Inflammatory Conditions Preferred Specialty Management Policy for Employer Plans: Legacy Prescription Drug Lists
Defines preferred and non-preferred specialty drugs for inflammatory conditions and the prior authorization/step therapy requirements for employer plans administered by Cigna (legacy prescription drug lists). Affects providers prescribing specialty inflammatory medications for covered members.
Policy Summary
PayerCigna
PolicyInflammatory Conditions Preferred Specialty Management Policy for Employer Plans: Legacy Prescription Drug Lists
Policy CodePolicy PSM017
Change TypeMultiple additions and step therapy updates
Effective DateMay 1, 2026
Next Review DateN/A
Key ActionSubmit prior authorization with documentation of required prior trials or claims history (90–130 day verification) to support initiation or continuation of specialty inflammatory medications.
Cimzia was added as an agent that counts towards a trial of a Preferred Product for Juvenile Idiopathic Arthritis.
Hyrimoz (NDCs starting with 61314) was removed from Preferred Products throughout the policy.
Tremfya subcutaneous was added as a Preferred Product for Ulcerative Colitis and was clarified as subcutaneous formulation in multiple indications.
Examples of adalimumab products were expanded to include multiple biosimilars and brand variants (e.g., adalimumab-aacf, adalimumab-adaz, adalimumab-adbm, adalimumab-ryvk, Simlandi, etc.).
Entyvio was added as an agent that counts towards a trial of a Preferred Product for multiple indications.
Imuldosa subcutaneous (NDCs starting with 69448) was added as a Preferred ustekinumab SC product and added to preferred lists for many non-preferred products.
Sotyktu was added as a Step 1 Preferred agent for Psoriatic Arthritis and added to preferred lists for several products.
Avtozma SC was added as a Step 2a product for Rheumatoid Arthritis and Juvenile Idiopathic Arthritis.
Removed 'tablets' from Xeljanz in the preferred products listing; Xeljanz oral solution added as a Step 2a agent for Psoriatic Arthritis.
Cosentyx was added as an agent that counts towards a trial of a Preferred Product for Bimzelx indications (AS, nr-axSpA, PsA).
Simponi SC: For Ulcerative Colitis, an exception was added for a patient < 18 years of age.
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>30biologic and targeted agents listed
1 yearcontinuation approval duration
130 daysclaims-history look-back
90/120 daysrequired prior-use duration
Step 1–3therapeutic step levels
NDC prefixesNDC-based routing noted
Coverage Criteria and Per-Indication Rules
Step therapy and continuation
Coverage requires meeting standard prior authorization criteria and following step therapy tiers; continuation rules apply for non-preferred products.
General program requirements: Patient must meet the respective standard Prior Authorization Policy criteria AND trials of Preferred Product(s) are required when clinically appropriate prior to approval of Non-Preferred Products.
See condition-specific prior authorization policies for details
Continuation verification: For continuation of therapy with a Non-Preferred subcutaneous or oral product, either prescription claims history must verify at least 90 or 120 days of use within a 130-day look-back, or prescriber verification of the specified duration if 130 days of claims history are unavailable.90 or 120 days within 130 days or prescriber verification
Approvals for continuation provided for 1 year unless noted otherwise
Step therapy rheumatology (example): Step 1 lists Preferred products by indication (e.g., Enbrel, adalimumab products, Taltz, Cimzia, Otezla, Skyrizi SC, Sotyktu, Ustekinumab SC products). Step 2a/2b non-preferred products are directed to one Step 1 product; Step 3a non-preferred products require directed trials of two Step 1/2a products or documentation as specified per indication.
Specific directed-to-product rules vary by indication (RA, JIA, AS, nr-axSpA, PsA)
Cimzia Exception Criteria (by indication)
Cimzia (non-preferred) is medically necessary when the following indication-specific criteria are met.
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 subcutaneous product, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR (documentation required).6 months
Trials of multiple products within a class (e.g., multiple adalimumab products) count as ONE product.
Ankylosing Spondylitis - Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard Cimzia PA criteria; AND (ii) patient has tried TWO of Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR (documentation required).6 months
Trials of multiple adalimumab products count as ONE product.
Juvenile Idiopathic Arthritis - Initial Therapy:
Plaque Psoriasis - Initial Therapy
Criteria for approval of various products for plaque psoriasis, including continuity rules for Cimzia and routing to other standard prior authorization policies when criteria not met.
Product-specific continuity: Patient has been established on Cimzia for at least 90 days and Cimzia was dispensed within the past 130 days (verification in prescription claims history required) or, if claims history not available, prescriber verification that patient has received Cimzia for at least 90 days.90 days established; dispensed within past 130 days
Exception allowed if prescriber attests and therapy obtained via paid claims (not samples/coupons).
Routing when standard criteria partially met: If standard Cimzia criteria met but secondary criterion not met, requests may be reviewed under respective standard Inflammatory Conditions prior authorization policy criteria for a Step 1 or Step 2 product (product lists vary by diagnosis).
Rheumatoid Arthritis - Initial Therapy
Approval for Simponi subcutaneous when both Simponi standard criteria are met and additional prior agent trial requirements are satisfied.
Simponi RA initial approval: Approve for 6 months if patient meets standard Simponi Subcutaneous Prior Authorization criteria AND has tried TWO of: a tocilizumab subcutaneous product, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR (documentation required).
Alternate review pathway: If Simponi Subcutaneous criteria met but the 'tried two' requirement is not met, requests for Step 1 or Step 2 products may be reviewed under respective standard prior authorization policies.
Ankylosing Spondylitis - Initial Therapy
Approval logic for Simponi subcutaneous in ankylosing spondylitis.
Simponi AS initial approval: Approve for 6 months if patient meets standard Simponi Subcutaneous Prior Authorization criteria AND has tried TWO of Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR (documentation required).
Alternate review pathway: If the 'tried two' requirement is not met, requests for Step 1 or Step 2 products may be reviewed under respective standard prior authorization policies.
Psoriatic Arthritis - Initial Therapy
Approval logic for Simponi subcutaneous in psoriatic arthritis.
Simponi PsA initial approval: Approve for 6 months if patient meets Simponi standard criteria AND has tried TWO of Enbrel, an adalimumab product, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Skyrizi subcutaneous, Sotyktu, an ustekinumab subcutaneous product, Taltz, Tremfya subcutaneous, or Xeljanz/XR (documentation required).
Alternate review pathway: If the 'tried two' requirement is not met, requests for Step 1 or Step 2 products may be reviewed under respective standard prior authorization policies.
Ulcerative Colitis - Initial Therapy and continuity
Approval logic for Simponi subcutaneous in ulcerative colitis and criteria for patients currently receiving Simponi or Simponi Aria.
UC initial approval: Approve for 6 months if patient meets standard Simponi Subcutaneous criteria AND (patient is <18 years OR patient ≥18 years and has tried one of an adalimumab product, Omvoh SC, Skyrizi SC (on-body injector), an ustekinumab SC product, Tremfya SC, Velsipity, or Zymfentra).
Current Simponi therapy continuation: Approve for 1 year if patient meets standard Simponi criteria AND meets one of multiple condition-specific options (e.g., established on Simponi Aria ≥90 days; established on Simponi SC with 90‑day supply dispensed within past 130 days; or indication-specific prior-agent trial history).
Polyarticular Juvenile Idiopathic Arthritis and other Tocilizumab-related pathways
Approval logic when Tocilizumab subcutaneous criteria are met and additional requirements for JIA and RA referencing adalimumab trials or specific clinical contraindications.
Polyarticular JIA initial approval: Approve for 6 months if patient meets Tocilizumab Subcutaneous criteria AND has tried one adalimumab product OR prescriber documents heart failure or previously treated lymphoproliferative disorder.
Alternate review pathway for Tocilizumab: If Tocilizumab criteria met but secondary requirements not met, requests for Preferred Products (Enbrel, Humira [NDCs starting with 00074], adalimumab-adbm, Cyltezo, adalimumab-ryvk [NDCs starting with 82009], or Simlandi) may be reviewed under respective standard prior authorization policies.
Tocilizumab (subcutaneous/intravenous) — approvals governed by both the standard Tocilizumab PA criteria and additional trial or clinical exception items.
Polyarticular Juvenile Idiopathic Arthritis - Initial: Approve for 6 months if BOTH: (i) patient meets the standard Inflammatory Conditions - Tocilizumab Subcutaneous PA criteria; AND (ii) ONE of: (a) patient has tried one adalimumab product (a trial of Enbrel/Cimzia/infliximab/Simponi Aria also counts); OR (b) prescriber documents heart failure or previously treated lymphoproliferative disorder.6 months
Examples of adalimumab products listed
Tocilizumab continuation
Continuation/renewal for patients currently receiving tocilizumab.
Currently receiving tocilizumab: Approve for 1 year if BOTH: (i) patient meets the standard Inflammatory Conditions - Tocilizumab criteria; AND (ii) ONE of: (a) polyarticular JIA and tried one adalimumab product; (b) RA and tried one adalimumab product; (c) prescriber documents heart failure or previous lymphoproliferative disorder; (d) established on tocilizumab IV ≥90 days; OR (e) established on tocilizumab SC ≥90 days with claims showing 90-day supply within past 130 days or prescriber verification.1 year
verification requirement with claims or prescriber
Kevzara initial and continuation
Kevzara prior authorization criteria require meeting the standard Kevzara PA criteria plus specified prior trials or prescriber-documented contraindications.
Rheumatoid Arthritis - Initial: Approve for 6 months if BOTH: (i) patient meets standard Kevzara PA criteria; AND (ii) ONE of: (a) patient has tried TWO of: a tocilizumab SC product, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR (documentation required); OR (b) prescriber documents heart failure or previously treated lymphoproliferative disorder.6 months
two prior products required (counts and examples listed)
Juvenile Idiopathic Arthritis - Initial: Approve for 6 months if BOTH: (i) patient meets standard Kevzara PA criteria; AND (ii) ONE of: (a) patient has tried TWO of: tocilizumab SC, Enbrel, an adalimumab product, Rinvoq/Rinvoq LQ, or Xeljanz (documentation required); OR (b) prescriber documents heart failure, previously treated lymphoproliferative disorder, previous serious infection, OR demyelinating disorder.6 months
two prior products required
Bimzelx coverage rules
Bimzelx approvals require meeting the standard Bimzelx PA criteria and prior trials of specified agents depending on indication.
Ankylosing Spondylitis - Initial: Approve for 6 months if BOTH: (i) patient meets standard Bimzelx PA criteria; AND (ii) patient has tried one of Enbrel, an adalimumab product, or Taltz (Cimzia, infliximab, Simponi, or Cosentyx may also count).6 months
one prior agent required
Hidradenitis Suppurativa - Initial: Approve for 3 months if BOTH: (i) patient meets standard Bimzelx PA criteria for HS; AND (ii) patient has tried ONE of an adalimumab product or Cosentyx SC.3 months
one prior agent required
nr-axSpA - Initial: Approve for 6 months if BOTH: (i) patient meets standard Bimzelx PA criteria; AND (ii) patient has tried one of Cimzia or Taltz (other biologics may count).
Cosentyx SC coverage rules
Cosentyx SC approvals require meeting the Cosentyx SC PA criteria plus specified prior trials.
Ankylosing Spondylitis - Initial: Approve for 6 months if BOTH: (i) patient meets standard Cosentyx SC PA criteria; AND (ii) patient has tried TWO of Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR (documentation required).6 months
two prior products required
nr-axSpA - Initial: Approve for 6 months if BOTH: (i) patient meets standard Cosentyx SC PA criteria; AND (ii) patient has tried TWO of Cimzia, Taltz, or Rinvoq (documentation required).6 months
two prior products required
Plaque Psoriasis - Initial: Approve for 3 months if BOTH: (i) patient meets standard Cosentyx SC PA criteria for plaque psoriasis; 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).
Ankylosing Spondylitis - Initial Therapy
Approve for 6 months when ALL of the following are met
Ankylosing Spondylitis initial: Patient meets the standard Inflammatory Conditions - Cosentyx Subcutaneous Prior Authorization Policy criteria
Prior therapy requirement: Patient has tried TWO of Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR (documentation required); specified alternative biologics may count
Trials of multiple adalimumab products count as one; Xeljanz and Xeljanz XR collectively count as one
Approve for 6 months when ALL of the following are met
nr-axSpA initial: Patient meets the standard Inflammatory Conditions - Cosentyx Subcutaneous Prior Authorization Policy criteria
Prior therapy requirement: Patient has tried TWO of Cimzia, Taltz, or Rinvoq (documentation required); other biologics listed may also count
Trials of multiple adalimumab products count as one
Plaque Psoriasis - Initial Therapy
Approve for 3 months when ALL of the following are met
Plaque psoriasis initial: Patient meets the standard Inflammatory Conditions - Cosentyx Subcutaneous Prior Authorization Policy criteria
Prior therapy requirement: 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)
Trials of multiple adalimumab or ustekinumab products count as one; Otezla formulations collectively count as one
Psoriatic Arthritis - Initial Therapy
Approve for 6 months when ALL of the following are met
Psoriatic arthritis initial - general: Patient meets the standard Inflammatory Conditions - Cosentyx Subcutaneous Prior Authorization Policy criteria
Age-based prior therapy requirement: If ≥18 years: tried TWO of listed agents (Enbrel, adalimumab products, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Skyrizi SC, Sotyktu, ustekinumab SC, Taltz, Tremfya SC, Xeljanz/XR). If <18 years: tried ONE of listed agents (Enbrel, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Xeljanz, Tremfya SC, or ustekinumab SC) (documentation required)
Trials of products within same molecule class count as one; TNFi trial rules for pediatric patients specified
Continuation Therapy - Cosentyx
Approve for 1 year when ALL of the following are met
Continuation - Cosentyx: Patient meets the standard Inflammatory Conditions - Cosentyx Subcutaneous Prior Authorization Policy criteria
Established therapy or prior trials: Patient meets one of several indication-specific prior trial lists OR has been established on Cosentyx IV or SC for ≥90 days with claims verification (90-day supply dispensed within past 130 days) or prescriber verification
Claims history: 90-day supply dispensed within past 130 days; exceptions allowed if prescriber confirms paid claims
Siliq - Plaque Psoriasis
Plaque psoriasis: Approve initial for 3 months and continuation for 1 year under conditions
Siliq plaque psoriasis initial: Patient meets the standard Inflammatory Conditions - Siliq Prior Authorization Policy criteria AND has tried TWO of listed comparators (Enbrel, adalimumab products, Otezla, Skyrizi SC, Sotyktu, ustekinumab SC, Taltz, Tremfya SC)
Siliq continuation: Patient meets the standard Inflammatory Conditions - Siliq Prior Authorization Policy criteria AND either has tried two comparators OR has been established on Siliq ≥90 days with claims verification (90-day supply within past 130 days)
Approve for 1 year
Other agents - general
Approval for listed agents when standard product-specific prior authorization policy criteria are met
Taltz: Approve for initial duration as directed or 1 year for continuation if patient meets standard Inflammatory Conditions - Taltz Prior Authorization Policy criteria
Ilumya: Plaque psoriasis initial: approve 3 months if meets Ilumya PA criteria and has tried TWO of listed comparators; continuation: approve 1 year if meets Ilumya PA criteria and either tried two comparators or is established ≥90 days with claims verification
Skyrizi/Omvoh/Tremfya: Approve initial for duration as directed or 1 year for patients continuing therapy if patient meets respective product-specific Inflammatory Conditions prior authorization policy criteria
Skyrizi/Ilumya/Omvoh
Skyrizi, Ilumya, Omvoh approvals
Skyrizi/Ilumya/Omvoh approvals: Approve specified subcutaneous products (Skyrizi, Ilumya, Omvoh) for initial therapy for a duration as directed or 1 year for continuation when the patient meets the respective standard Inflammatory Conditions - [Drug] Prior Authorization Policy criteria.
If Ilumya prior criteria met but paid-claims verification for a 90-day prior Ilumya trial is not met, reviewer may consider requests for preferred products per standard criteria.
Entyvio SC — Initial and continuation
Entyvio SC — Crohn's disease and ulcerative colitis
Initial therapy (Crohn's): Approve Entyvio SC for 6 months if patient meets standard Entyvio SC PA criteria AND has tried TWO of an adalimumab product, Skyrizi SC, Tremfya SC, an ustekinumab SC product, Zymfentra, Omvoh SC, Cimzia, or Rinvoq (documentation required) OR patient is undergoing/started Entyvio IV induction.two prior products or IV induction
Examples and counting rules provided; documentation required.
Initial therapy (Ulcerative colitis): Approve Entyvio SC for 6 months if patient meets standard Entyvio SC PA criteria AND has tried TWO of an adalimumab product, Skyrizi SC, an ustekinumab SC product, Zymfentra, Omvoh SC, Rinvoq, Simponi SC, Tremfya SC, Velsipity, or Xeljanz/XR (documentation required) OR patient is undergoing/started Entyvio IV induction.two prior products or IV induction
Documentation required; examples and counting rules provided.
Patient currently receiving Entyvio SC or IV:
Kineret
Kineret (an IL-1 blocker) — rheumatoid arthritis and other conditions
RA initial therapy: Approve Kineret for 6 months if patient meets standard Kineret PA criteria AND has tried TWO of: tocilizumab SC products, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR (documentation required).two prior products
Documentation required; alternative IV agents may count.
RA continuation: Approve for 1 year if patient meets standard Kineret PA criteria AND meets ONE of: trials of two specified agents OR established on Kineret ≥90 days with claims verification of at least a 90-day supply dispensed within past 130 days or prescriber verification.one of listed conditions
Claims verification rules and exception when claims file unavailable are specified.
Other conditions: Approve Kineret (initial therapy for duration as directed or 1 year for continuation) if patient meets standard Kineret PA criteria (includes CAPS and systemic JIA).
RA initial therapy: Approve Orencia SC for 6 months if patient meets standard Orencia PA criteria AND meets clinical considerations (including prescriber reporting heart failure, prior lymphoproliferative disorder, previous serious infection, or demyelinating disorder when applicable).
If prior biologic/JAK trials are not met, Step 1/Step 2 product review may be used.
JIA/JRA initial therapy: Approve for 6 months if patient meets standard Orencia SC PA criteria AND has tried TWO of tocilizumab SC, Enbrel, an adalimumab product, Rinvoq/Rinvoq LQ, or Xeljanz (documentation required), OR prescriber documents listed contraindicating comorbidities; continuation criteria mirror verification/claims rules similar to other agents.two prior products or comorbidity exception
Examples and counting rules provided.
Psoriatic arthritis initial therapy: Approve for 6 months if patient meets standard Orencia SC PA criteria AND (for adults) has tried TWO of specified agents or (for pediatric patients) has tried ONE listed agent, or prescriber documents listed comorbidities; if criteria not met, Step 1/Step 2 product review may be used.
Orencia standard policy AND condition-specific requirements: Patient meets the standard Inflammatory Conditions - Orencia Subcutaneous Prior Authorization Policy criteria
Referenced standard policy required
Age- and trial-based criteria: Patient meets ONE of: (a) ≥18 years and has tried TWO of listed agents (Enbrel, adalimumab product, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Skyrizi SC, Sotyktu, ustekinumab SC, Taltz, Tremfya SC, Xeljanz/XR) OR trial of specified alternatives counts; (b) <18 years and has tried ONE of specified agents; (c) prescriber reports heart failure, prior lymphoproliferative disorder, prior serious infection, OR demyelinating disorder.
Documentation required; multiple products in same molecule count as one
Orencia standard policy AND condition-specific requirements: Patient meets the standard Inflammatory Conditions - Orencia Subcutaneous Policy criteria
Referenced standard policy required
Condition-specific prior therapy options: Patient meets ONE of multiple subcriteria depending on diagnosis: e.g., RA: tried TWO of tocilizumab SC, Enbrel, adalimumab product, Rinvoq, or Xeljanz/XR; JIA: tried TWO of tocilizumab SC, Enbrel, adalimumab product, Rinvoq/Rinvoq LQ, or Xeljanz; PsA ≥18: tried TWO of specified agents; PsA <18: tried ONE; OR patient established on Orencia IV ≥90 days; OR prescriber documents listed contraindications; OR established on Orencia SC ≥90 days with claims evidence of 90-day supply within past 130 days.
Documentation/claims verification required; exceptions if claims unavailable with prescriber verification
Olumiant (baricitinib) — Rheumatoid Arthritis (Initial and continuation)
Covered when ALL of the following are met
Olumiant standard policy AND prior therapy: Patient meets the standard Inflammatory Conditions - Olumiant Prior Authorization Policy criteria
Referenced standard policy required
Prior therapy: Patient has tried TWO of tocilizumab SC, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR; OR patient is established on Olumiant ≥90 days with prescription claims evidence of at least a 90-day supply dispensed within the past 130 days (or prescriber verification if claims unavailable)
Covered when ALL of the following are met (varies by indication)
Rinvoq standard policy AND condition-specific prior therapy: Patient meets the standard Inflammatory Conditions - Rinvoq/LQ Prior Authorization Policy criteria
Referenced standard policy required
Indication-specific prior therapy requirements: For many indications initial approval requires prior trial of Enbrel or an adalimumab product (often one trial); Crohn's requires one adalimumab product; nr-axSpA requires Cimzia; UC and some continuation approvals require one adalimumab product; alternatives (infliximab, Simponi, Cimzia etc.) may count per notes
Examples and molecule-counting notes provided; Preferred product pathways exist if criteria not met
Continuation/established therapy: For continuation, patient may be approved for 1 year if established on Rinvoq ≥90 days with claims showing at least a 90-day supply within past 130 days or prescriber verification if claims unavailable90 days established use with 90-day supply within 130 days
Rinvoq — Ulcerative Colitis (Initial and continuation detailed criteria)
Covered when ALL of the following are met
Baseline standard policy AND additional requirement: Patient meets the standard Inflammatory Conditions - Rinvoq/LQ Prior Authorization Policy criteria
Referenced standard policy required
Initial therapy prior trials and longer-term options: Initial approval (6 months) typically requires trial of one adalimumab product; 1-year approvals require meeting one of multiple subcriteria dependent on indication (e.g., Ankylosing spondylitis: tried Enbrel or adalimumab; Crohn's: tried adalimumab; JIA: tried Enbrel or adalimumab; nr-axSpA: tried Cimzia; RA/PSA/UC: tried Enbrel or adalimumab etc.) OR established on Rinvoq ≥90 days with claims verification
Examples of agents that count toward trials are listed repeatedly
Rinvoq/LQ — Patient currently receiving
Approve Rinvoq/LQ for continuing patients when BOTH of the following are met:
Rinvoq/LQ continuation: (i) Patient meets the standard Inflammatory Conditions - Rinvoq/LQ PA criteria; AND (ii) Patient has been established on Rinvoq/LQ for at least 90 days with prescription claims history indicating at least a 90-day supply dispensed within the past 130 days, or if claims history unavailable, prescriber verification that patient has been receiving Rinvoq/LQ for at least 90 days via paid claims.90 days/130 days
Exception allowed when claims file unavailable if prescriber verifies paid claims
Xeljanz/XR — Ulcerative Colitis initial therapy
Approve Xeljanz/XR initial therapy for 6 months when BOTH of the following are met:
Xeljanz/XR initial UC: (i) Patient meets the standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND (ii) Patient has tried one adalimumab product OR a trial of an infliximab product or Simponi subcutaneous counts.prior biologic trial
Examples of adalimumab products enumerated in policy
Xeljanz/XR — Patient currently receiving
Approve Xeljanz/XR for 1 year for patients currently receiving therapy when BOTH of the following are met:
Xeljanz/XR continuation: (i) Patient meets the standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND (ii) Patient meets ONE of specified conditions: prior trial of Enbrel or adalimumab product for listed indications, OR has been established on Xeljanz/XR with claims verification as specified.90 days/130 days or prior biologic trial
If patient meets the standard PA criteria but required prior biologic trial is not met:
Alternate product review: A request for a Preferred or Step 1 Product may be reviewed using respective standard Inflammatory Conditions Prior Authorization Policy criteria; product lists provided per indication (Enbrel, Humira and adalimumab biosimilars, Omvoh, Skyrizi, Stelara/Imuldosa, Tremfya, Velsipity, Zymfentra, Otezla, etc.).N/A
Product lists vary by indication
Juvenile Idiopathic Arthritis - Initial Therapy
Covered when ALL of the following are met
JIA initial therapy prerequisites: Patient meets the standard Inflammatory Conditions prior authorization criteria AND patient has tried ONE of Enbrel or an adalimumab product (examples listed) — a trial of Cimzia, an infliximab product, or Simponi Aria also counts.
Examples of adalimumab products listed in policy
Juvenile Idiopathic Arthritis or Psoriatic Arthritis - Patient Currently Receiving Xeljanz
Approve for 1 year if BOTH are met
Xeljanz continuation criteria: (i) Patient meets the standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND (ii) patient meets ONE of: (a) JIA and has tried one of Enbrel or an adalimumab product; OR (b) PsA and has tried one of Enbrel or an adalimumab product; OR (c) patient has been established on Xeljanz for at least 90 days with claims verification (90-day supply within past 130 days) or prescriber verification if claims unavailable.90 days
Verification via claims or prescriber attestation required
A customer’s benefit plan document may supersede this Coverage Policy. In the event of a conflict, the specific terms of the member’s benefit plan (for example, the Group Service Agreement, Evidence of Coverage, Certificate of Coverage, or Summary Plan Description) determine benefits. Claims submitted for services without covered code(s) under the applicable Coverage Policy will be denied as not covered; follow the most appropriate codes as of the submission date.
Any non‑preferred product that does not meet the listed non‑preferred product exception criteria is considered not medically necessary. Requests for non‑preferred inflammatory condition products must meet the specified exception or step requirements described in the per‑product sections to be considered for approval.
Samples, coupons, manufacturer waivers, or other non‑paid access are not acceptable evidence of paid therapy for claims verification when evaluating continuation requests. Continuation approvals that require verification of established therapy must be supported by prescription claims history showing paid fills or by prescriber attestation confirming paid claims use; attestations that the patient received only samples or coupons do not satisfy verification requirements.
When the step‑therapy requirements for Kevzara (sarilumab) are not met, the request may be reviewed under the applicable Step 1 or Step 2 preferred product pathways per the respective standard Inflammatory Conditions prior authorization policies. In other words, alternative preferred products should be considered and reviewed using their standard PA criteria rather than approving Kevzara outside step therapy.
No content.
There are no additional explicit exclusions listed in the cited policy segments beyond the standard plan‑level and product‑specific prior authorization criteria; when prior‑trial requirements are not met, the policy redirects reviewers to the applicable standard prior authorization pathways for Step 1/Step 2 products.
If condition‑specific required prior trials are not met, reviewers should redirect the request to the applicable Step 1 or Step 2 preferred product review (refer to the respective standard Inflammatory Conditions prior authorization policy). In practice, this means assess the request under the standard PA criteria for the preferred product rather than approving under the higher‑tier product without required prior trials.
No explicit exclusions are stated in these segments; when required prior trials for a given condition are not met, the policy directs reviewers to evaluate the request under the standard prior authorization criteria for preferred/step products.
For Juvenile Idiopathic Arthritis, there are no additional explicit exclusions in the cited material. The policy lists preferred product options and directs reviewers to apply the referenced standard prior authorization criteria and the indicated prior‑trial rules for JIA.
Tables in Appendix A include entries marked with “--” indicating that specific agents are not approved for certain indications. These table markers denote that the product is not an approved/covered option for the listed indication per the appendix mapping and should not be used as a coverage pathway for that indication.
Several products in the appendix are marked as not applicable ("--") for specific indications (for example, Entyvio is not listed for rheumatology indications, and some IL‑6, IL‑1, or CD20 agents are not indicated for Crohn’s/UC). These notations indicate the product is not approved for that indication per the appendix and should not be considered as an alternative in step‑therapy sequencing for those diagnoses.
Requests for non‑preferred inflammatory condition products are considered not medically necessary unless they meet the specified non‑preferred exception criteria set out in the policy (for example, the 'tried two' or other indication‑specific prior‑trial requirements).
NDCs, Claims Verification Windows, and Coding Notes
Humira NDC prefix noted as preferred in some listings
NDCs starting with 82009
adalimumab-ryvk NDC prefix noted as preferred
NDCs starting with 69448
Imuldosa subcutaneous NDC prefix noted as preferred
NDCs mentioned (Imuldosa SC)NDC
NDCs starting with 69448
Imuldosa subcutaneous (ustekinumab SC) NDC prefix
inv-59: Claims-history look-back
Claims-history look-back period130 days look‑back for verification of continued therapy (claims must cover the 130‑day window)
If claims unavailablePrescriber verification allowed when 130 days of claims history unavailable (must confirm paid‑claim use, not samples/coupons)
Approval duration when verifiedContinuation approvals are provided for 1 year unless noted otherwise
inv-60: Required prior use duration for verification
Required prior use duration (standard)
Prior Authorization, Documentation & Denial Risks
Note
Provider action: Informational — used to guide step therapy
Informational — used to guide step therapy decisions. This section maps preferred and non-preferred products into Step 1, Step 2 (2a/2b), Step 3 placements by indication and documents when trials, documentation, or verification (claims or prescriber attestation) are required to satisfy step therapy or continuation criteria.
Step therapy structure: Preferred (Step 1) agents must generally be tried first; many Non-Preferred agents are Step 2a or 2b directed to one or more specific Step 1 agents; Step 3 agents often require trials of two Step 1 or Step 2 agents (documentation required).
Documentation: When noted as [documentation required], the prescriber must provide chart notes, prescription claims records, or receipts including patient identifiers to demonstrate prior trials.
Verification of prior therapy: Continuation approvals commonly require either verification in prescription claims history (130-day look-back with ≥90-day supply dispensed within 130 days) or, if claims unavailable, prescriber attestation that the patient has been established on therapy for the required period and that therapy was obtained via paid claims (no samples/coupons).
Examples of verification language used across the policy: "[verification in prescription claims history required]" or "[verification by prescriber required]". Claims-based verification rules apply equally to subcutaneous and oral agents where specified.
When a Non-Preferred product is directed to a specific Step 1 product (e.g., many Step 2a placements specify "Directed to adalimumab" or "Directed to Enbrel"), the required trial is of that specific Step 1 product unless the criteria allow alternative Step 1 agents.
Initial Therapy — Required Trials and Time-Limited Approvals
Step 1 Preferred agents
Step 1 Preferred products by rheumatology indication
Step 1 Preferred - RA/JIA/AS/PsA: Preferred Step 1 agents include Enbrel and adalimumab products (Cyltezo, Simlandi, Humira) across multiple rheumatology indications; additional Step 1 agents vary by indication (e.g., Taltz, Cimzia, Otezla, Skyrizi SC, Sotyktu, Ustekinumab SC products).
Specific products differ by RA, JIA, AS, nr-axSpA, PsA.
Cimzia Initial Therapy Rules
Initial therapy exception criteria for Cimzia by indication
RA Initial: Standard Cimzia PA criteria plus trial of TWO of specified agents (tocilizumab SC, Enbrel, adalimumab product, Rinvoq, or Xeljanz/XR).
AS Initial:
Continuation and Renewal — Established Therapy Verification
Continuation verification (general)
Continuation of therapy for patients on Non-Preferred products
Verification options: Either claims history showing 90 or 120 days of use within a 130-day look-back OR prescriber verification when claims history unavailable; prescriber verification must confirm product was obtained via paid claims (not samples/coupons).90 or 120 days within 130 days
Approvals for continuation are provided for 1 year.
Continuation (Cimzia)
Continuation (patients currently on Cimzia)
Continuation on Cimzia: Approve for 1 year if patient meets the standard Cimzia PA criteria and one of the specified clinical trial-history scenarios per indication, or has been established on Cimzia for >=90 days with Cimzia dispensed within the past 130 days (claims verification) or prescriber verification if claims unavailable.
Formulary Step-Therapy Structure and Preferred Product Lists
Step
Tier / Direction
Representative products / notes
Step 1
Preferred
Enbrel; Adalimumab products (Humira and listed biosimilars — e.g., Cyltezo, Simlandi, adalimumab-ryvk NDCs starting with 82009, Humira NDCs starting with 00074); other Step 1 by indication: Taltz, Cimzia (nr-axSpA), Otezla/Otezla XR, Skyrizi SC, Sotyktu, ustekinumab SC products (Imuldosa SC NDCs starting with 69448, Stelara SC, others).
Step 2a
Non‑Preferred directed to ONE Step 1 product
Examples: Tocilizumab SC products (Actemra SC, Avtozma SC, Tyenne SC) directed to adalimumab specifically; Rinvoq, Xeljanz (tablets/XR/oral solution) directed to Enbrel or adalimumab depending on indication.
Step 2b
Non‑Preferred directed to ONE Step 1 product
Examples by indication: Bimzelx listed as Step 2b for AS, nr‑axSpA, PsA (directed to one Step 1 product); reviewer may route to Step 1 preferred product when criteria not met.
Step 3a
Non‑Preferred directed to TWO Step 1 or 2a products (documentation required)
Examples: Certain agents (Cimzia, Kevzara, Kineret, Cosentyx SC, Orencia SC for some indications) require documentation of trials of two Step 1/2a products. Documentation required per policy.
Step 3b
Non‑Preferred directed to TWO Step 1 products
Some non‑preferred gastro/derm agents are directed to two Step 1 products (examples and notation in Appendix/tables).
Step tier(s)
Required prior trials (direction)
Exceptions / review pathway
Step 2a
Trial of ONE Step 1 preferred product as directed by indication (e.g., Rinvoq or Xeljanz directed to Enbrel or an adalimumab product; Tocilizumab SC directed to adalimumab specifically).
If required trial not met, request may be reviewed under the respective Step 1/Step 2 product standard PA policy (reviewer may route to preferred product criteria). Documentation of prior trial required when noted.
Step 2b
Similar to Step 2a: directed to ONE Step 1 product per indication (examples include Bimzelx in some indications).
If step criteria unmet, reviewer may consider Step 1 preferred products under standard PA criteria or accept documentation of alternative qualifying agents per policy notes.
Step 3a
Directed to TWO Step 1 or 2a products (documentation required) for many agents (e.g., Cimzia, Cosentyx SC, Orencia SC depending on indication).
Exceptions: prescriber‑documented contraindications or specific alternative IV agents may count; if documentation not provided, request may be reviewed under Step 1 product PA criteria.
Indication
Step requirement
Required prior agents (examples)
Rheumatoid arthritis
Typically Step 2a/3a depending on product; many approvals require trials of TWO prior agents for certain non‑preferred drugs
Examples: two of tocilizumab SC, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR (documentation required for some products).
Ankylosing spondylitis
Step placement varies (Step 1 agents exist); many non‑preferred agents require trials of TWO Step 1 products or ONE depending on drug
Examples: TWO of Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR for some agents; Bimzelx may require one prior agent (Enbrel, adalimumab, or Taltz).
Psoriatic arthritis
Step requirements age‑dependent for some products; generally require trials of one or two Step 1 agents before non‑preferred therapy
Examples: TWO of Enbrel, an adalimumab product, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Skyrizi SC, Sotyktu, ustekinumab SC, Taltz, Tremfya SC, or Xeljanz/XR (documentation required for many agents).
Ulcerative colitis / Crohn's disease
GI agents (e.g., Entyvio SC/IV, Rinvoq, Xeljanz) have indication‑specific prior trial rules — commonly require one or two prior biologics depending on product
Examples: Entyvio SC initial: tried TWO of adalimumab product, Skyrizi SC, Tremfya SC, ustekinumab SC, Zymfentra, Omvoh SC, Cimzia, or Rinvoq (documentation required); Xeljanz/XR initial UC: trial of one adalimumab product or specified infliximab/Simponi counts.
Juvenile idiopathic arthritis (JIA) / PJIA
Step rules often direct use of Step 1 preferred agents (Enbrel, adalimumab products); some agents count toward trials for JIA (Cimzia added to count in revisions)
Examples: initial JIA often requires trial of ONE of Enbrel or an adalimumab product (a trial of Cimzia, an infliximab product, or Simponi Aria also counts).
Product
Prior-trial requirement
Indications / notes
Cimzia (certolizumab pegol)
Requires prior trials per indication (commonly TWO of listed alternatives for many rheumatology indications; ONE for Crohn's) — documentation required when indicated
Indications: RA, AS, PsA, Plaque Psoriasis, Crohn's disease — lists of acceptable prior agents provided; continuation approval options include established use ≥90 days with claims within past 130 days or prescriber verification.
Simponi Subcutaneous / Simponi Aria
Initial approvals often require documented trials of TWO of listed agents (e.g., tocilizumab SC, Enbrel, adalimumab product, Rinvoq, Xeljanz/XR); if not met, may be reviewed under Step 1/2 product policies
Used across RA, AS, PsA, UC indications with indication‑specific prior therapy lists and continuation rules. Revisions removed certain NDCs from preferred lists and added Entyvio to count toward preferred trials for UC.
Entyvio (vedolizumab) SC/IV
Entyvio SC initial: trial of TWO listed biologics (adalimumab products, Skyrizi SC, Tremfya SC, ustekinumab SC, Zymfentra, Omvoh SC, Cimzia, Rinvoq) OR induction with Entyvio IV counts
Indications: Crohn's disease and Ulcerative colitis (per Entyvio PA); continuation requires established use or prior-trial evidence with claims verification. Entyvio was added to count toward preferred product trials in revisions.
Step level
Must try before
Notes / reviewer action
Higher‑tier agents (Step 2a/2b/3)
Trials of specified Step 1 or Step 2 agents (one or two agents depending on indication and product) are required prior to approval
Documentation required where noted; if trials not met, reviewer may route request to Step 1/Step 2 standard PA criteria for preferred products (lists provided by indication).
Examples
Many non‑preferred biologics require prior trial(s) of Enbrel or an adalimumab product (often one trial) before approval of non‑preferred agents such as Cosentyx SC, Bimzelx, Orencia, etc.
Per revisions, Entyvio, Imuldosa SC, Sotyktu, Avtozma SC and others were added/updated in preferred lists affecting what counts toward trials. Review Appendix A for mapping.
When prior trials not met
Alternative review
Applicable product lists / examples
Requests failing prior‑trial criteria
May be reviewed under Step 1 or Step 2 product lists using the respective standard Inflammatory Conditions prior authorization policy
Examples of Step 1 products: Enbrel, Humira (NDCs starting with 00074), adalimumab biosimilars (Cyltezo, Simlandi/adalimumab-ryvk NDCs starting with 82009), Omvoh, Skyrizi, Stelara/Imuldosa SC (NDCs starting with 69448), Tremfya, Otezla, Velsipity, Zymfentra etc.
Documentation pathway
Prescriber must provide written documentation of prior trials when noted as [documentation required]; claims verification may substitute per continuation rules
If claims history unavailable, prescriber attestation of ≥90 days established paid claims may be accepted in some continuation scenarios.
Indication
Preferred biologic(s) required first
Notes
Rheumatology (general)
Enbrel and adalimumab products are commonly required as Step 1 preferred agents before many non‑preferred biologics
Policy lists indication‑specific Step 1 preferred products; trials of multiple adalimumab products count as ONE prior trial. Revisions updated preferred lists (e.g., Imuldosa SC added).
Psoriatic arthritis / Dermatology
Step 1 includes Enbrel, adalimumab products, Otezla/Otezla XR, Skyrizi SC, Sotyktu, ustekinumab SC products; these are required prior to many non‑preferred agents
Sotyktu was added as Step 1 Preferred for PsA in revisions; Imuldosa SC added to preferred ustekinumab SC products. Documentation requirements apply where noted.
Reviewer action when prior trial missing
Step 1 product review
Notes / continuity
If prior trial requirement not met
Reviewer may evaluate request against the respective Step 1 preferred product PA criteria (route to preferred product policies such as Enbrel or adalimumab product lists)
Preferred product lists and NDC guidance (e.g., Humira NDCs starting with 00074; adalimumab-ryvk starting with 82009; Imuldosa SC starting with 69448) provided in policy and Appendix.
Continuation consideration
For patients currently receiving therapy, continuation may be approved if claims verify established use (≥90 days with 90‑day supply in past 130 days) or prescriber verification when claims unavailable
Claims verification rules apply across multiple products; samples/coupons not acceptable evidence of paid therapy.
Statement
Implication for JIA
Citations/notes
Step therapy applies to JIA
Specific Step 1 preferred products (Enbrel, adalimumab products) must be tried prior to higher‑tier agents; policy revisions added Cimzia to count toward JIA trials
Per revisions, Cimzia was added as an agent that counts towards a trial of a Preferred Product for Juvenile Idiopathic Arthritis; documentation required where noted.
Designation
Role in step therapy
Examples / counts
Step 1 Preferred
Primary agents to be tried before non‑preferred agents; counts toward prior‑trial requirements
Enbrel; adalimumab products (Humira, Cyltezo, Simlandi/adalimumab‑ryvk NDCs starting with 82009, others); Imuldosa SC and Sotyktu added to various preferred lists per revisions. Trials of multiple products within same molecule count as ONE trial.
Step 2a / Step 2b
Non‑preferred tiers directed to specific Step 1 products; may count as intermediary steps toward Step 3 requirements
Examples: Avtozma SC added as Step 2a for RA and JIA; Xeljanz oral solution added as Step 2a for PsA. Direction statements in policy indicate which Step 1 product to try first.
Appendix table
Purpose
Content / mapping
Appendix A — Table 4
Provides mapping of biologic classes and products by indication to inform step therapy sequences and highlight products that count toward trials
Includes classes (TNFis, IL‑6 blockers, IL‑17/23/12‑23 blockers, IL‑1 blocker, T‑cell modulators, integrin receptor antagonists, CD20 antibodies) and per‑indication markers (√ for approved, -- for not applicable); Entyvio SC/IV, Tocilizumab, Kevzara, Kineret, Orencia entries shown by indication. Use Appendix to verify which products may count toward Step requirements.
Site of Care Notes
Note
Infusion vs subcutaneous site-of-care (Entyvio)
Entyvio is available as IV and SC formulations; IV is used for infusion center/hospital outpatient settings, and Entyvio SC is noted for Crohn's disease and ulcerative colitis in the appendix.
Site-of-care: IV (infusion center/hospital outpatient) vs SC noted in appendix
Biosimilar Counting Rules and Notation
Billing Rule
Humira (adalimumab) preferred listing and NDC notes
Adalimumab products (Humira and multiple biosimilars) are listed as Step 1 Preferred agents across rheumatology indications; specific preferred NDC prefixes are noted in policy tables.
Preferred Step 1 includes Enbrel and adalimumab products (e.g., Humira, Cyltezo, Simlandi)
Billing Rule
Trials of multiple adalimumab products counted collectively
A trial of multiple adalimumab products counts collectively as one product trial when satisfying step or prior-trial requirements.
Billing Rule
Remicade (infliximab) may count toward prior therapy
Abbreviations, Trial Counting Rules, and Footnote Symbols
inv-113: JIA abbreviation
JIAJuvenile idiopathic arthritis
ASAnkylosing spondylitis
nr-axSpANonradiographic axial spondyloarthritis
PsAPsoriatic arthritis
PJIAPolyarticular juvenile idiopathic arthritis
inv-114: AS abbreviation
ASAnkylosing spondylitis
Policy Background and Scope
Multiple biologic and targeted therapies are available for inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis. This policy groups products into preferred and non‑preferred tiers and applies step therapy and prior authorization criteria to guide coverage decisions across these indications.
Non‑radiographic axial spondyloarthritis (nr‑axSpA) is included among the rheumatology indications covered by the policy; Cosentyx SC and several other IL‑17/23 agents are mapped in Appendix A and have indication‑specific prior‑trial requirements that must be met for initial approval.
Policy Updates and Material Changes
2026-05-01policy_effective_dateLatest
Policy modified effective 2026-05-01 with multiple material updates including addition of Cimzia to count toward JIA preferred‑product trials, removal of Hyrimoz NDCs (61314) from preferred lists, and addition of Tremfya subcutaneous as a preferred product for some indications.
revision_summary
Operational changes: Cimzia added to count toward preferred‑product trials for Juvenile Idiopathic Arthritis; Hyrimoz (NDCs starting with 61314) removed from Preferred Products across multiple sections; Tremfya subcutaneous added/clarified as preferred for select indications; Rinvoq LQ and Xeljanz listings updated to remove Hyrimoz NDCs and clarify formulations.
Policy Summary
PayerCigna
PolicyInflammatory Conditions Preferred Specialty Management Policy for Employer Plans: Legacy Prescription Drug Lists
Policy CodePolicy PSM017
Change TypeMultiple additions and step therapy updates
Effective DateMay 1, 2026
Next Review DateN/A
Key ActionSubmit prior authorization with documentation of required prior trials or claims history (90–130 day verification) to support initiation or continuation of specialty inflammatory medications.
Approve for 6 months if BOTH: (i) patient meets the standard Cimzia PA criteria; AND (ii) patient has tried TWO of a tocilizumab subcutaneous product, Enbrel, an adalimumab product, Rinvoq/Rinvoq LQ, or Xeljanz (documentation required); a trial of specified IV agents also may count.
6 months
Trials of both tocilizumab products count as ONE; multiple adalimumab products count as ONE.
Psoriatic Arthritis - Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard Cimzia PA criteria; AND (ii) patient has tried TWO of Enbrel, an adalimumab product, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Skyrizi SC, Sotyktu, an ustekinumab SC product, Taltz, Tremfya SC, or Xeljanz/XR (documentation required).6 months
Trials of multiple products within same product family count collectively as ONE.
Plaque Psoriasis - Initial Therapy: Approve for 3 months if BOTH: (i) patient meets the standard 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
If criterion not met, requests for Preferred Products may be reviewed under respective standard PA criteria.
Crohn's Disease - Initial Therapy: Approve for 6 months if BOTH: (i) patient meets the standard 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 (documentation required).6 months
A trial of specified IV products (infliximab, Entyvio, Omvoh IV, Skyrizi IV, Tremfya IV, or ustekinumab IV) also counts.
Patients Currently Receiving Cimzia: Approve for 1 year if BOTH: (i) patient meets the standard Cimzia PA criteria; AND (ii) patient meets ONE of the condition-specific continuation scenarios (e.g., prior trials per indication) OR has been established on Cimzia ≥90 days with Cimzia dispensed within past 130 days (claims verification) or prescriber verification if claims unavailable.12 months
Verification via prescription claims history required; prescriber attestation allowed when claims unavailable; samples/coupons not acceptable.
Currently receiving Kevzara: Approve for 1 year if BOTH: (i) patient meets standard Kevzara criteria; AND (ii) ONE of: (a) RA and tried TWO of listed alternatives; (b) JIA and tried TWO of listed alternatives; (c) prescriber documents heart failure or previously treated lymphoproliferative disorder; OR (d) established on Kevzara ≥90 days with claims verification (90-day supply in past 130 days) or prescriber verification.1 year
verification requirement with claims or prescriber
6 months
one prior agent required
Plaque Psoriasis - Initial: Approve for 3 months if BOTH: (i) patient meets standard Bimzelx PA criteria for plaque psoriasis; AND (ii) patient has tried ONE of Enbrel, an adalimumab product, Otezla/Otezla XR, Skyrizi SC, Sotyktu, an ustekinumab SC product, Taltz, or Tremfya SC.3 months
one prior agent required
Currently receiving Bimzelx: Approve for 1 year if BOTH: (i) patient meets standard Bimzelx PA criteria; AND (ii) ONE of the indication-specific prior trial conditions is met OR patient established on Bimzelx ≥90 days with claims verification (90-day supply in past 130 days) or prescriber verification.1 year
lists indication-specific alternatives
3 months
two prior products required
For patients currently receiving Entyvio (SC or IV), approve for 1 year if patient meets standard Entyvio PA criteria AND meets ONE of: (a) Crohn's with trials of two specified agents; (b) UC with trials of two specified agents; (c) established on Entyvio IV ≥90 days; or (d) established on Entyvio SC ≥90 days with claims evidence of at least 90-day supply dispensed within past 130 days or prescriber verification.
one of listed conditions
If continuation criterion not met, alternate products may be reviewed under respective policies.
two prior products in adults; one in pediatric patients
Counting rules and examples included.
Verification required
90 days (or 120 days when specified) of prior use required for verification
Look-back requirementRequired duration must be verified within the 130‑day claims look‑back period
Prescriber attestation alternativeIf claims history unavailable, prescriber must attest to the specified 90‑ or 120‑day duration and confirm paid‑claim use
inv-61: Established therapy verification window
Minimum established therapy for continuationAt least 90 days established on therapy required for continuation verification
Claims evidence requirementProduct must have been dispensed within the past 130 days with claims verifying the established use
Prescriber verification optionIf 130 days of claims history unavailable, prescriber verification of ≥90 days on therapy acceptable (must confirm paid claims)
inv-62: Established therapy verification window (alternate refs)
Established therapy threshold≥90 days of therapy plus evidence of a 90‑day supply dispensed within past 130 days (or prescriber verification)
Counting multiple formulationsTrials of multiple products within same molecule class count as one trial when applying verification rules
Claims exceptionWhen 130 days of claims history unavailable, prescriber attestation required confirming paid‑claim dispensing
inv-63: claims verification window
Claims verification window (supply)Verification typically requires evidence of a 90‑day supply dispensed within the past 130 days
ApplicabilityUsed to confirm continuation/established therapy for multiple products (e.g., Cosentyx, Siliq, others)
Prescriber attestationIf claims data not available, prescriber verification may be accepted confirming paid claims
inv-64: Prescription claims verification window
Prescription claims verification windowAt least a 90‑day supply dispensed within the past 130 days required to verify established prescription use
If claims missingPrescriber verification acceptable when claims history unavailable (must confirm paid claims)
Counts ruleMultiple products within same molecule (e.g., adalimumab biosimilars) count as one trial when evaluating prior use
inv-65: Established therapy verification window (summary)
Established therapy summaryAt least a 90‑day supply dispensed within the past 130 days is required to confirm established therapy for continuation approvals
Alternative verificationIf 130‑day claims file unavailable, prescriber attestation verifying ≥90 days of paid‑claim therapy is accepted
Use across productsThis window is applied across multiple agents (Rinvoq/LQ, Xeljanz/XR, Entyvio, etc.) for continuation determinations
inv-66: Xeljanz establishment window
Xeljanz establishment required durationPatient must be established on Xeljanz for at least 90 days to qualify for continuation
Claims verificationAt least a 90‑day supply of Xeljanz/XR dispensed within the past 130 days is required to verify ongoing therapy
Prescriber attestation alternativeIf claims history unavailable, prescriber verification confirming paid‑claim use for ≥90 days is acceptable
Appendix mapping: Appendix A and the Step tables should be used by providers to determine which agents are considered Step 1 (preferred) for the patient’s indication and which Non-Preferred agents require directed trials or documentation (see Appendix A and the Preferred/Non‑Preferred product tables).
Standard Cimzia PA criteria plus trial of TWO of Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR.
JIA Initial: Standard Cimzia PA criteria plus trial of TWO of tocilizumab SC, Enbrel, adalimumab product, Rinvoq/Rinvoq LQ, and Xeljanz (documentation required); IV agents may count.
PsA Initial: Standard Cimzia PA criteria plus trial of TWO of Enbrel, adalimumab product, Otezla/Otezla XR, Rinvoq/Rinvoq LQ, Skyrizi SC, Sotyktu, ustekinumab SC, Taltz, Tremfya SC, Xeljanz/XR.
Plaque Psoriasis Initial: Standard Cimzia PA criteria plus trial of TWO of Enbrel, adalimumab product, Otezla/Otezla XR, Skyrizi SC, Sotyktu, ustekinumab SC, Taltz, Tremfya SC (approve 3 months).
Crohn's Disease Initial: Standard Cimzia PA criteria plus trial of ONE of adalimumab product, Omvoh SC, Skyrizi SC (on-body), ustekinumab SC, Tremfya SC, or Zymfentra (approve 6 months); certain IV products also count.
Initial therapy requirements
Initial therapy approvals typically require meeting a product-specific standard prior authorization policy plus documented prior agent trials per indication.
General initial therapy: Patient meets the respective product's standard prior authorization criteria AND meets the indication-specific prior agent trial requirements (counts and examples specified).
Initial therapy nodes
Initial approval rules per drug and indication often require prior trials of specified agents or prescriber-documented contraindications.
Tocilizumab JIA initial: Approve 6 months if standard Tocilizumab PA criteria met AND patient tried one adalimumab product OR prescriber documents heart failure/prior lymphoproliferative disorder.
Bimzelx AS initial: Approve 6 months if standard Bimzelx PA criteria met AND patient tried one of Enbrel, an adalimumab product, or Taltz.
Cosentyx AS initial: Approve 6 months if standard Cosentyx PA criteria met AND patient tried TWO of Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR (documentation required).
Initial therapy rules
Initial therapy approvals are time-limited and require meeting product-specific PA criteria plus trials of listed comparators
General initial therapy: Patient meets the referenced standard product-specific prior authorization policy criteria
Initial approvals typically 3 months for plaque psoriasis, 6 months for others as specified
Comparator trial requirement: Patient has tried the required number of listed comparator agents (counts and lists vary by indication and age) with documentation
Multiple products within same molecule group often count as one trial
Entyvio SC initial
Entyvio SC initial therapy
Entyvio SC Crohn's initial: Approve for 6 months if patient meets standard Entyvio SC prior auth criteria AND has tried two of the listed biologics or is undergoing/started Entyvio IV induction.two prior agents or IV induction
Documentation required; examples provided.
Entyvio SC UC initial: Approve for 6 months if patient meets standard Entyvio SC prior auth criteria AND has tried two of the listed biologics or is undergoing/started Entyvio IV induction.two prior agents or IV induction
Documentation required; examples provided.
Kineret / Orencia initial
Kineret and Orencia initial therapy
Kineret RA initial: Approve for 6 months if patient meets standard Kineret criteria AND has tried two of specified agents (tocilizumab SC, Enbrel, adalimumab product, Rinvoq, Xeljanz/XR).two prior agents
Documentation required; alternative IV agents may count.
Orencia RA initial: Approve for 6 months if patient meets standard Orencia criteria and clinical considerations are met; for juvenile and psoriatic arthritis there are age-specific prior trial rules as specified.age- and trial-dependent
Documentation required; detailed lists provided.
Initial therapy rules (summary)
Initial approvals are duration-limited (commonly 6 months) and require meeting both the product-specific standard policy and indication-specific prior therapy trials.
Initial therapy gate: Patient meets standard product prior authorization policy and indication-specific prior trial requirements (examples: Rinvoq often requires prior Enbrel or adalimumab product; Orencia requires two prior agents for many adult indications or one for pediatric)
See condition-specific nodes in coverage.criteria_sets
Initial therapy — Xeljanz/XR
Initial therapy approval durations and prerequisites
Xeljanz/XR initial: (i) Patient meets standard Inflammatory Conditions - Xeljanz/XR PA criteria; AND (ii) patient has tried specified prior biologic (commonly Enbrel or an adalimumab product) or alternative biologic/infliximab counts.prior trial required
Initial approval commonly for 6 months
Initial therapy — Rinvoq/LQ
Initial therapy — Rinvoq LQ
Rinvoq/LQ initial: Approve Rinvoq LQ for initial therapy if patient meets the standard Rinvoq/LQ PA criteria and indication-specific requirements; duration as directed or 1 year for continuing patients.N/A
See indication-specific lists
Juvenile Idiopathic Arthritis - Initial Therapy
Initial therapy requirements for JIA
JIA initial therapy: Patient must have tried one of Enbrel or an adalimumab product; trials of Cimzia, infliximab products, or Simponi Aria/subcutaneous also count.
Continuation requirements
Criteria for patients already established on Cimzia or Simponi to receive continuation approvals.
Cimzia continuation: Patient established on Cimzia for at least 90 days and Cimzia dispensed within past 130 days (claims verification) OR prescriber attestation if claims unavailable; paid claims required (no samples/coupons).
Simponi continuation: Patient established on Simponi subcutaneous or Simponi Aria for at least 90 days with claims verification within past 130 days OR prescriber attestation if claims unavailable; paid claims required.
Continuation therapy verification
Continuation/renewal rules for patients currently receiving therapy require meeting standard PA criteria plus one of specified clinical or verification conditions.
Tocilizumab continuation: Approve for 1 year if standard Tocilizumab criteria met AND patient meets one of: prior trial of adalimumab (depending on indication), prescriber-documented heart failure/lymphoproliferative disorder, established on tocilizumab IV ≥90 days, OR established on tocilizumab SC ≥90 days with claims verification (90-day supply in past 130 days) or prescriber verification.
Kevzara continuation: Approve for 1 year if standard Kevzara criteria met AND patient meets one of: prior trials per indication (two alternate products), prescriber-documented heart failure/lymphoproliferative disorder, OR established on Kevzara ≥90 days with claims verification or prescriber verification.
Bimzelx continuation: Approve for 1 year if standard Bimzelx criteria met AND patient meets indication-specific prior trial condition OR established on Bimzelx ≥90 days with claims verification or prescriber verification.
Continuation therapy (selected agents)
Continuation approval conditions for patients already on therapy
Cosentyx continuation: Patient meets Cosentyx PA criteria and meets one of the indication-specific prior trial lists OR has been established on Cosentyx IV/SC ≥90 days with claims verification
Approve for 1 year
Siliq continuation: Patient meets Siliq PA criteria and either tried two comparator agents OR is established on Siliq ≥90 days with claims verification
Approve for 1 year
Continuation rules (selected agents)
Continuation coverage rules frequently require evidence of established therapy or recent paid-claims dispensing.
Entyvio continuation: Approve for 1 year if patient meets standard Entyvio criteria AND is established on Entyvio IV ≥90 days OR Entyvio SC ≥90 days with verification of 90-day supply dispensed within past 130 days or prescriber verification.≥90 days established therapy
Exception allowed if claims history unavailable with prescriber verification of paid-claim use.
Kineret continuation: Approve for 1 year if patient meets standard Kineret criteria AND has tried two specified agents OR is established on Kineret ≥90 days with claims verification or prescriber verification.≥90 days established therapy
Claims verification rules apply; exception if claims history unavailable.
Establishment verification
Continuation coverage rules require meeting the standard product prior authorization criteria and either meeting prior-therapy alternatives or evidence of established use.
Established on product: Patient has been established on product (Orencia SC, Olumiant, Rinvoq) for at least 90 days and prescription claims history indicates at least a 90-day supply dispensed within the past 130 days, or prescriber verification if claims unavailable90 days established use with 90-day supply within 130 days
Exceptions allowed if claims data unavailable but prescriber confirms paid claims
Continuation — Rinvoq/LQ
Criteria for patients currently receiving product (Rinvoq/LQ, Xeljanz/XR) include meeting standard PA criteria plus verification of ongoing therapy or prior biologic trial depending on indication.
Rinvoq/LQ continuation: Patient meets standard Rinvoq/LQ PA criteria AND has been established on Rinvoq/LQ for >=90 days with claims showing >=90-day supply within past 130 days or prescriber verification of paid claims.90 days/130 days
See Rinvoq/LQ section
Continuation — Xeljanz/XR
Xeljanz/XR continuation criteria
Xeljanz/XR continuation: Patient meets standard Xeljanz/XR PA criteria AND meets one of the indication-specific prior trial conditions or has claims verification of ongoing therapy as specified.90 days/130 days or prior trial
Multiple indication entries
Xeljanz continuation
Continuation when switching/ongoing therapy
Xeljanz continuation: Approve for 1 year if standard Xeljanz prior auth criteria met AND patient meets one of the listed prior-trial conditions or has been established on Xeljanz for >=90 days with verification.
A trial of infliximab products (e.g., Remicade and biosimilars) may count toward prior therapy requirements when listed for an indication.
Billing Rule
Examples of adalimumab biosimilars listed
Many adalimumab biosimilars and brand variants are enumerated in the policy and count as prior trials toward step requirements (examples listed in multiple criteria sections).
Adalimumab-ryvk (Simlandi/adalimumab-ryvk) NDCs starting with 82009 are specified as a Preferred adalimumab product in rheumatology, dermatology, and gastroenterology listings.
Preferred adalimumab-ryvk NDC prefix: 82009
JIA
Juvenile idiopathic arthritis
nr-axSpANonradiographic axial spondyloarthritis
PsAPsoriatic arthritis
inv-115: nr-axSpA abbreviation
nr-axSpANonradiographic axial spondyloarthritis
ASAnkylosing spondylitis
JIAJuvenile idiopathic arthritis
PsAPsoriatic arthritis
inv-116: PsA abbreviation
PsAPsoriatic arthritis
JIAJuvenile idiopathic arthritis
ASAnkylosing spondylitis
nr-axSpANonradiographic axial spondyloarthritis
inv-117: PJIA abbreviation
PJIAPolyarticular juvenile idiopathic arthritis
JIAJuvenile idiopathic arthritis
ASAnkylosing spondylitis
inv-118: Abbreviations list
JIAJuvenile idiopathic arthritis
ASAnkylosing spondylitis
nr-axSpANonradiographic axial spondyloarthritis
PsAPsoriatic arthritis
inv-119: Trial counting rules
Trial counting ruleA trial of multiple products within the same molecule class (e.g., multiple adalimumab or multiple ustekinumab products) counts as one product trial
Combination productsDifferent formulations of the same agent (e.g., Otezla and Otezla XR) collectively count as one trial
Rinvoq/Xeljanz groupingEither or both Rinvoq products or Xeljanz formulations collectively count as one trial when specified
inv-120: Adalimumab products list reference
Adalimumab products listPolicy lists many adalimumab originator and biosimilar brands (examples include Humira, Abrilada, adalimumab-aacf, adalimumab-adaz, adalimumab-adbm, adalimumab-ryvk, Simlandi, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry)
Counting implicationTrials across listed adalimumab products count as a single product trial for step/continuation purposes
Referenced across indicationsAdalimumab examples cited in multiple sections (psoriasis, rheumatology, gastroenterology) as acceptable prior trials
inv-121: Trial counts (example)
Trial counting exampleA trial of multiple adalimumab products counts as ONE product (policy examples list Humira, Abrilada, adalimumab-aacf, adalimumab-adaz, adalimumab-adbm, etc.)
Ustekinumab exampleA trial of multiple ustekinumab products also counts as ONE product (examples include Stelara, Imuldosa, Selarsdi, Yesintek)
Formulation groupingOtezla and Otezla XR collectively count as one trial when listed
inv-122: Trial counts (additional)
Additional trial counting noteTrials of multiple ustekinumab products count as one; trials of IV formulations (infliximab, Entyvio IV, Skyrizi IV, Tremfya IV) may also count when specified
Documentation requirementDocumentation required when these alternate IV or formulation trials are used to meet prior‑trial criteria
Applied to continuationCounting rules used when assessing continuation eligibility for Entyvio, Bimzelx, others
inv-123: Counts-as-note (operational)
Counts-as operational noteTrials of multiple products within a single molecular type count as one prior product (operational: treat biosimilars/brands of same molecule as one trial)
Examples providedPolicy gives numerous examples (adalimumab and ustekinumab families) to guide operational counting
Evaluator guidanceWhen counting trials, include IV/SC/formulation variants as allowed per indication-specific notes
inv-124: Examples of adalimumab products (detailed list)