Lomustine (Gleostine) Form

Lomustine (Gleostine®) is a nitrosourea and an alkylating agent. FDA Approved Indication(s) Gleostine is indicated for the treatment of patients with: • Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures; • Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. 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 Gleostine is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Brain Tumors (must meet all):

1. Diagnosis of brain tumor;
2. Prescribed by or in consultation with an oncologist;
3. For brand Gleostine requests, member must use generic lomustine, if available, unless contraindicated or clinically significant adverse effects are experienced;
   4. Request meets one of the following (a or b): a. Dose does not exceed 130 mg/m2 every 6 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: 6 months B. Hodgkin’s Lymphoma (must meet all):
4. Diagnosis of Hodgkin’s lymphoma;
5. Prescribed by or in consultation with an oncologist or hematologist;

6. Failure of an initial chemotherapy regimen (see Appendix B for examples), unless contraindicated or clinically significant adverse effects are experienced;

   4. Prescribed in combination with chemotherapy; Page 1 of 7

   CLINICAL POLICY Lomustine

   5. For brand Gleostine requests, member must use generic lomustine, if available, unless contraindicated or clinically significant adverse effects are experienced;
   6. Request meets one of the following (a or b): a. Dose does not exceed 130 mg/m2 every 6 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: 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. 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);
7. Member is responding positively to therapy;
8. For brand Gleostine requests, member must use generic lomustine, if available, unless contraindicated or clinically significant adverse effects are experienced;

9. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 130 mg/m2 every 6 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: 12 months
   Page 2 of 7

   CLINICAL POLICY Lomustine 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 FDA: Food and Drug Administration 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 Dose Limit/ Maximum Dose 200 mg/m2/day Temozolomide (Temodar®) Brain Tumors Glioblastoma multiforme: 75 mg/m2 PO QD for 42 days followed by maintenance therapy for 6 cycles with cycle 1 including temozolomide 150 mg/m2 PO QD for 5 days followed by 23 days without treatment and cycles 2-6 consisting of temozolomide 200 mg/m2 PO QD for the first 5 days of each cycle Page 3 of 7

   CLINICAL POLICY Lomustine Drug Name Dosing Regimen Dose Limit/ Maximum Dose Anaplastic astrocytoma: 150 mg/m2 PO QD for 5 days of each 28-day treatment cycle Hodgkin’s Lymphoma Varies per protocol and patient tolerance Hodgkin’s Lymphoma Varies per protocol and patient tolerance Hodgkin’s Lymphoma Varies per protocol and patient tolerance Doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) Doxorubicin, vinblastine, mechlorethamine, etoposide, vincristine, bleomycin, prednisone (Stanford V) Bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone (Escalated BEACOPP) Brentuximab vedotin, doxorubicin, vinblastine, dacarbazine (Adcetris®

   • AVD) Cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab (CVP + Rituxan®) Rituximab (Rituxan®) Hodgkin’s Lymphoma Hodgkin’s Lymphoma Varies per protocol and patient tolerance Hodgkin’s Lymphoma Varies per protocol and patient tolerance Varies Varies Varies Varies 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. Varies per protocol and patient tolerance Appendix C: Contraindications/Boxed Warnings • Contraindication(s): none reported • Boxed warning(s): o Delayed myelosuppression o Risk of overdosage V. Dosage and Administration
     Indication Brain tumors, Hodgkin’s lymphoma Dosing Regimen 130 mg/m2 PO one time every 6 weeks Maximum Dose 130 mg/m2 every 6 weeks Page 4 of 7

   CLINICAL POLICY Lomustine VI. Product Availability
   Capsules: 5 mg, 10 mg, 40 mg, 100 mg VII.