Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)
An enzyme that starves leukaemia cells of an amino acid they cannot make; a mainstay of childhood ALL therapy for 50 years, with new versions solving allergy and supply problems.
E. coli asparaginase (1978), pegaspargase (1994; first-line 2006), calaspargase pegol (2018, longer interval) and recombinant Erwinia asparaginase (Rylaze, 2021) after Erwinaze shortages. Asparaginase intensity underlies paediatric-inspired adult ALL regimens. Toxicities: hypersensitivity, pancreatitis, thrombosis, hepatotoxicity, hyperglycaemia; silent inactivation is monitored by asparaginase activity levels.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Pegaspargase (Oncaspar), calaspargase pegol (Asparlas) and Rylaze are clinician-administered Part B drugs; paediatric ALL patients are mostly on commercial family plans or Medicaid.
- Commercial insurance
- covered on label
Covered as part of standard paediatric and adult ALL protocols; Rylaze usually requires documented hypersensitivity to E. coli-derived asparaginase.
- Assistance programmes
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Acute lymphoblastic leukaemia in children, young people and adults
- Notes
- Erwinia asparaginase is used for hypersensitivity; recombinant Rylaze is not UK-licensed.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA408 · SMC advice: pegaspargase. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 1994 | ALL (pegaspargase, hypersensitivity to native); first line 2006 |
| US | 2018 | ALL in patients 1 month-21 years (calaspargase pegol) |
| US | 2021 | ALL/LBL with hypersensitivity to E. coli asparaginase (Rylaze) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
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