Asciminib (Scemblix) Form

Asciminib (Scemblix®) is a kinase inhibitor. FDA Approved Indication(s) Scemblix is indicated for the treatment of adult patients with: • Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs) • Ph+ CML in CP with the T315I mutation. 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 Scemblix is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chronic Myeloid Leukemia (must meet all):

1. Diagnosis of one of the following (a or b): a. Ph+ CML in CP; b. BCR::ABL1-positive CML in CP (off-label);
   2. Prescribed by or in consultation with an oncologist or hematologist;
2. Age ≥ 18 years;
3. Member meets one of the following (a or b): a. Member has had previous treatment with two or more TKIs (e.g., imatinib, Bosulif®, Iclusig®, Sprycel®, Tasigna®); b. Member has the T315I mutation;
   5. Member does not have the following mutations: A337T, P465S, or F359V/I/C;

4. For Scemblix requests, member must use generic asciminib, if available, unless contraindicated or clinically significant adverse effects are experienced;

   7. Request meets one of the following (a, b, or c):* a. For Ph+ CML, previously treated with two or more TKIs: Dose does not exceed 80 mg (2 tablets) per day; b. For Ph+ CML with the T315I mutation: Does not exceed 400 mg (10 tablets) per day; c. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Page 1 of 6

   CLINICAL POLICY Asciminib *Prescribed regimen must be FDA-approved or recommended by NCCN
   Approval duration: 6 months B. Myeloid/Lymphoid Neoplasm with Eosinophilia (off-label) (must meet all):

   1. Diagnosis of a myeloid/lymphoid neoplasm with eosinophilia (MLNE) in chronic phase or blast phase;
   2. Prescribed by or in consultation with an oncologist or hematologist;
5. Age ≥ 18 years;
6. Documentation of an ABL1 gene rearrangement;
7. For Scemblix requests, member must use generic asciminib, if available, unless contraindicated or clinically significant adverse effects are experienced;
   
   6. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN
      Approval duration: 6 months C. Other diagnoses/indications (must meet 1 or 2):
   7. 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
   8. 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. All Indications in Section I (must meet all):
   9. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Scemblix for a covered indication and has received this medication for at least 30 days;
   10. Member is responding positively to therapy;

8. For Scemblix requests, member must use generic asciminib, if available, unless contraindicated or clinically significant adverse effects are experienced;

   4. If request is for a dose increase, request meets one of the following (a, b, or c):* a. For Ph+ CML, previously treated with two or more TKIs: New dose does not exceed 80 mg (2 tablets) per day; Page 2 of 6

   CLINICAL POLICY Asciminib b. For Ph+ CML with the T315I mutation: New does not exceed 400 mg (10 tablets) per day; c. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

   1. 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
   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.
      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 CML: chronic myeloid leukemia FDA: Food and Drug Administration MLNE: myeloid/lymphoid neoplasm with eosinophilia TKI: tyrosine kinase inhibitor 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 Bosulif® (bosutinib) Iclusig® (ponatinib) imatinib (Gleevec®) Dosing Regimen Dose Limit/ Maximum Dose 600 mg/day 400 mg PO QD Starting dose 45 mg PO QD 45 mg/day 400-600 mg/day PO for chronic phase 800 mg/day Page 3 of 6

   CLINICAL POLICY Asciminib Drug Name Dosing Regimen Sprycel® (dasatinib) Tasigna® (nilotinib) 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. 100-140 mg/day PO 300 mg PO BID Dose Limit/ Maximum Dose 180 mg/day 600 mg/day Appendix C: Contraindications/Boxed Warnings None reported
   V. Dosage and Administration
   Indication CML
   CML with T315I mutation VI. Product Availability
   Tablets: 20 mg, 40 mg Dosing Regimen 80 mg PO QD or 40 mg PO BID 200 mg PO BID Maximum Dose 80 mg/day 400 mg/day VII.