CurrentCignaPolicy PSM013

Adalimumab Products Preferred Specialty Management Policy - Standard, Performance, Value, Advantage, and Total Savings

Defines Cigna's coverage and preferred-product management for adalimumab and adalimumab biosimilars across specified drug lists (Standard/Performance, Value/Advantage, Total Savings) and the requirements providers must meet for prior authorization and exceptions; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAdalimumab Products Preferred Specialty Management Policy - Standard, Performance, Value, Advantage, and Total Savings

Policy CodePolicy PSM013

Change TypeMaterial additions and revisions (Non-Covered NDCs, step designations, criteria relocation)

Effective Date05/01/2026

Next Review Date

Key ActionSubmit prior authorization that documents trials of required Preferred Products (and prescriber documentation if a formulation-related allergy/adverse reaction prevents continuation).

SourceLink

POLICY UPDATE CHANGES

Policy created by relocating criteria from a prior policy into a newly created policy for Standard/Performance, Value/Advantage, Total Savings drug lists.

Several adalimumab products (specific NDC groups) were added as Non-Covered and directed to Preferred Products; and product step designations and exception rules were updated.

Specified that trials of particular NDC groups count toward preferred-product trial requirements (e.g., adalimumab-ryvk NDCs starting with 51759 count).

17+adalimumab products listed (brands and biosimilars)

PSM013coverage policy number

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Coverage Criteria for Adalimumab Products

Non-Preferred Product Exception Criteria

Adalimumab non-preferred products are considered medically necessary only when the listed Non-Preferred Product Exception Criteria are met.

General requirement: Patient must meet the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy criteria

Applies to all requests

Exception criteria for Abrilada, Amjevita (NDCs starting with 55513 or 72511), Hadlima

A: Patient meets the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy criteria
Documentation of indication per standard PA
B
- B(i): Patient has tried BOTH Cyltezo (adalimumab-adbm) AND Simlandi (adalimumab-ryvk NDCs starting with 82009) [documentation required]
  Trial documentation may include chart notes, prescription claims records, or receipts
- B(ii): Patient cannot continue to use BOTH Preferred medications due to formulation differences in inactive ingredient(s) that, according to the prescriber, would result in a significant allergy or serious adverse reaction [documentation required]
  Prescriber attestation plus supporting documentation required

Exception criteria for Hulio, Hyrimoz (NDCs starting with 61314)/adalimumab-adaz, Idacio, Yuflyma, Yusimry

Option 1: Patient has tried BOTH Cyltezo (adalimumab-adbm) and Simlandi (adalimumab-ryvk NDCs starting with 82009) [documentation required] AND cannot continue to use BOTH Preferred medications due to formulation differences in inactive ingredients per prescriber [documentation required]
Both conditions required
Option 2: Patient is currently taking Humira
Current Humira use qualifies for exception for some Non-Preferred products

Failure to meet exception criteria: Any request for a Non-Preferred adalimumab product that does not meet the stated Non-Preferred product exception criteria is considered not medically necessary

Requests may be reviewed for Preferred Products per the standard PA

Step therapy directions

Directed step therapy rules for Non-Preferred products.

Step 2 direction: Non-Preferred Products designated Step 2 are directed to try ONE Preferred Product (documentation required)

Applies to Step 2 listed products: Cyltezo, Simlandi (adalimumab-ryvk NDCs starting with 82009), Humira (NDCs starting with 00074)

Step 3 direction: Non-Preferred Products designated Step 3 are directed to try ALL Preferred Products (documentation required) prior to approval

Applies to Step 3 product group including Abrilada, Amjevita (NDCs starting with 55513 or 72511), Hadlima, Hulio, Hyrimoz (NDCs starting with 61314)/adalimumab-adaz, Idacio, Yuflyma, Yusimry

Certain adalimumab products and specific NDC-series are designated as Non‑Covered for Employer Plans and are not approved on the pharmacy or medical benefit. Examples identified in the policy include adalimumab‑bwwd; adalimumab‑ryvk NDCs starting with 51759; Amjevita NDCs starting with 84612; Humira NDCs starting with 83457; and Hyrimoz NDCs starting with 83457. Requests for these Non‑Covered products should be referred to the directed Preferred Products per the policy.

Any request for a Non‑Preferred adalimumab product that does not meet the stated Non‑Preferred Product Exception Criteria is considered not medically necessary and will be denied on that basis.

Coding and NDC Groupings

Preferred / Covered NDCsNDCCovered

69448-xxxx-xx

adalimumab product group starting with 69448 (all relevant NDCs)

Non-Preferred / Not Covered NDCsNDCNot Covered

51759-xxxx-xx	adalimumab-ryvk NDCs starting with 51759
84612-xxxx-xx	Amjevita NDCs starting with 84612
83457-xxxx-xx	Humira and Hyrimoz NDCs starting with 83457
00074-xxxx-xx	Humira NDCs starting with 00074 (moved from Preferred to Step 2 Non-Preferred)

Step / Program NDC GroupingNDC

69448-xxxx-xx

Group includes all NDCs beginning with 69448 (consolidated list per policy requirement)

Provider Requirements and Billing Guidance

Prior Authorization

Prior Authorization Required

All adalimumab products require prior authorization per the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy. Requests for any adalimumab product will be reviewed against that policy's criteria before approval.

Applies to Preferred and Non-Preferred adalimumab products
Approvals follow duration specified in the standard Prior Authorization Policy

Step Therapy

Directed Trials of Preferred Products Required

This program directs trials of Preferred Products before approval of Non-Preferred Products. Some Non-Preferred products require documentation that the patient tried ONE Preferred Product; others require trials of ALL Preferred Products — review the product-specific directions in the policy.

Step 2 (certain Non-Preferred): directed to ONE Preferred Product; documentation required
Step 3 (other Non-Preferred): directed to ALL Preferred Products; documentation required

Definitions

Biosimilar definition

Core definitionA biosimilar demonstrates no clinically meaningful differences in safety and effectiveness compared to the reference product (Humira).

Comparable attributesShares the same mechanism of action, route of administration, dosage form, and strength as the reference product.

Allowed differencesMinor differences in clinically inactive (inactive) components are permitted.

Initial Therapy Requirements

Initial therapy requirements

Initial trial requirements for non-preferred products.

Initial trial for non-preferred Step 2: Directed to try ONE Preferred Product (documentation required)

Step 2 designated non-preferred products must document trial of one Preferred product before approval

Initial trial for non-preferred Step 3: Directed to try ALL Preferred Products (documentation required) or meet exception criteria

Step 3 designated non-preferred products must document trials of all Preferred products or satisfy exception criteria described in the Non-Preferred Product Exception Criteria

Continuation of Therapy

Continuation of therapy

Continuation allowances.

Continuation for current Humira users: Program allows continuation of therapy for a patient currently taking Humira

Preserves ongoing therapy; approvals provided for the duration noted in the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy

Step Therapy Rules

Step	Requirement
Step 2	Trial of ONE Preferred Product (documentation required). Preferred products directed for Step 2 include Cyltezo (adalimumab-adbm), Simlandi (adalimumab-ryvk NDCs starting with 82009), and Humira (NDCs starting with 00074)
Step 3	Trial of ALL Preferred Products (documentation required) OR meet Non‑Preferred Product Exception Criteria. Preferred products referenced for Step 3 include Cyltezo (adalimumab-adbm) and Simlandi (adalimumab-ryvk NDCs starting with 82009); Step 3 non‑preferred products listed include Abrilada; Amjevita (NDCs starting with 55513 or 72511); Hadlima; Hulio (adalimumab-fkjp); Hyrimoz (NDCs starting with 61314)/adalimumab-adaz; Idacio (adalimumab-aacf); Yuflyma (adalimumab-aaty); and Yusimry. Documentation of trials is required, or approval may be granted if the Non‑Preferred Product Exception Criteria are met (including documented trials of required Preferred products and prescriber attestation with supporting documentation)

Step

Requirement

Step 2

Trial of ONE Preferred Product (documentation required). Preferred products directed for Step 2 include Cyltezo (adalimumab-adbm), Simlandi (adalimumab-ryvk NDCs starting with 82009), and Humira (NDCs starting with 00074)

Step 3

Trial of ALL Preferred Products (documentation required) OR meet Non‑Preferred Product Exception Criteria. Preferred products referenced for Step 3 include Cyltezo (adalimumab-adbm) and Simlandi (adalimumab-ryvk NDCs starting with 82009); Step 3 non‑preferred products listed include Abrilada; Amjevita (NDCs starting with 55513 or 72511); Hadlima; Hulio (adalimumab-fkjp); Hyrimoz (NDCs starting with 61314)/adalimumab-adaz; Idacio (adalimumab-aacf); Yuflyma (adalimumab-aaty); and Yusimry. Documentation of trials is required, or approval may be granted if the Non‑Preferred Product Exception Criteria are met (including documented trials of required Preferred products and prescriber attestation with supporting documentation)

Site of Care Applicability

Note

Policy applies to pharmacy and medical benefits; some products not covered

This policy applies to both pharmacy and medical benefits; certain adalimumab products and specific NDC-series are listed as not covered on pharmacy and medical benefits for Employer Plans.

Non-covered examples include adalimumab-bwwd; adalimumab-ryvk NDCs starting with 51759; Amjevita NDCs starting with 84612; Humira NDCs starting with 83457; Hyrimoz NDCs starting with 83457.

Preferred Products and Biosimilar Direction

Note

Preferred products (Cyltezo and Simlandi) are the directed trials

Cyltezo (adalimumab-adbm) and Simlandi (adalimumab-ryvk NDCs starting with 82009) are designated Preferred Products and are the directed Preferred trials for many Non-Preferred products; trials of these products count toward the step/exception requirements.

Note

Specific Simlandi NDC-series (51759...) counts toward trial requirements

A trial of adalimumab-ryvk NDCs starting with 51759 is specified to also count toward the Preferred-product trial requirements in the exception criteria.

Background

Adalimumab and its biosimilars are tumor necrosis factor‑alpha (TNF‑alpha) inhibitor biologics indicated for multiple inflammatory conditions. Products approved as biosimilars to Humira have no clinically meaningful differences in safety or effectiveness compared with the reference product, and they share the same mechanism of action, route, dosage form and strength; minor differences in inactive ingredients are permitted and may be clinically relevant for some patients. The policy designates certain biosimilars (for example, Cyltezo/adalimumab‑adbm and Simlandi/adalimumab‑ryvk NDCs starting with 82009) as Preferred Products that are directed trials before Non‑Preferred products, with allowance for exception when formulation differences in inactive ingredients would, per the prescriber, cause a significant allergy or serious adverse reaction.