By Sarah Toy, Joseph Walker and Melanie Evans
Doses of monoclonal antibodies -- Covid-19 therapies authorized
for emergency use last month -- are sitting unused in hospital
pharmacies, even as cases surge across the country.
Hospitals say the rollout of the therapies has been stunted by a
lukewarm response from infectious-disease specialists, who say they
want more clinical trial data before using them on a regular basis.
Medical centers are also grappling with a lack of awareness and
interest from both the primary-care doctors who would normally
prescribe the drug and patients who are offered it. And some places
are dealing with a shortage of space and staff to administer the
therapies.
When monoclonal antibody therapies from Eli Lilly & Co. and
Regeneron Pharmaceuticals Inc. were approved for emergency use in
November, health agencies were worried there wouldn't be enough
supply to meet demand. Now, health-care providers are administering
just 20% of the doses they receive each week, according to
officials with Operation Warp Speed, the federal initiative to
support development of new drugs, vaccines and diagnostics for
Covid-19.
Monoclonal antibodies, which are also used to treat other
diseases, work by taking a page from the body's own natural
antibody defenses, targeting specific spots on intruding pathogens.
Eli Lilly's bamlanivimab and Regeneron's casirivimab and imdevimab
cocktail target the SARS-CoV-2 spike protein and are injected
intravenously. Early trial data of the therapies found they could
reduce hospitalization or emergency visits among high-risk
patients.
"Physicians are not ordering the drug," said Michael Ison, an
infectious-disease physician at Northwestern Memorial Hospital who
is helping lead the monoclonal-antibody rollout there and in the
wider Northwestern Medicine health system, which includes 10
hospitals across the Chicago area and northern Illinois.
Demand from doctors in the Northwestern system has been
relatively low and many patients aren't all that interested, he
said. Although several hospitals have set up spaces for the
infusions and have made arrangements for staff to deliver them,
some physicians just aren't comfortable with prescribing the
therapy because it is so new and it is hard to discern which
patients will benefit from it, Dr. Ison said.
The monoclonal antibody treatments from Eli Lilly and Regeneron
were approved by the U.S. Food and Drug Administration for use in
patients with mild or moderate Covid-19 who are at high risk of
progressing to severe symptoms or hospitalization. The FDA has a
specific definition of what high risk means, which includes people
who are 65 years of age or older, or people who are considered
obese, with a body-mass index of 35 or more. The therapies are
supposed to be administered as soon as possible after a patient
receives a positive test result, within 10 days of the onset of
symptoms.
But sussing out who would benefit and when isn't easy, doctors
say. And patients sometimes recover on their own within a couple of
days, which renders the therapy moot. Often, patients with mild
symptoms refuse the therapy after being offered it, doctors
say.
"A significant number of patients have declined it," said Emily
Rubin, a pulmonary and critical-care physician who has been helping
lead the monoclonal antibody rollout at Massachusetts General
Hospital in Boston.
MGH has received about 275 doses of Eli Lilly's bamlanivimab,
but only 10% of that has been administered so far, she said. The
hospital also received a small supply of Regeneron's product, but
that hasn't been used at all, she said.
Some patients who meet the high-risk criteria have mild or
moderate symptoms that are improving, so they aren't interested in
coming in for an infusion, Dr. Rubin noted. Others aren't able to
spare the two hours required for administration and monitoring.
Still others are told of the benefits of the drug according to
trial data and decide the benefit is too dubious.
A recently published interim analysis of Regeneron's cocktail
found that it could reduce viral load in some patients, and an
interim analysis of bamlanivimab found that five out of 309
patients who received the therapy required a visit to the emergency
department or hospitalization, compared with nine out of 143 of the
placebo population.
But some infectious-disease physicians aren't convinced, saying
more data are needed.
"To be really certain about the results, you need greater
numbers," said Rajesh Gandhi, an infectious-disease physician at
MGH and a member of the Covid-19 treatment guidelines panels at the
National Institutes of Health and the Infectious Diseases Society
of America.
The NIH has said there are insufficient data to recommend for or
against the use of the Eli Lilly and Regeneron treatments. Neither
should be considered the standard of care for treatment of patients
with Covid-19, NIH said. The IDSA also recommends against the
routine use of bamlanivimab.
The need for more data doesn't mean people shouldn't be treated
now, said Rich O'Neal, Regeneron's vice president of market access.
"It's going to be really challenging if we continue to wait too
long for information and data to continue to decrease the impact of
the crisis."
"The emergency-use authorization is based on a standard of data
which is different than the normal drug approval. We fully
acknowledge that," said Daniel Skovronsky, Eli Lilly's chief
scientific officer. "On the other hand, we're excited about the
potential that we've seen in our clinical trials: particularly, we
saw reduced hospitalizations and emergency-room visits. Although it
was a small trial, Regeneron had almost the exact same kind of
impact -- a different molecule but the same mechanism."
UW Medicine, which has four hospitals, largely isn't using the
monoclonal antibody therapies, said Shireesha Dhanireddy, an
infectious-disease doctor at the Seattle-based system.
Although the hospital system has made a few, limited requests
for some of Washington state's supply of Eli Lilly's monoclonal
antibody drug bamlanivimab, UW Medicine isn't routinely using it,
she said, after deciding the benefits were too uncertain and
administering the drugs would add additional strain on health-care
workers.
Administering bamlanivimab is time-intensive, she said, and
staff have been urgently needed to care for rising numbers of
Covid-19 patients.
UW Medicine in late November and early December also needed
staff to complete plans to vaccinate its employees for the novel
coronavirus, an effort that is now under way, Dr. Dhanireddy
said.
In contrast, health-care system Northwell Health in New York is
moving ahead with its monoclonal-antibody rollout, setting up five
sites where it can administer the intravenous drugs. Some are
located in tents that were used as overflow units during the
Covid-19 surge in New York City in the spring, said Warren Licht,
vice president of ambulatory operations at Northwell who has been
leading the effort. One is located in the emergency room of
Northwell's Cohen Children's Medical Center, he said.
He said Northwell hopes to open more sites and is planning for
more emergency-room locations. He is also hoping to include
Northwell's skilled-nursing facilities in the rollout and to set up
a program for home infusions.
States are beginning to expand the availability of infusions
outside of the hospital, including in nursing homes and outpatient
infusion clinics, and offering to administer the drugs in patients'
homes, said Janet Woodcock, head of drug evaluation and research at
the FDA who is on leave to work with Operation Warp Speed.
In the future, doctors' offices could also start offering to
provide the treatment, which may be particularly helpful in rural
areas where there aren't many nearby health facilities, she
said.
Write to Sarah Toy at sarah.toy@wsj.com, Joseph Walker at
joseph.walker@wsj.com and Melanie Evans at
Melanie.Evans@wsj.com
(END) Dow Jones Newswires
December 27, 2020 11:57 ET (16:57 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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