The cost of swabbing and testing all Americans for the coronavirus strain Covid-19 plus the price tag for testing them for virus antibodies could be as much as $44 billion a year, a new analysis funded by health insurers says.
“Diagnostic testing would cost between $6 billion and $25 billion a
year, and antibody testing would cost between $5 billion and $19 billion
a year,” the report from the Wakely Consulting Group, funded by the health insurance lobby America’s Health Insurance Plans (AHIP), says.
“These estimates include both the cost of the tests, as well as
affiliated health care services (e.g., provider visit, urgent care
visit) for administering the tests.”
The U.S. fight against Covid-19 has put diagnostic testing in the
spotlight to get patients treatment while helping society re-open to get
Americans back to work and children back to school this fall. But it’s
unclear who will pay for the tests with some members of Congress and
state lawmakers looking at the health insurance industry as a potential
target to pick up the tab.
But health insurers say it’s not that simple, indicating costs should be spread around.
“Testing strategies need to be part of a holistic public and occupational health strategy,” said AHIP,
which includes Anthem, Cigna, Centene and CVS Health, parent of Aetna,
as members. “Federal guidance should consider funding for testing in
that context, and should clearly articulate the roles of insurance
providers, employers, and public health officials.”
The first wave of testing is already well underway with clinicians
including doctors, retail clinics and hospitals testing Americans for
the virus with molecular assays to diagnosis COVID-19 virus so they can
begin treatment. These medically necessary tests made by companies like
Abbott Laboratories, Roche and others are designed to diagnose or treat
the disease.
Lately, companies including Abbott and Roche are beginning to roll out antibody tests for the mass population to know who has the virus so others don’t catch it and spread it in the future. Some states, including New York,
have already begun antibody testing with medical care providers in
their regions in an effort to know who has had the disease and whether
they have built up immunity.
Costs of testing in the report varied widely in part because it would
depend on who administered the tests and whether there was adequate
supply and materials to carry out either diagnostic testing or antibody
testing.
As one example of the wide range of test costs, the Wakely Consulting Group report said the estimated cost of the testing would vary depending on which line of health insurance picked up the tab.
“It was assumed to be between $40 and $70 for diagnostic testing for
Medicare and Medicaid and between $30 and $50 per test for antibody
testing for Medicare and Medicaid,” the report said. “Commercial testing was assumed to be approximately 25% higher than the average cost for Medicare and Medicaid.”
https://www.forbes.com/sites/brucejapsen/2020/06/10/price-tag-to-test-all-americans-for-coronavirus-44-billion-a-year/amp/
Wednesday, June 10, 2020
Japan’s AnGes speeds towards 2021 rollout in coronavirus ‘vaccine war’
Japanese biotech AnGes Inc expects its coronavirus vaccine to be
ready as early as the first half of 2021, if it can overcome supply
chain and production hurdles, the company’s founder said.
The Osaka-based firm had a headstart in the potential COVID-19
vaccine development by repurposing its hypertension vaccine that had
already passed through high safety and regulatory standards and other
hurdles.
Ryuichi Morishita told Reuters that Japan’s health ministry and Pharmaceuticals and Medical Devices Agency “already had strong confidence in our product” because of that experience.
The comments come as Japan’s government has earmarked $1.3 billion in its latest budget for vaccine production as it seeks to put the coronavirus vaccine into use and hopes to host a delayed Tokyo Olympics next year.
Drugmakers around the world are scrambling to develop treatments and vaccines for COVID-19, the respiratory disease caused by the highly infectious new coronavirus which has so far killed more than 400,000 people worldwide.
There are 10 vaccines in clinical trials and dozens more in
pre-clinical evaluation, according to the World Health Organization, but
mass production and allocation remain significant challenges.
Morishita also warned that shortages in everything from drug compounds to glass vials, as hundreds of institutes and companies carry out research simultaneously, have emerged in what he calls a “vaccine war” and could complicate production.
AnGes’s candidate is one of Japan’s best hopes at a coronavirus vaccine, as development is further along than some being produced by other firms such as Shionogi & Co and Daiichi Sankyo Co.
The AnGes candidate is a plasmid DNA vaccine that disables the connection between the protein spikes of the coronavirus and receptors in human cells.
Early results from tests in mice show increased antibody production, and tests in 30 human volunteers are due to begin in July, with first results expected in September.
By contrast, other candidates such as U.S. firm Moderna Inc’s vaccine
are based on messenger RNA (mRNA) that instructs human cells to make
specific coronavirus proteins that produce an immune response. Other
varieties are based on inactivated forms of the virus.
Morishita, who launched AnGes 20 years ago out of Osaka University, has seen the company’s market valuation surge more than five fold to $2.4 billion since it announced its coronavirus campaign in March.
“The future of COVID-19 is very mysterious,” said Morishita, adding that any vaccine would likely need constant tweaking as the virus mutates and returns.
https://www.reuters.com/article/us-health-coronavirus-japan-anges/japans-anges-speeds-towards-2021-rollout-in-coronavirus-vaccine-war-idUSKBN23H115
Ryuichi Morishita told Reuters that Japan’s health ministry and Pharmaceuticals and Medical Devices Agency “already had strong confidence in our product” because of that experience.
The comments come as Japan’s government has earmarked $1.3 billion in its latest budget for vaccine production as it seeks to put the coronavirus vaccine into use and hopes to host a delayed Tokyo Olympics next year.
Drugmakers around the world are scrambling to develop treatments and vaccines for COVID-19, the respiratory disease caused by the highly infectious new coronavirus which has so far killed more than 400,000 people worldwide.
Morishita also warned that shortages in everything from drug compounds to glass vials, as hundreds of institutes and companies carry out research simultaneously, have emerged in what he calls a “vaccine war” and could complicate production.
AnGes’s candidate is one of Japan’s best hopes at a coronavirus vaccine, as development is further along than some being produced by other firms such as Shionogi & Co and Daiichi Sankyo Co.
The AnGes candidate is a plasmid DNA vaccine that disables the connection between the protein spikes of the coronavirus and receptors in human cells.
Early results from tests in mice show increased antibody production, and tests in 30 human volunteers are due to begin in July, with first results expected in September.
Morishita, who launched AnGes 20 years ago out of Osaka University, has seen the company’s market valuation surge more than five fold to $2.4 billion since it announced its coronavirus campaign in March.
“The future of COVID-19 is very mysterious,” said Morishita, adding that any vaccine would likely need constant tweaking as the virus mutates and returns.
https://www.reuters.com/article/us-health-coronavirus-japan-anges/japans-anges-speeds-towards-2021-rollout-in-coronavirus-vaccine-war-idUSKBN23H115
Potential COVID-19 vaccine from China shows promise in animal tests
A potential COVID-19 vaccine being developed by Chinese researchers
showed promise in trials in monkeys, triggering antibodies and raising
no safety issues, researchers said, and a human trial with more than
1,000 participants is under way.
The vaccine candidate, called BBIBP-CorV, induced high-level neutralising antibodies that can block the virus from infecting cells in monkeys, rats, guinea pigs and rabbits, researchers said in a paper published in online by the medical journal Cell on Saturday.
“These results support the further evaluation of BBIBP-CorV in a clinical trial,” researchers said in the paper.
BBIBP-CorV, developed by Beijing Institute of Biological Products affiliated to state-owned China National Pharmaceutical Group (Sinopharm), is among five candidates China is testing in humans.
More than 100 potential COVID-19 vaccines are in various stages of
development around the world. Among front runners currently in human
trials are being developed by AstraZeneca, Pfizer, BioNtech, Johnson
& Johnson, Merck, Moderna, Sanofi and China’s CanSino Biologics.
As well as appearing safe and able to generate an immune response in animals, BBIBP-CorV did not appear to trigger antibodies that could boost the infection – a phenomenon known as antibody-dependent enhancement (ADE)- the researchers said, although this does not necessarily guarantee ADE won’t occur in human tests.
Apart from BBIBP-CorV, Sinopharm, which has invested 1 billion yuan ($141.40 million) in vaccine projects, is testing in humans another vaccine candidate developed by its Wuhan-based unit. The two shots have been given to more than 2,000 people in clinical trials.
https://www.reuters.com/article/us-health-coronavirus-vaccine/potential-covid-19-vaccine-from-china-shows-promise-in-animal-tests-idUSKBN23H15J
The vaccine candidate, called BBIBP-CorV, induced high-level neutralising antibodies that can block the virus from infecting cells in monkeys, rats, guinea pigs and rabbits, researchers said in a paper published in online by the medical journal Cell on Saturday.
BBIBP-CorV, developed by Beijing Institute of Biological Products affiliated to state-owned China National Pharmaceutical Group (Sinopharm), is among five candidates China is testing in humans.
As well as appearing safe and able to generate an immune response in animals, BBIBP-CorV did not appear to trigger antibodies that could boost the infection – a phenomenon known as antibody-dependent enhancement (ADE)- the researchers said, although this does not necessarily guarantee ADE won’t occur in human tests.
Apart from BBIBP-CorV, Sinopharm, which has invested 1 billion yuan ($141.40 million) in vaccine projects, is testing in humans another vaccine candidate developed by its Wuhan-based unit. The two shots have been given to more than 2,000 people in clinical trials.
https://www.reuters.com/article/us-health-coronavirus-vaccine/potential-covid-19-vaccine-from-china-shows-promise-in-animal-tests-idUSKBN23H15J
Alnylam’s shares dip as analyst backs rival after rare disease data reveal
Alnylam has revealed the data that forms the basis of its
filings for its latest potential rare disease drug lumasiran, but shares
dipped after an analyst suggested it could be outperformed by a
contender from rival biotech Dicerna.
The RNA therapeutics specialist announced the phase 3 data from the ILLUMINATE-A study of lumasiran, which is in development for the ultra-rare condition primary hyperoxaluria type 1 (PH1).
Lumasiran is the first drug shown to help patients with the ultra-rare disease clear a toxic substance called oxalate from their kidneys and other vital organs and – if approved – would become Alnylam’s third product based on its RNA interference platform.
It is already under review with the FDA and regulators in Europe for PH1, which is caused by a mutation in a gene called AGXT that leads to a deficiency in the AGT enzyme responsible for preventing the build-up of oxalate.
In its absence, the substance is deposited in the kidneys, urinary tract and other organs causing tissue damage and – if untreated – can progress to end-stage renal disease that may require dialysis or a kidney transplant. Lumasiran switches off production of a precursor to oxalate.
The latest clinical data was presented at a virtual session of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA).
In the 39-patient ILLUMINATE-A study, lumasiran met the primary efficacy endpoint of 24-hour urinary oxalate reduction from month three to month six relative to placebo and all tested secondary endpoints.
In 26 PH1 patients aged six years and older treated with lumasiran, there was a 65.4% mean reduction in urinary oxalate relative to baseline, with a mean treatment difference of 53.5% relative to the 13 patients in the trial’s placebo arm.
The mean maximal reduction with lumasiran was 76%, similar to results of 75-76% seen in phase 1/2 and phase 2 open label extension studies using a different assay method.
Lumasiran also showed a 62.5% mean reduction in 24-hour urinary oxalate:creatinine ratio – an alternative measure of urinary oxalate excretion – relative to baseline, with a mean treatment difference of 51.8% relative to placebo.
Safety-wise there were no deaths and no severe or serious adverse events reported and adverse events were reported in 22 out of 26 of lumasiran patients versus nine out of 13 placebo patients.
However shares in Alnylam were down more than 3% on the Nasdaq following the announcement after RBC Capital analyst Luca Issi told investors that a rival from Dicerna Pharma may outperform it if approved.
Dicerna’s drug has a more patient-friendly fixed dosing approach and could have a broader label tackling all PH subtypes. It may also capitalise on Alnylam’s “heavy lifting” on disease awareness, said Issi.
The RNA therapeutics specialist announced the phase 3 data from the ILLUMINATE-A study of lumasiran, which is in development for the ultra-rare condition primary hyperoxaluria type 1 (PH1).
Lumasiran is the first drug shown to help patients with the ultra-rare disease clear a toxic substance called oxalate from their kidneys and other vital organs and – if approved – would become Alnylam’s third product based on its RNA interference platform.
It is already under review with the FDA and regulators in Europe for PH1, which is caused by a mutation in a gene called AGXT that leads to a deficiency in the AGT enzyme responsible for preventing the build-up of oxalate.
In its absence, the substance is deposited in the kidneys, urinary tract and other organs causing tissue damage and – if untreated – can progress to end-stage renal disease that may require dialysis or a kidney transplant. Lumasiran switches off production of a precursor to oxalate.
The latest clinical data was presented at a virtual session of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA).
In the 39-patient ILLUMINATE-A study, lumasiran met the primary efficacy endpoint of 24-hour urinary oxalate reduction from month three to month six relative to placebo and all tested secondary endpoints.
In 26 PH1 patients aged six years and older treated with lumasiran, there was a 65.4% mean reduction in urinary oxalate relative to baseline, with a mean treatment difference of 53.5% relative to the 13 patients in the trial’s placebo arm.
The mean maximal reduction with lumasiran was 76%, similar to results of 75-76% seen in phase 1/2 and phase 2 open label extension studies using a different assay method.
Lumasiran also showed a 62.5% mean reduction in 24-hour urinary oxalate:creatinine ratio – an alternative measure of urinary oxalate excretion – relative to baseline, with a mean treatment difference of 51.8% relative to placebo.
Safety-wise there were no deaths and no severe or serious adverse events reported and adverse events were reported in 22 out of 26 of lumasiran patients versus nine out of 13 placebo patients.
However shares in Alnylam were down more than 3% on the Nasdaq following the announcement after RBC Capital analyst Luca Issi told investors that a rival from Dicerna Pharma may outperform it if approved.
Dicerna’s drug has a more patient-friendly fixed dosing approach and could have a broader label tackling all PH subtypes. It may also capitalise on Alnylam’s “heavy lifting” on disease awareness, said Issi.
Alnylam’s shares dip as analyst backs rival after rare disease data reveal
Substance use up amid pandemic
Some people with substance use disorders have increased their usage during the pandemic, according to a survey released Tuesday.
A survey of more than 1,000 people conducted by the Addiction Policy Forum found that 20 percent said they or a family member have increased substance use since COVID-19 began.
Four percent reported overdoses, and 1 percent of those were fatal, according to the survey.
“We are concerned that the progress we have made over the last
several years to address overdoses and the opioid epidemic, that we
might have lost ground during the pandemic shutdown,” said Jessica
Hulsey, co-author of the report and president of the Addiction Policy Forum, an advocacy group for people with substance use disorders.
“We need to make sure that we are doubling down efforts to make sure that the colliding epidemics of coronavirus and the opioid epidemic doesn’t mean more loss of life in communities that are hit hard by both.”
Drug overdose deaths declined in 2018 for the first time in nearly two decades, driven by drops in deaths from prescription opioids.
Still, nearly 68,000 people died of drug overdoses in 2018, the most recent data available. Overdose deaths from synthetic narcotics, mainly fentanyl, and cocaine and meth continue to increase. Overall, 20 million people in the U.S. are estimated to be addicted to substances.
Experts have worried that the stress of the pandemic and social distancing requirements could increase that number and put people with substance use disorders at risk for relapses.
Respondents to the survey were most concerned about the lack of access to in-person support groups and 12 step meetings due to social distancing requirements.
In the earlier days of the pandemic, the Centers for Disease Control
and Prevention (CDC) and other public health agencies had urged states
and localities to limit in-person gatherings and discretionary travel as
much as possible.
While some meetings have taken place virtually, it might not work for everyone, Hulsey said.
In all, 14 percent said they have been unable to access needed services during the pandemic. The web-based survey was conducted between April 27 and May 8 and is not representative of the broader population. The survey is a “rapid assessment” of the impact of COVID-19 on people with substance use disorders and is intended to inform additional research, the report states.
“In the future, I do think we need to readdress what are essential services and what isn’t,” Hulsey said.
“Addiction is a chronic health condition and some of the long-term
support that individuals need to stay healthy and well need to be met
even during a crisis like Covid-19.”
A recent analysis from the Well Being Trust estimated that 75,000 more people will die from drug or alcohol misuse and suicide if the U.S. Does not significantly invest in solutions to help “heal the nation’s isolation, pain and suffering” caused by COVID-19.
The Addiction Policy Forum and 47 other groups are asking Congressional leaders to appropriate millions of dollars in funding to help mitigate the impact of the pandemic on people with substance use disorders.
https://thehill.com/policy/healthcare/501923-substance-use-up-amid-pandemic-survey
A survey of more than 1,000 people conducted by the Addiction Policy Forum found that 20 percent said they or a family member have increased substance use since COVID-19 began.
Four percent reported overdoses, and 1 percent of those were fatal, according to the survey.
“We need to make sure that we are doubling down efforts to make sure that the colliding epidemics of coronavirus and the opioid epidemic doesn’t mean more loss of life in communities that are hit hard by both.”
Drug overdose deaths declined in 2018 for the first time in nearly two decades, driven by drops in deaths from prescription opioids.
Still, nearly 68,000 people died of drug overdoses in 2018, the most recent data available. Overdose deaths from synthetic narcotics, mainly fentanyl, and cocaine and meth continue to increase. Overall, 20 million people in the U.S. are estimated to be addicted to substances.
Experts have worried that the stress of the pandemic and social distancing requirements could increase that number and put people with substance use disorders at risk for relapses.
Respondents to the survey were most concerned about the lack of access to in-person support groups and 12 step meetings due to social distancing requirements.
While some meetings have taken place virtually, it might not work for everyone, Hulsey said.
In all, 14 percent said they have been unable to access needed services during the pandemic. The web-based survey was conducted between April 27 and May 8 and is not representative of the broader population. The survey is a “rapid assessment” of the impact of COVID-19 on people with substance use disorders and is intended to inform additional research, the report states.
“In the future, I do think we need to readdress what are essential services and what isn’t,” Hulsey said.
A recent analysis from the Well Being Trust estimated that 75,000 more people will die from drug or alcohol misuse and suicide if the U.S. Does not significantly invest in solutions to help “heal the nation’s isolation, pain and suffering” caused by COVID-19.
The Addiction Policy Forum and 47 other groups are asking Congressional leaders to appropriate millions of dollars in funding to help mitigate the impact of the pandemic on people with substance use disorders.
https://thehill.com/policy/healthcare/501923-substance-use-up-amid-pandemic-survey
Indian firm Panacea says aiming to make COVID-19 vaccine
Indian biotech firm Panacea Biotec Ltd said on Wednesday it would
partner with U.S.-based Refana Inc to make a potential vaccine for
COVID-19.
The collaboration aims to make more than 500 million doses of the vaccine candidate, with over 40 million doses expected to be available early next year, Panacea said in a statement to stock exchanges.
https://www.reuters.com/article/us-health-coronavirus-india-vaccine/indian-firm-panacea-says-aiming-to-make-covid-19-vaccine-idUSKBN23H0LL
The collaboration aims to make more than 500 million doses of the vaccine candidate, with over 40 million doses expected to be available early next year, Panacea said in a statement to stock exchanges.
https://www.reuters.com/article/us-health-coronavirus-india-vaccine/indian-firm-panacea-says-aiming-to-make-covid-19-vaccine-idUSKBN23H0LL
Japan’s Fujifilm to spend $928 million to double capacity of Danish drug facility
Fujifilm Holdings Corp (4901.T)
will spend $928 million to double capacity at a drug manufacturing
facility in Denmark, which it has pledged to use in producing COVID-19
treatments, as the Japanese company steps up its pivot towards
healthcare.
The investment in Fujifilm Diosynth Biotechnologies will expand production lines for bulk drug substances and cultivate cells for producing viral vaccines, Fujifilm announced on Tuesday. It bought the facility in Hillerod, Denmark, in August from Biogen Inc (BIIB.O) for about $890 million.
The investment expands Fujifilm’s presence as a global contract development and manufacturing organisation (CDMO), which supplies other companies in the pharma industry. Fujifilm started to diversify from cameras and office equipment and into healthcare more than a decade ago.
Fujifilm previously announced that the Denmark site would offer
future manufacturing capacity to the COVID-19 Therapeutics Accelerator
to speed-up the response to the global pandemic.
It is an initiative launched by the Bill & Melinda Gates Foundation and two other large charities, aimed at accelerating drug development and identifying a promising COVID-19 therapeutic candidate based on efficacy and safety data demonstrated in clinical trials.
Fujifilm’s pharma arm is testing its own anti-flu drug Avigan as a treatment for COVID-19.
The company aims to achieve 100 billion yen ($928.68 million) in
sales in its bio-CDMO business by the fiscal year ending March 2022.
https://www.reuters.com/article/us-fujifilm-investment-denmark/japans-fujifilm-to-spend-928-million-to-double-capacity-of-danish-drug-facility-idUSKBN23H0C3
The investment in Fujifilm Diosynth Biotechnologies will expand production lines for bulk drug substances and cultivate cells for producing viral vaccines, Fujifilm announced on Tuesday. It bought the facility in Hillerod, Denmark, in August from Biogen Inc (BIIB.O) for about $890 million.
The investment expands Fujifilm’s presence as a global contract development and manufacturing organisation (CDMO), which supplies other companies in the pharma industry. Fujifilm started to diversify from cameras and office equipment and into healthcare more than a decade ago.
It is an initiative launched by the Bill & Melinda Gates Foundation and two other large charities, aimed at accelerating drug development and identifying a promising COVID-19 therapeutic candidate based on efficacy and safety data demonstrated in clinical trials.
Fujifilm’s pharma arm is testing its own anti-flu drug Avigan as a treatment for COVID-19.
https://www.reuters.com/article/us-fujifilm-investment-denmark/japans-fujifilm-to-spend-928-million-to-double-capacity-of-danish-drug-facility-idUSKBN23H0C3
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