COPIKTRA, Duvelisib Form

Duvelisib (Copiktra®) is a kinase inhibitor. FDA Approved Indication(s) Copiktra is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. 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 Copiktra is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (must meet all):

1. Diagnosis of CLL or SLL;
   2. Prescribed by or in consultation with an oncologist or hematologist;
   3. Age ≥ 18 years;
   4. For brand Copiktra requests, member must use generic duvelisib, if available, unless contraindicated or clinically significant adverse effects are experienced;
2. Relapsed/refractory disease after at least one prior therapy (see Appendix B for examples);Prior authorization may be required.

3. Prescribed as a single agent;

   7. Request meets one of the following (a, b, or c): a. Dose does not exceed both of the following (i and ii): i. 50 mg per day; ii. 2 capsules per day; b. Dose does not exceed 80 mg per day if co-administered with a moderate CYP3A4 inducer; c. 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:
      Medicaid/HIM – 6 months
      Commercial – 12 months or duration of request, whichever is less Page 1 of 7

   CLINICAL POLICY Duvelisib B. T-Cell Lymphomas (off-label) (must meet all):

   1. Diagnosis of one of the following (a, b, or c): a. Hepatosplenic T-cell lymphoma after 2 first-line therapy regimens; b. Breast implant-associated anaplastic large cell lymphoma after at least one prior therapy; c. Peripheral T-cell lymphoma (PTCL) in one of the following settings (i or ii): Initial palliative intent therapy; i. ii. After at least one prior therapy;
4. Prescribed by or in consultation with an oncologist or hematologist;
   
   3. Age ≥ 18 years;
   4. For brand Copiktra requests, member must use generic duvelisib, if available, unless contraindicated or clinically significant adverse effects are experienced;
5. Disease is relapsed or refractory;
   6. Prescribed as a single agent;
   7. Request meets one of the following (a, b, or c): a. Dose does not exceed both of the following (i and ii): i. 50 mg per day; ii. 2 capsules per day; b. Dose does not exceed 80 mg per day if co-administered with a moderate CYP3A4 inducer; c. 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:
      Medicaid/HIM – 6 months
      Commercial – 12 months or duration of request, whichever is less C. Other diagnoses/indications (must meet 1 or 2):
6. 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

7. 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.
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   CLINICAL POLICY Duvelisib II. Continued Therapy A. All Indications in Section I (must meet all):

8. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Copiktra for a covered indication and has received this medication for at least 30 days;
9. Member is responding positively to therapy;
   3. For brand Copiktra requests, member must use generic duvelisib, if available, unless contraindicated or clinically significant adverse effects are experienced;
10. If request is for a dose increase, request meets one of the following (a, b, or c): a. New dose does not exceed both of the following (i and ii): i. 50 mg per day; ii. 2 capsules per day; b. New dose does not exceed 80 mg per day if co-administered with a moderate CYP3A4 inducer; 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:
    Medicaid/HIM – 12 months
    Commercial – 12 months or duration of request, whichever is less 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: 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.
    Page 3 of 7

    CLINICAL POLICY Duvelisib IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CLL: chronic lymphocytic leukemia FDA: Food and Drug Administration FL: follicular lymphoma NCCN: National Comprehensive Cancer Network PTCL: peripheral T-cell lymphoma SLL: small lymphocytic lymphoma 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 Varies Dose Limit/ Maximum Dose Varies CLL/SLL Examples of first-line, second-line and subsequent therapies: • FCR (fludarabine, cyclophosphamide, rituximab) • HDMP (high-dose methylprenisolone) + rituximab • Single-agent examples: Imbruvica® (ibrutinib); Venclexta® (venetoclax) ± Gazyva® (obinutuzumab) or rituximab; Campath® (alemtuzumab) ± rituximab; Gazyva; Copiktra® (duvelisib); Calquence® (acalabrutinib); Revlimid® (lenalidomide) ± rituximab; Arzerra® (ofatumumab) ± FC (fludarabine, cyclophosphamide); Leukeran® (chlorambucil) + rituximab T-cell lymphomas Examples of first-line and subsequent therapies: • ICE (ifosfamide, carboplatin, etoposide) • DHAP (dexamethasone, cytarabine, cisplatin) • DHAX (dexamethasone, cytarabine, oxaliplatin) • Single-agent examples: Adcetris® (bretuximab vedotin), Folotyn® (pralatrexate), Kesimpta® (alemtuzumab), belinostat, gemcitabine, bendamustine, lenalidomide, romidepsin Varies Varies 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. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): none reported • Boxed warning(s): fatal and serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis Appendix D: General Information • Examples of moderate CYP3A4 inducers include, but are not limited to: bosentan, efavirenz, etravirine, phenobarbital, and primidone. Page 4 of 7

    CLINICAL POLICY Duvelisib V. Dosage and Administration
    Indication Dosing Regimen CLL/SLL 25 mg PO BID (may reduce to 15 mg PO BID for adverse reactions). A cycle consists of 28 days Maximum Dose 50 mg/day If co-administered with a moderate CYP3A4 inducer: 40 mg PO BID if the initial Copiktra dose is 25 mg PO BID (25 mg PO BID if the initial Copiktra dose is 15 mg PO BID). After the inducer has been discontinued for at least 14 days, resume Copiktra at the dose taken prior to initiating the moderate CYP3A4 inducer If co-administered with a moderate CYP3A4 inducer: 80 mg/day VI. Product Availability
    Capsules: 25 mg, 15 mg VII.