In February 2021, the Drug Identification Number (DIN) for Erwinase^® (Erwinia L-asparaginase) – indicated for patients with Acute Lymphocytic Leukemia or ALL – was cancelled after years of supply challenges, causing a shortage of the drug, and causing concern for patients who were relying on the anti-blood-cell-cancer treatment. While ALL largely affects children, people of all ages are diagnosed with this type of cancer.

Erwinase^® is a crucial drug because of its role in a patient’s chemotherapeutic regimen. When a patient develops hypersensitivity to E. Coli-derived asparaginase, Erwinase^® can serve as a replacement or used in conjunction with other treatments. As can be naturally concluded, Erwinase^® is a vitally important product in oncology[1].

As reported by Ottawa Citizen, the drug shortage hit home in a devastating way for two young patients in Ottawa. “If the drug is missed, it can’t simply be given when it is available. It can only be resumed later, depending on the other drugs that are a part of the child’s treatment plan.” What’s more, writer Elizabeth Payne writes, “A recent study suggests that certain children with acute lymphoblastic leukemia who skip even one treatment of erwinia asparaginase may have lower survival rates than those who didn’t miss a treatment.”

Understanding the dire need for this drug on the market, HealthPRO pharmacy supplier, SteriMax Inc., stepped in, working with Health Canada and the international manufacturer to obtain supply for Canadian hospital pharmacies in need.

To do this, SteriMax utilized the Tier 3 shortage exceptional importation pathway, a government initiative spawned during COVID, which allows certain drugs to be imported and sold in Canada. When this first began, available supply of Erwinase^® was only able to meet pediatric quantity requirements. Since fall 2021, SteriMax has successfully supplied sufficient quantities to meet the requirements of all patients. Because of the interim order, allowing Tier 3 drugs to be imported, and because of SteriMax’s proactive work, HealthPRO members and patients with ALL now have reliable access to Erwinase^®.

“As a Canadian company we are committed to ensuring that every patient in Canada that requires Erwinase^® has access to it,” said Shannon Mitchell, Head of Commercial Operations, SteriMax. “We value our partnership with HealthPRO and its members and will continue to work with them to ensure Canadian patients have access to critical medications when and where they require it.”

Vice President of Pharmacy at HealthPRO, Christine Donaldson echoed Mitchell’s sentiment, stating, “HealthPRO is incredibly grateful to SteriMax for their work in assuring our members and their patients have access to this oncology drug. Amidst many drug shortages, this is a remarkable success story, and we look forward to continuing to work with SteriMax to fulfill the need in the market.”

Proton Biopharma Limited is in the process of obtaining a new license and authorization for Erwinase^® in Canada, for which SteriMax will be the primary distributor.

[1] http://sterimaxinc.com/wp-content/uploads/2021/05/ERWINASE-HPRC-Letter_English.pdf