TAVALISSE, Fostamatinib Disodium Form

Fostamatinib (Tavalisse™) is an oral spleen tyrosine kinase inhibitor. FDA Approved Indication(s) Tavalisse is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Tavalisse is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chronic Immune Thrombocytopenia (must meet all):

1. Diagnosis of chronic ITP;
   2. Prescribed by or in consultation with a hematologist;
   3. Age ≥ 18 years;
   4. One of the following (a or b):
      a. Current (within the last 30 days) platelet count < 30,000/µL;
      b. Member has an active bleed;
2. Member meets one of the following (a or b): a. Failure of a systemic corticosteroid; b. Member has intolerance or contraindication to systemic corticosteroids, and failure of an immune globulin, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B); *Prior authorization may be required for immune globulins
3. Tavalisse is not prescribed concurrently with thrombopoietin receptor agonists (e.g., Doptelet®, Nplate®, Promacta®, Mulpleta®);

4. Dose does not exceed both of the following (a and b):
   a. 300 mg per day;
   b. 2 tablets per day.
   Approval duration: 6 months Page 1 of 7

   CLINICAL POLICY Fostamatinib B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Chronic Immune Thrombocytopenia (must meet all):
7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
8. Member is responding positively to therapy (e.g., increase in platelet count from baseline, reduction in bleeding events);
9. Tavalisse is not prescribed concurrently with thrombopoietin receptor agonists (e.g., Doptelet®, Nplate®, Promacta®, Mulpleta®)
10. If request is for a dose increase, new dose does not exceed both of the following (a and b):
    a. 300 mg per day;
    b. 2 tablets per day.
    Approval duration: 12 months
    B. Other diagnoses/indications (must meet 1 or 2):

11. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 2 of 7

    CLINICAL POLICY Fostamatinib CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

12. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration ITP: immune thrombocytopenia Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose Corticosteroids* dexamethasone Oral dosage:
    Initially, 0.75 to 9 mg/day PO in 2 to 4 divided doses. Adjust according to patient response Intramuscular or intravenous dosage: Initially, 0.5 to 9 mg/day IV or IM in 2 to 4 divided doses. Adjust according to patient response Highly variable depending on the nature and severity of the disease, route of treatment, and on patient response. methylprednisolone Oral dosage: prednisone 4 to 48 mg/day PO in 4 divided doses. Adjust according to patient response. Intramuscular or intravenous dosage: 10-40 mg IV every 4-6 hours for up to 72 hours Initially, 1 mg/kg PO once daily; however, lower doses of 5 mg/day to 10 mg/day PO are preferable for long-term treatment Page 3 of 7

    CLINICAL POLICY Fostamatinib Drug Name Dosing Regimen Dose Limit/ Maximum Dose Refer to prescribing information Refer to prescribing information Immune globulins Immune globulins (e.g., Carimune® NF, Flebogamma® DIF 10%, Gammagard® S/D, Gammaked™, Gamunex®-C, Gammaplex®, Octagam® 10%, Privigen®, etc.) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. *Examples of corticosteroids/immunosuppressive agents provided are not all inclusive
    Appendix C: Contraindications/Boxed Warnings None reported Appendix D: General Information • Definitions of acute vs. chronic ITP: o Per an International Working Group consensus panel of ITP experts, ITP is defined as newly diagnosed (diagnosis to 3 months), persistent (3 to 12 months from diagnosis), or chronic (lasting for more than 12 months). Although not formally validated, these definitions are supported and used by the American Society of Hematology (ASH). • Per the 2019 ASH guidelines, a durable response to treatment was defined by the following: o A durable response would be defined as a platelet count ≥ 30,000/µL and a greater than 2-fold increase in platelet count from baseline at 6 months. o A failure would be defined as a platelet count < 30,000/µL or a less than 2-fold increase in platelet count from baseline.
    V. Dosage and Administration
    Indication Dosing Regimen ITP 100 mg PO BID; after 4 weeks, increase to 150 mg BID, if needed, to achieve platelet counts of at least 50 x 109/L Maximum Dose 300 mg/day VI. Product Availability
    Tablets: 100 mg, 150 mg VII.