FDA OKs 60P’s 1st preventative antimalarial in almost two decades

60° Pharmaceuticals (60P) announced today the Food and Drug Administration (FDA) approval of ARAKODA™ (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older. For the first time in more than eighteen years, the U.S. FDA approved a new drug for the prevention of malaria.

Millions of healthy individuals travel to areas where malaria is endemic, including those traveling for leisure, employees of non-governmental organizations, industrial and business workers, and military forces. ARAKODA™ has the potential to protect thousands of U.S. travelers from the devastating and life-threatening effects of malaria.

The marketing approval of ARAKODA™ is the culmination of years of scientific discovery and research by experts in the field of Malariology and Infectious Disease. Tafenoquine was originally discovered by scientists at the Walter Reed Army Institute of Research (WRAIR). The approval was based on a concerted effort by the U.S. Army and 60P, involving over 21 clinical trials and over 3,100 trial subjects, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria.

“We have worked closely with the U.S. Army as their commercial partners to bring ARAKODA™ to the U.S. market,” said Geoffrey Dow, Ph.D, CEO of 60P. “ARAKODA™ provides effective protection against both of the major types of malaria (P. vivax and P. falciparum), killing the parasites in both the blood and liver.” Dow continued, “this provides the travel medicine community the option to prescribe an anti-malarial which provides protection in a large spectrum of malaria hot zones while utilizing what is considered by many physicians to be a more compliant dosing regimen. ARAKODA™ is a significant addition to the armamentarium for the prevention of malaria.”

MAJ Victor Zottig, the product manager of tafenoquine for the U.S. Army Medical Materiel Development Activity stated “the FDA approval is a tremendous achievement for 60P and the U.S. military for their long, dedicated effort in the global protection of Service Members and civilian personnel against malaria.”

ARAKODA™ is supplied in 100 mg tablets for oral use only. After an initial loading dose prior to traveling, ARAKODA™ is intended to be taken once a week which could offer convenience to the traveler.

The U.S. FDA Anti-Microbial Drugs Advisory Committee recently recommended the approval of ARAKODA™ for the prevention of malaria based on its safety and efficacy profile. 60P has committed to the U.S. FDA to perform post-marketing safety surveillance studies to continue to gather data on this important tool against malaria.

https://bit.ly/2MgfEHy

The ‘disruption’ large employers are hoping Amazon brings to healthcare

Amazon, JPMorgan and Berkshire Hathaway’s buzzy partnership over their employee healthcare announced in January caught plenty of other large employers’ attention.

Sure, it could just end up being just another purchasing coalition.

But if it actually takes advantage of the breadth of Amazon’s connection with consumers? That could stand to truly—pardon the overused term—”disrupt” healthcare for employers, said National Business Group on Health President and CEO Brian Marcotte.

“If they begin to leverage Amazon’s footprint within the home, their relationship with the consumer, their customer obsession … the customer loyalty they have, and begin to leverage their ability,” Marcotte said, it could change everything.

“One of the challenges in healthcare is employees don’t touch the system with enough frequency in order for it to be routine, in order for them to be sophisticated consumers,” added Marcotte. Amazon and other online shopping platforms are routine, he said.

“When I look at this coming together, the opportunity is how do you leverage their platform to reach people in a more natural way, in a more frequent way then we reach them today,” he said.

Marcotte was speaking in Washington, D.C., on Tuesday, presenting the 2019 Health Care Strategy and Plan Design Survey. The survey, taken in May and June 2018, included responses from 170 large employers who have a total of 19 million covered.

Those employers indicated they are closely watching for innovations from Silicon Valley.

“They are coming out of that market or out of Boston and other areas. It’s not just about the Valley,” Marcotte said. “But then we talk about all of these different solutions around physical therapy or emotional health and well-being, or lifestyle management, or sleep, a lot of them are coming from innovations coming out of the Valley.”

Seven in ten responding employers said they believe “a new entrant from outside the healthcare industry is necessary to disrupt the market in a positive way,” compared to 10% who disagreed.

When it came to disruptive technologies, the majority of large employers said they believe virtual care will play a significant role in how healthcare is delivered in the future. Nearly as many believe artificial intelligence will. More than half of the employers said their top healthcare initiatives in 2019 are based around implementing more virtual care solutions.

“One of the challenges they have is point-solution fatigue right now,” Marcotte said. “There are so many of these solutions on the market they don’t necessarily have the bandwidth to contract with them all and then, even if they contract, how to they integrate them in with everything else they have?”

https://bit.ly/2KI5GtN

Digital healthcare for seniors shouldn’t have junior status

The areas of AI that are impacting seniors the most are for enhanced vision and hearing and speech recognition among others.

Perhaps, like me, you have recently had parents die, passing through the ignominies of the death process—loss of hearing, loss of sight, loss of mobility, and decreased cognitive power.  Maybe you are in your late 50’s and your parents are in their early 80’s and you are considering how to maintain a high quality of life for them.  You might even be someone in your 80’s thinking about how to improve the life of your children who are constantly worried about you.

The future of a quality existence for seniors  is not about the stupendous achievements in artificial intelligence with respect to robotic surgery, virtual nursing assistants, clinical judgments, or administrative workflow as suggested in Bernard Marrs article on How Is AI Used In Healthcare. It is about those basic social constructs and safety measures that give us purpose, make us feel loved, provide confidence, and enhance our diminishing senses, and AI is one of many players that will play a critical role in improving all our lives.

AI is a broad category that includes many types of technology solutions. Those areas of AI that are impacting seniors the most are for enhanced vision and hearing, speech recognition, various types of health and wellness pattern recognition among others.

Other areas that will secure a senior’s health and freedom soon may include some AI but rely on advancements in health education and awareness, autonomous vehicles, senior services, battery technology, robotics, sensor technology, material science, big data, community design, remote healthcare, and crowds source community help. I predict that these technologies and processes working in concert, even with a doubling of our senior population, over the next 10 years will:

• Reduce senior fall related deaths by 80%
• Reduce negative drug interactions by 80%
• Reduce urinary tract infections and sepsis by 50%
• Increase aging in place by 50%
• Decrease the cost of emergency transport per year from $224 billion to $50 billion
• Reduce emergency room visits by seniors by 50%
• Reduce the cost of dementia care by more than 50%

Let’s look at the mechanics of how these technologies will play out in reducing falls and keep in mind that the same process is applicable to heart health, mental health, sepsis, and various diseases such as diabetes.

Falls among seniors are a major expense category with a current annual cost of more than $50 billion. Minimizing falls or diminishing their impact by just 20% over the next 5 years saves the economy $10 billion dollars a year and is completely doable with processes in place that include:

• Identification of frailty as a leading indicator of a fall resulting in a hip fracture.
• Identification of a change in behavior through continuous measurement such as distance walked, distance traveled from their bed, speed of travel, speed of rising from sitting, heart rate, oxygen efficiency, and gate analysis
• Use technology to measure status
• Use technology to provide immediate on-site care and resolution

Those areas of AI that are impacting seniors the most are for enhanced vision and hearing, speech recognition, various types of health and wellness pattern recognition among others.

The clear majority of all hip fractures occur in the frail.  Identifying them allows us to concentrate our time and resources on those who will most benefit from our efforts.

Automated CGA analysis is at its heart a measurement and integration problem with known solutions.  Identifying the frail is the first step towards providing protocols to limit their catastrophic risks while maintaining and even improving their health through nutrition, exercise, sleep, meditation, environmental safety, and exoskeletons.

Modifying the environment

Environmental design is a major factor in safety and livability.  This is particularly true for seniors and the frail. Familiarity, ease of access, ease of use, and lack of small injuries and frustrations empowers frail seniors to be more active and either stabilize their condition or enhance their health.

Environmental safety requires that there be processes to ensure their effectiveness.  This is especially true when emergencies occur like flooding, fire, and accidents. In these situations, access to doorways, readiness of drugs, and methods of escape and home entry are very important.

Deaths due to falls has risen 31% in the last 10 years.  There are many reasons for the increase in mortality such as an older population who are more frail.  It is obvious, however, that much more must be done to protect our frail.  Protective Clothing is an excellent way minimize the number of fatalities directly due to falls.  The frail do not have the level of bone density to absorb the forces that affect their bones during falls.  Modern elastomeric materials used for extreme sports and built into fashionable senior clothing can distribute that force by up to 50% and still be comfortable.

Use technology to measure status

Technology has improved every market sector performance it has touched in the last 50 years and protecting frail seniors is no exception.  Since 2014 El Camino Hospital in California has reduced their falls by 39% using predictive analytics.  In their case, they are using data acquired in the healthcare setting.  This same technique using real-time data collected from sensors in senior communities can easily be implemented to inform caregivers and stakeholders of a need for intervention to limit falls and other problems such as urinary tract infections.  Measurement of the seniors and the environment using various types of sensors and GPS when measured in near real-time build an accurate picture of what characteristics predict negative life trends.

There is no lack of systems to notify emergency services in case of emergencies with respect to seniors.  The problem with all the current systems is the prioritization of notification and the method by which they are employed. Current systems use a central dispatch system much like emergency services. These in turn use systems that distribute calls to various authorities and relations to achieve their desired goal. Unfortunately, seniors often feel very uncomfortable with the dispatch of services when they are not sure of the level of their need. They often feel uncomfortable with strangers. In fact, the most important response requirement is time and the second most important is familiarity.  To achieve this end, result a stratified system is required that notifies neighbors, friends, physicians, and families and then notifies emergency services.

When all these systems are applied together reducing falls that result in hospitalization by 80% and saving Americans $40 billion annually is a target within reach in the next 10 years.  More importantly, improving the entire health system through measurement, AI and the appropriate analytics is just on the horizon.

https://bit.ly/2OqoVdU

Altarum: Hospital spend hikes drive slight rise in overall health spend growth

Healthcare spending growth took a slight uptick over the past year, according to a new report.

The latest monthly spending brief (PDF) from Altarum Institute shows that spending grew by 5.2% between June 2017 and June 2018, compared to 4.2% the year prior. By comparison, the nation’s gross domestic product grew by 4.9% in that same window; healthcare spending accounts for 17.9% of GDP.

Americans spent $3.66 trillion on healthcare in the first five months of the year, according to the report, which is an increase of just under 1% from projections of $3.61 trillion in spending. Altarum attributes that uptick to an increase in spending on hospital care, which accounts for about 32% of spending overall.

“As a fraction of GDP, we’re about where we were,” George Miller, Ph.D., Altarum fellow and one of the report’s authors, told FierceHealthcare, “but we’re spending and growing more than we expected.”

The figures align with projections from the Centers for Medicare & Medicaid Services, which issues both a retrospective and prospective spending report each year. In February, CMS’ Office of the Actuary estimated that healthcare spending could increase by 5.5% annually and reach $5.7 trillion by 2026.

CMS estimated in its 2017 projections that growth in healthcare spending would outpace GDP growth, a trend it expects to continue through 2026 and is reflected in Altarum’s findings.

As of June, spending on hospital care has reached $1.173 trillion, significantly outpacing the next largest spending category: physician services, at $733 billion or 20% of spending, according to Altarum. Spending on drugs accounted for 10%, or $355 billion.

Though spending on hospital care makes up a large chunk of spending overall, growth in such spending is on par with the year prior; growth rates were just under 4% in June 2017 and just over 4% in 2018.

Far larger gaps in spending were recorded in dental care and nursing home care. Dental care spending growth increased the most overall between June 2017 and 2018, jumping by 7.7%. By comparison, spending on dental care increased by about 3% between June 2016 and 2017.

Spending on nursing home care increased by about 6% over the past year, compared to just over 2% the year before.

Altarum uses data from the Bureau of Economic Analysis, figures that typically align with CMS’ data, and Miller said that BEA issued a five-year “benchmark” update in July—changes that are also likely to be reflected in CMS’ forthcoming updates to its own projections.

https://bit.ly/2P0ybGG

WellCare cashes in nearly $2B in stocks and bonds to fund Meridian purchase

As WellCare finalizes its deal to acquire Meridian Health Plans, the company is scraping together the cash to fund its $2.5 billion purchase.

On Tuesday, WellCare announced it had entered into an underwriting agreement to sell more than $4.5 million in common stock in a public offering at $265 per share. After deducting underwriting expenses, WellCare will use the nearly $1.2 billion payoff to fund it’s acquisition of Meridian Health Plan, according to a financial filing on Wednesday.

The underwriters also have the option of purchasing nearly 680,000 additional shares, which would add another $180 million if purchased at the same price.

Meanwhile, WellCare has also priced an offering of senior notes worth $750 million that will also go towards the purchase.

Combined the two offerings would net the company nearly $2 billion. The company plans to finance the deal with another $450 million to $500 million in loans to meet the $2.5 billion cash offer.

WellCare expects to close the Meridian deal within the next several months. On an earnings call last month, CEO Kenneth Burdick said the company was working with regulators in Illinois and Michigan to finalize approval.

The company expects the acquisition to produce $4.8 billion in revenue in 2018. Burdick said he expects Meridian’s PBM to “create some interesting optionality” in the long term by helping the insure manage the pharmacy value chain beyond Illinois and Michigan.

https://bit.ly/2vSh1lz

Community Health Systems facing EHR Meaningful Use investigation

One of the nation’s largest for-profit health systems is under investigation regarding the company’s adoption of electronic health records (EHRs) and adherence to federal standards that govern incentive payments.

A new disclosure buried in a recent financial filing indicates Community Health Systems is responding to a civil investigative demand “relating to the Company’s adoption of electronic health records technology and the meaningful use program.”

The federal government used the Meaningful Use program, now known as Promoting Interoperability, to distribute more than $38 billion to eligible providers to install EHR systems, including $21.7 billion to hospitals. Civil investigative demands are often used by state and federal authorities in conjunction with allegations of False Claims Act violations or fraud investigations.

While the disclosure is short on specifics, CHS indicated it is currently responding to subpoenas and administrative demands concerning the Meaningful Use program. It’s unclear based on the filing whether the CID came from a state attorney general’s office or from federal investigators at the Department of Justice or the Office of Inspector General (OIG).

“At this time we do not plan to comment beyond what is in our public filing,” CHS spokesperson Tomi Galin said in an emailed statement to FierceHealthcare.

Headquartered in Franklin, Tennessee, Community Health Systems operates 118 hospitals in 20 states. CHS hospitals use three different hospital EHRs: Cerner, Medhost and a homegrown solution from Health Management Associates (HMA), a 70-hospital system acquired by CHS in 2014. According to annual financial filings, CHS has received more than $865 million in EHR incentive payments through the HITECH Act between 2011 and 2017.

In 2013, HMA reported that it improperly accepted approximately $31 million in EHR incentive payments through the Meaningful Use program from July 2011 through June 2013. HMA self-reported the error to the Centers for Medicare & Medicaid Services (CMS) after an internal investigation found that 11 of its hospitals failed to meet meaningful use criteria.

Medhost spokesperson Samra Khan said it is company policy to “not make specific comments regarding customer operational or confidential matters.”

“CHS is a large and complex healthcare organization with various vendors that may have some involvement relating to its adoption of electronic health records technology and the meaningful use program,” she wrote in an email.

A Cerner spokesperson declined to comment.

EHR incentive payments have emerged as a focal point for federal investigators. Last year, the OIG said the feds issued $729 million in inappropriate incentive payments. In response to the OIG’s report, the CMS agreed to pursue $2.6 million in payments identified by auditors.

Shortly after that audit, OIG embarked on a second review of Medicare EHR incentive payments, which it is scheduled to publish this year.

Few instances of hospitals falsely obtaining EHR incentive payments have been documented. In 2015, a Texas hospital chief financial officer was sentenced to nearly two years in prison and ordered to pay back $4.5 million to Medicare’s EHR incentive program.

Last year, EHR vendor eClinicalWorks paid $155 million to settle claims it violated certification requirements, causing providers to falsely submit incentive reimbursement.

Additionally, the CHS has received an “inquiry” regarding its use of the Windows 2003 operating system. Microsoft sued the health system earlier this year for “willful copyright infringement,” alleging that CHS allowed hospitals it sold off to continue using Microsoft products hosted on CHS servers.

https://bit.ly/2OUaxeJ

Supercomputer Named Dr. Crusher Perfects Cancer Therapies For 21 Patients

Sequencing tumor genes and then selecting treatments that target certain mutations is routine in the treatment of several tumor types, including breast and lung cancer. But it’s not common practice for treating hematological malignancies like multiple myeloma, even though oncologists who treat those diseases are well aware that each patient’s cancer has unique characteristics that may make it more or less responsive to certain targeted treatments.

Oncologist Samir Parekh and his colleagues at the Mount Sinai Icahn School of Medicine in New York wanted to change the treatment paradigm in multiple myeloma. So they developed a system that uses an algorithm to match up multiple myeloma patients with drugs that are already on the market to treat other cancers. They tried the resulting recommendations in a group of 21 patients with treatment-resistant multiple myeloma and got positive results in all but five—a response rate that’s so high Parekh believes the idea could be extended to many other cancers.

“The response was quite amazing, considering this was a challenging population that had pretty much failed every treatment out there,” says Parekh, director of translational research in myeloma at Mount Sinai. The study was published yesterday in the journal JCO Precision Oncology.

The technique that Parekh’s team employed is often called “multi-omics.” That means they didn’t just use genomic sequencing to scour the DNA of the patients’ cancers for targetable mutations, but they also sequenced their RNA. Because RNA plays a major role in the coding and expression of genes, it can also drive cancer, so they were confident the information they gleaned would point them to targets that might respond to existing drugs.

Problem was, they needed a supercomputer to produce all that data quickly, but they didn’t want to have to wait in line to access the shared technology that academic institutions like Mount Sinai generally use. “In myeloma, when patients relapse, we typically have a few days to a couple of weeks before we need to decide on a treatment,” Parekh says. “Otherwise the patients progress.”

So they built their own myeloma supercomputer and named it Dr. Crusher, a nod to the popular redheaded physician in Star Trek: The Next Generation. The system takes the sequencing data and runs it against databases of DNA and RNA patterns that indicate sensitivity to certain drugs. “We have curated those databases to make our own knowledgebase that is myeloma-specific. Our system queries the database and comes up with recommendations for physicians,” Parekh explains.

The team started with a group of 64 patients who had undergone a median of seven lines of treatment prior to starting the study. They found 21,166 mutations in 10,403 genes. Six of those genes had mutations that were “actionable,” meaning there were drugs already on the market that could target them. Only one of those genes, BRAF V600E, was known to be associated with multiple myeloma. The others were more closely associated with different blood cancers or with solid tumors.

They were able to recommend drug treatments for most of the original group, and 21 patients went on try the suggested therapies and to be tracked until the end of the trial. The most frequently recommended drugs were AbbVie’s and Genentech’s Venclexta (venetoclax) for chronic lymphocytic leukemia and Novartis’ Mekinist (trametinib), which is approved to treat melanoma, lung cancer and thyroid cancer with BRAF mutations. Venclexta is in clinical trials to treat multiple myeloma but those studies may not be completed until 2022.

Parekh and his colleagues described several of the patients who responded well to the recommended treatments in their paper. One 72-year-old woman who had failed multiple lines of chemotherapy, for example, started to get better when she went on a combination of Venclexta and two approved multiple myeloma drugs. A 55-year old man who had also failed past therapies responded well to a combination of Venclexta, Mekinist and a multiple myeloma drug called Kyprolis (carfilzomib). Five of the patients in the trial were still responding to their treatments at the end of the two-year study period.

The oncology community has long been interested in using AI to guide treatment decisions—an idea that IBM championed with Watson, the supercomputer that won the TV game show Jeopardy and went on to be marketed as an oncology decision-support tool. But Watson never quite lived up to the hype, and recent coverage by STAT suggests Watson sometimes suggested cancer treatments that were inaccurate and that could be unsafe.

Parekh says that Dr. Crusher has a different approach. “Watson takes patients’ medical records to learn and then make predictions,” he says. “We aren’t doing that so much as using the patients’ genetic data. That’s a key difference in the methodologies.”

There is one major obstacle that could slow down the widespread adoption of Dr. Crusher-like systems: insurance pushback. Because some of the treatments that the system recommends have not been approved to treat multiple myeloma, convincing insurance companies to cover them often takes several phone conversations with medical higher-ups, Parekh says. “The system needs to understand that as we get evidence for the drivers of disease, and we have drugs against those drivers, treatments should be based on that genetic information and they should be approvable by insurance,” he says. “A smoother system would definitely help, and it would save more patients at the end of the day.”

The Mount Sinai team continues to perfect Dr. Crusher, with the goal of reducing the turnaround time for treatment recommendations from six weeks to a few days. Parekh envisions a day when machine learning systems like it are used in the treatment of many cancer types—provided insurance obstacles and other challenges can be overcome.

“The traditional way oncologists treat tumors is based on their identification under the microscope, which doesn’t tell us how each individual patient differs from someone else whose tumor looks the same but may have a completely different responses to treatment,” Parekh says. “Specialty oncologists need to work more closely with technology experts” to implement machine learning, he says, “and there needs to be an institutional infrastructure that allows for this type of interchange to happen.”

https://bit.ly/2vxW2oV