CurrentAvMedPolicy N/A

Wayrilz (rilzabrutinib) prior authorization criteria

Pharmacy prior authorization and reauthorization criteria for Wayrilz (rilzabrutinib) for treatment of chronic immune thrombocytopenia (ITP) in members, including required provider types, prior therapy trials, laboratory documentation, dosing, quantity limits, and specialty pharmacy dispensing.

Policy Summary

PayerAvMed

PolicyWayrilz (rilzabrutinib) prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescribing physician must sign the prior authorization and submit required documentation including recent platelet counts (within 28-30 days), lab results, prior therapy dates/doses, and hematology consultation; fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or authorization criteria.

1Indication covered (Chronic ITP)

18+Minimum age

6Authorization length (months) initial/repeat

50 x10^9/LMaintenance platelet threshold

Coverage Summary

Coverage stance: covered_with_criteria for treatment of Chronic Immune Thrombocytopenia (ITP) in adults. Scope: pharmacy prior authorization for Wayrilz (rilzabrutinib) in members with chronic ITP including required provider type, prior therapy trials, laboratory documentation, dosing/quantity limits, and specialty pharmacy dispensing. Population: adults ≥ 18 years. Authorization length: Initial Authorization: 6 months; Reauthorization: 6 months (maintenance contingent on response and absence of unacceptable toxicity).

Thresholds and Key Stats

Minimum age18+

Initial Authorization length6 months

Reauthorization length6 months

Platelet threshold - severe thrombocytopenia< 30 x 10^9/L (documented within last 30 days)

Platelet threshold - symptomatic/high-risk bleeding< 50 x 10^9/L (documented within last 30 days)

Maintenance platelet threshold>= 50 x 10^9/L (achieved and maintained)

Initial Therapy Criteria (Authorization — 6 months)

Initial Authorization (6 months)

All criteria must be met for approval. To support each line checked, all documentation including lab results, diagnostics, and/or chart notes must be provided or request may be denied.

ALL of the following

Member is ≥ 18 years of age
Requesting provider is a hematologist, or has been in consultation with one
Member must have a diagnosis of Chronic Immune Thrombocytopenia (ITP), refractory after previous treatment for 6 months or greater
Member's condition meets ONE of the following
- Documentation of platelet levels within the last 30 days confirming < 30 x 10^9/L< 30 x 10^9/L
  platelet levels must be within last 30 days
- Documentation of symptomatic bleeding, or high risk for bleeding, and platelet levels within the last 30 days confirming < 50 x 10^9/L< 50 x 10^9/L
  requires symptomatic bleeding or high bleeding risk and platelet levels drawn within last 30 days
Member's interval treatment history must record ONE of the following prior treatments
- Member must have failed a first-line therapy option with a corticosteroid such as prednisone 0.5-2.0 mg/kg per day
  DRUG/DOSE and dates of therapy should be provided
- Member's interval treatment history must record ONE of the following prior treatments
  - IVIG (accepted if taken in combination with corticosteroids)
  - Rituximab
  - Splenectomy
  - Documented trial and failure of therapy with a thrombopoietin (TPO) receptor agonist such as eltrombopag, romiplostim, or avatrombopag
    TPO agonist prior authorization may require a different prior authorization form; failure defined as platelet trend history not reaching target/goal
Clinical hematology laboratory tests and liver function tests have been monitored regularly and the most recent results are submitted
Laboratory values for platelet count required to be attached to request (drawn within previous 28 days)
A platelet count of at least 50 × 10^9/L has been achieved and maintained>= 50 x 10^9/L
If platelet count does not increase to sufficient level within the initial authorization period, therapy will not be continued

Continuation / Reauthorization Criteria (6 months)

Reauthorization (6 months)

All criteria must be met for approval. Documentation including lab results, diagnostics, and/or chart notes must be provided or request may be denied.

ALL of the following

Member is NOT experiencing unacceptable toxicity from the drug (e.g., diarrhea, liver toxicity, hypertension, neutropenia)
Clinical hematology laboratory tests and liver function tests have been monitored regularly and the most recent results are submitted
Laboratory values for platelet count required to be attached to request (drawn within previous 28 days)
A platelet count of at least 50 × 10^9/L has been achieved and maintained>= 50 x 10^9/L

Required Provider Actions

Prior Authorization

Prior authorization required

Prescribing physician must sign the prior authorization request; submit all required documentation including recent platelet counts (within 28-30 days), lab results, chart notes, prior therapy dates and doses, and provider consultation with a hematologist. Fax the completed request to 1-305-671-0200.

Documentation Required

Document prior therapies and failures

Provide dates and doses for first-line corticosteroid therapy and document interval treatment history showing at least one of the following prior therapies. Include evidence of failure where indicated (platelet trend history not reaching target):

Corticosteroid (e.g., prednisone 0.5–2.0 mg/kg/day) — include dates and doses
IVIG (accepted if taken in combination with corticosteroids)
Rituximab
Splenectomy
Thrombopoietin (TPO) receptor agonist (e.g., eltrombopag, romiplostim, avatrombopag) — documented trial and failure (platelet trend history not reaching target)

Billing Rule

Quantity limit and dispensing

Recommended dosage and dispensing instructions:

Recommended dosage: 400 mg by mouth twice daily
Quantity limit: 2 tablets per day
Medication provided by Specialty Pharmacy - Proprium Rx

Documentation Required

Lab monitoring required

Submit the most recent clinical hematology laboratory tests and liver function tests. Platelet count must be drawn within the previous 28–30 days (attach laboratory values to the request).

Background

Background: Wayrilz (rilzabrutinib) is specified for use in adult patients with chronic immune thrombocytopenia (ITP) refractory after ≥6 months of prior treatment. The policy defines required prior therapies (first-line corticosteroid trial, and an interval history documenting at least one of IVIG, rituximab, splenectomy, or trial and failure of a TPO receptor agonist), required laboratory monitoring (recent platelet counts, clinical hematology labs, and liver function tests), and response criteria for authorization (achievement and maintenance of a platelet count ≥ 50 × 10^9/L and documentation of platelet counts drawn within the required window).

Definitions

Initial AuthorizationApproval period of 6 months for initiation of therapy if all initial criteria are met.

ReauthorizationApproval period of 6 months for continued therapy if maintenance criteria are met and no unacceptable toxicity is present.

Clinical Evidence & Monitoring Notes

Clinical monitoring and toxicity considerations: Prior to and during therapy the policy requires submission of recent platelet counts (drawn within the previous 28–30 days), routine clinical hematology laboratory tests, and liver function tests. Reauthorization requires that the member is not experiencing unacceptable toxicity (examples listed include diarrhea, liver toxicity, hypertension, neutropenia). The policy notes that if platelet count does not increase to the sufficient level within the initial authorization period, therapy will not be continued.