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In Reply to: RE: Truth.... posted by Ivan303 on November 21, 2020 at 05:40:33
From your initial response and the Reuters article (which found after reading your response), I got that cost is apparently not the issue. That was not the point of my response to you.The confusion is that you are apparently talking about the antibody drug Regeneron (the one which was used on the President) which has yet to receive an emergency use authorization (EUA). So, you are right about the use of Regeneron. I was talking about the Lilly antibody drug/treatment bamlanivimab which was given an EUA last week by the Food and Drug Administration.
The FDA emergency use authorization (EUA) allows for the investigational monoclonal antibody therapy bamlanivimab to be administered in an outpatient setting (not hospitalized) for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
Per FDA: "Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of bamlanivimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation."
Edits: 11/21/20Follow Ups:
and neither do much good (and may even harm) hospitalized patients with severe symptoms.
The problem is that outpatient infusion centers, of which there are many (think chemo), are already in use and fully so, plus they are not suited to handle COVID positive patients.
So who gets the drug?
Those who have the power to do so.
Like everything else regarding treatment of this novel coronavirus, health care systems will have to adapt. The alternative is to not adapt the outpatient/emergency settings and not administer the antibody drugs and subsequently overload the already stressed hospitals with increased inpatient admissions.A challenge, for sure.
From the Healthcare Financial Management Association (HFMA) article "HHS seeks hospitals to administer new COVID-19 treatment":"Outreach to hospitals is underway
To accommodate IV infusions, HHS officials said they have been reaching out to hospitals to provide the treatment. To segregate COVID-19-positive patients from noninfected hospital patients, the new treatment is to be delivered in outpatient facilities.
...
Janet Woodcock, MD, director of the Center for Drug Evaluation Research at the FDA, said the administration is talking to health systems and other types of providers about whether they can meet the requirements."We will be looking at the ability of the healthcare system to get this into people's veins," Woodcock said in a call with reporters.
The treatment also may be administered in hospital emergency departments and "alternate care sites" set up by hospitals and health departments under the "hospital without walls" waiver provided by CMS to support a surge of hospitalized patients."
Edits: 11/21/20
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