Biopharmaceutical manufacturer Genentech notified 340B entities this week that it is running out of Actemra IV (tocilizumab)—a key tool in treating hospitalized COVID-19 patients. It told entities they will be subject to the same allocation procedures as other buyers.
The U.S. Health Resources & Services Administration (HRSA) posted Genentech’s notice to entities on its website. As of Aug. 20, the notice said, 20, 10, and 4 milliliter vials were unavailable and 0.9 milliliter autoinjector pens were available on allocation. The U.S. Food and Drug Administration (FDA) drug shortages website this morning states that, as of Aug. 30, only 4 milliliter vials were unavailable.
“To minimize disruption to patient care and address the current imbalance between supply and increasing demand, authorized distributors will be allocating the Actemra subcutaneous autoinjector and any new supply of Actemra IV for all customers until supply can meet demand,” Genentech said in its notice on the HRSA website. “340B entities will be subject to the same allocation as all other purchasers.”
Pricing for Actemra ranges from about $491 to more than $2,400 per vial, depending on the dosage.
Actemra was originally developed to treat rheumatoid arthritis. However, the FDA issued an emergency use authorization for the drug in late June. It is being used to treat hospitalized COVID-19 patients who are also receiving steroids and require either supplemental oxygen, a ventilator, or extracorporeal membrane oxygenation (ECMO), a treatment for the most gravely ill of patients. The FDA said that clinical trials demonstrated Actemra was effective in reducing both the mortality rate of hospitalized COVID-19 patients and the amount of time they are inpatients.
Demand for the drug has spiked along with cases involving the Delta variant of COVID-19, which has caused hospitalizations in the U.S. to rise in recent months. Genentech suggested in its notice that supplies of Actemra could be uneven for months to come.
The company “expects the scheduled replenishments to arrive by the end of August and at intervals through the end of 2021,” it said in its notice. “However, if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead, at least through the end of the year.”