NIH puts out the call for more effective, easier-to-use COVID tests

 In the two-and-a-half years of the COVID-19 pandemic, diagnostic test makers have fine-tuned their development and manufacturing processes to quickly roll out countless tests for the virus, many of them helped along by infusions of federal funding specifically set aside for innovative new testing approaches.

And the government isn’t done yet. With its sights set on the endemic stage of the coronavirus, the National Institutes of Health has re-upped its call for new and improved COVID diagnostics, it announced Thursday.

The summons arrives via the Rapid Acceleration of Diagnostics Tech program, or RADx, which launched in the early days of the pandemic with an initial commitment of $1.5 billion and a “Shark Tank”-style competition to quickly develop both at-home and point-of-care tests for the virus.

RADx is managed by the NIH's National Institute of Biomedical Imaging and Bioengineering, with additional support from other government agencies such as the FDA, CDC and the Biomedical Advanced Research and Development Authority (BARDA). Since the start of the pandemic, it’s had a hand in developing at least four dozen COVID testing technologies.

This time around, RADx is offering a total of $300 million in funding from the 2021 American Rescue Plan Act. The funds will help support not only the development of the new tests but also their regulatory aspirations—including both pandemic-induced emergency use authorization and full market clearance.

The program is specifically seeking diagnostics that fall into two categories, both aimed at improving accessibility and usability. The first category is aimed at people with blindness, low vision, fine motor skill difficulties, aging-related disabilities and other conditions that may make certain tests challenging to use. The NIH is looking for over-the-counter tests that’ll be easier to use and that can be ready for commercialization within one to two years.

The other category of tests will combine updated designs that make them simpler to use and improved diagnostic technology that eliminates the need for repeated testing and variant-specific adjustments. Proposals in this category can include both over-the-counter and point-of-care tests and should be ready for commercialization within two to three years.

The NIH will begin accepting applications for this new phase of the RADx program Sept. 20.

The NIH’s revamped call for COVID tests comes as another area of the executive branch re-ups its own efforts to make diagnostics more accessible across the country.

On Thursday, the Biden Administration outlined a plan to purchase another 100 million at-home rapid tests from U.S.-based manufacturers. Though it noted that the buy won’t fully replenish the national stockpile of at-home diagnostics, “this procurement will help meet some testing needs in the months ahead and will put us in a better position to manage a potential increase in testing demand this fall and winter.”

The White House’s announcement comes a week after it paused the distribution of free test kits through the COVIDTests.gov website, citing Congress’ repeated denials of its requests for more COVID-focused funding.

https://www.fiercebiotech.com/medtech/radx-reloaded-nih-puts-out-call-more-effective-easier-use-covid-tests

GSK: asthma sufferers unhappy with how condition is managed

 Fewer than half of asthma patients think their condition is managed well, according to a new study sponsored by asthma drug maker GSK and conducted by creative think tank Economist Impact. The result is the FUture of RespiraTory HEalth Readiness (FURTHER) Initiative.

The report, "Every breath you take: Taking the patient voice FURTHER in their asthma journey" launched early September at the ERS International Congress 2022. Economist Impact surveyed asthma patients in 13 countries, asking how they felt about their current treatment and what hopes they had for future improvements.

Not only did it find that asthma diagnosis has increased by around 3.6% over the last 15 years, but, of the respondents, 56% said the pandemic made managing their asthma even more difficult. The report found a lot of general dissatisfaction around asthma care. More than 20% said they’d been to the hospital twice due to asthma, 30% couldn’t stick to their plan due to cost and nearly 75% said there was a need for better asthma education in their community.

Environmental factors such as climate change are adding to the problem, and it’s not only individuals who are affected by asthma. According to the study, when not controlled, there is an economic impact as well.

“Adults with frequent asthma exacerbations need more hospital care, and so are experiencing missed workdays and productivity losses at a higher rate (average 13 days a year)," the report's authors noted. "Compare that to those with controlled asthma, for whom these rates are similar to that of healthy people.“

GSK is heavily invested in asthma via its three-in-one inhaler Trelegy and its asthma injection Nucala—which is used for severe eosinophilic asthma, among other indications. They gained blockbuster status for the first time in 2021, with sales of 1.22 billion and 1.14 billion pounds sterling, respectively. 

https://www.fiercepharma.com/marketing/gsk-report-finds-asthma-sufferers-are-unhappy-how-condition-managed

Clovis Rubraca Improves Progression-Free Survival in Advanced Ovarian Cancer

 

• Subgroup analysis from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented in a Mini Oral session at the ESMO Congress 2022
• Results reinforce potential of Rubraca as a first-line maintenance treatment option in a broad population of patients with ovarian cancer irrespective of molecular characteristics, with or without high risk factors for progression

https://www.marketscreener.com/quote/stock/CLOVIS-ONCOLOGY-INC-9500801/news/Clovis-Oncology-s-Rubraca-Rucaparib-as-First-Line-Maintenance-Treatment-Improves-Progression-Free-41747647/

Can nurses help grow buprenorphine treatment capacity?

 Despite a slowdown in new waivers to prescribe buprenorphine during COVID-19, treatment capacity nonetheless grew at a stable rate, a new Health Affairs study has found. 

This was due to already authorized clinicians obtaining waivers to prescribe for larger groups of patients. Advanced practice nurses (APNs) accounted for the largest portion of capacity growth during the pandemic, the study found. 

The study relied on DEA Registrant Files from 2018 through 2022, which indicated clinician type and whether they have an X waiver to prescribe buprenorphine. It also included the number of patients authorized by the waiver, which the researchers used to track quarterly growth and potential treatment capacity.

Until mid-2021, though, there was a slowdown in new waivers among all clinicians; a significantly larger number of APNs obtained waivers afterward as opposed to physicians. In addition, physician assistants also obtained new waivers, together growing treatment capacity to a higher point than before the pandemic. 

Opioid overdose deaths surged during the pandemic, and access to buprenorphine treatment continues to be key to combating the crisis. During the pandemic, there were numerous efforts to maintain access, including emergency authorization for the use of telehealth for buprenorphine prescribing, offering home delivery and suspending urine drug testing. The Drug Enforcement Administration also relaxed training requirements for clinicians to obtain waivers mid-2021.

The study referred to existing research that shows newly waivered rural APNs are more likely than rural physicians to prescribe buprenorphine, and waivered APNs are more likely than physicians to prescribe buprenorphine to Medicaid enrollees. APN waiver growth could slow, and buprenorphine prescribing could be affected by state restrictions requiring physician oversight, the study noted. Nevertheless, for now, APN and physician assistant treatment capacity has continued to rise despite these regulatory barriers. 

“Policy and practice leaders need to support growth in the buprenorphine prescribing workforce and to facilitate clinicians prescribing to the maximum level allowed,” the study authors concluded. 

https://www.fiercehealthcare.com/providers/drop-authorized-prescribers-buprenorphine-during-covid-study

Consumers willing to pay more for healthcare services based on some factors: survey

 Quality of care, care team choice, location and speed all play a role in how much consumers are willing to spend on their healthcare, according to new survey responses from more than 2,000 American adults.

Fifty-seven percent of those polled in mid-March said they would be willing to pay more based on the quality of care they would receive, according to the survey commissioned by revenue cycle and automation vendor AKASA.

Forty-seven percent said that having the ability to work with their chosen care team would impact their willingness to pay, and 41% said the same for having the hospital of their choice. Location proximity or convenience was a price factor for 41% of respondents, while the ability to get appointments quickly moved the needle for 40%, AKASA said.

Most consumers also said they had limits to how far they would be willing to journey for the best medical care prices.

Assuming equivalent care quality, 51% of respondents said they would travel 10 to 20 miles for a better price while another 31% would go as far as 50 miles, according to the survey data. Thirteen percent more said they’d be willing to travel up to 100 miles for cheaper care, 2% up to 200 miles and 3% up to 400 miles.

AKASA’s survey was conducted online by market research firm YouGov, which included a total sample of 2,026 adults weighted to be representative of the country’s adult population.

Of note, just 721 of those polled said they had ever attempted to look up healthcare prices when seeking care or services.

“The findings can help healthcare leaders prioritize what to focus on when thinking about their bottom lines through the lens of what patients are willing to pay for and aligning it with improving the patient experience,” Amy Raymond, vice president of revenue cycle operations at AKASA, said in a statement accompanying the survey data.

With medical bills a leading weight on many Americans’ financial stability, healthcare prices have been center stage for policymakers for some time. Hospitals were instructed to begin publicly posting prices for hundreds of common services in patient-friendly formats in an effort to help patients shop for cheaper care, although reports suggest awareness of and compliance with the transparency requirements have been lacking.

Still, healthcare spending and prices have been slow to grow in comparison to the broader economy’s inflation spike—although that could change as public and private payers begin to lock in their annual rate adjustments.

https://www.fiercehealthcare.com/providers/heres-what-healthcare-consumers-say-theyre-willing-pay-more

New playbook aims to help employers, plan sponsors negotiate hospital prices

 A new playbook aims to arm employers with the tools needed to negotiate hospital prices.

The National Alliance of Healthcare Purchaser Conditions released the book on Thursday, and it offers strategies for plan sponsors to harness newly-released price transparency and quality data as leverage to drive down prices. The book notes that hospitals charge commercial plans significantly more than Medicare, often with prices 140% to 200% higher than Medicare rates.

The group says a "fair price" would instead "allow for a reasonable markup from costs and a price that is competitive with peer hospitals" without price-gouging the commercial market.

“For the first time, we finally have data that reinforces what we’ve long known—hospitals prices are out of control—and we can’t rely on health systems and health plans to course correct,” said Michael Thompson, National Alliance president and CEO, in a release. “Employers not only have the right, but a responsibility as plan fiduciaries, to negotiate fair prices. Now is the time for honest discourse and action on what is reasonable to pay for services provided.”

So what can employers do in these negotiations? For one, using the data now available, they can identify what a hospital needs to earn to break even and can build potential rates from there. Once that breakeven point is determined, plan sponsors can compare prices between hospitals to get a feel for market dynamics.

The Employers’ Forum of Indiana has launched Sage Transparency, a free hospital pricing dashboard that employers can use to compare hospital pricing and quality data. The tool pulls from multiple data sources, including RAND Corporation, the Centers for Medicare & Medicaid Services and Turquoise Health.

The National Alliance says that this tool and others like it are valuable resources that employers can tap into when determining a fair market price for hospital services.

And While there isn't a one-size-fits-all solution, plan sponsors can mix and match the suggestions in the playbook to meet their local needs, the alliance said.

The playbook also includes a comprehensive guide to hospital price transparency regulations, providing employers with a clear resource to look to when navigating these policies.

“While there is much to fix in our nation’s healthcare system, one of the greatest offenders is hospitals that are overcharging and realizing huge profit margins at the expense of employers, their employees and families,” Thompson said in the release. “Regional coalitions and their employer-purchaser members are playing a key role in driving and leveraging transparency data to get to a fair price and overcome the imbalance of power.”

https://www.fiercehealthcare.com/payers/new-playbook-aims-help-employers-plan-sponsors-negotiate-hospital-prices

CVS survey: Teens turn to educators in search of mental health support

 Both parents and educators play key roles in addressing adolescent mental health needs, but teenagers are approaching the latter with such concerns more often, new survey data show.

The analysis, conducted by CVS Health and Morning Consult, found that 78% of educators had been approached by a child about mental health concerns, compared to 58% of parents. The survey was conducted in mid-August and polled 500 parents and 340 educators of youths aged 13 to 17.

Educators were also more concerned about teen mental health, according to the survey, with 76% of those surveyed saying it is a concern. By comparison, 43% of parents said the same.

However, nearly half (49%) of parents said they initiate conversations with adolescents about their mental health, compared to 22% of educators. Most parents and educators (94%) said they feel they can find necessary support for a teenager struggling with mental health needs, according to the survey.

"Young people continue to face a mental health crisis, but they are not facing it alone. Most are turning to the adults in their lives for help both at home and at school," said CVS Health CEO Karen Lynch said in a release.

"To increase our attention on adolescents' mental health, we have launched new programs to reach them and their families directly, and resources to help parents and caregivers better understand mental distress and available support," Lynch added. "Mental health can, and should, become a part of everyday conversation in the classroom, during lunch hour and at the dinner table."

In most cases, both parents and educators said that should a mental health concern surface, they would speak to the child directly, reach out to one another or reach out to a mental health professional.

The survey also found that educators and parents identify different factors that are having a negative impact on teens' mental health. Most educators (94%) cited family dynamics and relationships, 91% named self-esteem, 85% said bullying and social dynamics and 83% cited social media as the key factors harming adolescent mental health.

Parents, meanwhile, cited academic pressures (54%), self-esteem (51%), pandemic-related stress (48%) and bullying or social dynamics (43%) as having a negative impact on their kids' mental health.

In addition, a majority of educators (72%) named issues stemming from gender, race and sexuality as a key factor, compared to just a quarter of parents. Many educators (63%) and parents (54%) agree that making mental health care more affordable is a key resource for adolescents.

"Parents and educators create a critical, complementary team that supports adolescents through the impacts of academic and family pressures, self-esteem concerns, COVID-19 and more," Cara McNulty, president of behavioral health and mental well-being at CVS Health, said in the release. "By helping adolescents, we can prevent mental health issues and the risk of suicide from arising or becoming worse and set healthy well-being habits in this generation for years to come."

https://www.fiercehealthcare.com/payers/cvs-survey-teens-turn-educators-search-mental-health-support