ModifiedCignaPolicy N/A

Inflammatory Conditions Preferred Specialty Management Policy for National Preferred and Basic Formularies - Choice/Alternate

Cigna's preferred specialty management policy governing coverage and step therapy for biologic and targeted therapies used in inflammatory and rheumatologic conditions for members under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions Preferred Specialty Management Policy for National Preferred and Basic Formularies - Choice/Alternate

Policy CodePolicy N/A

Change TypePreferred product list and step-therapy updates (NDC-level additions/removals)

Effective Date

Next Review Date

Key ActionProvide prior-therapy documentation or prescription claims showing required trials (and a 90-day established-use claim window when required) to meet prior authorization and step-therapy requirements.

SourceLink

POLICY UPDATE CHANGES

Humira (NDCs starting with 00074) and Hyrimoz (NDCs starting with 61314) were removed from the Preferred Products across many indications.

Tremfya subcutaneous and Omvoh subcutaneous were added as Preferred Products for Ulcerative Colitis (and Tremfya subcutaneous clarified as the subcutaneous formulation for some indications).

Velsipity was added as a Preferred Product for Ulcerative Colitis and for other specified pathways (multiple selected revisions).

Cimzia was added to certain pediatric/JIA pathways and as counting toward preferred-product trials in select indications.

Preferred product lists were updated across multiple indications (e.g., removal/addition of Humira NDCs, Hyrimoz, addition of Tremfya SC/IV and Omvoh SC as Preferred products for Ulcerative Colitis and Crohn's Disease; addition of Velsipity as Preferred for Ulcerative Colitis).

Hidradenitis Suppurativa was added as a targeted indication and specific adalimumab biosimilars and Cosentyx SC were designated Preferred for HS.

Stelara subcutaneous was changed from a required prior trial reference to a more general 'ustekinumab subcutaneous product'; multiple ustekinumab products were added as Preferred or listed as examples.

For multiple indications, direction to a Step 1 Product was generalized from adalimumab specifically to 'one Step 1 Product'; previous trial of infliximab IV (Omvoh IV) and certain IV ustekinumab/skyrizi/tremfya also count.

Cyltezo was removed as a Preferred adalimumab product for rheumatology, dermatology, and gastroenterology indications; adalimumab-ryvk NDCs starting with 82009 specified as Preferred.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

83 pagesdocument length

multipleNDC updates

1 yearcontinuation duration

6 monthsinitial approval (many)

90 daysestablished therapy requirement

Coverage and Step Therapy Criteria

Policy Overview

POLICY STATEMENT For all medications, this program requires the patient to meet the respective standard Prior Authorization Policy criteria. Additionally, this program requires trial(s) of the Preferred Product(s) according to the table below, when clinically appropriate, prior to the approval of the Non-Preferred Products. There are also situations when trials of Non-Preferred Products will be considered; see criteria below. Other details of the program are as follows:

Continuation of Therapy: Approval for a patient continuing therapy with a Non-Preferred subcutaneous or oral Product must be supported with verification, noted in the criteria as either [verification in prescription claims history required] or, if not available, as [verification by prescriber required].

- If the patient has at least 130 days of prescription claims history on file, claims history must support that the patient has received the Non-Preferred Product for the specified period of time (90 or 120 days) within a 130-day look-back period; OR

- When 130 days of the patient’s prescription claim history file is unavailable for verification, the prescriber must verify that the patient has been receiving the Non-Preferred Product for the specified period of time (90 or 120 days), AND that the patient has been receiving the Non-Preferred Product via paid claims (e.g., patient has not been receiving samples or coupons or other types of waivers in order to obtain access to the Non-Preferred Product).

- For a patient continuing therapy, other conditions may also apply. Refer to criteria below.

Approval Duration: All approvals for continuation of therapy for Preferred and Non-Preferred Products are provided for 1 year unless noted otherwise below. In cases where the initial approval is authorized in months, 1 month is equal to 30 days.

Documentation: When documentation is required, the prescriber must provide written documentation supporting the trials of these other Products, noted in the criteria as [documentation required]. Documentation may include, but is not limited to, chart notes, prescription claims records, and/or prescription receipts. All documentation must include patient-specific identifying information.

Cimzia Exception Criteria

NON-PREFERRED PRODUCT EXCEPTION CRITERIA (Cimzia)

1. Rheumatoid Arthritis – Initial Therapy: Approve for 6 months if ALL of the following are met:

- Patient meets the standard Inflammatory Conditions – Cimzia Prior Authorization Policy criteria; AND

- Patient has tried TWO of the following [documentation required]: a tocilizumab subcutaneous product (e.g., Actemra SC, Tyenne SC), Enbrel, an adalimumab product (examples listed in policy), Rinvoq, or Xeljanz/XR. Note: A trial of multiple tocilizumab products counts as ONE product; a trial of multiple adalimumab products counts as ONE product; trials of Xeljanz and Xeljanz XR collectively count as ONE product.

If the patient meets the standard Cimzia criteria but has not met the prior-trial requirement, offer to review for a Step 1 or Step 2a Preferred Product (Tyenne SC, Enbrel, adalimumab-adbm/adaz/ryvk, Simlandi, Rinvoq, Xeljanz tablets/XR) using the respective standard Inflammatory Conditions Prior Authorization Policy criteria.

Simponi Subcutaneous: Initial and Continuation Criteria

SIMPONI SUBCUTANEOUS – INITIAL THERAPY (excerpted criteria)

1. Plaque Psoriasis – Initial Therapy: Approve for 6 months if ALL of the following are met:

- Patient meets the standard Inflammatory Conditions – Simponi Subcutaneous Prior Authorization Policy criteria; AND

- Patient has tried TWO of a tocilizumab subcutaneous product, Enbrel, an adalimumab product, Rinvoq, or Xeljanz/XR [documentation required]. Note: Trials of multiple agents in the same product class count as one trial as specified in policy.

If the patient meets the Simponi SC PA criteria but not the prior-trial requirement, offer to review for Step 1 or Step 2a Products (Tyenne SC, Enbrel, adalimumab-adbm/adaz/ryvk, Simlandi, Rinvoq, Xeljanz tablets/XR) per standard PA criteria.

Actemra Subcutaneous: JIA and RA Criteria

ACTEMRA SUBCUTANEOUS (tocilizumab SC) – SELECTED CRITERIA

1. Polyarticular Juvenile Idiopathic Arthritis – Initial Therapy: Approve for 6 months if ALL of the following are met:

- Patient meets the standard Inflammatory Conditions – Tocilizumab Subcutaneous Prior Authorization Policy criteria; AND

- Patient has tried Tyenne subcutaneous [documentation required]; AND

- Patient cannot continue Tyenne subcutaneous due to formulation differences in inactive ingredients that, according to the prescriber, would result in a significant allergy or serious adverse reaction [documentation required]; AND

- Patient has tried ONE of Enbrel or an adalimumab product OR the prescriber documents heart failure or a previously treated lymphoproliferative disorder.

Bimzelx: Initial and Continuation Criteria

BIMZELX – INDICATION-SPECIFIC INITIAL THERAPY (excerpt)

1. Ankylosing Spondylitis, nr-axSpA, Psoriatic Arthritis – Initial Therapy: Approve for 6 months if ALL of the following are met:

- Patient meets the standard Inflammatory Conditions – Bimzelx Prior Authorization Policy criteria; AND

- Patient has tried ONE of Enbrel, an adalimumab product, or Taltz. Note: Trials of Cimzia, infliximab products, Simponi (Aria or SC), or Cosentyx also count in some contexts per policy notes.

If prior-trial requirement not met, offer review for Preferred Products (Enbrel, adalimumab-adbm/adaz/ryvk, Simlandi, Taltz) per PA criteria.

Cosentyx Subcutaneous: Coverage Criteria

COSENTYX SUBCUTANEOUS – SELECTED CRITERIA (excerpt)

1. Ankylosing Spondylitis – Initial Therapy: Approve for 6 months if ALL of the following are met:

- Patient meets the standard Inflammatory Conditions – Cosentyx SC Prior Authorization Policy criteria; AND

- Patient has tried TWO of Enbrel, an adalimumab product, Rinvoq, Taltz, or Xeljanz/XR [documentation required]. Note: Trials of Cimzia, infliximab products, Simponi, or Bimzelx may also count as specified.

If prior-trial requirement not met, offer to review for Step 1 or Step 2a Products (adalimumab-adbm/adaz/ryvk, Simlandi, Enbrel, Rinvoq, Taltz, Xeljanz tablets/XR) per PA criteria.

Coverage Criteria (General Guidance)

GENERAL COVERAGE CRITERIA (initial therapy and continuation examples)

Medically necessary coverage decisions require meeting the respective standard Prior Authorization Policy criteria for the specific product.

For initial therapy approvals, many Non-Preferred Products require documented trials of one or more Preferred (Step 1) or directed (Step 2a/2b) products; the required number and which products qualify vary by indication and by Non-Preferred agent. Documentation must be provided when noted.

Continuation approvals commonly require verification of established use: typically at least a 90-day supply dispensed within the past 130 days [verification in prescription claims history required], or if claims history is not available, verification by the prescriber [verification by prescriber required].

If required prior therapy trials are not met, the reviewer should offer review for appropriate Preferred or Step products using the respective standard Prior Authorization Policy criteria; absence of required trials may lead to denial.

Drug/Product Identifiers and Code Lists

Listed specialty products (by brand/agent)mixed

adalimumab-adbm	adalimumab-adbm subcutaneous injection (Boehringer Ingelheim, Quallent)
adalimumab-adaz	adalimumab-adaz subcutaneous injection (Sandoz/Novartis)
adalimumab-ryvk	adalimumab-ryvk subcutaneous injection (Quallent/Teva)
Simlandi	Simlandi (adalimumab-ryvk subcutaneous injection - Alvotech/Teva)
Cimzia	certolizumab pegol subcutaneous injection - UCB
Enbrel	etanercept subcutaneous injection - Amgen
Simponi	golimumab subcutaneous injection - Janssen Biotech/Johnson & Johnson
Zymfentra	infliximab-dyyb subcutaneous injection - Celltrion
Actemra	tocilizumab subcutaneous injection - Genentech/Roche
Tyenne	tocilizumab-aazg subcutaneous injection - Fresenius Kabi

1–10 of 36

1/4

Referenced NDCsNDC

NDCs starting with 82009

Referenced NDC prefix for certain adalimumab-ryvk products

Referenced product identifiersNDC | mixed

NDCs starting with 82009

adalimumab-ryvk products (specified NDC prefix)

Referenced NDC identifier examplesNDC

NDCs starting with 82009

adalimumab-ryvk NDC prefix

Referenced NDC identifiersNDC

NDCs starting with 82009

adalimumab-ryvk NDC prefix referenced for certain preferred products

Preferred / NDC-level products referencedNDC

NDCs starting with 82009	adalimumab-ryvk NDC prefix cited as preferred in some pathways
NDCs starting with 00074	Humira NDCs (removed from Preferred Products in revisions)
NDCs starting with 61314	Hyrimoz NDCs (removed from Preferred Products in revisions)

Referenced NDC prefixesNDC

NDCs starting with 00074	Humira product NDC prefix referenced as removed from Preferred Products
NDCs starting with 61314	Hyrimoz product NDC prefix referenced as removed from Preferred Products
NDCs starting with 82009	adalimumab-ryvk NDCs specified as Preferred product

Drug indication tablesmixed

Tables 1-3

Lists of approved biologic and targeted agents by indication (TNFis, IL-17/23/12-23 blockers, oral tsDMARDs/JAK inhibitors)

inv-62: Established therapy verification window (90 days / 130 days)

Established therapy durationPatient must have been receiving the agent for at least 90 days.

Claims verification requirementPrescription claims history must show at least a 90-day supply dispensed within the past 130 days.

Prescriber attestation optionIf claims history unavailable, prescriber verification that patient has been on therapy ≥90 days is accepted (paid-claims requirement may apply).

inv-63: Established therapy verification window (alternate chunks)

Minimum established period

Prescriber Responsibilities and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for Non‑Preferred products and many agents are subject to step‑therapy requirements. Providers must follow the referenced standard Inflammatory Conditions prior authorization policies for specific agents and indications. Requests for Non‑Preferred products will be denied unless exception criteria are met or required documentation and verification are provided.

Prior Authorization applies — consult the respective standard Prior Authorization Policy for the agent/indication.
Non‑Preferred product prior authorization requirement: Non‑Preferred agents (e.g., Cimzia, Simponi, others listed) require meeting the exception criteria in this policy or meeting the referenced standard PA criteria.
Step‑therapy structure: Step 1 = Preferred products; later steps (Step 2a/2b, Step 3a/3b) are directed to one or more Step 1/2 products as specified by indication.

Documentation Required

Continuation of Therapy Verification

Continuation of therapy approvals for Preferred and Non‑Preferred products require verification of established therapy. For subcutaneous or oral Non‑Preferred products, verification is either via prescription claims history or prescriber attestation when claims are unavailable.

Policy Background and Scope

Background: Multiple biologic and targeted therapies are used to treat inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis. The policy documents FDA‑approved indications in Appendix A and establishes Preferred and Non‑Preferred product pathways with step therapy and prior authorization rules for these therapeutic classes.

The policy references the FDA‑approved indications for each product and documents that those FDA‑approved indications are listed in Appendix A; reviewers should consult Appendix A and the referenced standard Prior Authorization Policies for condition‑specific FDA indication details.

Definitions and Abbreviations

inv-122: PJIA abbreviation

PJIAPolyarticular juvenile idiopathic arthritis.

Usage noteAbbreviation appears in definitions and indication tables.

ContextUsed in multiple indication-specific criteria (e.g., Actemra PJIA).

inv-123: SC = subcutaneous

SCSubcutaneous (route of administration).

AppearanceUsed throughout to denote subcutaneous formulations (e.g., Actemra subcutaneous, Cimzia subcutaneous).

Verification relevance

Policy Updates and Selected Revisions

Effective 01/01/2025preferred_product_update

Humira (NDCs starting with 00074) and Hyrimoz (NDCs starting with 61314) were removed from the Preferred Products across multiple indications; prior trials of these NDCs continue to count toward an adalimumab product trial.

Effective 01/01/2025preferred_product_addition

Tremfya subcutaneous and Omvoh subcutaneous were added as Preferred Products for Ulcerative Colitis (Tremfya SC clarified as the subcutaneous formulation for some indications).

2024-11-20selected_revision

Policy Summary

PayerCigna

PolicyInflammatory Conditions Preferred Specialty Management Policy for National Preferred and Basic Formularies - Choice/Alternate

Policy CodePolicy N/A

Change TypePreferred product list and step-therapy updates (NDC-level additions/removals)

Effective Date

Next Review Date

SourceLink

On This Page

If the patient meets Tocilizumab SC PA criteria but not the above, offer review for Preferred Products (Tyenne SC, Enbrel, adalimumab-adbm/adaz/ryvk, Simlandi) per standard criteria.

Approvals durations shown in this policy reflect indication-specific initial approval periods (commonly 3 or 6 months) and 1-year continuation approvals unless otherwise noted.

Patient must have been established on therapy for at least 90 days to qualify for continuation approvals.

Dispensing lookback windowAt least a 90-day supply must have been dispensed within the past 130 days per claims history.

Exception when claims unavailableIf 130-day claims history is not available, prescriber verification that patient has been receiving therapy ≥90 days and via paid claims is allowed.

inv-64: Established therapy verification window (additional refs)

General established-use ruleContinuation requests require verification that at least a 90-day supply was dispensed within the past 130 days.

Verification methodsVerification via prescription claims history is required; if unavailable, prescriber attestation is accepted with evidence of paid claims.

ScopeApplies to multiple agents referenced (e.g., Siliq, Ilumya, Entyvio subcutaneous) for continuation approvals.

inv-65: Established therapy verification window (duplicate refs)

Rinvoq/Rinvoq LQ established-use rulePatient established on Rinvoq/Rinvoq LQ for ≥90 days with claims showing a 90-day supply within past 130 days is required for continuation approvals.

Olumiant/other agentsSimilar 90-day established + 90-day supply within 130-day lookback requirement noted for Olumiant and related agents.

Prescriber verification allowanceIf claims history unavailable, prescriber verification that patient has been on therapy ≥90 days with paid claims suffices as exception.

inv-66: Prescription claim verification window

Prescription claim lookbackVerify at least a 90-day supply dispensed within the past 130 days in prescription claims history.

Agents referencedApplied to agents including Rinvoq, Ilumya, Entyvio subcutaneous, Olumiant, and others where continuation/established-use is required.

Exception processWhen 130-day claims history is unavailable, prescriber attestation and evidence of paid claims allow continuation verification.

inv-67: Established therapy (Xeljanz/XR) specific window and verification

Xeljanz/XR established-use requirementPatient must have been receiving Xeljanz/XR for at least 90 days with prescription claims showing a 90-day supply dispensed within the past 130 days.

Prescriber attestation alternativeIf claims history unavailable, prescriber verification that patient has been receiving Xeljanz/XR ≥90 days and via paid claims is accepted.

ApplicationThis verification is required for continuation approvals under the Xeljanz/XR prior authorization criteria.

Continuation verification requirement: claims history must show at least a 90‑day (or where specified 120‑day) supply dispensed within the past 130 days [verification in prescription claims history required]; OR prescriber must verify the patient has received the product for the specified period and that therapy was via paid claims (no samples/coupons).
Missing established therapy verification may lead to denial.
Prescription claims verification examples cited across agents (e.g., Cimzia, Simponi, Bimzelx, Cosentyx, Ilumya, Rinvoq, Xeljanz, Olumiant, Kineret, Entyvio) — each agent section repeats the 90‑day within 130‑day verification rule for continuation.

Documentation Required

Documentation and Verification Requirements

Documentation of prior trials, contraindications, and prescriber attestations is required per the criteria for many Non‑Preferred agents and indications. Failure to document prior trials or to provide required verification may result in denial of the request.

Required documentation of prior trials and prescriber verification: chart notes, prescription claims records, and/or prescription receipts with patient identifiers [documentation required].
Required documentation of prior drug trials and contraindications: when criteria list trials of specific alternatives (e.g., adalimumab products, tocilizumab products, Enbrel, Rinvoq, Xeljanz/XR, ustekinumab products), the prescriber must document these trials or provide acceptable verification.
Claims history / prescriber verification rule: when 130 days of claims history are not available, prescriber attestation that the patient received the agent for the required period AND via paid claims is acceptable; samples/coupons do not meet verification.

Note

Approval Duration and Indication‑Specific Durations

Approval durations vary by circumstance: initial approvals for Non‑Preferred agents are commonly 3 or 6 months for initial therapy depending on indication; continuation approvals are generally provided for 1 year unless otherwise noted.

Approval durations: continuation approvals — 1 year for Preferred and Non‑Preferred products unless specified otherwise.
Indication‑based PA approvals: plaque psoriasis initial approvals commonly 3 months when criteria met (examples: Cimzia, Bimzelx, Cosentyx, Siliq, Ilumya, Ilumya, etc.); most rheumatology and gastroenterology initial approvals are 6 months when criteria met.
Agent‑ and indication‑specific examples: many Non‑Preferred agent sections explicitly state 6‑month initial approvals (e.g., Cimzia for RA/AS/JIA, many IL‑blockers and JAK inhibitors), while plaque psoriasis approvals often specify 3 months.

Step Therapy

Step‑Down / Alternate Product Review

When criteria for a Non‑Preferred product are not met, the prescriber will be offered review for Step‑down to a Preferred Product or an alternate product per the step routing instructions in the policy.

Step‑down / preferred product offer: if required prior trials are not met, the policy directs providers to offer review for specified Step 1 or Step 2 products (examples: Enbrel, adalimumab products, Taltz, Skyrizi SC, Otezla/Otezla XR, Tremfya SC, etc.).
Step/Preferred product routing: each agent/indication block lists the alternatives to be reviewed using the respective standard Inflammatory Conditions Prior Authorization Policy criteria.
Requests for Non‑Preferred products will be denied unless exception criteria are met or acceptable documentation/verification is provided; when denied, consider evaluation of suggested Step 1/Step 2 options.

Step Therapy

Prior Trials and Step Therapy Requirements

Many indications require documented prior trials of specified alternatives — often TWO prior products (or other counts as specified) — with rules about how multiple products of the same class count.

Prior trial documentation: multiple adalimumab products count as ONE Preferred Product trial; multiple ustekinumab products count as ONE Preferred Product trial. Trials of either/both Xeljanz products collectively count as ONE product; likewise for Rinvoq variants.
PA and required prior biologic trial: specific agents (e.g., Rinvoq/Rinvoq LQ, Olumiant, Kineret, Actemra SC, Orencia SC, etc.) require trials of one or two Step 1/Step 2 products as specified in each agent/indication section.
Prior authorization: confirm preferred agent trials and NDCs per tables and lists (e.g., adalimumab‑ryvk NDCs starting with 82009 are referenced repeatedly as counting toward Step 1).

Denial Risk

Billing/Coding and Denial Risk

Operational note: coding and claims without required covered diagnosis/procedure codes or without the documented criteria will be denied. Providers should use the most appropriate codes and ensure all supporting documentation is submitted with the PA request.

Coding/claims denial risk: claims submitted without covered codes under the applicable Coverage Policy will be denied as not covered.
Failure to document prior trials of alternatives or to provide claims/prescriber verification may lead to denial.
No explicit authorization/denial trigger beyond the listed criteria — follow the referenced standard PA policies and the detailed agent/indication criteria to determine approval eligibility.

Claims verification rules often reference subcutaneous products and associated supplies dispensed.

inv-124: Trial counts rule for multiple products within same molecular/class family

Counting ruleTrials of multiple products within the same molecular/class family count as ONE product trial for step-therapy purposes.

Examples of applicable classesApplies to adalimumab products, tocilizumab products, ustekinumab products, and similar within-class groups.

DocumentationDocumentation required when claiming multiple products as a single class trial (chart notes, claims, receipts).

inv-125: Examples of adalimumab products listed

Sample adalimumab productsHumira, Abrilada, adalimumab-aacf, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp, adalimumab-aaty, adalimumab-ryvk, Simlandi, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry.

Counting implicationA trial of more than one adalimumab product counts as ONE Preferred Product trial.

Policy useExamples listed to clarify acceptable prior-product trials for step/PA criteria.

inv-126: Established on therapy definition (90 days / 130 days lookback)

Established-on-therapy definitionPatient considered established on therapy after at least 90 days of prior treatment.

Claims proof requiredClaims must show a 90-day supply dispensed within the past 130 days to confirm established use.

Prescriber verificationIf claims unavailable, prescriber attestation confirming ≥90 days of therapy (with paid-claims history where possible) is acceptable.

inv-127: Established on therapy (duplicate reference)

Established-on-therapy (continuation)Continuation approvals require the patient to have been on the agent ≥90 days with claims showing a 90-day supply within past 130 days.

Applies to multiple agentsReferenced for agents including Bimzelx, Cosentyx, Siliq and others in continuation criteria.

Exception mechanismPrescriber attestation allowed when claims history unavailable; paid-claims evidence recommended.

inv-128: Established on therapy (additional refs)

Established-on-therapy verificationVerification requires prescription claims history showing at least a 90-day supply dispensed within the past 130 days.

Agent examplesSpecification appears across multiple agent sections (Siliq, Ilumya, Entyvio) where continuation requires claims verification.

Prescriber alternativeIf 130-day claims history not available, prescriber verification that patient has been receiving therapy ≥90 days and via paid claims is acceptable.

inv-129: Trial counts (duplicate note)

Trial counting reminderA trial of multiple products within the same molecular family counts as one trial when calculating prior-product requirements.

Duplicate-note usageThis rule is reiterated across many agent-specific sections to prevent double-counting biosimilar/formulation variants.

DocumentationProviders must document the specific products and dates when claiming prior trials under this rule.

inv-130: Count rules for product trials (tocilizumab/adalimumab examples)

Count rule examplesTrials of multiple tocilizumab products, multiple adalimumab products, or multiple formulations (e.g., IV vs SC) count as one product trial for step purposes.

Specific examplesTocilizumab: Actemra IV and Actemra SC count within class; Adalimumab: Humira and adalimumab biosimilars count as one adalimumab trial.

IV products countingCertain IV trials (eg, infliximab, Omvoh IV, Skyrizi IV, Tremfya IV, IV ustekinumab) may count toward SC product trial requirements when specified.

inv-131: Established on therapy typical definition (>=90 days; 90-day supply within 130 days)

Typical established definitionTypically defined as having been on the agent for at least 90 days with claims showing a 90-day supply dispensed within the past 130 days.

Applies to continuation decisionsUsed across multiple continuation/renewal criteria (Kineret, Orencia, Olumiant, etc.).

Verification alternativePrescriber verification accepted if claims history unavailable; paid-claims evidence recommended to support attestation.

inv-132: Adalimumab product trial examples

Adalimumab trial examplesExamples listed include Humira, Abrilada, adalimumab-aacf, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp, adalimumab-aaty, adalimumab-ryvk, Simlandi, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry.

Counting noteMultiple adalimumab products tried count as a single adalimumab product trial for prior-trial requirements.

Policy applicationUsed in step therapy and exception criteria across dermatology, rheumatology, and gastroenterology indications.

inv-133: nr-axSpA definition

nr-axSpANon-radiographic spondyloarthritis.

Table usageAbbreviation appears in indication tables (Table 1) and relates to ankylosing/non-radiographic axial spondyloarthritis criteria.

ContextUsed in agent-indication mapping across biologic/tsDMARD tables.

inv-134: Induction/Maintenance dosing symbols explanation (^, #, µ)

^ symbolMaintenance dosing only.

# symbolInduction dosing only.

µ symbolInduction and maintenance dosing.

inv-135: tsDMARDs abbreviation defined

tsDMARDsTargeted synthetic disease-modifying antirheumatic drugs.

Table contextTerm used in Table 3 (Approved Oral tsDMARDs for Targeted Indications).

ExamplesIncludes oral agents such as Olumiant, Rinvoq, Xeljanz, etc., referenced in the policy tables.

inv-136: Indication abbreviations (RA, JIA, AS, nr-axSpA, PsA, PsO, CD, UC)

RARheumatoid arthritis.

JIA / PJIAJuvenile idiopathic arthritis / Polyarticular juvenile idiopathic arthritis.

ASAnkylosing spondylitis.

nr-axSpANon-radiographic axial spondyloarthritis.

PsAPsoriatic arthritis.

PsOPlaque psoriasis.

CD / UCCrohn's disease / Ulcerative colitis.

Velsipity was added as a Preferred Product for Ulcerative Colitis and other specified pathways; multiple selected revisions updated preferred product lists and step routing.

Effective 01/01/2025step_therapy_change

Cimzia was added to selected Juvenile Idiopathic Arthritis pathways and designated to count toward preferred-product trial requirements in select indications.

Effective 01/01/2025step_therapy_change

Bimzelx was added to Step 2a for certain indications and directed to trial of one Step 1 Product; step therapy routing for Crohn's disease and Ulcerative Colitis was generalized to direct a patient to one Step 1 Product rather than adalimumab specifically.

2024-10-30preferred_product_specification

Adalimumab-ryvk NDCs starting with 82009 were specified as the Preferred adalimumab product in selected pathways; Cyltezo was removed as a Preferred adalimumab product in some specialties.

2025-09-10policy_reviewLatest

Policy last reviewed as documented in the brief (last_review date).

History notes document NDC‑level Preferred product updates across the policy, including removal of certain Humira (NDCs starting with 00074) and Hyrimoz (NDCs starting with 61314) NDCs from Preferred lists; prior trials of those NDCs continue to count toward an adalimumab product trial.

Selected revisions across the policy added and updated Preferred product lists for multiple indications. Examples include addition of Tremfya subcutaneous, Omvoh subcutaneous, and Velsipity as Preferred Products for Ulcerative Colitis and related pathways.

The Selected Revision table entries and history notes list the effective change descriptions and dates for preferred/NDC updates, product additions (e.g., Tremfya SC, Omvoh SC, Velsipity), and removals; consult the history section for the specific revision dates and affected pathways.