Wayrilz™

Drug - Wayrilz™ (rilzabrutinib) [Genzyme Corporation.]

August 2026

Therapeutic Area - Chronic immune thrombocytopenia (ITP)

Initial approval criteria

  • Patient must meet an age-appropriate medically accepted indication, as defined in Section 1927 of the Social Security Act, for the requested agent; AND
  • The patient has a diagnosis of persistent (defined as 3 to 12 months) or chronic (defined as lasting for > 12 months) immune (idiopathic) thrombocytopenia (ITP); AND
  • Patient has a platelet count ≤ 30 x 109/L OR;
  • Patient has a platelet count > 30 x 109/L but < 50 x 109/L AND has symptomatic bleeding and/or an increased risk of bleeding AND;
  • Patient has one of the following:
    • Patient has tried and had an inadequate response to ONE corticosteroid used for the treatment of ITP; OR
    • Patient has an intolerance or hypersensitivity to ONE corticosteroid used for the treatment of ITP; OR
    • Patient has an FDA labeled contraindication to ALL corticosteroids used for the treatment of ITP; OR
    • Patient has tried and had an inadequate response to another thrombopoietin receptor agonist (e.g., avatrombopag [Doptelet], romiplostim [Nplate], eltrombopag [Promacta]); OR
    • Patient has tried and had an inadequate response to immunoglobulins (intravenous immunoglobulin [IVIg] or Anti-D); OR
    • Patient has had an inadequate response to a splenectomy; OR
    • Patient has tried and had an inadequate response to rituximab; AND
  • Patient will NOT use Wayrilz in combination with other kinase inhibitors with similar indications (e.g., fostamatinib [Tavalisse]); AND
  • Prescriber has reviewed Wayrilz Warning/Precautions and Drug Interactions and will monitor patient status as appropriate; AND
  • Patient of reproductive potential should have a negative pregnancy test prior to initiating Wayrilz and should use effective contraception during treatment and for one week after the last dose.
  • Initial approval is for 6 months

Renewal criteria

  • Patient must continue to meet the initial approval criteria; AND
  • Patient must have disease improvement and/or stabilization demonstrated by the patient’s platelet count of ≥ 50 x 109/L or the patient’s platelet count has increased sufficiently to avoid clinically significant bleeding; AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., serious infections, hepatotoxicity including drug-induced liver injury).
  • Renewal approval is for 12 months

Quantity limits

  • 60 tablets/30 days (max dose: 400 mg orally twice daily)

Questions

Provider Call Center: (844) 575-7887