CurrentCignaPolicy PSM013

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

Defines preferred, non-preferred, and non-covered adalimumab products and the prior authorization and exception requirements for Cigna-administered health plans (Standard, Performance, Value/Advantage, and Total Savings). Affects prescribers and pharmacy/medical benefit administrators for covered members.

Policy Summary

PayerCigna

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

Policy CodePolicy PSM013

Change TypeStep reorganizationNon‑Covered product additionsClarified documentation

Effective DateMar 1, 2026

Next Review DateMar 1, 2026

Key ActionPrescriber must document patient-specific trials of Preferred products (Cyltezo and Simlandi) or provide evidence of intolerance to support exceptions.

SourceLink

POLICY UPDATE CHANGES

Adalimumab-bwwd, adalimumab-ryvk (NDCs starting with 51759), Amjevita (NDCs starting with 84612), Humira (NDCs starting with 83457), and Hyrimoz (NDCs starting with 83457) were added as Non-Covered products and directed to Preferred Products.

Preferred/non-preferred product steps were reorganized: Cyltezo and Simlandi are Step 1 Preferred; Humira (NDCs starting with 00074) moved to Step 2 Non-Preferred; multiple branded biosimilars assigned to Step 3 Non-Preferred with exception criteria.

Exception criteria require documented trials of specified Preferred products and prescriber documentation if formulation inactive ingredients preclude use.

~18listed adalimumab product names (brand & biosimilar)

Step 1, 2, 3

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Coverage Criteria

Step therapy and exception criteria

Covered when the applicable step and prior authorization criteria are met and required documentation is provided.

Program-wide requirement

Step 1 Preferred Products: Patient has tried BOTH Preferred products: Cyltezo (adalimumab-adbm) AND Simlandi (adalimumab-ryvk; NDCs starting with 82009).
Documentation required
Step 2 Humira (NDCs starting with 00074): For Humira (NDCs starting with 00074), patient must have tried ONE Preferred product (Cyltezo OR Simlandi) with documentation OR be currently taking Humira to allow continuation of therapy.
Documentation required for trial; current Humira users allowed continuation per exception
Step 3 Non-Preferred Products: For Step 3 Non-Preferred products (e.g., Abrilada; Amjevita NDCs starting with 72511; Hadlima; Hulio; Hyrimoz NDCs starting with 61314; Idacio; Yuflyma; Yusimry), approve only if A) patient meets the standard prior authorization criteria AND B) either i) has tried BOTH Preferred products OR ii) cannot continue BOTH Preferred products due to formulation differences in inactive ingredients that, per prescriber, would cause a significant allergy or serious adverse reaction.
Documentation required to support trials or inability to use Preferred products (chart notes, prescription claims, receipts).

The following products are not covered on the pharmacy and medical benefits for Employer Plans: adalimumab-bwwd, adalimumab-ryvk (NDCs starting with 51759), Amjevita (NDCs starting with 84612), Humira (NDCs starting with 83457), and Hyrimoz (NDCs starting with 83457). Refer to the customer's benefit plan document for details of covered product(s).

When documentation is required for coverage determinations, the prescriber must provide written, patient-specific documentation supporting trials of other products. Acceptable documentation may include chart notes, prescription claims records, and/or prescription receipts and must include patient identifying information.

Adalimumab non-preferred products are not approved unless the non-preferred exception criteria are met. Approval of non-preferred products requires that the patient meet the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy criteria and one of the exception pathways described in the policy.

Exception criteria include documentation that the patient cannot continue to use the Preferred medications (Cyltezo/adalimumab-adbm or Simlandi/adalimumab-ryvk, NDCs starting with 82009) due to formulation differences in inactive ingredients that, per the prescriber, would cause a significant allergy or serious adverse reaction (documentation required). A trial of adalimumab-ryvk with NDCs starting with 51759 also counts toward the preferred-product trial in the exception note. Alternatively, patients currently taking Humira may be eligible for continuation under the policy provisions.

NDC Groups and Coding Designations

Preferred NDC groupsNDCCovered

NDCs starting with 82009	Simlandi/adalimumab-ryvk preferred NDC group
Cyltezo/adalimumab-adbm	Cyltezo/adalimumab-adbm (Preferred product)

Step 2 Non-Preferred NDC groups (directed to ONE Preferred Product)NDC

NDCs starting with 00074

Humira moved to Step 2 Non-Preferred

Step 3 Non-Preferred NDC groups (directed to ALL Preferred Products)NDC

NDCs starting with 72511	Amjevita NDC example (Step 3 Non-Preferred)
NDCs starting with 61314	Hyrimoz NDC group referenced (Step 3 Non-Preferred)
Hadlima	Hadlima (adalimumab-bwwd / Step 3 listing context)
Abrilada	Abrilada (Step 3 Non-Preferred)
Hulio/adalimumab-fkjp	Hulio/adalimumab-fkjp (Step 3 Non-Preferred)
Idacio/adalimumab-aacf	Idacio/adalimumab-aacf (Step 3 Non-Preferred)
Yuflyma/adalimumab-aaty	Yuflyma/adalimumab-aaty (Step 3 Non-Preferred)
Yusimry	Yusimry (Step 3 Non-Preferred)

Non-Covered NDC groups for Employer PlansNDCNot Covered

adalimumab-bwwd	adalimumab-bwwd (Non-Covered)
NDCs starting with 51759	adalimumab-ryvk (-ryvk NDCs starting with 51759) (Non-Covered)
NDCs starting with 84612	Amjevita (NDCs starting with 84612) (Non-Covered)
NDCs starting with 83457	Humira (NDCs starting with 83457) (Non-Covered)
NDCs starting with 83457	Hyrimoz (NDCs starting with 83457) (Non-Covered)

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. All requests (Preferred and Non-Preferred) must meet the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy criteria. Approvals follow the duration and conditions specified in that standard prior authorization policy. Employer Plan non-covered products (see policy) will be denied; consider directing to Preferred products per the member's benefit document.

All products require review under the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy.
Employer Plan non-covered products (e.g., adalimumab-bwwd, certain adalimumab-ryvk and Amjevita, Humira, Hyrimoz NDCs listed in policy) are not covered and will be denied; refer to the member's benefit plan for covered products.

Step Therapy

Required Product Sequencing and Steps

Step-therapy sequencing is enforced. Members should be directed to Preferred Products first (Step 1). Non-Preferred Products in Step 2 may require trial of ONE Preferred Product; Step 3 Non-Preferred Products require trials of ALL Preferred Products or meeting exception criteria. Non-covered products are explicitly listed and will be denied.

Background

Adalimumab (Humira) and multiple biosimilar adalimumab products are indicated for a variety of inflammatory conditions. Biosimilars are approved based on demonstrating no clinically meaningful differences in safety and effectiveness compared with Humira, though they may differ in inactive ingredients. The program is designed to encourage use of specified Preferred Products (e.g., Cyltezo and Simlandi) and manages interchangeability and access through a step-therapy structure and prior authorization.

Per the policy, all adalimumab product requests must meet the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy criteria; the step-therapy program directs trials of Preferred products before approval of Non-Preferred products, while allowing continuation for patients already on Humira when appropriate.

Definitions

Biosimilar (approved biosimilar meaning and inactive component differences)

Regulatory meaningProducts approved as biosimilar to Humira indicating no clinically meaningful differences in safety and effectiveness and the same mechanism of action, route of administration, dosage form, and strength as Humira.

Allowed differencesMinor differences in clinically inactive (inactive) components are permitted between a biosimilar and Humira.

Implication for interchangeabilityBiosimilars share the same mechanism, route, dosage form, and strength as Humira, supporting therapeutic equivalence in clinical use per approvals.

Unbranded formulationsUnbranded versions of multiple biosimilars (e.g., Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Simlandi, Yuflyma) may be identically formulated and packaged by the same manufacturer as the branded biosimilar.

Scope of approvalApproval as a biosimilar reflects no clinically meaningful differences in safety and effectiveness compared with Humira, as determined by regulatory review.

Initial Therapy Criteria

Initial Preferred product requirement

Initial coverage requires trials of Preferred products per step therapy.

Initial Preferred trial: Patient must try Cyltezo (adalimumab-adbm) AND Simlandi (adalimumab-ryvk; NDCs starting with 82009) as Preferred products before approval of Non-Preferred adalimumab products unless exception criteria are met.

Documentation of trials required (e.g., chart notes, prescription claims, receipts).

Continuation Criteria

Continuation for current Humira users

Continuation allowed under specific conditions.

Continuation for current users: Patients currently taking Humira (NDCs starting with 00074) are allowed an exception to the Preferred product trial requirement to continue therapy.

Policy history documents this continuation allowance; documentation of current use may be required.

Step Therapy Details

Step	Required trial(s) / sequencing	Documentation required	Coverage note
Step 1 (Preferred)
Patient must try BOTH Preferred products: Cyltezo (adalimumab-adbm) AND Simlandi (adalimumab-ryvk; NDCs starting with 82009).
Yes — prescriber must provide patient-specific documentation of trials (e.g., chart notes, prescription claims, receipts).
Approval of Non-Preferred products requires meeting Step 1 trials or documented exception per policy.

Step	Humira (NDCs starting with 00074) requirement	Documentation required	Continuation exception
Step 2 (Humira)
Humira (NDCs starting with 00074) is directed to a trial of ONE Preferred product (Cyltezo OR Simlandi).
Yes — documentation of the ONE Preferred product trial is required per the standard prior authorization and this step-therapy policy.
Patients currently taking Humira (NDCs starting with 00074) are allowed an exception to continue therapy (continuation permitted).

Biosimilar Product Notes

Billing Rule

Humira (00074) directed to trial one Preferred product; continuation allowed

Humira is designated in the step structure as a directed Step 2 product; patients starting Humira (NDCs starting with 00074) must try ONE Preferred product first, though current Humira users may be allowed continuation per the policy exception.

Humira (NDCs starting with 00074) — must try one Preferred (Cyltezo or Simlandi) [documentation required] unless qualifying for continuation.
Continuation for current Humira users is allowed under the policy's continuation criteria.

Note

Simlandi (adalimumab-ryvk) Preferred designation and NDC exceptions

Simlandi/adalimumab-ryvk is specified as a Preferred Step 1 product (NDCs starting with 82009); note the policy also specifies that adalimumab-ryvk NDCs starting with 51759 are addressed separately (count toward trials in the note but may be listed as non‑covered in some Employer Plan contexts).