WHA

RYLAZE (asparaginase erwinia chrysanthemi [recombinant]-rywn)

Self-Administration - Intramuscular (IM) Injection

 

Indications for Prior Authorization:

 

  • Acute lymphoblastic leukemia (ALL); lymphoblastic lymphoma (LBL) – an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

 

Coverage Criteria:

 

For diagnosis of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL):

 

  • Dose does not exceed 25 mg/m2 administered intramuscularly every 48 hours; AND
  • Diagnosis of ALL or LBL; AND
  • Medical records document a hypersensitivity to E. coli-derived asparaginase (e.g., Asparlas [calaspargase pegol-mknl], Oncaspar [pegaspargase]); AND
  • Attestation that Rylaze will be administered in a setting with necessary agents to treat anaphylaxis (e.g., epinephrine, oxygen, intravenous steroids, antihistamines, resuscitation equipment).

 

Reauthorization Criteria:

 

For diagnosis of ALL or LBL:

 

  • Dose does not exceed 25 mg/m2 administered intramuscularly every 48 hours; AND
  • Patient does not show evidence of progressive disease while on therapy.

 

Coverage Duration:

 

  • 2 weeks (a total of 6 doses).
Coverage Duration:
  • 2 weeks (a total of 6 doses).

 

Additional Information:

 

  • Hypersensitivity reactions observed with L-asparaginase class products include angioedema, urticaria, lip swelling, eye swelling, rash or erythema, blood pressure decreased, bronchospasm, dyspnea, and pruritus.
  • Because of the risk of serious allergic reactions (e.g., life-threatening anaphylaxis), administer RYLAZE in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, oxygen, intravenous steroids, antihistamines).
  • Lymphoblastic lymphoma (LBL) is indistinguishable from acute lymphoblastic leukemia (ALL) based on morphologic, genetic, and immunophenotypic features (NCCN 2021).

 

Policy Updates:

 

  • 11/16/2021 – New policy approved by P&T.

 

References:

 

  1. Empaveli Prescribing Information. Apellis Pharmaceuticals, Inc. Waltham, MA. May 2021.
  2. Kulasekararaj AG., et al. “Ravulizumab (ALXN1210) vs Eculizumab in C5-Inhibitor–Experienced Adult Patients with PNH: the 302 Study.” Blood, vol. 133, no. 6, 2019, pp. 540–549.
  3. Hillmen P, et al. “Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria.” New England Journal of Medicine, vol. 384, no. 11, 2021, pp. 1028–1037.