CurrentCignaPolicy PSM014

Adalimumab Products Preferred Specialty Management Policy for Individual and Family Plans

Defines Cigna's preferred and non-preferred adalimumab products and the prior authorization and exception criteria for Individual and Family Plans for inflammatory conditions.

Policy Summary

PayerCigna

PolicyAdalimumab Products Preferred Specialty Management Policy for Individual and Family Plans

Policy CodePolicy PSM014

Change TypeMaterial revisions and operational relocation

Effective DateMay 15, 2025

Next Review DateN/A

Key ActionPrescriber must provide written documentation of trials of preferred products or formulation-difference rationale when requesting approval for non-preferred adalimumab products.

SourceLink

POLICY UPDATE CHANGES

New policy created relocating criteria from PSM003 into a newly created policy for Individual and Family Plans.

Non-Preferred products were given a Step 3 designation and the 120-day treatment requirement for requested Non-Preferred products was removed.

Humira (NDCs starting with 00074) was moved from Preferred to Step 2 Non-Preferred with a directed trial of one Preferred product and an exception to allow continuation for patients currently taking Humira.

Hyrimoz requests are directed to adalimumab-adaz (preferred product); Hyrimoz is not approved as listed.

Appendix A updated to add and revise Preferred non-adalimumab products (e.g., Cosentyx, Selarsdi, ustekinumab-ttwe, Yesintek, Tremfya) across indications.

>15adalimumab product formulations listed

3Preferred adalimumab products (Step 1)

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Coverage Criteria — Non-Preferred Adalimumab Products

Non-Preferred Product Exception Criteria

Adalimumab non-preferred products are considered medically necessary only when the specified exception criteria are met.

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

Reference to separate standard prior authorization policy

Product-specific exception – Abrilada/Amjevita/Hadlima/Hulio/Idacio/Yuflyma (Step 3): Approve if BOTH A and B are met: A) patient meets the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy criteria; AND B) patient meets BOTH i and ii: i) patient has tried ALL of Cyltezo/adalimumab-adbm, adalimumab-adaz, and Simlandi/adalimumab-ryvk with documentation; AND ii) patient cannot continue to use ALL Preferred medications due to formulation differences in inactive ingredient(s) expected to cause a significant allergy or serious adverse reaction (documentation required).

Documentation required for trials and formulation-difference rationale

Product-specific exception – Humira (NDCs starting with 00074) (Step 2): Approve if BOTH A and B are met: A) patient meets the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy criteria; AND B) patient meets ONE of the following: i) patient meets BOTH a and b: a) patient has tried ONE of Cyltezo/adalimumab-adbm, adalimumab-adaz, or Simlandi/adalimumab-ryvk with documentation; AND b) patient cannot continue to use the Preferred medication tried due to formulation differences in inactive ingredient(s) expected to cause a significant allergy or serious adverse reaction (documentation required); OR ii) patient is currently taking Humira (allow continuation).

Continuation allowed for current Humira users; documentation required for trial and formulation-difference reasons

Hyrimoz is not approved; requests may be reviewed for the Preferred product adalimumab-adaz under the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy criteria.

Directed to adalimumab-adaz

Any exception outside the specified non-preferred product exception criteria is considered not medically necessary. The policy’s Non-Preferred Product Exception Criteria define the only circumstances in which Non-Preferred adalimumab products may be approved; requests that do not meet those explicit exception conditions will be denied as not medically necessary.

Requests for Non-Preferred products that do not meet the listed exception criteria are considered not medically necessary. The policy requires meeting the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy criteria plus the product‑specific exception conditions (e.g., documented trial(s) of Preferred Products and documented formulation‑difference intolerance or continuation on Humira where specified); absent those conditions, Non‑Preferred product requests will not be approved.

Coding and Drug Identifiers

Humira specific NDCsNDC

NDCs starting with 00074

Humira (specific NDC range referenced for Humira products)

Prior requirement duration removed

Removed requirementThe prior requirement that a patient be taking the requested Non‑Preferred product for at least 120 days has been removed.

Effective dateChange effective 01/01/2025.

Operational impactNon‑Preferred products were redesignated (some to Step 3) and no longer require a 120‑day exposure to the requested Non‑Preferred product for approval consideration.

Documentation implicationDocumentation requirements remain for trials of Preferred products and formulation‑difference rationale; removal of the 120‑day rule does not eliminate those documentation expectations.

Provider Actions, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

All adalimumab products require prior authorization under the standard Inflammatory Conditions - Adalimumab Products Prior Authorization Policy. Requests for non-preferred products will be reviewed against the exception criteria in this policy. Approvals are issued for the duration specified in the standard prior authorization policy. When documentation is required, the prescriber must provide written documentation supporting product trials (e.g., chart notes, prescription claims records, prescription receipts).

Applies to all adalimumab products per the standard Inflammatory Conditions prior authorization policy.
Documentation supporting prior trials or formulation-difference exceptions may include chart notes, prescription claims records, and prescription receipts.

Step Therapy

Step Therapy Sequencing

Step therapy sequencing is enforced: Step 1 = Preferred Products (Cyltezo/adalimumab-adbm; adalimumab-adaz; Simlandi/adalimumab-ryvk). Step 2 = Humira (NDCs starting with 00074) — directed to ONE Preferred Product [documentation required]. Step 3 = Other Non‑Preferred Products — directed to ALL Preferred Products [documentation required]. Non‑preferred products are considered medically necessary only when the applicable non‑preferred product exception criteria are met.

Initial Preferred Adalimumab Options

Initial preferred adalimumab options

Preferred first-line within adalimumab products.

Step 1 Preferred Products: Try Cyltezo/adalimumab-adbm, adalimumab-adaz, and Simlandi/adalimumab-ryvk

Documentation of trials may be required when seeking exceptions

Step Therapy Sequencing and Requirements

Step	Products / Direction	Notes
Step 1	Preferred Products: Cyltezo (adalimumab-adbm); adalimumab-adaz; Simlandi (adalimumab-ryvk)	Try ALL Preferred Products prior to approval of most Non-Preferred adalimumab products; documentation of trials may be required when seeking exceptions.
Step 2	Humira (NDCs starting with 00074) — Non-Preferred (directed to ONE Preferred Product)	Approve if patient meets standard prior authorization criteria AND either: i) patient has tried ONE Preferred product with documentation and cannot continue it due to formulation differences in inactive ingredients causing significant allergy/serious adverse reaction (documentation required); OR ii) patient is currently taking Humira (continuation allowed).
Step 3	Other Non-Preferred Products: Abrilada; Amjevita; Hadlima; Hulio (adalimumab-fkjp); Hyrimoz (directed to adalimumab-adaz); Idacio (adalimumab-aacf); Yuflyma (adalimumab-aaty); Yusimry	Directed to trial ALL Preferred Products with documentation prior to approval; Hyrimoz is not approved and may be reviewed for adalimumab-adaz under standard prior authorization criteria. Documentation required to support trials and formulation-difference rationale.

Continuation and Exception Policies

Continuation exceptions

Continuation allowed in specified circumstances.

Continuation for Humira users: Patient is currently taking Humira (NDCs starting with 00074) — allowed exception to preferred product requirement to continue therapy

Referenced in Humira exception criteria

Biosimilar Designation and Preferred Products

Billing Rule

Try the three Preferred adalimumab products first (Step 1)

Cyltezo (adalimumab-adbm), adalimumab-adaz, and Simlandi (adalimumab-ryvk) are designated Preferred Products (Step 1) and must be tried prior to approval of most Non‑Preferred adalimumab products.

Document trials of these three Preferred products per step therapy requirements when seeking Non‑Preferred product coverage.

Site of Care and Dosing Considerations

Note

Document clinically appropriate dosage, frequency, duration, and site of care

Ensure dosage, frequency, duration of therapy, and site of care are reasonable and clinically appropriate and supported by evidence‑based literature; adjust based on severity, alternative treatments, and prior response to therapy.

Site of care (including home) and treatment parameters must be supported by evidence‑based literature.
Adjust regimen based on clinical severity and previous treatment response.

Background — Adalimumab Products

Adalimumab products are tumor necrosis factor alpha (TNF‑alpha) inhibitors indicated for a variety of inflammatory conditions. Multiple biosimilar adalimumab products have been approved as biosimilars to the reference product, and the policy recognizes that these biosimilars are alternatives to Humira; specific exception and step‑therapy rules apply to the various branded and biosimilar adalimumab products.

Definitions

Biosimilar definition

Biosimilar approval standardBiosimilar approval indicates no clinically meaningful differences in safety and effectiveness compared to the reference product (Humira).

Mechanism and formulation parityApproved biosimilars share the same mechanism of action, route of administration, dosage form, and strength as the reference product.

Inactive componentsMinor differences in clinically inactive components are allowed between a biosimilar and the reference product.

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