ModifiedUnitedHealthcarePolicy 2026 P 3201-1

Wayrilz™ (rilzabrutinib) - Step Therapy -UnitedHealthcare Commercial Plansopen_in_new

UnitedHealthcare commercial plans step therapy program requiring trials of two alternative ITP therapies before approving Wayrilz (rilzabrutinib). Applies to pharmacy benefit prior authorization and authorizations issued for 12 months; state mandates and plan benefits may affect coverage.

Policy Summary

PayerUnitedHealthcare

PolicyWayrilz™ (rilzabrutinib) - Step Therapy -UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2026 P 3201-1

Change TypeNew step therapy program (modified)

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization showing failure/inadequate response, contraindication, or intolerance to two listed agents and document drug name, dates, and duration of prior trials.

SourceLink

POLICY UPDATE CHANGES

New step therapy program established requiring failure/intolerance/contraindication to two agents (eltrombopag, avatrombopag, fostamatinib) prior to Wayrilz approval.

2Required prior therapies

12Authorization duration

2026-05-01Effective date

Summary of change and key dates

Coverage / Approval Criteria for Wayrilz (rilzabrutinib)

Initial approval (Step Therapy) for Wayrilz (rilzabrutinib)

Wayrilz will be approved when ALL of the following are met:

ALL of the following

Patient has diagnosis of persistent or chronic immune thrombocytopenia (ITP) (Wayrilz indicated for adults with persistent or chronic ITP who had an insufficient response to prior treatment)
Two of
- Eltrombopag (e.g., Alvaiz, generic Promacta)
- Doptelet (avatrombopag)
- Tavalisse (fostamatinib)

Authorization duration

Authorization will be issued for 12 months

Program operational rules

Additional rules that may affect approvals:

UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic

Use of automated approval and re-approval processes varies by program and/or therapeutic class

Medical necessity, supply limits and/or notification may be in place

State mandates, federal regulatory requirements, and member-specific benefit plan coverage may impact coverage criteria

Referenced drugs and code groups

Referenced drugs (step therapy alternatives)mixedCovered

Eltrombopag	Eltrombopag (e.g., Alvaiz, generic Promacta) - thrombopoietin receptor agonist
Doptelet	Doptelet (avatrombopag) - thrombopoietin receptor agonist
Tavalisse	Tavalisse (fostamatinib) - kinase inhibitor
Wayrilz	Wayrilz (rilzabrutinib) - kinase inhibitor; subject of step therapy

What providers must do

Prior Authorization

Step therapy prior authorization requirement

Obtain prior authorization demonstrating history of failure/inadequate response, contraindication, or intolerance to two of the listed agents (document drug, date, and duration of trial).

Document drug, date, and duration of trials for two required alternative agents.

Documentation Required

Documentation of prior trials

Document drug name, dates, and duration of prior trials for the two required alternative agents to support approval.

Drug name
Dates of trial
Duration of trial

Billing Rule

Authorization duration

When approved, issue authorization for up to 12 months.

Prior Authorization

Automated approval possibility

UnitedHealthcare may approve initial and re-authorization based solely on claims/medication history and diagnosis codes; providers should ensure claims accurately reflect prior therapy.

Ensure claims accurately reflect prior therapy when relying on automated approval processes.

Definitions and supporting evidence

Step therapy requires trial of preferred, typically lower-cost alternatives before coverage of Wayrilz (rilzabrutinib). Wayrilz is a kinase inhibitor indicated for adults with persistent or chronic immune thrombocytopenia (ITP) with insufficient response to prior treatment; comparator therapies include eltrombopag, avatrombopag (Doptelet), and fostamatinib (Tavalisse).

Failure/inadequate response: provider-documented lack of clinical benefit from prior therapy, or intolerance/contraindication preventing continued use (document drug, date, and duration).

Evidence sources

P&T approval date2026-02

Wayrilz package insertAugust 2025