counts).6 months
If criterion ii not met, requests for Step 1 Products may be reviewed under standard PA policy.
Ulcerative Colitis - Initial Therapy
Ulcerative Colitis - Initial Therapy: Approve for 6 months when ALL of the following are met
UC initial therapy: i. Patient meets the standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND ii. Patient has tried one adalimumab product (a trial of an infliximab product or Simponi subcutaneous also counts).6 months
If criterion ii not met, requests for Preferred Products may be reviewed under respective standard PA policy.
Xeljanz/XR continuation criteria
Ankylosing Spondylitis, Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, or Ulcerative Colitis - Patient is Currently Receiving Xeljanz/XR: Approve for 1 year when ALL of the following are met
Xeljanz continuation: i. Patient meets the standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND ii. Patient meets ONE of: prior trials of specified agents by indication OR established on Xeljanz/XR for ≥90 days with claims verification (90‑day supply within past 130 days) or prescriber verification if claims unavailable.1 year
If second criterion not met, alternative products may be reviewed under respective PA policy for each indication.
Other Conditions / Agent-specific approvals
Other specialty agents — general stance
Other agents approval: Approvals for Otezla/Otezla XR, Velsipity, Zeposia, Sotyktu, and others are allowed if patient meets the respective standard prior authorization policy criteria for those agents.as directed or 1 year for continuation
Specific prior authorization policies are referenced for each agent.
Table-based indication mappings
Table-based coverage/approval status for biologic and targeted agents by indication (as shown in revision details).
Table entries: Rows map drug classes and specific products to indications with symbols indicating approval or lack thereof (e.g., √ = approved for that indication, -- = not approved).
See footnotes for special pediatric indications (#, ^) and maintenance dosing (¥).
Coverage Policies provide guidance based on Cigna’s standard benefit plans but do not replace a customer's specific benefit plan document. In the event of a conflict between a Coverage Policy and a customer's benefit plan document (for example, the Group Service Agreement, Evidence of Coverage, or Summary Plan Description), the customer's benefit plan document supersedes the Coverage Policy. Coverage determinations require consideration of the applicable benefit plan terms, relevant laws/regulations, collateral materials (including Coverage Policies), and the specific facts of the request.
Any request for a non-preferred product that does not meet the documented indication‑specific exception criteria in this policy is considered not medically necessary and may be denied. The policy requires adherence to the stated exception rules for non‑preferred products; deviations from those rules do not constitute an approved exception.
Requests that do not meet the referenced standard prior authorization policy criteria for a specific product or that lack the required prior‑therapy documentation will not be approved under these non‑preferred product exception criteria. Such requests should be evaluated under the respective standard Inflammatory Conditions Prior Authorization Policy for the step or preferred product noted.
When a targeted product type is listed, requests may be routed to review under an alternate preferred‑product policy if the listed prior‑therapy requirements are not met. In other words, if step requirements directing to a Preferred Product are unmet, the request may be reviewed under the referenced standard prior authorization criteria for that Preferred Product.
Use of samples, coupons, or other manufacturer waivers does not satisfy the policy's claims-based verification requirements. Documentation of paid claims or prescription receipts is required to verify therapy; only when prescriber verification demonstrates that therapy was obtained via paid claims (not samples/coupons) will the use be considered verifiable.
If prescription claims history cannot be verified and the prescriber cannot confirm that the patient has received at least 90 days of paid therapy (or the applicable 90/120‑day threshold specified for an agent), continuation verification may not be met. In such cases, prescriber attestation of paid claims may be accepted where explicitly allowed by the drug‑specific criteria; samples and coupons do not satisfy this requirement.
No additional miscellaneous exclusions are explicitly listed in this extracted segment beyond the claims‑verification, prior‑therapy, and step‑therapy rules described elsewhere in the policy.
Removal of specific NDCs (for example, Hyrimoz NDCs starting with 61314) from the Preferred Products lists indicates those NDCs are no longer designated as Preferred for the listed indications. Prior trials of those removed NDCs, however, continue to count toward required adalimumab product trials as described in the revision notes.
The policy tables use symbols to indicate where agents are not indicated for certain conditions (entries marked -- denote agents not approved for that indication). Refer to the revision tables and footnotes for indication‑specific mappings and pediatric/maintenance annotations.
Revision tables in this policy show several products marked as not approved (--) for specific indications. Examples include agents listed as not approved for particular rheumatology or gastroenterology indications; consult the table rows and footnotes for product‑by‑indication details.
Non‑preferred products that do not meet the documented exception criteria will be considered not medically necessary and may be denied. Approval of non‑preferred agents requires meeting the specific, indication‑based exception rules set forth in this policy.
Requests lacking required prior‑therapy documentation or where prescription claims cannot verify established use (for example, inability to show a ≥ 90‑day supply within the past 130 days) may be denied or routed to review under alternate preferred product prior authorization criteria. If claims are unavailable, prescriber verification may be required per the drug‑specific rules.
This extracted portion does not include additional explicit statements beyond the prior‑therapy and continuation verification rules already described; refer to the full policy for any other exclusions or specifics not shown here.
Although this segment does not always state a formal 'not medically necessary' line item for every scenario, the policy makes clear that failure to meet required prior trials or standard prior authorization criteria implicitly places a request at risk of being considered not medically necessary.
In this excerpt there are no additional explicit 'not medically necessary' policy statements beyond the implication that requests failing to meet documented step, prior‑therapy, or verification requirements may not meet medical necessity. The appendix tables instead show per‑product approval mappings rather than separate NMN text.
RA/JIA/AS/PsA Step 1 examples: Step 1 Preferred: Enbrel and Adalimumab products (Cyltezo/adalimumab-adbm, Simlandi/adalimumab-ryvk (NDCs starting with 82009), Humira (NDCs starting with 00074)) for multiple rheumatology indications; other agents included per specific indications.
Indication-specific initial therapy exception criteria for non-preferred products
RA initial - example: Patient meets standard Cimzia PA criteria AND has tried TWO of specified agents (tocilizumab SC, Enbrel, adalimumab product, Rinvoq, or Xeljanz/XR) with documentation.
Continuation and Reauthorization Criteria
Continuation of Non-Preferred Therapy
Requirements to continue therapy on non-preferred product
Continuation verification: If patient has ≥130 days of prescription claims history, claims must show 90 or 120 days use within a 130‑day look‑back; if <130 days history, prescriber must verify 90 or 120 days of use and that product was obtained via paid claims (not samples/coupons).130 days look‑back; 90 or 120 days use
Approvals for continuation provided for 1 year unless noted otherwise.
Continuation Therapy - Cimzia
Patients currently receiving Cimzia
Continuation for current Cimzia recipients: Approve for 1 year if patient meets standard Cimzia PA criteria AND meets one of the indication‑specific prior trial conditions (e.g., RA: tried TWO of tocilizumab SC, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR) [documentation required].
Formulary Step Structure and Operational Direction
Step
Description
Examples / Notes
Step 1 (Preferred)
Preferred agents by indication — primary Step 1 options that non-preferred products are directed to when applicable.
Rheumatology examples: Enbrel; Adalimumab products (Cyltezo/adalimumab-adbm, Simlandi/adalimumab-ryvk [NDCs starting with 82009], Humira [NDCs starting with 0074]). Also includes other Step 1 agents by indication (e.g., Taltz for AS, Cimzia/Taltz for nr-axSpA, Otezla/Skyrizi/ustekinumab SC products for PsA).
Step 2a (Non‑Preferred, directed to ONE Step 1 Product)
Non-preferred agents that require trial of a specified single Step 1 product prior to approval.
Rheumatology examples: Tocilizumab SC products (Actemra, Tyenne) directed to adalimumab specifically; Rinvoq/Xeljanz agents directed to Enbrel or adalimumab as noted; indication-specific direction varies (see policy).
Step 2b (Non‑Preferred, directed to ONE Step 1 Product)
Additional non-preferred agents directed to a single Step 1 product; listing varies by indication.
Examples: Bimzelx listed as Step 2b for AS, nr-axSpA, and PsA; other cells shown as '--' where not applicable.
Step 3a (Non‑Preferred, directed to TWO Step 1 or 2a Products) [documentation required]
Higher-tier non-preferred agents that require documented trials of two Step 1 or 2a products (prescriber must provide written documentation).
Rheumatology examples (RA): Cimzia, Kevzara, Kineret, Olumiant, Orencia SC, Simponi SC. JIA/AS/PsA have separate lists; documentation required per policy. Trial-counting rules and examples provided in policy.
Non-Preferred Product
Directed To (Step 1 Product)
Documentation / Trial Requirement
Tocilizumab SC products (Actemra SC, Tyenne SC)
Adalimumab (specific adalimumab Step 1 product)
Directed to one Step 1 product (adalimumab) — documentation of trial required when noted in indication criteria.
Rinvoq / Rinvoq LQ
Enbrel or Adalimumab (depending on indication)
Directed to the specified Step 1 product for the indication; prior trial of the Step 1 product required as described in indication-specific criteria.
Bimzelx
Step 1 product (varies by indication; e.g., Enbrel or adalimumab for some diagnoses)
Listed as Step 2b in several indications (AS, nr-axSpA, PsA); trial direction is to one Step 1 product per table. Documentation required per indication when specified.
Simponi SC / Simponi Aria
Adalimumab or Enbrel (depending on indication and table direction)
Directed to a Step 1 product for Gastroenterology indications (e.g., UC) or rheumatology as shown; indication-specific prior trial and documentation requirements apply.
Patient has tried TWO of: a tocilizumab SC product, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR (documentation required)
If criterion not met, request for a Step 1 or Step 2 Product (Actemra SC, Enbrel, Humira NDCs starting with 00074, adalimumab-adbm, adalimumab-ryvk [NDCs starting with 82009], Simlandi, Rinvoq, Xeljanz) may be reviewed under respective standard PA criteria.
Psoriatic Arthritis — Cosentyx/related initiation
Patient has tried TWO of Enbrel, an adalimumab product, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Skyrizi SC, ustekinumab SC, Taltz, Tremfya SC, or Xeljanz/XR (documentation required)
If prior-step requirement not met, a request for a Preferred Product (e.g., Enbrel, Humira NDCs starting with 00074, adalimumab biosimilars, Taltz, etc.) may be reviewed under respective standard PA criteria.
Ankylosing Spondylitis — Cosentyx initiation
Patient has tried TWO of Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR (documentation required)
If criterion ii not met, request for an alternative Preferred Product may be reviewed using the respective standard Inflammatory Conditions PA criteria (examples listed in policy).
Plaque Psoriasis — Ilumya / Siliq initiation
Patient has tried TWO of listed Step 1 agents (Enbrel, adalimumab product, Otezla/Otezla XR, Skyrizi SC, Sotyktu, ustekinumab SC, Taltz, Tremfya SC) (documentation required)
If not met, Preferred Product requests may be reviewed under respective standard PA policies; continuation options include established-use verification (90‑day supply in past 130 days) when applicable.
Scenario
Action
Reference / Notes
Required prior therapy not documented
Request may be reviewed under the respective standard Inflammatory Conditions prior authorization policy for the Step 1/Step 2 or Preferred product.
Policy lists specific Step 1/Preferred products by indication that may be used for alternate review when step criteria are unmet (e.g., Enbrel, Humira NDCs starting with 00074, adalimumab-adbm, Simlandi, Rinvoq, Xeljanz).
Non-preferred initial criteria not met
Reviewer may evaluate the request against standard PA criteria for Step 1 or Step 2 products as appropriate.
See indication‑specific preferred product lists in policy (chunks 75, 81, 87) for applicable alternatives and examples. Documentation requirements remain in force.
Continuation / Initial Trial Failure
Review Path
Documentation / Verification Required
Patient does not meet continuation established-use criteria (claims not verifiable)
Request may be reviewed under the respective standard Prior Authorization Policy for the indicated Step 1/Preferred product.
If 130 days of claims history unavailable, prescriber verification that patient has received ≥90 days via paid claims may be accepted; samples/coupons do not satisfy verification. (Siliq continuation example).
Initial trial failures for non-preferred product
Requests can be reviewed under standard PA criteria for Step 1/Step 2 products listed for the indication.
Policy includes lists of Step/Preferred alternatives that may be considered when initial non-preferred criteria are not met (see Entyvio/Step 1 options).
Continuation / Initial Trial Failures
Alternative Review
Examples / Notes
Continuation criteria not met for Entyvio/Cimzia/other agents
May be reviewed under respective standard Inflammatory Conditions prior authorization policies for Preferred/Step 1/Step 2 products.
Entyvio: Step 1 or Step 2 Product requests (Humira NDCs starting with 00074, adalimumab-adbm, Cyltezo, adalimumab-ryvk NDCs starting with 82009, Simlandi, Omvoh SC, Skyrizi SC, Stelara SC, Tremfya SC, Zymfentra) may be reviewed per standard PA criteria. Documentation/claims verification requirements apply.
Patient established on therapy but lacks required prior-step trials
Reviewer may consider Preferred/Step 1 product PA criteria or require documentation of prior trials as specified.
Claims verification (90-day supply dispensed within past 130 days) or prescriber attestation required for continuation approvals; samples/coupons do not count.
Required Prior Biologic(s)
Applies To (Example Indications)
Notes / Counting Rules
One of Enbrel or an adalimumab product (or equivalent agents such as Cimzia/infliximab/Simponi variants)
Rinvoq, Xeljanz, many initiation criteria across RA, PsA, Crohn's, UC
A trial of infliximab products, Cimzia, or Simponi may count toward the requirement depending on indication; examples of acceptable adalimumab products listed in policy. Documentation required where noted.
Cimzia, Kineret, Orencia initiation for RA/JIA/PsA etc.
Multiple products from same molecular/class group count as one product (e.g., multiple adalimumab products count as one). See policy for examples and prescriber documentation requirements.
Prior Trial Rule
Implication for Initiation
Examples / Clarifications
Prior trial of one of Enbrel or an adalimumab product is required for initiation of many higher-tier agents
Applies to initiation of agents such as Rinvoq, Xeljanz/XR, and other non-preferred Step agents for multiple indications
Policy notes a trial of Cimzia, infliximab products, or Simponi variants may also satisfy the requirement in some indications; see indication-specific nodes for permitted alternatives.
If prior trial not documented, request may be reviewed under Step 1/Preferred product PA criteria
Reviewer may require documented trials or accept prescriber attestation where claims unavailable (per continuation rules)
Examples: Crohn's Disease for Rinvoq requires one adalimumab product; Ulcerative Colitis Xeljanz/XR requires one Enbrel or adalimumab product. Trial-counting rules apply.
Rule
Effect on Trial Counting
Examples / Expanded Prior IV agents
Trials of multiple ustekinumab products count as ONE prior product
Reduces need to trial multiple ustekinumab-brand variations to meet prior-product counts
Examples of ustekinumab products expanded in revisions: Stelara, Wezlana, Otulfi, Pyzchiva, ustekinumab-ttwe, Selarsdi, Steqeyma, Yesintek, etc. (policy clarifies these count collectively as one).
Prior IV products counted expanded to include Omvoh IV, Skyrizi IV, Tremfya IV, and IV ustekinumab products
These IV agents may satisfy prior-trial requirements where policy permits counting IV formulations toward Step 1/Preferred trials.
Revision notes: Omvoh IV/SC and Tremfya IV included as examples where applicable for Crohn's Disease/UC and other criteria updates. See revision details for effective dates.
Humira NDC prefix referenced for preferred product listing
NDCs starting with 82009
adalimumab-ryvk NDC prefix referenced for preferred product listing
Referenced NDC prefixes for adalimumab productsNDC
NDCs starting with 82009
adalimumab-ryvk NDC prefix referenced
NDCs starting with 00074
Humira NDC prefix referenced
Preferred/Step product NDC prefixesNDC
NDCs starting with 00074
Humira (specified NDC prefix)
NDCs starting with 82009
adalimumab-ryvk (specified NDC prefix)
Examples of NDC prefixes referencedNDC
NDCs starting with 00074
Humira (examples noted by NDC prefix)
NDCs starting with 82009
adalimumab-ryvk (example NDC prefix)
Referenced NDC prefixes for certain biologicsNDC
NDCs starting with 00074
Humira (referenced NDC prefix)
NDCs starting with 82009
adalimumab-ryvk / related products (referenced NDC prefix)
Preferred product NDC prefixesNDC
NDCs starting with 00074
Humira NDC prefix referenced for preferred product identification
NDCs starting with 82009
adalimumab-ryvk NDC prefix referenced for preferred product identification
Drug/biologic product mapping (no billing codes listed in this segment)mixed
No codes listed
Continuation verification look-back — inv-64: Continuation verification look-back — patient must have received Non-Preferred Product for specified 90 or 120 days within a 130-day look-back
RequirementIf ≥130 days of prescription claims history exist, claims must show the member received the Non‑Preferred product for the specified 90 or 120 days within a 130‑day look‑back period; if <130 days of claims history is available, the prescriber must verify the patient received the Non‑Preferred product for the specified 90 or 120 days and that it was obtained via paid claims (not samples/coupons).
Look‑back window130‑day look‑back period for claims verification
Provider Responsibilities, Prior Authorization, and Documentation
Prior Authorization
Prior Authorization Requirement
Prior Authorization Required — This program requires patients to meet the respective standard Prior Authorization Policy criteria for all medications listed. Prior authorization is required for Non‑Preferred products; Non‑Preferred products are considered medically necessary only when the specific exception criteria in this policy are met. Providers should refer to the selected standard Prior Authorization Policies for specific patient populations and indications.
All medications require meeting the respective standard Inflammatory Conditions prior authorization criteria.
Non‑Preferred products require meeting exception criteria to be considered medically necessary.
Prior Authorization
Simponi Subcutaneous Prior Authorization
Biosimilar and Product Grouping Guidance
Note
Note
Note
Note
Note
Background
Multiple biologic and targeted synthetic agents are available to treat inflammatory conditions such as rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis. FDA‑approved indications are documented in the policy appendices, and prior authorization criteria are defined in the referenced standard Inflammatory Conditions prior authorization policies.
Terminology and Abbreviations
inv-113: RA — Rheumatoid arthritis
TermRA = Rheumatoid arthritis
ContextUsed across multiple step‑therapy and prior‑authorization rules (see Step 1/2/3 criteria for rheumatology indications).
Actionable noteRefer to standard Inflammatory Conditions prior authorization policy for drug‑specific RA criteria and step requirements.
inv-114: JIA — Juvenile idiopathic arthritis
TermJIA = Juvenile idiopathic arthritis
UseAppears in pediatric indication rules (e.g., PJIA/polyarticular JIA) and in trial counting guidance for agents like Orencia, Tocilizumab, etc.
Policy Changes and Effective Dates
01/01/2025preferred_list_update
Hyrimoz NDCs starting with 61314 were removed from Preferred Products across multiple indications (e.g., RA, Psoriatic Arthritis, Plaque Psoriasis, Crohn's Disease, Ulcerative Colitis); prior trials of those NDCs continue to count toward an adalimumab product trial.
03/15/2025preferred_list_update
Omvoh subcutaneous moved from Step 2a to Preferred (Step 1) for Crohn's Disease and Ulcerative Colitis, and Omvoh SC was added to various gastroenterology preferred listings; Velsipity added as Preferred for Ulcerative Colitis in select mappings.
04/01/2025preferred_list_update
Policy Summary
PayerCigna
PolicyInflammatory Conditions Preferred Specialty Management Policy for Employer Plans: Legacy Prescription Drug Lists
Policy CodePolicy PSM017
Change TypeMultiple preferred-product and step updates (adds/removals/clarifications)
Effective Date03/01/2026
Next Review DateN/A
Key ActionProvide prior authorization documentation showing required trials of Step 1/Preferred products or claims verification (90‑day supply within a 130‑day look‑back) when requesting initiation or continuation.
Approve for 6 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cimzia PA criteria; AND (ii) patient has tried TWO of: a tocilizumab SC product, Enbrel, an adalimumab product, Rinvoq/Rinvoq LQ, or Xeljanz [documentation required]; trials of certain IV agents (Actemra IV, infliximab, Omvoh IV, etc.) or other biologics may count as specified.
6 months
Trials of IV forms or alternative biologics may count per policy; multiple product trials in same class may count as one.
Cimzia - Psoriatic Arthritis Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cimzia PA criteria; AND (ii) patient has tried TWO of: Enbrel, an adalimumab product, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Skyrizi SC, an ustekinumab SC product, Taltz, Tremfya SC, or Xeljanz/XR [documentation required].6 months
Class/product counting rules apply as specified.
Plaque Psoriasis Initial Therapy: Approve for 3 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cimzia PA criteria; AND (ii) patient has tried TWO of: Enbrel, an adalimumab product, Otezla/Otezla XR, Skyrizi SC, Sotyktu, an ustekinumab SC product, Taltz, or Tremfya SC [documentation required].3 months
See policy for product examples and counting rules.
Crohn's Disease Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cimzia PA criteria; AND (ii) patient has tried ONE of: an adalimumab product, Omvoh SC, Skyrizi SC (on-body injector), an ustekinumab SC product, Tremfya SC, or Zymfentra (with certain IV biologics counting as specified).6 months
Some IV biologics or alternatives count toward requirement as noted.
Currently Receiving Cimzia - Continuation: Approve for 1 year if BOTH: (i) patient meets the standard Inflammatory Conditions - Cimzia PA criteria; AND (ii) patient meets one of the indication-specific prior trial conditions or is established on Cimzia per verification rules.1 year
Lists multiple indication-specific prior-trial combinations that qualify for continuation approval.
Approve for 3 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cosentyx SC PA criteria; AND (ii) patient has tried TWO of: Enbrel, an adalimumab product, Otezla/Otezla XR, Skyrizi SC, Sotyktu, an ustekinumab SC product, Taltz, or Tremfya SC [documentation required].
3 months
Preferred product review pathway if criterion ii not met.
Psoriatic Arthritis - Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Cosentyx SC PA criteria; AND (ii) patient meets ONE of: (a) age ≥18 and has tried TWO of listed agents; OR (b) age <18 and has tried ONE of specified agents [documentation required].6 months
Age‑specific trial requirements and counting rules apply.
Patients currently receiving Cosentyx/other agent: Approve for 1 year if BOTH: (i) patient meets the standard Inflammatory Conditions - Cosentyx SC PA criteria; AND (ii) patient meets one of multiple listed prior therapy histories appropriate to the indication or has established use (≥90 days with claims verification).1 year
Includes multiple indication‑specific prior‑therapy options; see criteria for specifics.
6 months initial; 1 year continuation
Lists of acceptable Step/Step 1/Step 2 products provided in policy.
AS initial - example:
Patient meets standard Cimzia PA criteria AND has tried TWO of specified agents (Enbrel, adalimumab product, Rinvoq, Taltz, or Xeljanz/XR) with documentation.
JIA initial - example: Patient meets standard Cimzia PA criteria AND has tried TWO of specified agents (tocilizumab SC, Enbrel, adalimumab product, Rinvoq/Rinvoq LQ, Xeljanz) OR other listed agents count as noted.
PsA initial - example: Patient meets standard Cimzia PA criteria AND has tried TWO of specified agents (Enbrel, adalimumab product, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Skyrizi SC, ustekinumab SC, Taltz, Tremfya SC, Xeljanz/XR) with documentation.
Plaque Psoriasis initial - example: Patient meets standard Cimzia PA criteria AND has tried TWO of specified agents (Enbrel, adalimumab product, Otezla, Skyrizi SC, Sotyktu, ustekinumab SC, Taltz, Tremfya SC) with documentation; approve for 3 months.3 months
Crohn's Disease initial - example: Patient meets standard Cimzia PA criteria AND has tried ONE of specified agents (adalimumab product, Omvoh SC, Skyrizi SC on‑body injector, ustekinumab SC, Tremfya SC, or Zymfentra); approve for 6 months.6 months
Initial therapy — Initial approval rules by indication
Initial approval rules by indication
General: Patient meets standard Simponi Subcutaneous Prior Authorization Policy criteria.
Referenced standard policy must be met
Prior therapy requirement: Patient has tried TWO of the specified prior therapies per indication (lists differ by indication) or other listed single-product requirements where specified.2 (or as specified)
Examples and grouping rules provided; multiple products within same molecular group count as one trial
Tocilizumab initial therapy (polyarticular JIA)
Tocilizumab subcutaneous initial therapy for Polyarticular Juvenile Idiopathic Arthritis
Tocilizumab criteria: Patient meets standard Tocilizumab Subcutaneous PA criteria AND (has tried one adalimumab product OR, per prescriber, has heart failure or a previously treated lymphoproliferative disorder).1 adalimumab product or prescriber‑stated condition
A trial of Cimzia, Enbrel, an infliximab product, or Simponi Aria also counts
Initial therapy nodes
Indication-specific initial therapy approval when all criteria are met
Ankylosing Spondylitis initial: See Cosentyx criteria: approve for 6 months when standard Cosentyx SC PA criteria and specified two‑agent prior‑trial requirements are met.
nr-axSpA initial: See Cosentyx criteria: approve for 6 months when standard Cosentyx SC PA criteria and specified two‑agent prior‑trial requirements are met.
Plaque Psoriasis initial: See Cosentyx criteria: approve for 3 months when standard Cosentyx SC PA criteria and specified two‑agent prior‑trial requirements are met.
Psoriatic Arthritis initial: See Cosentyx criteria: approve for 6 months when standard Cosentyx SC PA criteria and age‑specific prior‑trial requirements are met.
Initial therapy rules — Initial approval durations and requirements vary by drug and indication
Initial approval durations and requirements vary by drug and indication.
Ilumya initial: Approve for 3 months if patient meets Ilumya PA criteria AND has tried two listed prior agents (documentation required).3 months
Multiple products of same molecule count as one.
Entyvio initial: Approve for 6 months if patient meets Entyvio PA criteria AND has tried two listed prior agents for the specific indication, or prescriber indicates Entyvio IV induction therapy is underway.6 months
Examples and counting rules provided.
Kineret/Orencia initial: Approve for 6 months if patient meets standard PA criteria AND has tried two listed prior agents (documentation required) or meets other specified clinical exceptions per prescriber (Orencia).6 months
Initial Therapy Common Pattern: i. Patient meets the respective standard Inflammatory Conditions Prior Authorization Policy criteria for the indicated drug; AND ii. Patient has tried specified prior biologic or targeted therapies (commonly two products for many Orencia indications; lists vary by indication).
Approval duration often 6 months for initial therapy.
Initial therapy rules — Initial therapy approvals typically for 6 months when standard PA criteria met plus prior biologic trial
Initial therapy approvals typically for 6 months when standard prior authorization criteria are met plus prior biologic trial
ALL of the following
criterion i: Meets standard Inflammatory Conditions - Rinvoq/LQ or Xeljanz/XR PA policy criteria
criterion ii: Has tried required prior biologic (e.g., Enbrel or an adalimumab product; infliximab, Cimzia, Simponi variants may count)
Initial therapy rules — Initial therapy approvals and requirements by indication
Initial therapy approvals and requirements by indication
Initial therapy general: Patient meets standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND patient has trialed specified Step 1 products (commonly Enbrel or an adalimumab product) or equivalent agents as listed per indication.6 months
If step trials not met, requests for Preferred or Step products may be reviewed under respective PA policies.
Initial preferred product assignments
Preferred/Step 1 product direction
Step preference examples: Omvoh subcutaneous moved to Preferred (Step 1) for Crohn's Disease and Ulcerative Colitis; Velsipity and Tremfya SC added as Preferred products for select GI and rheumatology indications; adalimumab‑ryvk (NDCs starting with 82009) specified as the Preferred adalimumab product across indications.
See revision details for specific moved/added products and effective dates.
Continuation/renewal rules for patients currently receiving Simponi subcutaneous or Simponi Aria
Continuation approval: Approve for 1 year if patient meets standard Simponi SC PA criteria and meets one of the listed clinical/prior therapy conditions (e.g., prior trials per indication or established therapy ≥90 days with claims verification or prescriber attestation).90 days for established therapy option
Claims verification required or prescriber attestation when claims not available.
Continuation therapy verification
Criteria for patients currently receiving therapy
Established on product (general): Patient has been established on product (e.g., Bimzelx, Cosentyx SC, Siliq) for at least 90 days and prescription claims history indicates at least a 90‑day supply was dispensed within the past 130 days, or if claims history unavailable, prescriber verification is required. Exceptions allowed if prescriber attests to paid claims.>=90 days; 90‑day supply within past 130 days
Verification rules apply consistently across continuation criteria.
Continuation therapy (selected agents)
Continuation approvals require meeting the referenced drug-specific standard prior authorization criteria plus evidence of established use or prior trials.
Siliq continuation: Patient meets Siliq standard PA criteria AND either has tried two listed alternative agents OR has been established on Siliq ≥90 days with claims showing ≥90‑day supply within past 130 days (or prescriber verification if claims unavailable).90 days established; 90‑day supply in past 130 days
Approve for 1 year when met.
Entyvio continuation
Entyvio continuation rules
Entyvio continuation: Approve for 1 year when patient meets Entyvio standard PA criteria AND either has tried two specified prior agents (for indication) OR has been established on Entyvio IV/SC per prescriber/claims verification as described.>=90 days established; 90‑day supply in past 130 days
Initial approvals often 6 months; continuation 1 year.
Continuation therapy - Orencia
Continuation criteria for patients currently receiving agent
Continuation - Orencia: i. Meets standard Inflammatory Conditions - Orencia criteria; AND ii. Either prior trials per indication or evidence of establishment on therapy (≥90 days and 90‑day supply within past 130 days) as described.1 year
Approval commonly for 1 year.
Rinvoq continuation
Continuation approval requirements for patients currently on Rinvoq/Rinvoq LQ
ALL of the following
duration verification: Patient has been established on Rinvoq/Rinvoq LQ for at least 90 days with claims verifying at least a 90‑day supply dispensed within the past 130 days or prescriber verification if claims not available90 days; 130‑day look‑back
Exception allowed if prescriber verifies paid claims exist and patient did not use samples or coupons
Xeljanz/XR continuation
Criteria for patients currently receiving Xeljanz/XR or Xeljanz
Xeljanz established use: i. Meet standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND ii. Meet one of: prior trials of specified agents by indication OR established on Xeljanz/XR for ≥90 days with at least a 90‑day supply dispensed within past 130 days (or prescriber verification if claims unavailable).1 year
Verification required via prescription claims history or prescriber.
Verified duration optionsSpecified continuation verification period: 90 days or 120 days of use within the 130‑day look‑back (as noted per criterion).
Prescriber attestation allowanceWhen claims history is unavailable, prescriber verification may substitute if prescriber confirms ≥90/120 days of paid claims (samples/coupons do not qualify).
inv-65: Established therapy verification window — At least a 90-day supply dispensed within the past 130 days
Minimum dispensed supplyAt least a 90‑day supply dispensed within the past 130 days (claims history verification required).
Established therapy durationPatient generally must be established on therapy ≥90 days to qualify for continuation verification options referencing claims.
Prescriber verificationIf claims history unavailable, prescriber verification of ≥90 days and paid claims may be accepted (samples/coupons excluded).
Applies toContinuation criteria for multiple agents (e.g., Cimzia, Simponi, Bimzelx, Cosentyx) reference this 90‑day supply / 130‑day look‑back verification window.
inv-66: Established therapy verification window — At least 90 days established on therapy and evidence of at least a 90-day supply dispensed within the past 130 days
Core requirementPatient established on therapy ≥90 days AND prescription claims show at least a 90‑day supply dispensed within the past 130 days for continuation approval.
Claims vs prescriberVerification via claims is preferred; if claims unavailable, prescriber attestation verifying ≥90 days of paid claims may be accepted (samples/coupons do not satisfy).
Applies toUsed broadly across continuation rules for agents such as Cosentyx, Bimzelx, Siliq and others where established‑use verification is required.
inv-67: Claims verification window — At least a 90-day supply dispensed within the past 130 days
Claims verification standardAt least a 90‑day supply dispensed within the past 130 days is required in prescription claims history to verify established use for continuation approvals.
Prescriber fallbackIf claims history cannot be verified, prescriber verification of ≥90 days of paid claims may be accepted (use of samples/coupons does not satisfy verification).
Applies to agentsReferenced in continuation criteria for Siliq, Ilumya, Entyvio and similar agents where claims verification is required for continuation coverage.
inv-68: Established therapy verification — Patient established on therapy ≥ 90 days and prescription claims show ≥ 90‑day supply dispensed within past 130 days
Established therapy definitionPatient established on therapy ≥90 days and prescription claims show at least a 90‑day supply dispensed within the past 130 days (claims verification required).
Prescriber verificationIf claims history unavailable, prescriber attestation confirming ≥90 days of paid claims may be accepted; samples/coupons excluded.
Continuation durationWhen verified, continuation approvals are typically authorized for 1 year unless noted otherwise.
inv-69: Rinvoq established therapy verification window — 90-day supply dispensed within past 130 days
Rinvoq verification requirementVerification in prescription claims history that at least a 90‑day supply of Rinvoq was dispensed within the past 130 days is required for continuation; if claims unavailable, prescriber verification may be accepted.
Established durationPatient must have been receiving Rinvoq/Rinvoq LQ for at least 90 days to meet established‑use continuation criteria.
Samples/coupons exclusionPrescriber verification must confirm the use was via paid claims (samples/coupons do not satisfy continuation verification).
inv-70: Established Xeljanz therapy verification — At least a 90-day supply dispensed within the past 130 days (or prescriber verification if claims unavailable)
Xeljanz established‑use verificationAt least a 90‑day supply of Xeljanz/XR dispensed within the past 130 days in prescription claims history is required to verify established therapy; if claims are unavailable, prescriber verification may be accepted.
Applies to formulationsRequirement applies to Xeljanz and Xeljanz XR (including oral solution where noted) for continuation approvals across listed indications.
Paid claims requirementPrescriber attestation must confirm therapy was obtained via paid claims (samples/coupons excluded) when used in lieu of claims history.
inv-71: Maintenance dosing note — Maintenance dosing only (¥)
Maintenance dosing annotation^ or ¥ annotation in tables indicates maintenance dosing only (maintenance dosing restrictions apply as noted).
Table footnote useFootnotes in Appendix/tables reference maintenance‑only dosing and other special annotations for indicated products.
ImplicationProducts marked with maintenance‑only annotation are intended for ongoing therapy rather than initial/induction dosing per table guidance.
Simponi® (golimumab) subcutaneous — Prior authorization is required. Requests for Simponi subcutaneous are reviewed against the standard Inflammatory Conditions - Simponi Subcutaneous Prior Authorization Policy criteria. When initial-therapy criteria require prior trials, the prescriber must provide documentation that the patient has tried the required Step 1/2 agents as noted.
Patient currently receiving Simponi subcutaneous: verification in prescription claims history (≥90 days supply within past 130 days) or prescriber verification when claims history unavailable.
If prior‑step trials are not documented, requests may be reviewed under the respective standard Inflammatory Conditions PA criteria for Step 1/Step 2 products.
Prior Authorization
Reference Standard Prior Authorization Policies
Reference Standard Inflammatory Conditions Prior Authorization Policies — Many approvals and step‑directed reviews require that patients meet the referenced standard prior authorization policy for the specific biologic/subcutaneous product. If the standard policy criteria are met, but the step/agent‑trial requirements in this policy are not, reviewers may route requests to the respective standard Inflammatory Conditions PA policy for adjudication.
When this policy directs review to a Step 1 or Step 2 product, the request may be reviewed using the respective standard Inflammatory Conditions prior authorization policy criteria.
Authorization Durations and Prior Authorization Requirements — Prior authorization approvals are duration‑limited and vary by agent and indication. Continuation approvals are generally provided for 1 year unless noted otherwise; some initial approvals are issued for shorter durations (e.g., 3 or 6 months) as specified in indication‑specific criteria.
Continuation of therapy approvals for Preferred and Non‑Preferred products: typically 1 year unless otherwise noted.
Initial therapy approvals: commonly 3 or 6 months depending on the agent and indication (see indication‑specific criteria).
When initial approval is in months, 1 month = 30 days.
Prior Authorization
Prior Authorization and Approval Durations
Prior Authorization and Duration — Some products (e.g., Xeljanz/XR, Rinvoq, Simponi, Cimzia, Orencia, Cosentyx, Entyvio, Siliq, Ilumya, etc.) have indication‑specific initial approval durations stated in the criteria. Continuation approvals frequently require verification of prior use via claims history or prescriber attestation.
Initial-therapy approvals: commonly 6 months for many indications; some products/indications list 3 months.
Continuation approvals: commonly 1 year if verification requirements are met (claims history or prescriber verification).
Step Therapy
Impact of Preferred/Step Changes on PA
Preferred Product and Step Changes Affect Prior Authorization — Changes to the Preferred/Step assignments (e.g., Omvoh moved between Step 2a and Preferred, addition of Velsipity as Preferred for UC) may alter required prior‑step trials and reviewed pathways. Providers should check the current Step 1 (Preferred) and Step 2/3 (Non‑Preferred) direction for each indication before submitting documentation.
When a product moves to Preferred (Step 1) or between steps, prior‑trial requirements for Non‑Preferred agents directed to that product may change.
Example: Omvoh subcutaneous was moved from Step 2a to Preferred for UC/Crohn's Disease — affects directed trials for some Non‑Preferred agents.
Denial Risk
Non‑Preferred Product Exception Criteria
Non‑Preferred Product Exceptions — Non‑Preferred products are considered medically necessary only when the specific exception criteria in this policy are met. Any other exception not described in the policy is considered not medically necessary and may be denied.
Exception approvals require meeting BOTH the referenced standard PA policy criteria and the additional exception criteria (e.g., required prior trials, documentation).
If exception criteria are not met, the request will be considered not medically necessary.
Denial Risk
Failure to Meet Step or PA Prerequisites
Failure to Meet Step/PA Prerequisites — Requests that do not document required prior‑step therapy trials, or that fail to meet the referenced standard prior authorization policy criteria, may be denied or routed to review under Preferred Product criteria if documentation is insufficient.
If required prior trials are not documented, a request may be reviewed under Preferred Product or Step 1/2 criteria where applicable.
Claims lacking covered codes under the policy will be denied (see Billing/Coding instructions in 'INSTRUCTIONS FOR USE').
Documentation Required
Documentation for Preferred Product Trials
Documentation for Preferred Product Trials — When the criteria indicate [documentation required], the prescriber must supply written documentation of prior trials of Preferred Products. Acceptable documentation includes chart notes, prescription claims records, and/or prescription receipts. All documentation must include patient‑specific identifying information.
Documentation may be used to demonstrate trials when claims history is unavailable.
A trial of more than one adalimumab or ustekinumab product may count as ONE preferred product trial where noted.
Documentation Required
Prior Therapy Documentation and Claims Verification
Prior Therapy Documentation and Claims Verification — For continuation requests, verification of prior use is required as specified (e.g., [verification in prescription claims history required] or [verification by prescriber required]). If prescription claims history of at least 130 days is available, claims must show the required 90‑ or 120‑day supply within the 130‑day look‑back. If claims history is unavailable, prescriber attestation must confirm the patient has been receiving the agent for the specified duration and via paid claims.
Typical verification: ≥90 days of therapy dispensed within past 130 days (or 120 days where specified).
When claims history is unavailable, prescriber verification must attest to duration and that therapy was via paid claims (no samples/coupons).
Documentation Required
Required Prior Therapy Documentation
Prior Therapy Documentation — Many indication‑specific criteria require documentation that the patient has tried specified prior biologic or targeted therapies (examples include trials of adalimumab products, tocilizumab SC, Enbrel, Rinvoq, Xeljanz/XR, etc.). Prescribers must provide written proof when the criteria indicate [documentation required].
A trial of multiple products within the same class (e.g., multiple adalimumab or ustekinumab products) may count as ONE trial when stated.
Documentation can include chart notes, claims, or prescription receipts and must be patient‑specific.
Documentation Required
Required Documentation and Verification
Required Documentation and Verification — Failure to provide required documentation or claims verification may result in denial or review under alternate Preferred Product criteria. Reviewers may accept claims history verification or prescriber attestation per the criteria. For certain products (e.g., Rinvoq, Simponi, Entyvio, Siliq, Ilumya, Xeljanz/XR), verification of at least 90 days of prior therapy within 130 days is a common requirement for continuation approvals.
If prescription claims history is insufficient, prescriber must attest to duration and paid‑claim status.
Missing documentation may lead to routing to alternative review pathways or denial.
Documentation Required
Documentation and Verification of Prior Therapies
Required Documentation of Prior Therapy and Claims Verification — Many initial and continuation criteria explicitly count prior biologic/targeted therapies toward required trials (e.g., infliximab IV products, Orencia IV/SC, Actemra IV/SC, Entyvio, Omvoh). When the policy counts these products, prescribers must document those prior therapies per the [documentation required] instruction.
Prior IV or alternate route products may count toward required trials where specified (document accordingly).
A trial of an infliximab IV product, Omvoh IV, or other IV biologic is explicitly accepted as counting for some indications — include documentation.
Note
Provider Action — Additional Details Not Present
Provider Action Notes Not Present in This Excerpt — Specific provider actions or denial triggers beyond general documentation, claims‑verification, and referenced standard PA policies are not explicitly stated in this excerpt. Providers should follow the general instructions above and consult the referenced standard Prior Authorization Policies for additional, indication‑specific procedural requirements.
No additional explicit denial triggers detailed here; follow the standard PA policies and documentation/verification rules in this section.
Step Therapy
Formulary Step Direction and Structure
Formulary Step Direction and Step Therapy Review — This policy uses a multi‑step formulary structure: Step 1 = Preferred Products; Step 2/3 = Non‑Preferred Products (with direction to specific Step 1 or Step 2 agents). Many Non‑Preferred approvals require trials of one or more Step 1 or 2a products directed to specific agents.
Step 2a/2b/3a directions specify the required number and identity of prior Step 1/2 trials.
When a Non‑Preferred agent is directed to a specific Step 1 product, the trial must be of that agent unless the policy states otherwise.
Step Therapy
Step Therapy and Alternative Review Pathways
Step Therapy and Alternative Review — If the required prior‑step therapies are not met or documented, requests for Non‑Preferred products may be reviewed under the Step 1/Step 2 Preferred Product PA criteria instead. Reviewers may accept alternative agents that the policy lists as counting toward Step 1/Preferred trials.
Examples: When Cosentyx SC criteria are met but required prior trials are not documented, requests for certain Preferred Products may be reviewed under the respective standard PA policies.
Policy lists alternative agents that count toward required trials — include those in documentation.
Step Therapy
Step Therapy / Preferred Product Review Path
Step Therapy / Preferred Product Review — Requests may be reviewed under Step 1 (Preferred) or Step 2 Preferred Product PA criteria when prior‑step therapies are not met or when the policy directs a review to a Preferred Product. Providers should submit documentation of all prior agents tried to expedite correct routing.
If documentation shows trials of Preferred Products, reviewers will apply the appropriate standard Inflammatory Conditions PA criteria.
Where the policy directs review to a Preferred Product, the provider may submit under that product's standard PA policy.
Step Therapy
Step Product Review Pathway
Step Product Review Pathway and Requirements — Initial failures of Step 1 or Step 2 therapies are generally reviewed under the respective standard Inflammatory Conditions PA policies. Many Non‑Preferred agent approvals require trials of specific biologics (examples listed in each indication). Prescribers must provide documentation as noted to demonstrate compliance with these step requirements.
Examples of required prior trials: Enbrel, Humira or other adalimumab products, Actemra SC/Tyenne SC, Cimzia, Xeljanz/XR, Rinvoq, etc.
A trial of multiple products within a class may count as one trial per policy notes.
Step Therapy
Step Therapy Trial Requirements
Step Therapy Requirements — The policy often requires trials of specified prior biologic therapies before a Non‑Preferred agent will be approved (e.g., two distinct prior products for many indications). Where noted, a trial of more than one product in the same branded class (adalimumab or ustekinumab examples) may count as ONE trial. Prescribers should document each distinct agent and duration per the criteria.
Many indications require trials of TWO prior products from listed agents for initial approvals.
When the policy specifies that a trial of multiple adalimumab or ustekinumab products counts as ONE product, indicate that in documentation.
Actionable noteRefer to age‑specific prior‑trial lists and documentation requirements when evaluating JIA requests.
inv-115: AS — Ankylosing spondylitis
TermAS = Ankylosing spondylitis
ApplicationListed in step‑therapy direction and prior‑trial requirements for IL‑17/other agents (e.g., Cosentyx, Taltz).
Actionable noteCheck indication‑specific Step 1 preferred agents and required prior trials for AS when authorizing therapy.
ApplicationAppears in IL‑17/IL‑23 agent criteria and counts toward prior‑trial options (examples provided).
Actionable noteVerify trials of listed preferred agents (e.g., Enbrel, adalimumab products, Cimzia/Taltz) per nr‑axSpA criteria.
inv-117: PsA — Psoriatic arthritis
TermPsA = Psoriatic arthritis
ApplicationUsed in age‑specific and adult prior‑trial requirements across multiple agents (Orencia, Cosentyx, Cimzia, etc.).
Actionable noteConfirm indication‑specific required prior products (number/age criteria) before approval; see referenced PA policy for details.
inv-118: SC — Subcutaneous
TermSC = Subcutaneous
ContextMany preferred/non‑preferred products are listed by formulation (SC vs IV) and the SC formulation is frequently referenced in Step 1 preferred lists and continuation criteria.
Actionable noteConfirm requested formulation (SC vs IV) against the indication‑specific preferred product lists and table footnotes.
inv-119: Preferred/Step 1 Product definition
DefinitionPreferred/Step 1 Product = products designated as preferred at Step 1 for each indication (examples include adalimumab products, Enbrel, Cosentyx SC, Skyrizi SC, ustekinumab SC products).
ImplicationTrials of Preferred/Step 1 products are generally required before approval of Non‑Preferred (Step 2/3) products unless exception criteria are met.
DocumentationWhen noted, prescriber must supply written documentation supporting trials of Preferred Products (chart notes, claims records, receipts).
inv-120: Non-Preferred/Step 2 or 3 Product definition
DefinitionNon‑Preferred/Step 2 or 3 Product = products designated as non‑preferred at Step 2a/2b/3a/3b which require trials of specified Step 1 (or Step 1/2) products or documentation to qualify for coverage.
Directed trialsStep 2/3 products are often directed to ONE or TWO Step 1 products (per indication) and may require documentation of prior trials as specified.
Review pathwayIf step criteria not met, requests may be reviewed under respective standard Inflammatory Conditions prior authorization policies for Preferred/Step products.
inv-121: Grouped product trials — rules for counting multiple products in same class
RuleGrouped product trials: trials of multiple products within the same molecular/class group (e.g., multiple adalimumab products, multiple tocilizumab products, both Xeljanz formulations, both Rinvoq products) count as a single product trial toward prior‑therapy requirements.
ExamplesMultiple adalimumab products counted as ONE trial; multiple ustekinumab products count as ONE trial; both Xeljanz formulations collectively count as ONE trial.
ImplicationWhen evaluating required prior trials, aggregate products by molecular/class grouping per policy rules to determine trial counts.
inv-122: Adalimumab products — examples list
ExamplesAdalimumab products listed as examples include Humira, Abrilada, adalimumab‑aacf, adalimumab‑adaz, adalimumab‑adbm, adalimumab‑fkjp, adalimumab‑aaty, adalimumab‑ryvk (Simlandi), Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, and Yusimry.
Counting ruleA trial of multiple adalimumab products counts as ONE prior product toward step requirements.
UseThese examples are referenced across many indication‑specific prior‑trial lists (RA, JIA, Crohn's, UC, PsA, PsO, etc.).
inv-123: Ustekinumab products — examples list
ExamplesUstekinumab products examples include Stelara/ustekinumab and additional listed SC/IV examples (Stelara, Wezlana, Otulfi/Otufli, Pyzchiva, ustekinumab‑ttwe, Selarsdi, ustekinumab‑aekn, Starjemza, Steqeyma, Yesintek).
Counting ruleA trial of multiple ustekinumab products counts as ONE product toward prior‑therapy requirements (policy note added).
ImplicationUstekinumab SC or IV examples may count as prior trials where specified for Crohn's, UC, PsA, and psoriasis criteria.
inv-124: Trial counts — A trial of multiple products within same molecule counts as one
RuleTrial counts: A trial of multiple products within the same molecule class (e.g., multiple adalimumab products or multiple ustekinumab products) counts as one product toward the required prior trial count.
Xeljanz/Rinvoq groupingTrials of both formulations of Xeljanz collectively count as one product; trials of both Rinvoq formulations collectively count as one product.
Operational impactWhen documenting prior trials, group same‑molecule products together to determine whether required number of distinct trials is met.
inv-125: Trial counting rules — A trial of multiple products within same molecular class counts as one
RuleTrial counting rules: a trial of multiple products within the same molecular class counts as one product toward prior‑therapy requirements (applies to adalimumab, ustekinumab, tocilizumab, etc.).
ExamplesMultiple adalimumab products or multiple tocilizumab products count as ONE trial; multiple ustekinumab products also count as ONE trial.
DocumentationPrescriber documentation should reflect specific products tried and dates to support grouped counting when required.
inv-126: Established on Rinvoq/Rinvoq LQ — definition for continuation verification
DefinitionEstablished on Rinvoq/Rinvoq LQ = patient has been receiving Rinvoq/Rinvoq LQ for at least 90 days with prescription claims indicating at least a 90‑day supply dispensed within the past 130 days, or prescriber verification if claims unavailable.
VerificationClaims verification of a 90‑day supply within 130 days is required when available; otherwise prescriber attestation confirming paid claims may be accepted.
Use caseApplied in continuation criteria for Rinvoq across multiple indications (approve for 1 year when verified).
ExamplesAdalimumab products lists include numerous named products (Humira, Abrilada, adalimumab‑aacf, adalimumab‑adaz, adalimumab‑adbm, adalimumab‑ryvk/Simlandi, Cyltezo, etc.).
Preferred NDC noteSome adalimumab‑ryvk NDCs (starting with 82009) and Humira NDC prefixes are referenced when identifying Preferred products in Step 1 lists.
Counting ruleA trial of multiple adalimumab products counts as ONE trial toward prior‑therapy requirements.
inv-128: Preferred Product definition
DefinitionPreferred Product = product designated as Preferred (Step 1) for an indication; listed Preferred products include adalimumab products, Enbrel, Cosentyx SC, Skyrizi SC, ustekinumab SC products, etc.
ImplicationPreferred designation drives step‑therapy routing: Non‑Preferred products are directed to specific Preferred/Step 1 products for required trials.
ReferencingRefer to Appendix/tables and standard prior authorization policies for the specific Preferred product list by indication and any NDC qualifiers.
inv-129: ^ annotation in tables — maintenance dosing only
Annotation meaning^ or ¥ annotation in tables denotes maintenance dosing only (maintenance‑only entries).
Where usedAnnotation appears in Appendix/tables mapping products to indications and denotes maintenance‑only dosing applicability.
ActionWhen a product is annotated as maintenance‑only, initial/induction dosing may not be supported under that table entry; consult the referenced PA policy.
UseThese acronyms are used throughout the policy and Appendix tables to denote indications (juvenile idiopathic arthritis, rheumatoid arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis).
ActionConfirm the clinical indication using these acronyms when applying step‑therapy and continuation rules.
Preferred ustekinumab subcutaneous product examples expanded (Selarsdi, ustekinumab-ttwe, Yesintek, etc.) and these were added to Preferred listings affecting multiple non-preferred product criteria.
05/15/2025preferred_list_update
Tremfya subcutaneous added as a Preferred Product for selected indications (including Crohn's Disease and Ulcerative Colitis); criteria for Cimzia, Rinvoq, and Entyvio SC updated to include Tremfya SC as a Preferred Product.
03/01/2026operational_updateLatest
Multiple adalimumab/biosimilar and other product preferences were updated across indications including specification that adalimumab-ryvk NDCs starting with 82009 are the Preferred adalimumab product and additions such as Otezla XR and other step/preferred assignments were made.
01/01/2025preferred_removalLatest
Hyrimoz NDCs starting with 61314 were removed from Preferred Products throughout the policy; the policy notes a previous trial of these NDCs still counts toward an adalimumab product trial.
05/15/2025preferred_addition
Tremfya subcutaneous was added as a Preferred Product for Ulcerative Colitis and Crohn's Disease in selected criteria; Tremfya SC clarified as the subcutaneous formulation in Psoriatic Arthritis and Plaque Psoriasis rules.
03/01/2026preferred_and_step_updateLatest
Cosentyx and Bimzelx were added as agents counting toward preferred product trials for adults with Psoriatic Arthritis; Otezla XR was added to Step 1 for Psoriatic Arthritis and Plaque Psoriasis; multiple clarifications on Tremfya SC and counting rules were implemented.
03/15/2025step_to_preferred_change
Omvoh subcutaneous was moved from Step 2a to Preferred (Step 1) for Crohn's Disease and Ulcerative Colitis, and Omvoh SC was added to Preferred product listings for multiple gastroenterology indications.
04/15/2025preferred_updateLatest
Omvoh SC and other gastroenterology preferred assignments were reflected across related product criteria; additional preferred ustekinumab products were added affecting criteria for multiple agents.
04/15/2025trial_counting_clarification
A general note was added that a trial of multiple ustekinumab products counts as one product and examples of ustekinumab products (Stelara, Wezlana, Otufli, Pyzchiva, ustekinumab-ttwe, Selarsdi, Steqeyma, Yesintek, etc.) were expanded.
Criteria examples were expanded to clarify that prior intravenous ustekinumab and other prior IV products (e.g., Omvoh IV, Tremfya IV, infliximab products) may count toward required trials in some indication-specific rules.