Rilzabrutinib (Wayrilz)
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Defines medical necessity and prior authorization criteria for Wayrilz (rilzabrutinib) for adult patients with persistent or chronic immune thrombocytopenia (ITP) across specified lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria for Wayrilz (rilzabrutinib)
inv-01: Initial Therapy
Covered when ALL of the following are met
Approval duration: 12 months
inv-02: Continuation Therapy
Covered for continuation when ALL of the following are met
Approval duration: 12 months
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or the member's evidence of coverage documents.
Coverage decisions and the administration of benefits for rilzabrutinib are governed by the member's coverage documents and applicable Health Plan administrative policies. This clinical policy is a guide to medical necessity and does not constitute a contract or guarantee of payment; therefore, all determinations remain subject to the terms, conditions, exclusions and limitations of the applicable evidence of coverage, certificate of coverage, policy, contract of insurance, and to state and federal requirements.
Requests for rilzabrutinib to treat non‑FDA approved indications that are not addressed in this policy require supporting documentation per the Health Plan’s off‑label use policies. Without sufficient evidence of efficacy and safety as defined in those referenced off‑label policies, such requests are not authorized.
Provider Requirements and Prior Authorization
Prior Authorization Required
Prior authorization is required. Submit documentation demonstrating diagnosis of persistent or chronic immune thrombocytopenia, specialist involvement (prescribed by or in consultation with a hematologist), age ≥ 18 years, and platelet/bleeding criteria (current platelet count < 30,000/µL within 30 days or active bleed). Prior authorization may also be required for immune globulin therapy where relevant.
- Approval duration: 12 months
- Dose limit: ≤ 800 mg (2 tablets) per day
- Wayrilz must not be used concurrently with rituximab, thrombopoietin receptor agonists (e.g., Doptelet®, Promacta®, Mulpleta®, Nplate®), or spleen tyrosine kinase inhibitors (e.g., Tavalisse™)
Required Clinical Documentation
Providers must submit supporting clinical documentation such as office chart notes, relevant laboratory results (including recent platelet counts), and any consultation notes that substantiate meeting all approval criteria. Failure to provide required documentation or to supply requested reauthorization information may result in denial or delay of the request.
- Examples: office notes, platelet lab results within 30 days, hematology consult notes, records of prior therapies and responses
Documentation and Contractual Compliance
Coverage decisions are governed by the member's benefit plan and applicable contracts. Authorization and payment remain subject to the terms, conditions, exclusions, and limitations of the member's evidence of coverage, certificate of coverage, policy, contract of insurance, and state/federal requirements. Providers should follow any additional Health Plan-level administrative policies and contractual obligations.
- Authorizations do not guarantee payment — adjudication follows member benefit terms
- State continuity-of-care requirements may affect coverage for members currently receiving therapy
Therapeutic Alternatives / Prior Therapy Expectations
Therapeutic alternatives and prior therapy expectations: members must have failed systemic corticosteroids or have intolerance/contraindication to them and have failed immune globulin therapy unless immune globulin is contraindicated or causes clinically significant adverse effects. Prior authorization may be required for immune globulins (see Appendix B). Review Appendix B and state-specific addenda for details on acceptable prior therapies and dosing.
- Required prior therapy: systemic corticosteroid failure OR intolerance/contraindication plus immune globulin failure (unless contraindicated)
- Prior‑authorization may be required for immune globulins — check plan-specific requirements (Appendix B)
Grounds for Denial
Denials may be issued if requested services fall outside the member's benefit terms (exclusions, limits, or lack of coverage), if required documentation is not supplied, if clinical criteria are not met, or if concurrent excluded therapies are prescribed. Providers and members may appeal adverse determinations per the member's plan procedures.
- Common denial reasons: missing documentation, failure to meet medical necessity criteria, contract exclusions or limitations, concurrent use with excluded agents
Initial Authorization Criteria and Dosing
inv-20: Initial Therapy
Initial authorization criteria and dosing
Approval duration: 12 months
Continuation Authorization Criteria
inv-21: Continuation Therapy
Continuation criteria for ITP
Prior Treatment Requirements / Step Therapy
| Step | Required prior treatment failure or intolerance |
|---|---|
| 1 | Failure of a systemic corticosteroid; if systemic corticosteroids are contraindicated or not tolerated, failure of an immune globulin unless contraindicated or clinically significant adverse effects are experienced |
Coding, Thresholds, and Related Values
Quantity Limits and Product Information
Site of Care Restrictions
No site-of-care restrictions specified
No site-of-care restrictions are specified in this section of the policy.
Definitions and Clinical Terms
Background and Drug Information
Rilzabrutinib (Wayrilz) is an oral Bruton's tyrosine kinase (BTK) inhibitor available as a 400 mg tablet. It is FDA‑approved for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior treatment. The approved dosing for ITP is 400 mg PO twice daily (maximum 800 mg/day), and authorization is intended for adults aged ≥ 18 years. ITP classifications and response definitions referenced in this policy follow international consensus and ASH guidance (e.g., response often defined as platelet count ≥30,000/µL with a >2‑fold increase from baseline and absence of bleeding).
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