ONCASPAR, Pegaspargase ASPARLAS, Calaspargase Pegol-mknl Form

Pegaspargase (Oncaspar®) and calaspargase pegol-mknl (Asparlas™) are asparagine specific enzymes.
FDA Approved Indication(s) Oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with: • Acute lymphoblastic leukemia (ALL), as first-line treatment • ALL and hypersensitivity to native forms of L-asparaginase Asparlas is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL in pediatric and young adult patients age 1 month to 21 years. 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 Oncaspar and Asparlas are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acute Lymphoblastic Leukemia (must meet all):

1. Diagnosis of ALL;

   2. Prescribed by or in consultation with an oncologist or hematologist;
   3. If request is for Asparlas, age 1 month to ≤ 21 years;
   4. Prescribed as part of a multi-agent chemotherapeutic regimen;
   5. Request meets one of the following (a, b, or c): a. Oncaspar: Dose does not exceed 2,500 IU/m2 every 14 days (age ≤ 21 years) or 2,000 IU/m2 every 14 days (age > 21 years); b. Asparlas: Dose does not exceed 2,500 units/m2 every 21 days; 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: 6 months Page 1 of 7

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   Pegaspargase, Calaspargase Pegol-mknl B. T-Cell Lymphoma (off-label) (must meet all):

   1. Diagnosis of one of the following (a or b): a. Extranodal NK/T-cell lymphoma; b. Hepatosplenic T-cell lymphoma;
2. Request is for Oncaspar;
   3. Prescribed by or in consultation with an oncologist or hematologist;
   4. Age ≥ 18 years;
   5. Prescribed as a component of any of the following regimens (a, b, c, or d): a. Modified-SMILE (steroid [dexamethasone], methotrexate, ifosfamide, pegaspargase, etoposide); b. P-GEMOX (gemcitabine, pegaspargase, oxaliplatin); c. DDGP (dexamethasone, cisplatin, gemcitabine, pegaspargase); d. AspaMetDex (pegaspargase, methotrexate, dexamethasone); Prior authorization may be required
3. 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):
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. All Indications in Section I (must meet all):

6. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Oncaspar or Asparlas for a covered indication and has received this medication for at least 30 days;

   2. Member is responding positively to therapy;
   3. If request is for Asparlas, age 1 month to ≤ 21 years; Page 2 of 7

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   Pegaspargase, Calaspargase Pegol-mknl

7. If request is for a dose increase, request meets one of the following (a, b, or c): a. Oncaspar: New dose does not exceed 2,500 IU/m2 every 14 days (age ≤ 21 years) or 2,000 IU/m2 every 14 days (age > 21 years); b. Asparlas: New dose does not exceed 2,500 units/m2 every 21 days; 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):
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: 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 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 Key ALL: acute lymphoblastic leukemia FDA: Food and Drug Administration NCCN: National Comprehensive Cancer Network Appendix B: Therapeutic Alternatives
   Not applicable Page 3 of 7

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   Pegaspargase, Calaspargase Pegol-mknl Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o History of serious allergic reactions to Oncaspar or to pegylated L-asparaginase therapy o History of serious thrombosis with prior L-asparaginase therapy o History of pancreatitis with prior L-asparaginase therapy o History of serious hemorrhagic events with prior L-asparaginase therapy o Severe hepatic impairment • Boxed warning(s): none reported V. Dosage and Administration
   Drug Name Oncaspar (pegaspargase)
   Indication Dosing Regimen ALL Age ≤ 21 years: 2,500 IU/m2 IM or IV no more frequently than every 14 days
   Age > 21 years: 2,000 IU/m2 IM or IV no more frequently than every 14 days
   Age 1 month to 21 years: 2,500 units/m2 IV no more frequently than every 21 days
   Asparlas (calaspargase pegol-mknl) ALL VI. Product Availability
   Maximum Dose Age ≤ 21 years: 2,500 IU/m2 every 14 days
   Age > 21 years: 2,000 IU/m2 every 14 days 2,500 units/m2 every 21 days Drug Name Availability Oncaspar (pegaspargase) Single-dose vial: 3,750 IU/5 mL solution Asparlas (calaspargase pegol-mknl) Single-dose vial: 3,750 units/5 mL solution VII.