ModifiedColorado Rocky Mountain Health Plans | UnitedHealthcarePolicy 2025 P 3104-12

Kevzara® (sarilumab) - Step Therapy - UnitedHealthcare Commercial Plans

Step therapy program requiring members new to Kevzara (sarilumab) to trial specified preferred alternatives for rheumatoid arthritis prior to approval; current users on claims history may continue without meeting new step requirements. Applies to UnitedHealthcare Commercial Plans; effective 2025-09-01.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare

PolicyKevzara® (sarilumab) - Step Therapy - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 3104-12

Change TypeStep therapy criteria updated; new effective date

Effective DateSep 1, 2025

Next Review Date

Key ActionFor members new to therapy, obtain authorization only after documentation of failure, contraindication, or intolerance to required preferred products per criteria (document drug, date, and duration of trial).

SourceLink

POLICY UPDATE CHANGES

Effective date set to 9/1/2025 for the step therapy program.

Added 'Actemra or Tyenne' to step criteria where applicable (6/2025).

Updated preferred adalimumab product listing and removed example specifics; now references preferred adalimumab products via drug coverage tools (4/2025 and 10/2024 prior revisions).

Multiple historical updates to step therapy medications and references between 2017 and 2025 (formatting, product additions/removals).

1Primary covered indication (RA)

12 monthsAuthorization duration

Required preferred trials (step 1)

2Required non-TNF preferred products

Summary of changes & effective date

Material change: Effective 2025-09-01, the Kevzara (sarilumab) step therapy program is updated. This is a material edit setting the program effective date to 9/1/2025 and adding Actemra (tocilizumab) or Tyenne (tocilizumab-aazg) as a required non‑TNF preferred product step option where applicable.

Change history: the changes[] entries identify the date the effective date was set (9/1/2025) and the addition of Actemra/Tyenne (6/2025) as material edits; other historical edits noted in the changes[] array (formatting, background updates, and preferred product list wording changes) are non‑material.

Key stats

Primary covered indicationRheumatoid arthritis (RA)

Authorization duration12 months

Required trials of preferred products (step 1 count)2

Required non-TNF preferred products2 (Actemra/Tyenne and Orencia)

Policy number2025 P 3104-12

Effective date2025-09-01

Last review2025-06-01

Scope summaryStep therapy program requiring members new to Kevzara (sarilumab) to trial specified preferred alternatives for RA prior to approval; current users on claims history may continue without meeting new step requirements. Applies to UnitedHealthcare Commercial Plans; effective 2025-09-01.

Approval criteria (who qualifies)

Rheumatoid Arthritis (RA) - Initial approval criteria

Kevzara will be approved based on one of the following:

ANY of the following

Option A
- ALL of the following
  - Preferred products (choose 2)
    Preferred adalimumab product (document specific product)
    Cimzia (certolizumab)
    Enbrel (etanercept)

Referenced products (no billing codes provided)

Referenced product names (no billing codes provided)mixed

	Kevzara (sarilumab)
	Actemra (tocilizumab) / Tyenne (tocilizumab-aazg)
	Orencia (abatacept)
	Adalimumab preferred products (Humira, Amjevita, adalimumab-adaz/unbranded Hyrimoz, Nuvaila examples historically)
	Cimzia (certolizumab)
	Enbrel (etanercept)
	Rinvoq (upadacitinib)
	Simponi (golimumab)
	Xeljanz / Xeljanz XR (tofacitinib)

No NDC, CPT, or HCPCS billing codes were provided in the brief. Refer to the payer's drug coverage tools and formularies for definitive preferred product lists and billing guidance.

Historical notes and the brief direct users to 'reference drug coverage tools' for the list of preferred products and billing/code specifics.

What clinicians and billing staff must do

Prior Authorization

Step therapy requirement for new Kevzara starts

For members new to therapy, obtain authorization only after documentation of failure, contraindication, or intolerance to the required preferred products per the step criteria. Document the specific drug(s), dates, and duration of each trial to support medical necessity before Kevzara is approved.

Documentation Required

Document prior trials

Provide documentation of the specific preferred products tried, including the drug name, the dates of the trial, and the duration of the trial(s) to support medical necessity for Kevzara.

Change log & prior edits

2025-09-01effective_date_set

Effective date for the Kevzara (sarilumab) step therapy program set to 9/1/2025.

6/2025material_additionLatest

Added 'Actemra (tocilizumab) or Tyenne (tocilizumab-aazg)' to the required non-TNF preferred product step criteria for rheumatoid arthritis.

4/2025non_material_revision

Removed example product names for preferred adalimumab products and added footnote directing users to drug coverage tools for the list of preferred products.

Program scope & background

Step therapy purpose: Step therapy is used to encourage use of lower‑cost alternatives by requiring trials of preferred products before coverage of Kevzara.

Kevzara indication: Kevzara (sarilumab) is an interleukin‑6 (IL‑6) receptor antagonist indicated for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more DMARDs.

Continuation for current users: Members currently on Kevzara therapy as documented in claims history will be allowed to continue therapy without meeting new step trials; ensure claims history supports current use.

Quick scope facts

Payer nameColorado Rocky Mountain Health Plans / UnitedHealthcare Commercial Plans

Policy number2025 P 3104-12

Status

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare

PolicyKevzara® (sarilumab) - Step Therapy - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 3104-12

Change TypeStep therapy criteria updated; new effective date

Effective DateSep 1, 2025

Next Review Date

SourceLink

On This Page

Rinvoq (upadacitinib)

Xeljanz/Xeljanz XR (tofacitinib)

ALL of the following

Actemra (tocilizumab) or Tyenne (tocilizumab-aazg)
Either Actemra or Tyenne satisfies this subcriterion
Orencia (abatacept)

Option B (current user exception)

Patient is currently on Kevzara therapy
Patient has not received a manufacturer-supplied sample at no cost in the prescriber's office, or any form of assistance from the Sanofi and Regeneron sponsored KevzaraConnect (e.g., sample card redeemable at a pharmacy) as a means to establish as a current user of Kevzara
Patients established via free samples/assistance must meet initial authorization criteria as if new to therapy

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Rheumatoid Arthritis (RA) - Initial approval criteria

Other Diagnoses

Kevzara will be approved for other diagnoses as indicated (no additional criteria provided).

ALL of the following

Kevzara will be approved for other diagnoses (authorization issued for 12 months)

Current user: A member with Kevzara therapy documented in claims history; excludes patients established solely via manufacturer samples or assistance.

Failure, contraindication, or intolerance: Clinical‑judgment supported reasons a preferred product could not be used or was ineffective; documentation must include the specific drug, date, and duration of trial.

Prior Authorization

Continuation for current users

Members with Kevzara therapy documented in claims history will be allowed to continue on therapy without meeting the initial step trial requirements. Verify the member's claims history supports current use of Kevzara.

Billing Rule

Authorization duration

Authorizations for Kevzara will be issued for 12 months.

Prior Authorization

Manufacturer assistance/sample exclusion

Patients established on therapy solely via manufacturer-supplied samples or through KevzaraConnect assistance are not considered current users for the continuation exception and must meet the initial authorization criteria as if new to therapy.

10/2024non_material_revision

Updated RA step requirement to note specific adalimumab product examples (adalimumab-adaz/unbranded Hyrimoz, Amjevita for Nuvaila, and Humira) with no change to clinical intent.

2017-2025historical_updates

Multiple historical updates between 2017 and 2025 including program creation, annual reviews, formatting and background edits, additions/removals of preferred step therapy medications, and reference updates (see change control history).

Last review2025-06-01

Effective date2025-09-01