Revolutionary new COVID-19 treatment arrives in Madison County
REXBURG, Idaho (KIFI/KIDK) - Madison Memorial will be among the first medical facilities nationwide to implement the just-released monoclonal antibody treatment known as bamlanivimab, providing this cutting-edge procedure for targeted COVID-positive patients in Madison County and the surrounding areas.
On Tuesday, Madison Memorial will begin administering the just-released COVID-19 treatment bamlanivimab. Developed by Eli Lilly and Company, this investigational medicine is comparable to the treatment that President Trump received after he contracted coronavirus last month.
On Monday, the FDA issued an emergency use authorization (EUA) for the use of bamlanivimab to treat mild to moderate COVID-19 in adult and pediatric patients 12 and older.
“Most of the medications and so forth that have been approved under an emergency use authorization so far have been meant for just patients that are very sick in the hospital, where we’re trying to combat severe illness,” Dr. Clay Prince, Chief Medical Officer at Madison Memorial said. “In this case, it’s meant to be given very early in the course of the disease before it becomes severe.”
The procedure involves a one-time intravenous infusion, and is intended for high-risk patients at the onset of SARS-CoV-2. Bamlanivimab was shown in clinical trials to reduce COVID-19 hospitalizations and ER visits in patients who presented a high probability of potential disease progression.
“Patients have to have a positive coronavirus test,” Dr. Prince said. “And then they also have to fall into a category of risk that’s been identified as placing them at a higher risk for hospitalization and bad outcomes like death.”
Dr. Prince says those risk categories include patients over the age of 65 and people over 55 with chronic health problems such as high blood pressure, diabetes, patients with obesity, and those with certain immune-compromising conditions.
The treatment is not authorized for patients who are already hospitalized or who require oxygen therapy due to COVID-19. Rather, its intended use is for high-risk patients in whom the disease has not yet progressed to that phase. It is an outpatient procedure. Its use is not intended for patients who have already been admitted to the hospital for inpatient stays.
“We anticipate that we will charge our usual and customary fees for the infusion, for the nurses’ time, and for the facility,” Dr. Prince said. “There are other medications in this class that we know are very expensive. In this instance, because it’s provided to us at no charge through operation warp speed, we’re not charging patients for that medication and it’s free.”
Dr. Prince says these costs are relatively minor compared to the usual cost of COVID-19 treatment medications and most insurances will pay these costs as they would any other hospital visit.
“We’re excited to be receiving a number of these bamlanivimab treatment kits,” Dorsie Sullenger, Pharmacy Director at Madison Memorial said. “Monoclonal antibodies, which we refer to as ‘mAbs,’ have been shown to be quite effective, especially when given early enough in the infection of the patient.”
To maximize the safety of patients and staff, Madison Memorial has set up a dedicated satellite facility located inside the Madison Memorial Rexburg Medical Clinic for COVID-positive patients who will be receiving bamlanivimab treatments.
Trained infusion therapists will administer the procedures to a limited number of pre-qualified patients who’ve tested positive within the previous three days and for whom the risk of disease progression is high.
Selection of appropriate patients for the treatment will be done by local Rexburg providers and confirmed by Madison Memorial prior to administration. The hospital will be reaching out to educate local physicians regarding availability of this exciting new tool in our fight to curtail the effects of the ongoing pandemic.
“We don’t have a great handle on how many of our patients in our region will qualify under those categories of risk but we hope to be able to give it to all of them,” Dr. Prince said. “We have a plan in place to get this information out to our community of providers that are seeing these patients and that are identifying the cases of coronavirus in our community. And then we want them to get those patients identified at high risk up to our infusion center and get this done because it’s a treatment that is thought to be most effective when administered early.”
Dr. Prince says early studies of bamlanivimab use in hospitalized patients proved it could be harmful when administered in more advanced infections of COVID-19 to include those patients who already required the use of oxygen.
As with any medication, there can be side effects associated with bamlanivimab. Most side effects recorded have been mild. Severe reactions have been rare. Dr. Prince says they do not have a full characterization of the side effects of this drug because it hasn’t been administered widely yet.
Dr. Prince says this is why the treatment will be administered in a supervised infusion setting where hospital staff can be ready to treat any severe or life-threatening reactions. According to Dr. Prince, early data suggests those situations should be rare if not non-existent. Patients will be observed for an hour after receiving the infusion.
Dr. Prince says Madison Memorial Hospital expects other hospitals within the region will soon receive these treatments as well, if they haven’t already. He says Madison Memorial Hospital went through an application process to receive allocation for this medication.
“For a mid-sized regional healthcare facility, Madison Memorial once again has shown that state-of-the-art care is available right here, in our own community, right now,” Dr. Prince said. “From the FDA’s emergency release on Monday, to deployment and implementation here in Madison County only a week later, the hospital’s response has been both immediate and impressive.”
Dr. Prince says the government purchased about 1 million doses of this medication across the nation in preparation for it being approved as a viable treatment option for COVID-19 for immediate distribution.
“I think it’s important to understand that this new treatment is exciting. It’s promising. It is still somewhat experimental and it’s certainly not the be-all-end-all or the magic cure for the coronavirus. It’s one tool out of many that we have to fight this pandemic,” Dr. Prince said. “It’s intended for patients who already have coronavirus and it’s better if they don’t get it in the first place. So it’s important to remember our preventative measures...and particularly if we know we’ve been exposed or have the coronavirus, we should take great care to not spread that to our community. It’s great that we have this new tool. It will be great, hopefully, that we have a vaccine in the near future. We have other tools for severely ill patients, but we need to use all of those tools and not focus on any one thing.”