CurrentcareoregonPolicy N/A

Wayrilz (rilzabrutinib) prior authorization for immune thrombocytopenic purpura (ITP)

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Prior authorization requirements for initiation and reauthorization of Wayrilz (rilzabrutinib) for members with immune thrombocytopenic purpura (ITP), including clinical criteria and documentation required for CareOregon members.

Policy Summary

Payercareoregon

PolicyWayrilz (rilzabrutinib) prior authorization for ITP

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of failed eltrombopag plus another TPO-RA and required platelet lab records to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moapproval length

ITPindication

<20k / <30k w/ bleedplatelet thresholds

eltrombopag +1 TPO‑RAprior therapy

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CurrentcareoregonPolicy N/A

Wayrilz (rilzabrutinib) prior authorization for immune thrombocytopenic purpura (ITP)

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Policy Summary

Payercareoregon

PolicyWayrilz (rilzabrutinib) prior authorization for ITP

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of failed eltrombopag plus another TPO-RA and required platelet lab records to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moapproval length

ITPindication

<20k / <30k w/ bleedplatelet thresholds

eltrombopag +1 TPO‑RAprior therapy

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization criteria: 1) Diagnosis of immune thrombocytopenic purpura (ITP).

Initial Authorization criteria: 2) Treatment initiated by or is being supervised by a hematologist.

One of the following must be met

Option A: Member has failed, or has a contraindication to, rituximab (rituximab failure/contraindication not required for members under 18 years of age).
Option B: History of splenectomy.

Prior TPO-RA therapy requirement: Member has failed both eltrombopag and at least one additional thrombopoietin receptor agonist (TPO-RA) such as avatrombopag (Doptelet) or romiplostim (Nplate).

Approval length: 6 months

Continuation/Reauthorization

Reauthorization covered when ALL of the following are met:

Reauthorization criteria: Submission of medical records (e.g., chart notes) confirming either: (a) maintenance of platelet counts between 30,000/mm3 and 100,000/mm3, OR (b) a doubling of platelet counts from baseline with resolution of bleeding episodes; and documentation of initial severe platelet counts (<20,000/mm3) or <30,000/mm3 with symptoms of bleeding as applicable.

Reauthorization approval length: 6 months

The source document does not list any specific exclusions for Wayrilz (rilzabrutinib) in the treatment of immune thrombocytopenic purpura (ITP). CareOregon’s approval criteria and prior‑authorization guidance present required diagnostic, specialist involvement, prior‑therapy, and laboratory documentation elements but do not state any explicit exclusions or conditions that would categorically make the therapy ineligible.

The policy does not provide additional coverage‑criteria remarks beyond the stated requirements for diagnosis, hematology oversight, prior therapies (including failed eltrombopag and one additional TPO‑RA), rituximab failure/contraindication or splenectomy history, and documentation of platelet response for reauthorization. No further clarifying notes, limitations, or noncovered scenarios are specified in the document.

Provider Requirements and Documentation

Prior Authorization

Prior authorization required (approval length 6 months)

Prior authorization is required for Wayrilz (rilzabrutinib) when used to treat immune thrombocytopenic purpura (ITP). Initial approvals are granted for 6 months.

Documentation Required

Reauthorization requires documented platelet response

For reauthorization, submit medical records showing the platelet response used to determine continued coverage; reauthorizations are granted for 6 months.

Records must demonstrate maintenance of platelet counts between 30,000/mm3 and 100,000/mm3 or a doubling of platelet counts from baseline with resolution of bleeding.
Reauthorization approval length: 6 months.

Step Therapy

Must fail eltrombopag and one additional TPO‑RA

Documented failure of eltrombopag is required, plus failure of one additional thrombopoietin receptor agonist (e.g., avatrombopag/Doptelet or romiplostim/Nplate) prior to Wayrilz.

Required prior agents: Eltrombopag and one additional TPO‑RA (examples listed in policy: Doptelet or Nplate).

Step Therapy

Rituximab failure or contraindication required (pediatric exception)

Document that the member failed rituximab or has a contraindication to rituximab prior to Wayrilz, unless the member is under 18 years of age (rituximab requirement is not required for members <18).

Documentation Required

Submit platelet counts and dates in medical records

Submit clinical records/chart notes with platelet counts and dates: initial severe platelet counts (<20,000/mm3) or <30,000/mm3 with bleeding as applicable, and for reauthorization the maintenance counts (30,000–100,000/mm3) or documented doubling from baseline with resolution of bleeding.

Initial documentation: platelet count <20,000/mm3 or <30,000/mm3 with symptoms of bleeding (include date).
Reauthorization documentation: platelet counts between 30,000/mm3 and 100,000/mm3 or doubling from baseline (include dates and trend).

Documentation Required

Hematologist initiation or supervision must be documented

Provide documentation that treatment with Wayrilz was initiated by or is being supervised by a hematologist.

Denial Risk

Denial risk: missing prior therapy documentation

If prior TPO‑RA therapies (eltrombopag and an additional TPO‑RA) or rituximab failure/contraindication are not documented, the request may be denied.

Denial risk applies when prior TPO‑RA trials are not shown.
Denial risk applies when rituximab failure or contraindication is not documented (unless member <18).

Denial Risk

Denial risk: insufficient laboratory documentation

Failure to submit medical records confirming required platelet counts (initial severe counts or reauthorization maintenance/doubling) may result in denial of the request.

Missing evidence of platelet count <20,000/mm3 or <30,000/mm3 with bleeding for initial approval risks denial.
Missing evidence of maintenance platelet counts 30,000–100,000/mm3 or documented doubling from baseline for reauthorization risks denial.

Background

Immune thrombocytopenic purpura (ITP) is described in the policy context as the indication for which Wayrilz is authorized when criteria are met. CareOregon’s guideline requires a confirmed diagnosis of ITP and that treatment is initiated or supervised by a hematologist. For initial authorization, members must have failed or have a contraindication to rituximab (not required if <18 years old) or have a history of splenectomy, and must have failed eltrombopag and one additional thrombopoietin receptor agonist (TPO‑RA) (e.g., avatrombopag or romiplostim). Reauthorization depends on medical records documenting platelet response, such as maintenance platelet counts between 30,000/mm3 and 100,000/mm3 or a doubling from baseline, with initial severe counts documented as <20,000/mm3 (or <30,000/mm3 with bleeding) where applicable. Approval length for both initial and reauthorization periods is 6 months.

Wayrilz (rilzabrutinib) prior authorization for immune thrombocytopenic purpura (ITP)

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Wayrilz (rilzabrutinib) prior authorization for immune thrombocytopenic purpura (ITP)

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Coverage Criteria for Wayrilz (rilzabrutinib)

Clinical Thresholds & Coding-relevant Values

Provider Requirements and Documentation

Background

Definitions