In June, the U.S. Food & Drug Administration (FDA) issued an emergency use authorization (EUA) for tocilizumab (Actemra) for treatment of hospitalized COVID-19 adults and children who are receiving systemic corticosteroids and supplemental oxygen. Since this announcement, the tocilizumab manufacturer, Genentech, has not been able to produce enough product to meet the higher demand. The ACR recognizes the importance of this treatment for patients with rheumatoid arthritis and other conditions. The ACR practice and advocacy team is in constant communication with the FDA and the manufacturer to highlight the urgency of the tocilizumab shortage and the impact on rheumatology patients, and to ensure we are able to provide the most up-to-date information.
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As we continue to navigate this shortage, the ACR has finalized guiding principles on the allocation of intravenous tocilizumab. The ACR has sent letters to the nation’s 30 largest payers urging them to refrain from imposing utilization management tools on this class of therapies to ensure patients have access to their treatment, and to temporarily permit off-label use of alternative therapies with similar mechanism of action to avoid loss of access and prevent disease flares and irreversible patient harm. The ACR will also continue to engage with the FDA, Genentech and the Centers for Medicare & Medicaid Services on such issues as wastage reimbursement.
Genentech has created a customer service website dedicated to this issue, including new ordering procedures. The ACR will provide additional information as it becomes available. Contact [email protected] with any questions.