Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Pegaspargase (Oncaspar) may be considered medically necessary when any of the following criteria are met:
Food and Drug Administration (FDA) Indications
Acute Lymphoblastic Leukemia, ALL
- As a component of a multiagent chemotherapeutic regimen for the first-line treatment of pediatric and adult individuals with acute lymphoblastic leukemia (ALL); or
- As a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult individuals with ALL and hypersensitivity to native forms of L-asparaginase; or
National Comprehensive Cancer Network (NCCN) Recommendations
Acute Lymphoblastic Leukemia, ALL, Pediatric
- Induction therapy as a component of:
- Standard arm of COG AALL1731 regimen, based on COG AALL0932 regimen (SR arm) for Ph-negative B-ALL; or
- Standard arm of COG AALL1732 regimen, based on COG AALL1131 regimen (HR arm) for Ph-negative B-ALL; or
- DFCI ALL Protocol 16-001, based on DFCI ALL Protocol 11-001 for Ph-negative B-ALL; or
- Total Therapy XVII regimen, based on Total Therapy XVI regimen for Ph-negative B-ALL; or
- COG AALL1131 regimen + dasatinib for Ph-like B-ALL; or
- DFCI ALL Protocol 16-001 (VHR arm) + dasatinib for Ph-like B-ALL with ABL class kinase fusion; or
- Total Therapy XVII regimen + dasatinib for Ph-like B-ALL with ABL class kinase fusion; or
- Total Therapy XVII regimen with or without ruxolitinib for Ph-like B-ALL with mutations associated with JAK-STAT pathway activation; or
- COG AALL0622 regimen + dasatinib or imatinib for Ph-positive B-ALL; or
- Total Therapy XVII regimen + dasatinib for Ph-positive B-ALL; or
- COG AALL1231 regimen for T-ALL; or
- COG AALL0434 regimen for T-ALL; or
- DFCI ALL Protocol 16-001, based on DFCI ALL Protocol 11-001 for T-ALL; or
- SJCRH regimen, based on Total Therapy XVII Protocol for T-ALL; or
- Interfant regimens for infant ALL; or
- Consolidation therapy as a component of:
- Standard arm of COG AALL1731 regimen, based on COG AALL0932 regimen (SR-Avg/High arm) for Ph-negative B-ALL; or
- Standard arm of COG AALL1732 regimen, based on COG AALL1131 regimen (HR arm) for Ph-negative B-ALL; or
- DFCI ALL Protocol 16-001, based on DFCI ALL Protocol 11-001 (SR arm or HR/VHR arms) for Ph-negative B-ALL; or
- COG AALL1131 regimen + dasatinib for Ph-like B-ALL and CRLF2- with ABL class kinase fusion; or
- COG AALL1521 regimen with or without ruxolitinib for Ph-like B-ALL and CRLF2+ or CRLF2- with JAK2 fusions, EPOR rearrangements, SH2B3 alterations, IL7R insertions/deletions; or
- DFCI ALL Protocol 16-001 + dasatinib for Ph-like B-ALL with ABL class kinase fusion; or
- Standard arm of COG AALL1631 (based on COG AALL1122/EsPhALL regimen) + imatinib or dasatinib combined with an HR backbone of the Berlin-Frankfurt-Münster regimen for Ph-positive B-ALL; or
- COG AALL0622 regimen + dasatinib for Ph-positive B-ALL; or
- Total Therapy XVII regimen (SR/HR arm) + dasatinib for Ph-positive B-ALL; or
- COG AALL1231 regimen for T-ALL; or
- COG AALL0434 regimen for T-ALL; or
- SJCRH regimen, based on Total Therapy XVII Protocol for T-ALL; or
- Interfant regimens for infant ALL (LR arm, intermediate risk and HR arms post-consolidation, and HR arm not undergoing HSCT); or
- Therapy for relapsed/refractory Ph-negative B-ALL, or in combination with dasatinib or imatinib for relapsed/refractory Ph-positive B-ALL as a component of:
- UKALL R3 backbone chemotherapy; or
- COG AALL01P2 regimen; or
- ALL-REZ BFM 90 regimen; or
- COG AALL07P1 regimen; or
- high-dose cytarabine-based regimens; or
- Therapy for relapsed/refractory T-ALL as a component of:
- A bortezomib-containing regimen (e.g. bortezomib, vincristine, doxorubicin, pegaspargase, and prednisone or dexamethasone); or
- UKALL R3 Block 1; or
- BFM Intensification Block 1; or
Acute Lymphoblastic Leukemia, ALL, Adult and Adolescent
- Induction/consolidation therapy for Philadelphia chromosome-negative ALL in adult and young adolescent individuals as a component of:
- CALGB 10403 regimen (daunorubicin, vincristine, prednisone, and pegaspargase); or
- COG AALL0232 regimen (daunorubicin, vincristine, prednisone, and pegaspargase) (individuals aged less than or equal to 21 years); or
- COG AALL0434 regimen (daunorubicin, vincristine, prednisone, and pegaspargase; nelarabine added to consolidation) (for T-ALL); or
- DFCI ALL regimen based on DFCI Protocol 00-01 (doxorubicin, vincristine, prednisone, high-dose methotrexate, and pegaspargase); or
- GRAALL-2005 regimen (daunorubicin, vincristine, prednisone, pegaspargase, and cyclophosphamide) with rituximab for CD20-positive disease (individuals aged less than 60 years); or
- PETHEMA ALL-96 regimen (daunorubicin, vincristine, prednisone, pegaspargase, and cyclophosphamide) (individuals aged less than 30 years); or
- USC ALL based on CCG-1882 regimen (daunorubicin, vincristine, prednisone, and methotrexate with augmented pegaspargase) (individuals aged 18-57 years); or
- Linker 4-drug regimen (daunorubicin, vincristine, prednisone, pegaspargase); or
- Induction/consolidation therapy for Philadelphia chromosome-negative ALL in adult individuals without substantial comorbitidies as a component of:
- CALGB 8811 Larson regimen (daunorubicin, vincristine, prednisone, pegaspargase, and cyclophosphamide); or
- GRAALL-2005 regimen (daunorubicin, vincristine, prednisone, pegaspargase, and cyclophosphamide) with rituximab for CD20-positive disease (individuals aged less than 60 years); or
- Linker 4-drug regimen (daunorubicin, vincristine, prednisone, and pegaspargase) with or without rituximab for individuals aged less than 60 years of age; or
- MRC UKALLXII/ECOG2993 regimen (daunorubicin, vincristine, prednisone, and pegaspargase) (induction phase I); or
- Induction therapy for Philadelphia chromosome-negative ALL in adults aged greater than or equal to 65 years or with substantial comorbidities as a component of CALGB 9111 regimen (cyclophosphamide, daunorubicin, vincristine, prednisone, and pegaspargase) (high intensity); or
- Therapy for relapsed/refractory Philadelphia chromosome-negative ALL or for relapsed/refractory Philadelphia chromosome-positive ALL refractory to TKIs as a component of:
- Augmented Hyper-CVAD (hyper-fractionated cyclophosphamide, intensified vincristine, doxorubicin, intensified dexamethasone, and pegaspargase, alternating with high-dose methotrexate and cytarabine); or
- MOpAD regimen (methotrexate, vincristine, pegaspargase, dexamethasone) with rituximab for CD20-positive disease; or
- Therapy for relapsed/refractory Philadelphia chromosome-positive ALL as a component of MOpAD regimen (methotrexate, vincristine, pegaspargase, dexamethasone) with rituximab for CD20-positive disease and TKI; or
- Central nervous system directed therapy as systemic chemotherapy for ALL; or
- For Philadelphia chromosome-positive ALL in adult and young adolescent individuals as a component of:
- EsPhALL regimen: TKI (bosutinib, dasatinib, imatinib, nilotinib, or ponatinib. Dasatinib and imatinib are the preferred TKIs for induction therapy; ponatinib is also preferred for the HyperCVAD regimen) plus backbone of the Berlin-Frankford-Munster regimen (cyclophosphamide, vincristine, daunorubicin, dexamethasone, cytarabine, methotrexate, pegaspargase, and prednisone) for induction/consolidation therapy or for relapsed/refractory disease (if not used for induction) with or without addition of rituximab to chemotherapy for CD20-positive individuals; or
T-Cell Lymphomas, Extranodal NK/T-Cell Lymphoma, nasal type
- For the treatment of non-Hodgkin’s Lymphoma - Extranodal NK/T-Cell Lymphoma, nasal type:
- Therapy for relapsed/refractory disease (if not used in first-line therapy) following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used, as a component of:
- Modified-SMILE (steroid [dexamethasone], methotrexate, ifosfamide, pegaspargase, etoposide); or
- P-GEMOX (gemcitabine, pegaspargase, oxaliplatin); or
- DDGP (dexamethasone, cisplatin, gemcitabine, pegaspargase); or
- AspaMetDex (pegaspargase, methotrexate, dexamethasone); or
- Induction regimen if no response or progressive disease after primary treatment, as a component of:
- Modified-SMILE (steroid [dexamethasone], methotrexate, ifosfamide, pegaspargase, etoposide); or
- P-GEMOX (gemcitabine, pegaspargase, oxaliplatin); or
- DDGP (dexamethasone, cisplatin, gemcitabine, pegaspargase); or
- AspaMetDex (pegaspargase, methotrexate, dexamethasone); or
- Used as a component of modified SMILE (dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide) regimen as:
- Induction therapy followed by radiation for stage I-II nasal disease in individuals fit for chemotherapy; or
- Induction therapy as a component of combination chemotherapy with or without radiation for stage IV nasal disease or stage I-IV extranasal disease; or
- Additional therapy (if regimen not previously used) in individuals with a positive biopsy following partial response to induction therapy or no response to induction therapy; or
- Aggressive NK-cell leukemia (ANKL); or
- When used as a component of P-GEMOX (gemcitabine, pegaspargase, and oxaliplatin) regimen as:
- Induction therapy as a component of sandwich chemoradiation (preceding and following radiation) for stage I-II nasal disease in individuals who are fit for chemotherapy; or
- Induction therapy as a component of combination chemotherapy with or without radiation for stage IV nasal disease or stage I-IV extranasal disease; or
- Additional therapy (if regimen not previously used) in individuals with a positive biopsy following partial response to induction therapy or no response to induction therapy; or
- Aggressive NK-cell leukemia (ANKL); or
- As a component of DDGP (dexamethasone, cisplatin, gemcitabine, pegaspargase) or AspaMetDex (pegaspargase, methotrexate, and dexamethasone) regimen for:
- Induction therapy as a component of combination chemotherapy with or without radiation for stage IV nasal disease or stage I-IV extranasal disease; or
- Additional therapy (if regimen not previously used) in individuals with a positive biopsy following partial response to induction therapy or no response to induction therapy; or
- Aggressive NK-cell leukemia (ANKL)m
Pegaspargase (Oncaspar) is considered experimental/investigational for any other indication and therefore non-covered.Scientific evidence does not support its use for any other indication.
Procedure Codes
