The barriers holding medical innovations out of the reach of patients take many forms. Too often in Canada those barriers are due to onerous regulations. In the case of bamlanivimab, the barrier is logistics.
The Interim Order under which bamlanivimab was authorized for use here was put in place by Health Canada to account for the urgency of the current global medical emergency and to make necessary medicines available to Canadians more quickly.
According to the Government of Canada, “the Order is predicated on the Minister's determination that the evidence provided supports the conclusion that the benefits outweigh the risks associated with the drug, taking into account the uncertainties related to the benefits and risks…. This includes weighing the risks of modifying certain requirements for information to support the safety and effectiveness of a drug, such as allowing consideration of a foreign regulatory approval, against the benefits of having it available to Canadians quickly.”
With the Interim Order, the Government of Canada created an avenue for the rapid approval of medicines to treat this disease. Shortly thereafter, Health Canada authorized the use of bamlanivimab, and Public Services and Procurement Canada bought 26,000 doses. The Government of Canada moved with great speed, and now 17,000 of those doses are in Canada awaiting the creation and/or implementation of plans to use it.
Provincial and territorial health authorities from coast to coast to coast are ramping up their vaccination programs, and their acceleration is commendable. Their apparently singular focus on vaccination, however, is to the detriment of people who nevertheless contract the disease.
Antibody therapies play an important role even now that a vaccine is available. For example, certain populations may choose not to get vaccinated or may not be able to get vaccinated or not have a robust response to a vaccine, due to issues like compromised immune systems, chronic disease or falling within an age group which typically does not respond as robustly to vaccination. Effectively managing this disease across entire populations requires a diverse set of approaches.
Lilly is committed to supporting our partners in health care in creating and implementing programs to use bamlanivimab. We’re confident in its value in helping fight the rapidly increasing burden of this global pandemic. We’ve seen it successfully put to use, and we’re eager to share clinicians’ experiences and best practices.
The pharmaceutical industry has moved mountains to run entire clinical development programs on purpose-discovered medicines within unprecedented timelines; we have data from trials involving more than 4000 participants treated with bamlanivimab, alone or with etesevimab, showing that bamlanivimab’s risk/benefit profile strongly recommends its use in appropriate patients—we must not allow the logistics of using this medicine to stand as a barrier.
In the United States, more than 4200 sites have found ways to infuse neutralizing antibodies, including more than 2600 sites that are infusing bamlanivimab. Meanwhile, in Canada, thousands of doses authorized by Health Canada to treat patients sit in refrigeration, and case counts continue to rise.