CurrentmhnPolicy CP.PHAR.751

Rilzabrutinib (Wayrilz) — Coverage Criteria for Immune Thrombocytopenia

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Defines medical necessity and prior authorization criteria for rilzabrutinib (Wayrilz) for adults with persistent or chronic immune thrombocytopenia (ITP) across commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyRilzabrutinib (Wayrilz) — Coverage Criteria for Immune Thrombocytopenia

Policy CodePolicy CP.PHAR.751

Change TypeFormulary redirectionoperational update

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation demonstrating diagnosis of persistent or chronic ITP, hematologist involvement, age ≥18, qualifying platelet count or active bleed, prior corticosteroid and eltrombopag failure (unless contraindicated), and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Added redirection to generic Promacta for ITP and removed redirection to immune globulin if intolerant or contraindicated to systemic corticosteroid.

12 monthsApproval duration

800 mg/dayMax daily dose

400 mg BIDTypical dosing

≥18Eligible age

Platelets <30k/µLLab criterion

Coverage Criteria for Wayrilz (rilzabrutinib)

Initial Therapy

Covered when ALL of the following are met

Initial Approval - ITP: Diagnosis of persistent or chronic immune thrombocytopenia (ITP); prescribed by or in consultation with a hematologist; age ≥ 18 years; one of the following: (a) current (within 30 days) platelet count < 30,000/µL, or (b) member has an active bleed; failure of a systemic corticosteroid unless contraindicated or clinically significant adverse effects; failure of eltrombopag (Promacta) unless contraindicated or clinically significant adverse effects; Wayrilz is not prescribed concurrently with rituximab, a thrombopoietin receptor agonist (e.g., Doptelet, Promacta, Mulpleta, Nplate), or a spleen tyrosine kinase inhibitor (e.g., Tavalisse); dose does not exceed 800 mg (2 tablets) per day.N/A

Approval duration: 12 months

Continuation Therapy

Covered when ALL of the following are met

Continued Therapy - ITP: Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; member is responding positively to therapy (e.g., increase in platelet count from baseline, reduction in bleeding events); Wayrilz is not prescribed concurrently with rituximab, a thrombopoietin receptor agonist (e.g., Doptelet, Promacta, Mulpleta, Nplate), or a spleen tyrosine kinase inhibitor (e.g., Tavalisse); if request is for a dose increase, new dose does not exceed 800 mg (2 tablets) per day.N/A

Approval duration: 12 months

Coverage does not extend to non‑FDA approved indications that are not specifically addressed by this policy. For any off‑label use, the provider must supply sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or other applicable evidence of coverage documents.

Use of the medication for indications that are not FDA‑approved and not addressed in this policy is not authorized unless the submission includes adequate documentation meeting the referenced off‑label use policy standards. Requests lacking such documentation will be considered non‑covered.

Initial Approval Criteria

Initial Therapy

Initial approval requirements for ITP

Initial use: Diagnosis of persistent or chronic ITP; prescribed by or in consultation with a hematologist; age ≥18 years; platelet <30,000/µL within 30 days or active bleed; failure of systemic corticosteroid unless contraindicated; failure of eltrombopag unless contraindicated; Wayrilz not used concurrently with rituximab, a thrombopoietin receptor agonist, or a spleen tyrosine kinase inhibitor; dose ≤ 800 mg/day (typical regimen 400 mg PO BID).N/A

Approval duration: 12 months

Criteria for Continued Coverage

Continued Therapy

Criteria for continued coverage

Continued use: Member is currently receiving medication via the benefit or previously met initial approval criteria (or is in continuity of care); member is responding to therapy (e.g., increase in platelet count from baseline or reduction in bleeding events as defined by response criteria); Wayrilz is not prescribed concurrently with rituximab, a thrombopoietin receptor agonist, or a spleen tyrosine kinase inhibitor; if dose increase requested, new dose does not exceed 800 mg/day.N/A

Approval duration: 12 months

Coding and Product Information

Product availability / NDCNDC

NDC	Tablet: 400 mg

inv-06: Platelet count threshold — < 30,000/µL

Platelet threshold for initiationCurrent platelet count < 30,000/µL (within 30 days) is a qualifying laboratory criterion for initial approval.

Response definition (ASH 2019)Response defined as platelet count ≥ 30,000/µL and >2-fold increase from baseline on two occasions >7 days apart without bleeding.

Failure definition (ASH 2019)Failure defined as platelet count < 30,000/µL or <2-fold increase from baseline or presence of bleeding; platelet counts measured on ≥2 occasions >1 day apart.

Prior Authorization, Documentation, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation demonstrating that the member meets criteria for treatment of persistent or chronic immune thrombocytopenia (ITP) and other policy requirements.

Affected drug: Wayrilz (rilzabrutinib)
Approval duration: 12 months
Maximum dose: 800 mg (2 tablets) per day

Step Therapy

Step Therapy Requirements

Step therapy requires documented failure of specified prior therapies before approval of Wayrilz, unless contraindicated or clinically significant adverse effects are documented.

Required failures: systemic corticosteroid and eltrombopag (Promacta) prior to Wayrilz
Document contraindications or clinically significant adverse effects if exceptions are claimed
For IL HIM members (from 2026-01-01), step therapy does not apply per IL HB 5395

Documentation Required

Required Documentation

Provider must submit supporting clinical documentation with the prior authorization request to demonstrate that all approval criteria are met.

Diagnosis documentation: evidence of persistent or chronic ITP (see Appendix D)
Lab results: current platelet count (within 30 days) or documentation of active bleeding
Therapy history: documentation of trial and failure/intolerance of systemic corticosteroid and eltrombopag, or documented contraindication/adverse effects
Specialist involvement: note indicating prescribed by or in consultation with a hematologist
For continuation: evidence of clinical response (increase in platelet count from baseline or reduced bleeding events) or prior approval records

Denial Risk

Reasons for Denial

Requests may be denied if the member does not meet policy criteria or required documentation is missing or inadequate.

Insufficient documentation of diagnosis (persistent/chronic ITP) or absence of required lab results
Member under 18 years of age
No documentation of failure of systemic corticosteroid and/or eltrombopag and no documented contraindication
Concurrent prescription with rituximab, TPO receptor agonist (Promacta/Doptelet/Mulpleta/Nplate), or spleen tyrosine kinase inhibitor (Tavalisse)
Requested dose exceeds 800 mg (2 tablets) per day

Step Therapy Requirements

Step	Requirement	Notes
1	Prior failure of a systemic corticosteroid is required unless contraindicated or clinically significant adverse effects are experienced.	Per Initial Approval Criteria: failure of systemic corticosteroid (see Appendix B).
2	Prior failure of eltrombopag (generic Promacta) is required unless contraindicated or clinically significant adverse effects are experienced.	Policy added redirection to generic Promacta for ITP (see references).
3	Step therapy requirement does not apply to Illinois HIM requests effective 1/1/2026 per IL HB 5395.	Illinois HIM exemption noted in policy footnote.
4	Wayrilz must not be prescribed concurrently with rituximab, a thrombopoietin receptor agonist, or a spleen tyrosine kinase inhibitor.	Concurrent use prohibition is part of initial approval conditions; dose must also not exceed 800 mg/day.

Quantity Limits and Dispensing

inv-17: Wayrilz (rilzabrutinib) — 2 tablets

Quantity limit2 tablets per day (400 mg tablet; maximum 800 mg/day).

Typical dosing regimen400 mg PO twice daily (400 mg tablet).

Maximum daily dose800 mg/day (equivalent to 2 tablets).

Site-of-Care Restrictions

Note

No site‑of‑care restrictions

No site‑of‑care restrictions are specified in this policy.

Clinical Definitions and Response Criteria

inv-12: ITP timing definitions

Newly diagnosed ITPDiagnosis to 3 months.

Persistent ITP3 to 12 months from diagnosis.

Chronic ITPGreater than 12 months from diagnosis.

inv-13: Treatment response/failure

Treatment response (2019 ASH)Platelet count ≥ 30,000/µL and >2-fold increase from baseline on two occasions >7 days apart without bleeding.

Treatment failure (2019 ASH)Platelet count < 30,000/µL, or <2-fold increase from baseline, or presence of bleeding; platelet counts should be measured on ≥2 occasions more than 1 day apart.

Measurement timing for responseTwo occasions >7 days apart for response assessment.

Background

This policy specifically lists diagnoses and indications for which coverage is not authorized. Non‑FDA approved indications not addressed in this policy require demonstration of efficacy and safety per the applicable off‑label policies before coverage will be considered.

Revision History & Policy Changes

2025-12-04formulary_redirection

Added redirection to generic Promacta for ITP and removed redirection to immune globulin if intolerant or contraindicated to systemic corticosteroid.

2025-09-09policy_creation

Policy created (initial document creation).

2025-11-25p_and_t_approval

Policy received P&T approval.

2025-02-26p_and_t_approvalLatest

P&T approval recorded for formulary changes noted in December SDC.

Policy Summary

Payermhn

PolicyRilzabrutinib (Wayrilz) — Coverage Criteria for Immune Thrombocytopenia

Policy CodePolicy CP.PHAR.751

Change TypeFormulary redirectionoperational update

Effective DateDec 1, 2025

Next Review Date

SourceLink

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