RWJBarnabas Health moved forward quickly in treating COVID-19 patients with monoclonal antibody therapy, giving the medication to patients within 10 days of emergency use authorization.
RWJBarnabas Health has embraced monoclonal antibody therapy for high-risk COVID-19 patients, providing the medication at all 11 of the health system's hospitals.
On Nov. 9, bamlanivimab became the first monoclonal antibody to receive an emergency use authorization (EUA) for the treatment of COVID-19 patients. The EUA for bamlanivimab marked a milestone in the coronavirus pandemic because the monoclonal antibody became the first medication that could be administered to COVID-19 patients on an outpatient basis.
"On the outpatient side, we really did not have anything to manage COVID-19 before monoclonal antibodies. People were just doing supportive care at home. Now we have a therapy that can be used to prevent the progression of COVID-19 in an outpatient setting," says Indu Lew, PharmD, senior vice president and chief pharmacy officer at RWJBarnabas Health.
The West Orange, New Jersey-based health system moved quickly to treat eligible patients with bamlanivimab, she says. "The EUA for bamlanivimab came out on Nov. 9; and within 10 days of the EUA being approved, we were treating our first patients. Ten days is extraordinarily quick from EUA approval to actual implementation."
Monoclonal antibodies mimic the body's immune response, and they have been approved to treat COVID-19 patients who are at high risk of developing severe illness, according to an article published recently in the Journal of the American Medical Association. "An antibody is a protein that is naturally produced by the immune system in response to an infection. A monoclonal antibody is a molecule developed in a laboratory that is designed to mimic or enhance the body's natural immune system response against an invader, such as cancer or an infection," the article says.
Monoclonal antibodies limit the ability of the coronavirus to bind to human cells and replicate, Lew says. "It binds to the receptor binding part of the spiked protein of the COVID-19 virus. What it does is it prevents the attachment of the spiked protein with the human receptor cells. So, if you cannot have the spiked protein attach to the human receptor cells, it prevents the virus from replicating and going into the severe symptoms that you see with COVID-19."
Under the EUA, there are four primary eligibility criteria for COVID-19 patients to receive monoclonal antibody treatment. A patient must:
- Test positive for coronavirus
- Present for treatment within 10 days of COVID-19 symptom onset
- Not be sick enough to require oxygen or hospitalization
- Be at high risk for progression to severe illness such as being over age 65
Model of care
RWJBarnabas Health is administering monoclonal antibody therapy at emergency departments in all 11 of the health system's hospitals.
There are two pathways for patients to receive the treatment, according to Christopher Freer, DO, senior vice president for emergency and hospitalist medicine at the health system.
1. Referrals: "We can get referrals from our doctors in the community. They are calling us and having a conversation between the emergency department doctor and primary care doctor to see whether a patient is a candidate. If the patient is a candidate, they are sent into the emergency department for the therapy," he says.
2. Presenting at the emergency department: If an ill patient tests positive for the coronavirus in the ED, the patient is assessed for whether hospital admission is necessary. If hospitalization is not necessary and the patient meets the other criteria for monoclonal antibody therapy, the patient receives an infusion of the medication that takes about an hour. Then the patient is observed for at least an hour for any side effects such as an allergic reaction.
After the monoclonal antibody therapy has been administered, the patient is discharged from the ED with a pulse oximeter and is monitored via telemedicine, Freer says. "We do telehealth visits on day 1 and day 3. We have a core group of doctors who have become outpatient specialists in the three regions served by our 11 hospitals. They call these patients and know what to ask and what to look for to see whether patients are progressing in the right direction or are taking a turn for the worse."
As of Feb. 11, the health system had administered monoclonal antibody therapy to about 3,200 patients. Among these patients, there was one fatality. "When you have 3,200 high-risk patients and you only have one death, that is a good number," Freer says.
For monoclonal antibody patients, the primary metric the health system has been following is whether any of the patients have required hospitalization. Out of the 3,200 patients, more than 95% have not required hospitalization.
The positive outcomes are good news for patients and the health system, he says. "Keeping people out of the hospital keeps our beds open for people who need it. Our supplies, our ventilators, our personal protective equipment, and our medications for the patients are conserved. It has been a welcomed change compared to early in the pandemic when we did not have this type of therapy."
As of Feb. 25, RWJBarnabas Health had provided monoclonal antibody therapy to 3,800 patients.
Patients do not have to pay the cost of the medication, Lew says.
"Right now, the therapy we are using is provided by the federal Department of Health and Human Services. The monoclonal antibodies go from Health and Human Services, come to our state, then our Department of Health allocates the monoclonal antibodies to our facilities. So, there is no cost to the patient for the therapy because we are receiving it for free. There is a cost that goes through insurance for the actual administration of the therapy and the ED visit," she says.
All eligible patients can get the therapy, Lew says. "At the end of the day, regardless of insurance or not, if someone comes to our facility and they are a candidate for monoclonal antibodies, we will treat them."
RWJBarnabas Health is a national leader in monoclonal antibody treatment for COVID-19 patients, Freer says. "We are way ahead of other health systems. I am getting calls from other health systems to discuss how we rolled out this therapy."
Christopher Cheney is the senior clinical care editor at HealthLeaders.
At RWJBarnabas Health, all eligible high-risk COVID-19 patients can receive monoclonal antibody therapy in the health system's emergency departments.
After COVID-19 patients get monoclonal antibody therapy, they are discharged from the emergency department and are monitored using telemedicine.
Out of the 3,200 patients who had received the therapy as of Feb. 11, more than 95% did not require hospitalization.