ALIQOPA, Copanlisib HCl Form

Copanlisib (Aliqopa®) is a phosphatidylinositol-3-kinase inhibitor. FDA Approved Indication(s) Aliqopa is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. __ Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 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 Aliqopa is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Follicular and Other B-Cell Lymphomas (must meet all):

1. Diagnosis of one of the following B-cell lymphoma subtypes (a or b): a. FL; b. Marginal zone lymphoma (off-label) (i, ii, or iii): i. Splenic marginal zone lymphoma; ii. Nodal marginal zone lymphoma; iii. Extranodal marginal zone lymphoma (a or b): a) Gastric MALT lymphoma; b) Nongastric MALT lymphoma;
2. Prescribed by or in consultation with an oncologist or hematologist;
   3. Age ≥ 18 years;
   4. Relapsed/refractory disease after ≥ 2 prior therapies (see Appendix B for examples);Prior authorization may be required

3. Request meets one of the following (a or b): a. Dose does not exceed 60 mg (1 vial) per week for 3 out of 4 weeks; b. 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 Page 1 of 6

   CLINICAL POLICY
   Copanlisib Commercial – 6 months or duration of request, whichever is less 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.
   II. Continued Therapy A. Follicular and Other B-Cell Lymphomas (must meet all):
6. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Aliqopa for a covered indication and has received this medication for at least 30 days;
7. Member is responding positively to therapy;
   3. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 60 mg (1 vial) per week for 3 out of 4 weeks; b. 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 – 6 months or duration of request, whichever is less 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 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 6

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

9. 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 policy – 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 FL: follicular lymphoma NCCN: National Comprehensive Cancer Network 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 Follicular Lymphoma Examples of first-line, second-line and subsequent therapies: • bendamustine + Gazyva® (obinutuzumab) or rituximab • CHOP (cyclophosphamide, doxorubicin, vincristine, predenisone) + Gazyva or rituximab • CVP (cyclophosphamide, vincristine, prednisone) + Gazyva or rituximab • Single-agent examples: rituximab; Revlimid® (lenalidomide) ± rituximab
   Marginal Zone Lymphomas
   Examples of first-line, second-line and subsequent therapies: • bendamustine + rituximab, bendamustine + Gazyva® • RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) • RCVP (rituximab, cyclophosphamide, vincristine, prednisone) Page 3 of 6 Varies Varies

   CLINICAL POLICY
   Copanlisib Drug Name Dosing Regimen Dose Limit/ Maximum Dose • Single-agent examples: rituximab; Leukeran® (chlorambucil) ± rituximab; cyclophosphamide ± rituximab; Imbruvica® (ibrutinib); Revlimid ± rituximab; Copiktra® (duvelisib); Zydelig® (idelalisib) 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 None reported V. Dosage and Administration
   Indication FL Dosing Regimen 60 mg IV on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (3 weeks on/1 week off) Maximum Dose 60 mg/dose/week VI. Product Availability
   Single-dose vial: 60 mg
   VII.