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Source: https://www.cidrap.umn.edu/news-pers...an-jan-14-2022
News Scan for Jan 14, 2022
Spending on ivermectin for COVID-19; COVID monoclonal antibody combo; CWD in Alabama for first time; US flu declines slightly; Polio in 2 nations
Filed Under:
COVID-19; Chronic Wasting Disease; Influenza, General; Polio
Insurers may be spending $130 million on ivermectin for COVID-19
Needless insurer spending on ivermectin prescriptions for COVID-19, estimated at $2.5 million in the United States for the week of Aug 13, 2021—the most recent week analyzed—would extrapolate to $130 million annually, US researchers reported yesterday in JAMA.
Ivermectin has become a hot-button drug because some, especially anti-vaccine advocates, have touted its effectiveness against COVID-19 despite a dearth of supportive data. The Food and Drug Administration has approved it in people for infections caused by some parasitic worms, head lice, and skin conditions like rosacea but warns against taking it for COVID-19.
The study investigators, from the University of Michigan and Boston University, analyzed data from the IQVIA PharMetrics Plus for Academics database from Dec 1, 2020, through Mar 31, 2021. During that period, the database included a convenience sample of 5 million patients with private insurance and 1.2 million with Medicare Advantage across the country.
For each payer type, the authors calculated mean insurer reimbursement, out-of-pocket spending, and total spending per ivermectin prescription. To assess the degree to which insurers covered prescription costs, they divided aggregate insurer reimbursement by total spending.
For each ivermectin prescription, mean out-of-pocket spending was $22.48 for privately insured patients and $13.78 for Medicare Advantage patients, while mean insurer reimbursement was $35.75 and $39.13, respectively.
To assess the potential magnitude of what US insurers have spent on ivermectin reimbursement, the researchers looked at prescriptions during the week of Aug 13, 2021, the most recent week with complete data. They assumed that all 88,000 ivermectin prescriptions dispensed that week were for COVID-19 except 3,600, the average US weekly dispensing total in the 12 months before the pandemic. They also estimated that 52% (43,888) and 28% (23,632) of the remaining 84,400 prescriptions were paid by private and Medicare plans, respectively, based on prescribing data.
For the week, private and Medicare plans paid an estimated $1,568,996 and $924,720, respectively, for ivermectin prescriptions for COVID-19. The researchers extrapolated the weekly total of $2,493,716 to $129,673,240 annually.
The authors say the findings suggest that "insurers could prevent substantial waste by restricting ivermectin coverage; for example, by requiring prior authorization."
Jan 13 JAMA study
Casirivimab-imdevimab reduces symptomatic COVID-19 in phase 3 trial
A phase 3 clinical trial today in JAMA finds that only 29.0% of 314 asymptomatic COVID-19–infected people living with an infected household member developed symptomatic illness after receiving the monoclonal antibodies casirivimab and imdevimab, compared with 42.3% given a placebo.
Scientists from Regeneron, maker of the casirivimab-imdevimab combination Regen-CoV, led the randomized, double-blind trial at 112 sites in the United States, Romania, and Moldova. The combination is available through an emergency use authorization for high-risk, nonhospitalized COVID-19 patients.
Asymptomatic, SARS-CoV-2 antibody-negative participants 12 years and older who tested positive for COVID-19 within 96 hours of the index case were enrolled from Jul 13, 2020, to Jan 28, 2021, with follow-up until Mar 11. Participants were randomly assigned to receive one dose of subcutaneous casirivimab-imdevimab (158 participants) or placebo (156). Average participant age was 41.0 years.
The drug combination significantly averted progression to symptomatic illness (29.0% vs 42.3% with placebo), for an odds ratio (OR) of 0.54 and an absolute risk difference of -13.3%.
Casirivimab-imdevimab lowered the risk of symptomatic infection from 19.2% to 10%, the duration of COVID-19 symptoms by 5.6 days per participant, and the symptom duration per 1,000 participants by 489.8 weeks, relative to 811.9 weeks with placebo. The proportion of participants receiving casirivimab-imdevimab who had at least one treatment-emergent adverse event was 33.5%, versus 48.1% for placebo.
In a secondary analysis, none of 100 casirivimab-imdevimab participants were hospitalized or visited an emergency department because of COVID-19, compared with 6 of 104 in the placebo group.
In a related editorial, Jonathan Li, MD, and Rajesh Gandhi, MD, both of Harvard Medical School, said that if casirivimab-imdevimab is authorized for use in asymptomatic COVID-19 patients, the combination could be useful for immunosuppressed patients. "In immunocompetent patients, monoclonal antibodies are likely to be reserved for symptomatic individuals as long as there continue to be supply and logistical constraints," they wrote.
"However, casirivimab and imdevimab activity is compromised by the Omicron variant, and it is unknown whether the results of this study can be extrapolated to other monoclonal antibody therapies," they added.
Jan 14 JAMA study and editorial
With positive test in a deer, Alabama becomes 28th state to detect CWD
Chronic wasting disease (CWD) has been detected for the first time in Alabama, the Alabama Department of Conservation and Natural Resources (ADCNR) confirmed last week.
A sample collected from a hunter-harvested white-tail deer in west-central Lauderdale County has tested positive for CWD, an always fatal disease that has been detected in North American deer and related cervids like elk and moose. The disease has now been found in 28 US states and four Canadian provinces.
The sample from the CWD-positive deer was submitted as part of the state's surveillance efforts. Preliminary tests were performed at the Alabama Department of Agriculture and Industries, with confirmation provided by the National Veterinary Services Laboratories in Ames, Iowa.
"CWD was first detected in Tennessee and Mississippi in 2018 and has been moving slowly toward Alabama," said Chris Blankenship, ADCNR commissioner. "We take the presence of this disease very seriously, which is why we developed a plan of action using CWD best practices to deal with the disease."
The ADCNR has designated all of Lauderdale and Colbert counties as a CWD management zone, which opens the area to more hunting. The agency also designated an area in Lauderdale County surrounding the new detection as a high-risk zone, wherein hunters are now required to submit heads for CWD testing from all deer that they harvest.
CWD has yet to be detected in people, but the Centers for Disease Control and Prevention (CDC) warns against eating the meat of cervids that test positive for the prion disease.
Jan 7 ADCNR news release
US flu markers show slight declines in activity
The nation's flu activity showed small signs of decline last week, but levels are still elevated, with circulation expected to continue for several more weeks, the CDC said today in its latest weekly update, which covers last week.
The percentage of doctor's visits for flulike illness declined from 4.8% to 4.3% last week, with the current level still above the national baseline. The CDC notes that other respiratory viruses are circulating, contributing to the overall respiratory illness picture.
The number of states reporting high or very high flu activity, another measure of clinic visits for flulike illness, dropped from 31 to 21.
Hospitalizations reported to the Health and Human Services Protect system declined slightly, and the percentage of respiratory samples that tested positive for flu at clinical labs dropped from 3.8% to 2.2% last week.
One more pediatric flu death was reported, which involved a patient with an unsubtyped influenza A infection who died during the week ending on Dec 25. So far, three pediatric flu deaths have been reported for the current flu season.
H3N2 is still the dominant strain. The CDC said though most H3N2 viruses are closely related to the vaccine strain, testing shows some antigenic changes as the viruses evolve. H3N2 is known to cause higher rates of complications in younger and older age-groups, and antigenic changes with the subtype have been linked to vaccine mismatches in the past.
Jan 14 CDC FluView report
DRC and Yemen report more vaccine-derived polio cases
Two countries—the Democratic Republic of the Congo (DRC) and Yemen—reported more polio cases this week, both involving circulating vaccine-derived poliovirus type 2 (cVDPV2), according to the latest weekly update from the Global Polio Eradication Initiative (GPEI).
The DRC reported 2 cases, both in Maneima province, to raise its total for 2021 to 19 cases.
Yemen reported 4 more cases, which are also part of its total for the previous year, which now stands at 10. For 2021, Yemen also reported 3 illnesses involving circulating vaccine-derived poliovirus type 1 (cVDPV1).
Jan 13 GPEI update
News Scan for Jan 14, 2022
Spending on ivermectin for COVID-19; COVID monoclonal antibody combo; CWD in Alabama for first time; US flu declines slightly; Polio in 2 nations
Filed Under:
COVID-19; Chronic Wasting Disease; Influenza, General; Polio
Insurers may be spending $130 million on ivermectin for COVID-19
Needless insurer spending on ivermectin prescriptions for COVID-19, estimated at $2.5 million in the United States for the week of Aug 13, 2021—the most recent week analyzed—would extrapolate to $130 million annually, US researchers reported yesterday in JAMA.
Ivermectin has become a hot-button drug because some, especially anti-vaccine advocates, have touted its effectiveness against COVID-19 despite a dearth of supportive data. The Food and Drug Administration has approved it in people for infections caused by some parasitic worms, head lice, and skin conditions like rosacea but warns against taking it for COVID-19.
The study investigators, from the University of Michigan and Boston University, analyzed data from the IQVIA PharMetrics Plus for Academics database from Dec 1, 2020, through Mar 31, 2021. During that period, the database included a convenience sample of 5 million patients with private insurance and 1.2 million with Medicare Advantage across the country.
For each payer type, the authors calculated mean insurer reimbursement, out-of-pocket spending, and total spending per ivermectin prescription. To assess the degree to which insurers covered prescription costs, they divided aggregate insurer reimbursement by total spending.
For each ivermectin prescription, mean out-of-pocket spending was $22.48 for privately insured patients and $13.78 for Medicare Advantage patients, while mean insurer reimbursement was $35.75 and $39.13, respectively.
To assess the potential magnitude of what US insurers have spent on ivermectin reimbursement, the researchers looked at prescriptions during the week of Aug 13, 2021, the most recent week with complete data. They assumed that all 88,000 ivermectin prescriptions dispensed that week were for COVID-19 except 3,600, the average US weekly dispensing total in the 12 months before the pandemic. They also estimated that 52% (43,888) and 28% (23,632) of the remaining 84,400 prescriptions were paid by private and Medicare plans, respectively, based on prescribing data.
For the week, private and Medicare plans paid an estimated $1,568,996 and $924,720, respectively, for ivermectin prescriptions for COVID-19. The researchers extrapolated the weekly total of $2,493,716 to $129,673,240 annually.
The authors say the findings suggest that "insurers could prevent substantial waste by restricting ivermectin coverage; for example, by requiring prior authorization."
Jan 13 JAMA study
Casirivimab-imdevimab reduces symptomatic COVID-19 in phase 3 trial
A phase 3 clinical trial today in JAMA finds that only 29.0% of 314 asymptomatic COVID-19–infected people living with an infected household member developed symptomatic illness after receiving the monoclonal antibodies casirivimab and imdevimab, compared with 42.3% given a placebo.
Scientists from Regeneron, maker of the casirivimab-imdevimab combination Regen-CoV, led the randomized, double-blind trial at 112 sites in the United States, Romania, and Moldova. The combination is available through an emergency use authorization for high-risk, nonhospitalized COVID-19 patients.
Asymptomatic, SARS-CoV-2 antibody-negative participants 12 years and older who tested positive for COVID-19 within 96 hours of the index case were enrolled from Jul 13, 2020, to Jan 28, 2021, with follow-up until Mar 11. Participants were randomly assigned to receive one dose of subcutaneous casirivimab-imdevimab (158 participants) or placebo (156). Average participant age was 41.0 years.
The drug combination significantly averted progression to symptomatic illness (29.0% vs 42.3% with placebo), for an odds ratio (OR) of 0.54 and an absolute risk difference of -13.3%.
Casirivimab-imdevimab lowered the risk of symptomatic infection from 19.2% to 10%, the duration of COVID-19 symptoms by 5.6 days per participant, and the symptom duration per 1,000 participants by 489.8 weeks, relative to 811.9 weeks with placebo. The proportion of participants receiving casirivimab-imdevimab who had at least one treatment-emergent adverse event was 33.5%, versus 48.1% for placebo.
In a secondary analysis, none of 100 casirivimab-imdevimab participants were hospitalized or visited an emergency department because of COVID-19, compared with 6 of 104 in the placebo group.
In a related editorial, Jonathan Li, MD, and Rajesh Gandhi, MD, both of Harvard Medical School, said that if casirivimab-imdevimab is authorized for use in asymptomatic COVID-19 patients, the combination could be useful for immunosuppressed patients. "In immunocompetent patients, monoclonal antibodies are likely to be reserved for symptomatic individuals as long as there continue to be supply and logistical constraints," they wrote.
"However, casirivimab and imdevimab activity is compromised by the Omicron variant, and it is unknown whether the results of this study can be extrapolated to other monoclonal antibody therapies," they added.
Jan 14 JAMA study and editorial
With positive test in a deer, Alabama becomes 28th state to detect CWD
Chronic wasting disease (CWD) has been detected for the first time in Alabama, the Alabama Department of Conservation and Natural Resources (ADCNR) confirmed last week.
A sample collected from a hunter-harvested white-tail deer in west-central Lauderdale County has tested positive for CWD, an always fatal disease that has been detected in North American deer and related cervids like elk and moose. The disease has now been found in 28 US states and four Canadian provinces.
The sample from the CWD-positive deer was submitted as part of the state's surveillance efforts. Preliminary tests were performed at the Alabama Department of Agriculture and Industries, with confirmation provided by the National Veterinary Services Laboratories in Ames, Iowa.
"CWD was first detected in Tennessee and Mississippi in 2018 and has been moving slowly toward Alabama," said Chris Blankenship, ADCNR commissioner. "We take the presence of this disease very seriously, which is why we developed a plan of action using CWD best practices to deal with the disease."
The ADCNR has designated all of Lauderdale and Colbert counties as a CWD management zone, which opens the area to more hunting. The agency also designated an area in Lauderdale County surrounding the new detection as a high-risk zone, wherein hunters are now required to submit heads for CWD testing from all deer that they harvest.
CWD has yet to be detected in people, but the Centers for Disease Control and Prevention (CDC) warns against eating the meat of cervids that test positive for the prion disease.
Jan 7 ADCNR news release
US flu markers show slight declines in activity
The nation's flu activity showed small signs of decline last week, but levels are still elevated, with circulation expected to continue for several more weeks, the CDC said today in its latest weekly update, which covers last week.
The percentage of doctor's visits for flulike illness declined from 4.8% to 4.3% last week, with the current level still above the national baseline. The CDC notes that other respiratory viruses are circulating, contributing to the overall respiratory illness picture.
The number of states reporting high or very high flu activity, another measure of clinic visits for flulike illness, dropped from 31 to 21.
Hospitalizations reported to the Health and Human Services Protect system declined slightly, and the percentage of respiratory samples that tested positive for flu at clinical labs dropped from 3.8% to 2.2% last week.
One more pediatric flu death was reported, which involved a patient with an unsubtyped influenza A infection who died during the week ending on Dec 25. So far, three pediatric flu deaths have been reported for the current flu season.
H3N2 is still the dominant strain. The CDC said though most H3N2 viruses are closely related to the vaccine strain, testing shows some antigenic changes as the viruses evolve. H3N2 is known to cause higher rates of complications in younger and older age-groups, and antigenic changes with the subtype have been linked to vaccine mismatches in the past.
Jan 14 CDC FluView report
DRC and Yemen report more vaccine-derived polio cases
Two countries—the Democratic Republic of the Congo (DRC) and Yemen—reported more polio cases this week, both involving circulating vaccine-derived poliovirus type 2 (cVDPV2), according to the latest weekly update from the Global Polio Eradication Initiative (GPEI).
The DRC reported 2 cases, both in Maneima province, to raise its total for 2021 to 19 cases.
Yemen reported 4 more cases, which are also part of its total for the previous year, which now stands at 10. For 2021, Yemen also reported 3 illnesses involving circulating vaccine-derived poliovirus type 1 (cVDPV1).
Jan 13 GPEI update
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