MULPLETA, Lusutrombopag Form

Lusutrombopag (Mulpleta®) is a thrombopoietin (TPO) receptor agonist. FDA Approved Indication(s) Mulpleta is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. 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 Mulpleta is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Thrombocytopenia (must meet all):

1. Diagnosis of chronic liver disease;
2. Prescribed by or in consultation with a hematologist, hepatologist, or gastroenterologist;
   3. Age ≥ 18 years;
3. Recent (within the past 14 days) platelet count is < 50 x 109/L;

4. Member is scheduled to undergo an invasive medical or dental procedure within the next 30 days;

   6. Mulpleta is not prescribed concurrently with another thrombopoietin receptor agonist (e.g., Doptelet®, Nplate®, Promacta®) or spleen tyrosine kinase inhibitor (e.g., Tavalisse™);
   7. Dose does not exceed 3 mg per day (1 tablet per day). Approval duration: 14 days (no more than 7 total days of treatment)
      B. Other diagnoses/indications (must meet 1 or 2):
   8. 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 Page 1 of 5

   CLINICAL POLICY Lusutrombopag 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

   2. 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. Thrombocytopenia:
   3. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):
   4. 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
   5. 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 TPO: thrombopoietin
      Appendix B: Therapeutic Alternatives
      Not applicable Page 2 of 5

   CLINICAL POLICY Lusutrombopag Appendix C: Contraindications/Boxed Warnings None reported
   Appendix D: General Information
   • Examples of chronic liver disease include: alcoholic liver disease, chronic viral hepatitis (e.g., hepatitis B and C), and nonalcoholic steatohepatitis. V. Dosage and Administration
   Indication Thrombocytopenia Dosing Regimen 3 mg PO QD for a total of 7 days Maximum Dose 3 mg/day Begin dosing 8‐14 days prior to a scheduled procedure. Patients should undergo their procedure 2‐8 days after the last dose. VI. Product Availability
   Tablet: 3 mg VII.