MHN Wayrilz (rilzabrutinib) Coverage Prior Auth

Coverage Criteria for Wayrilz (rilzabrutinib)

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Approval - ITP: 1. Diagnosis of persistent or chronic immune thrombocytopenia (ITP) (see Appendix D); 2. Prescribed by or in consultation with a hematologist; 3. Age ≥ 18 years; 4. One of the following: (a) current (within 30 days) platelet count < 30,000/µL; OR (b) member has an active bleed; 5. One of the following: (a) failure of a systemic corticosteroid; OR (b) intolerance or contraindication to systemic corticosteroids AND failure of an immune globulin unless contraindicated or clinically significant adverse effects are experienced; 6. Wayrilz (rilzabrutinib) 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); 7. Dose does not exceed 800 mg (2 tablets) per day.see node text

Approval duration: 12 months

inv-02: Continuation Therapy

Covered for continuation when ALL of the following are met

Continuation Therapy - ITP: 1. 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; 2. Member is responding positively to therapy (e.g., increase in platelet count from baseline, reduction in bleeding events); 3. 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); 4. If request is for a dose increase, new dose does not exceed 800 mg (2 tablets) per day.see node text

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.

inv-06: Platelet count threshold

Platelet count threshold for authorizationCurrent platelet count < 30,000/µL (measured within 30 days) is an initial-approval criterion

Response definition (per 2019 ASH guidelines)Platelet count ≥ 30,000/µL and >2‑fold increase from baseline measured on 2 occasions >7 days apart and absence of bleeding

Failure definition (per 2019 ASH guidelines)A failure is defined as platelet count < 30,000/µL or <2‑fold increase from baseline or presence of bleeding; platelets must be measured on 2 occasions >1 day apart

Provider Requirements and Prior Authorization

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™)

Documentation Required

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.

Initial Authorization Criteria and Dosing

inv-20: Initial Therapy

Initial authorization criteria and dosing

Initial: 1. Diagnosis of persistent or chronic ITP; 2. Prescribed by or in consultation with a hematologist; 3. Age ≥ 18 years; 4. Current platelet count < 30,000/µL (within 30 days) OR active bleed; 5. Prior failure of a systemic corticosteroid OR intolerance/contraindication to systemic corticosteroids AND failure of an immune globulin unless contraindicated or clinically significant adverse effects are experienced; 6. Not prescribed concurrently with rituximab, a thrombopoietin receptor agonist, or a spleen tyrosine kinase inhibitor; 7. Dosing: 400 mg PO twice daily (400 mg BID) with a maximum dose of 800 mg/day (2 tablets per day).Dose: 400 mg PO BID; Max 800 mg/day

Approval duration: 12 months

Continuation Authorization Criteria

inv-21: Continuation Therapy

Continuation criteria for ITP

Continuation: 1. Member meets continuity criterion (currently receiving medication via benefit or previously met initial approval criteria OR enrolled in state/product with continuity of care); 2. Member demonstrates positive response to therapy (e.g., increase in platelet count from baseline, reduction in bleeding events); 3. Wayrilz is not prescribed concurrently with rituximab, a thrombopoietin receptor agonist, or a spleen tyrosine kinase inhibitor; 4. If dose increase is requested, new dose does not exceed 800 mg (2 tablets) per day.

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

inv-06: Platelet count threshold

Authorization platelet criterionCurrent (within 30 days) platelet count < 30,000/µL required for one pathway to initial approval

Alternate initial criterionActive bleeding at time of assessment may substitute for platelet threshold

Response metric used in continuationResponse defined as platelet count ≥ 30,000/µL with >2‑fold increase from baseline on 2 occasions >7 days apart and no bleeding

Quantity Limits and Product Information

inv-23: Wayrilz (rilzabrutinib) — quantity limit / maximum dose (800 mg)

Maximum daily dose800 mg per day (maximum) — equivalent to 2 tablets/day

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

Quantity limit recordQuantity limits specify 800 mg per day as the allowable maximum

Site of Care Restrictions

Note

No site-of-care restrictions specified

No site-of-care restrictions are specified in this section of the policy.

Definitions and Clinical Terms

inv-16: Immune thrombocytopenia (ITP) — newly diagnosed, persistent, chronic timeframes

Newly diagnosed ITPNewly diagnosed: diagnosis to 3 months from onset (per International Working Group)

Persistent ITPPersistent: 3 to 12 months from diagnosis

Chronic ITPChronic: lasting for more than 12 months

inv-17: Response to treatment (per 2019 ASH guidelines) — platelet count criteria for response

Primary response criterionPlatelet count ≥ 30,000/µL and a >2‑fold increase from baseline measured on 2 occasions >7 days apart and absence of bleeding

Measurement timingPlatelet measurements must be taken on two occasions more than 7 days apart for full response assessment

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).