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Wednesday, September 26, 2018

Piper remains buyer of Inovio after management meetings


Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on shares of Inovio Pharmaceuticals with a $12 price target following a day of investor meetings with management. The analyst looks to 2019 efficacy updates for MEDI0457 and INO-5401 in combination with PD-(L)1 in head and neck, bladder cancer, and glioblastoma as validating for the Aspire platform. He continue to like the stock’s set-up and remain buyers of the shares.
https://thefly.com/landingPageNews.php?id=2795531

Tandem Diabetes price target raised to $56 from $32 at Piper Jaffray


Piper Jaffray analyst JP McKim raised his price target for Tandem Diabetes to $56 following the company’s “positive” analyst day. The analyst has confidence in above average growth over the next 12 months and sees “lots of room” for estimates to go higher. The shares need to be owned during this “Goldilocks Period” where the company has the best closed loop system on the market, McKim tells investors in a research note. He reiterates an Overweight rating on Tandem Diabetes.
https://thefly.com/landingPageNews.php?id=2795529

Express Scripts praises, then takes credit for Gilead’s authorized generics launches


With its hepatitis C franchise suffering from pricing pressure, Gilead Sciences has unveiled a plan to release authorized generics to its own medications at a fraction of the price. Due to drug market dynamics, the tactic could actually reach new patients and potentially grow sales.
Now, Express Scripts is taking credit for the idea. In a post after Gilead’s announcement, the pharmacy benefit giant said it suggested such a move in its response to the Trump administration’s drug pricing blueprint, released in May.
Express Scripts—which has tussled with Gilead over drug pricing before—said Gilead’s announcement is “a step in the right direction, and we are encouraged that a drug maker is taking meaningful action to bring prices down for cash-paying customers.”
Under its plan, Gilead will sell authorized generics of Eplcusa and Harvoni at a list price of $24,000, a significant discount to Epclusa’s $74,760 sticker price and Harvoni’s $94,500. Due to high rebates in the hep C drug class, actual prices for the branded and generic meds will be “similar,” Gilead CEO John Milligan said in a post explaining the plan. The authorized generics could save patients up to $2,500 out of pocket per course of drugs.
As government and industry have examined potential changes to drug pricing this year, Express Scripts did indeed suggest a similar approach. Back in July, in response to the Trump administration’s pricing blueprint, Express Scripts’ vice president of corporate government affairs Jonah Houts wrote to Department of Health and Human Services Secretary Alex Azar that the administration “could encourage some drug makers to reintroduce their products as competing brand drugs.” As Houts wrote at the time, list price decreases pose challenges.
But, he wrote, “should the Administration allow drug makers to introduce competing brands of their own drugs with lower list prices, uninsured Americans would benefit immediately.” The Express Scripts exec explained that patients with high deductible plans would “immediately have new treatment options” and that the entire system could shift to the “new pricing model over time.”
Although Express Scripts praised Gilead’s recent move, the companies have had a contentious history in hep C. Under scrutiny after Gilead released Sovaldi and Harvoni at list prices of $84,000 and $94,500, respectively, a former exec for the company said pharmacy benefit managers and payers prefer high list prices and high rebates. An Express Scripts exec quickly shot back and not only disputed the claim but asked for repayment on the drugs.
Before that skirmish, Express Scripts Chief Medical Officer Steve Miller held firm against Gilead’s hep C pricing. When AbbVie launched a competitor, Express Scripts struck a deal with that company; Miller said the tactic saved billions in drug costs.

Agilent acquires ACEA Bioscience for $250M in cash


Agilent Technologie announced it has signed a definitive agreement to acquire privately-owned ACEA Biosciences Inc. , a developer of cutting-edge cell analysis instruments for life science research and clinical diagnostics, for $250M in cash. Since its inception in 2002, ACEA has launched two ground-breaking, highly differentiated platforms. ACEA is revolutionizing the field of flow cytometry with its high-performance, customizable line of NovoCyte benchtop flow cytometers. ACEA’s xCELLigence instruments enable label-free, real-time monitoring of cell growth, cell function, and cellular responses to a variety of treatments, providing scientists information-rich cellular assays. ACEA also has a CFDA approved and CE-IVD labelled cytometer configuration. ACEA’s clinical flow cytometer, currently commercialized primarily in China, brings a unique opportunity with Agilent’s Reagent Partnership business within Agilent’s Diagnostics and Genomics Group which provides reagents for flow cytometry. ACEA instruments are used worldwide in both academia and industry across a wide range of life science applications from basic research to clinical diagnostics including preclinical drug discovery and development, toxicology & safety pharmacology, and various disease studies.

Tuesday, September 25, 2018

Quest Acquires ReproSource Advanced Fertility Diagnostics


Quest Diagnostics (NYSE :DGX ), the world’s leading provider of diagnostic information services, today announced it has acquired ReproSource, a national leader in specialty fertility diagnostic services.
About 10 percent of women of child-bearing age in the United States have difficulty getting or staying pregnant, according to the Centers for Disease Control and Prevention. Woburn, Mass-based ReproSource provides a range of advanced diagnostic services, such as genetics-based ovarian health and recurrent pregnancy loss assessments, to help patients identify and surmount obstacles to fertility and pregnancy.
“Our acquisition of ReproSource delivers on our accelerate growth strategy, particularly in advanced diagnostics, and our goal to deliver the broadest access to diagnostic innovation,” said Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics. “ReproSource is recognized for evidence-based expertise in reproductive diagnostics and will extend our breadth of services for providers and their patients.”
Quest plans to offer ReproSource’s services nationally as part of its comprehensive women’s health and reproductive offerings for obstetricians, gynecologists, fertility specialists and other physicians.
Quest is a leader in advanced diagnostics services that help guide women and their physicians through the reproductive journey. These services include the company’s proprietary QNatal™ noninvasive prenatal and QHerit™ carrier genetic screening services.

5 need-to-know leaps in telehealth


Learn about the next generation of programs from leading health systems.


KEY TAKEAWAYS

Reimbursement progress paves the way for innovation.
An enterprise approach helps health systems achieve scale, enhance margins, and optimize resources.
Technology developments enable further specialty growth.
Telehealth can address ED overuse and support population health initiatives.
The stars are aligning for the next phase of growth in telehealth. Many states have resolved parity issues, CMS is proposing payment changes in 2019 to accommodate telehealth visits, and Next Generation ACOs include a telehealth waiver.
With significant progress on the reimbursement front, the door to innovation swings further open.
In this month’s edition of “Need-to-Know Leaps,” I explore how telehealth is changing at health systems and take a closer look at some of the novel approaches two leading organizations, Banner Health of Mesa, Arizona, and The University of Mississippi Medical Center, (UMMC) in Jackson, Mississippi, are using to launch the next generation of virtual care.
First, a quick look at the trends:
Telehealth is experiencing explosive growth. The virtual healthcare market is expected to reach revenues of more than $3.5 billion by 2022, according to Verify Markets, as reported in March 2016 by HIT Consultant.
The 2018 U.S. Telemedicine Industry Benchmark Surveyproduced by REACH Health, which surveys health system professionals, physicians, and nurses, indicates:
  • 45% rank telemedicine as a high priority
  • 86% want to use telemedicine to improve patient outcomes

1. THE AGE OF THE ENTERPRISE

As the practice of telemedicine matures, one of the biggest health system trends is that telemedicine is moving from fragmented, departmental initiatives into an enterprise approach, pulling disparate elements under one single umbrella for the entire system.
“This opens up a whole new world for health systems to scale and find margin in the business model behind it, so it’s sustainable and optimizes resources,” says telehealth consultant Matthew Rumbaugh, executive director of TeleHealth Suite.
The REACH Health survey indicates almost half of respondents are taking an enterprise approach to telemedicine, a 23% increase compared to 2017. More than 50% of hospitals that started with a departmental approach are evolving toward or have already transitioned to a holistic operation.
There’s a reason to do so—organizations that operate their telehealth program as an enterprise are almost 30% more successful in achieving their objectives than those managed out of separate departments, according to the benchmark report.
Organizations are examining the benefits of merging resources under single management, sometimes bringing all elements together in one physical facility. A few have taken their programs on even broader ventures, contracting with outside hospitals and health systems to expand their scope of influence and revenue potential.
  • After 12 years of successful growth in a variety of departments, Banner Health is adopting an enterprise approach, falling under the purview of CEO of Telehealth Mark VanderWerf, who was hired earlier this year.
Examples of systems already operating telehealth as large-scale enterprises include:
  • UMMC’s Center for Telehealth was named a National Telehealth Center of Excellence by the federal Health Resources and Services Administration last year. It has established telehealth locations at 234 sites across the state, including hospitals, clinics, private physician’s offices, colleges and universities, corporations, prisons, and federally qualified health centers, nearly all in collaboration with outside entities and even competitors.
  • St. Luke’s Health System in Boise, Idaho, which recently opened a 35,000-square-foot Virtual Care Center
  • Mercy Virtual, in Chesterfield, Missouri, which opened in 2015 and provides services not only to the 40-plus hospitals in the Mercy health system, but contracts with outside organizations to provide telehealth services in more than 20 states

2. DISCOVERING NEW APPLICATIONS: ED TELETRIAGE

Telehealth is not new to the emergency department, but at least one health system has found a novel way to deploy it. Next month Banner Health is launching a teletriage program in its high-volume emergency departments in the Phoenix area with a threefold mission: to relieve pressure on staff, to make sure patients don’t leave without service due to long waits, and to provide the most appropriate treatment at the lowest cost.
When patients visit the triage nurse, low-acuity individuals also interact with a nurse practitioner via a telehealth monitor located in the same room. The triage nurse takes vitals and observes interactions, so the patient won’t have to repeat information should they require traditional emergency services. If appropriate, patients are treated on the spot or redirected to urgent care services provided in a separate area of the facility.
A pilot study demonstrated that the program could reduce time in the department by two hours, says Natalya Faynboym, MD, CPE, executive director of Banner’s innovation think tank, Imaginarium.
This approach will offer “substantial cost reduction for almost everybody involved, ” says VanderWerf, including the patient, provider, and payer. While the pilot demonstrated significant savings, he says, figures have not been projected due to the short time frame of the test period.
Banner also plans to test a completely different concept in emergency care: at home observation. Somewhat similar to hospital at home programs, the pilot will send home select Medicare Advantage patients who have been assigned observation status. In addition to a home visit by healthcare personnel, the patient will be monitored via a tablet and peripheral devices, and have two-way communication with telehealth providers.
The goal is to provide care in an environment where the patient is more comfortable, evaluate the financial implications, and possibly eliminate the unexpected charges the patient bears when assigned observation status.

3. EXPANDING SPECIALTY ACCESS: CHILD ABUSE ASSESSMENT

Specialty services are one of the greatest areas of growth in telehealth. While some specialties are a natural fit for telemedicine, others may be more difficult to adapt. Sometimes, innovation is required to change the dynamic.
In Mississippi, “we have exactly one pediatric forensic medicine specialist in the state,” says Michael Adcock, FACHE, executive director for UMMC’s Center for Telehealth. “This is obviously a very needed resource, and he was spending a lot of his time driving.” Time on the road meant fewer patient encounters.
Converting his practice to a telehealth operation proved to be a challenge. The specialist needed secure 4K video combined with the ability to capture high-resolution still images from a remote-controlled tripod.
“There was nothing encrypted to the level needed,” says Adcock, so the Center devised a solution combining a variety of technologies. Three clinics across the state are now outfitted with the equipment, the physician is able to serve more patients, and families aren’t as inconvenienced by long distance driving either.

4. EMPLOYING NEW TECHNOLOGY: TELEOPHTHALMOLOGY

Ophthalmology is another specialty now positioned for rapid growth, thanks to the development of inexpensive specialized equipment that can be employed at the point of service.
This year Banner Health launched teleophthalmology services in 12 of its emergency departments in the Phoenix metropolitan area with an investment of about $2,000 per facility, plus licensing fees with Verana Health (formerly DigiSight Technologies). The equipment includes an Apple iPod, with a special scope that slips over the device’s camera to take high-resolution pictures of the eye. The portable device provides image quality as good as specialized equipment that could cost as much as $35,000 per location, says Deborah Dahl, vice president of patient care innovation at Banner Health.
Images taken in the ED are sent directly via a secure transmission to the 24/7 on-call ophthalmologist, who determines whether to visit the patient immediately, advise the emergency physician what services to provide, or schedule an immediate or follow-up appointment in one of the specialty practice’s clinics.
For a relatively inexpensive investment, Banner is able to expand its scope of service, improve patient care, and offer more convenience to ophthalmologists, says Jean Schmitz, RN, CDE, director of teleambulatory services at Banner.
The system is exploring an additional way to use teleophthalmology services by having primary care physicians use similar devices to screen diabetic patients for retinopathy during their regular checkups. Dilation is not required, ophthalmologists will screen results within 24 hours, and it’s expected that 20% of patients will require a follow-up visit.
Schmitz says this will help improve patient care and outcomes because “80% of patients with diabetes will develop some type of diabetic retinopathy. Up to 95% of those cases can be prevented through early detection, yet it’s documented that less than 50% of diabetic patients actually comply with getting an annual retinal exam. With this technology, we can move these patients toward getting the care that they need.”

5. ENHANCING POPULATION HEALTH: PREVENTING LOW-BIRTH RATE BABIES

Low-birth weight is the second-leading cause of death during the first year of life and also increases the risk for chronic disease in later life, according to UMMC’s Center for Developmental Disorders Research.
Because Mississippi has the highest rate of low-birth weight in the United States (11.6% versus the national percentage of 8%), and the rate within the state’s African-American population is even higher, at 16.3%, the health system is working with other state government resources and a foundation to develop a telehealth solution. They plan to address this concern and other issues related to perinatal health, as well as help provide support to mothers during the first year of their infant’s life.
The virtual perinatal program for high-risk pregnancies has launched a pilot, says Adcock, and the post-natal program is in development. “It’s very simple,” he says, “and allows [participants] to be educated in their homes.”
Participants receive the same single-app iPad UMMC provides to patients in its chronic disease remote monitoring program. In addition to the ability to interact with providers, the solution also delivers educational content each day, broken into mini five- to seven-minute installments that include videos, slide shows, animation, Q&As, and self-tests. As the program progresses, the hope is that the efforts will result in healthier babies.

Ali Parsa plans to make digital health startup Babylon ‘Google of healthcare’


For the latest installment of our Big Interview series where we catch up with some of the world’s most exciting business leaders, The Drum makes an appointment with Ali Parsa – founder and chief exec of digital health startup Babylon – to find out about his plans to become the Google of healthcare.
“I was in Brussels for a speaking engagement when I got very ill, with a high temperature. As I got off the stage and made my way to the cab I made an appointment with a doctor. I spoke to the doctor on the way to the airport and when I landed at Heathrow there was someone waiting for me with antibiotics. I did this through the Babylon app. Bill Gates can’t get this done, right? And that is who we are. Not just an AI system, but an end-to-end healthcare service.”
This is just one of the stories Babylon’s founder, Ali Parsa, tells me in explanation of how his diagnostic platform really works.
As well as a consummate storyteller when it comes to the intersection of modern technology and healthcare innovation, Parsa also oversees 500 of the “world’s finest engineers” who are building an AI offering that acts as a screening service, directing patients to human professionals when necessary.
But unlike other apps that check symptoms or monitor fitness and weight goals, Babylon is the first to offer a comprehensive service. Patients can book scans and x-rays, or get instant referrals to Babylon specialists or Bupa consultants if a face-to-face consultation is required. And prescriptions can be delivered directly.
The app – available on both iPhone or Android – is priced in the UK from an affordable £5 a month or £50 a year. Patients can also opt for a pay-as-you-go-service, which charges £25 per consultation.

Doctor in your pocket

Babylon has also found its way on to China’s most popular app, WeChat, through a deal with Tencent, and on to the latest Samsung Galaxy smartphones in the UK as a pre-installed app through a deal with Samsung. The service is expected to be rolled out in the US later this year.
“Did you know that the day Samsung promoted the fact Babylon is now available on all its phones we were getting 12,500 registrations on the app an hour? How many other products or services can match that?”
Parsa quickly adds: “This is not about me saying I’m great. I came here as a refugee from Iran in the 70s and now don’t need more money than I already have. But what I recognize is that, globally, we have a problem in healthcare.
“The global GDP is around $70tn and $10tn of that goes into healthcare. As 50% of the world’s population receives no healthcare, all of that money is going on just half of the world’s population. On top of that, the world is short of 5 million doctors. That’s cruel, but it is a problem that can be solved. We’ve shown it can be done.”
There are now some 3 million registered members of Babylon worldwide. In Rwanda it goes by the name Babyl and operates a universal health coverage scheme in partnership with the Rwandan Ministry of Health. In the UK there are over 30,000 users signed up to its service across central London (among them the health secretary Matt Hancock) after the NHS awarded Babylon the contract to provide digital technology and consultations in the UK capital – there is no charge to use the service if a patient is registered with an NHS GP practice that offers it. This hasn’t saved Parsa from a merciless media attempting to paint him as a bogeyman – a tech provider ready to disrupt and privatize a 70-year-old publicly-funded healthcare institution.

The problem solver

He has little time for skeptics, though, and points to the words written large on the walls of the company’s South Kensington offices: ‘Our mission is to put an accessible and affordable health service in the hands of every person on Earth.’
They are words Parsa repeats throughout our conversation as he compares Babylon to Uber, Sky, Google and even Amazon. He wants to do for healthcare what Google did for information, what Uber did for transportation and, indeed, what Amazon did for books.
At the same time he refuses to view Amazon as a threat, saying that, at best, Bezos’ e-commerce giant is thinking only of delivering drugs and as such is a competitor to the likes of UK pharmacy chain Boots, rather than to GPs.
“What Amazon or Alexa can do with AI is a very wide layer. We are a very narrow but deep layer of AI, which is why Tencent is taking Babylon inside Tencent and Samsung has done the same.
“At the moment we don’t have any competition, but if tomorrow Amazon did succeed in doing what we’re doing and Babylon did cease to exist, I wouldn’t really care. Babylon would have instigated a solution to one of the biggest problems we have – the shortfall of healthcare to all.”

Innovation for all

Does he ever wish Babylon had launched in the US first, where the appetite for entrepreneurship and new technologies is perhaps greater than the UK?
“I’m amazed about the vitriolic way one or two doctors attack me – it’s always the same people. But being an entrepreneur is not a popularity contest, it’s just a set of beliefs. If somebody dislikes it that’s their problem.”
As a remainer in the Brexit debate, Parsa says he doesn’t believe that, just because one vote has taken place, a country cannot allow its citizens another once negotiations have taken place. That is not fair, he says. The optimist in him thinks, whatever the final outcome, Brexit won’t determine the future of the country. Instead it will be this: “Are we going to be an enterprising, forward looking, future striving country or a backward looking provincial part of the world?
“Are we a kind of country that cherishes innovation and allows its best to flourish? Are we a fair society that also allows those who are less fortunate have a great life?”
It will be these points that define the prosperity of the nation in the future, he says.
“And anyway, I don’t want to emigrate again. I’ve done it once and hope this place works.”
So, what is his ultimate ambition for Babylon?
“We want to create an AI doctor you can rely on. Our primary care AI at the moment is 80% as accurate as a human doctor, but that is a fraction of medicine. Now we need to train machines to do gynecology, orthopedics, paediatrics etc.
“I want healthcare to be in the hands of every human being.”