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Friday, June 7, 2019

Why Alexa’s bedside manner is bad for healthcare

It remains an open question whether virtual medicine will prove a valuable, convenient adjunct to healthcare.

KEY TAKEAWAYS

If virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make healthcare worse.
Children who have a telemedicine visit for an upper-respiratory infection are far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work.
Alexa still can’t provide many things patients want, such as a reliable price estimate for surgery, the infection rates at the local hospital, or the location of the cheapest cholesterol test nearby.

Amazon has opened a new healthcare frontier: Now Alexa can be used to transmit patient data. Using this new feature — which Amazon labeled as a “skill” — a company named Livongo will allow diabetes patients — which it calls “members” — to use the device to “query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.”
Private equity and venture capital firms are in love with a legion of companies and startups touting the benefits of virtual doctors’ visits and telemedicine to revolutionize healthcare, investing almost $10 billion in 2018, a record for the sector. Without stepping into a gym or a clinic, a startup called Kinetxx will provide patients with virtual physical therapy, along with messaging and exercise logging. And Maven Clinic (which is not actually a physical place) offers online medical guidance and personal advice focusing on women’s health needs.
In April, at Fortune’s Brainstorm Health conference in San Diego, Bruce Broussard, CEO of health insurer Humana, said he believes technology will help patients receive help during medical crises, citing the benefits of home monitoring and the ability of doctors’ visits to be conducted by video conference.
But when I returned from Brainstorm Health, I was confronted by an alternative reality of virtual medicine: a $235 medical bill for a telehealth visit that resulted from one of my kids calling a longtime doctor’s office. It was for a five-minute phone call answering a question about a possible infection.
Virtual communications have streamlined life and transformed many of our relationships for the better. There is little need anymore to sit across the desk from a tax accountant or travel agent or to stand in a queue for a bank teller. And there is certainly room for disruptive digital innovation in our confusing and overpriced healthcare system.
But it remains an open question whether virtual medicine will prove a valuable, convenient adjunct to healthcare. Or, instead, will it be a way for the U.S. profit-driven healthcare system to make big bucks by outsourcing core duties — while providing a paler version of actual medical treatment?
After all, my doctors have long answered my questions and dispensed phone and email advice for free — as part of our doctor-patient relationship — though it didn’t have a cool branding moniker like telehealth. And my obstetrician’s office offered great support and advice through two difficult pregnancies — maybe they should have been paid for that valuable service. But $235 for a phone call (which works out to over $2,000 per hour)? Not even a corporate lawyer bills that.
Logic holds that some digital health tools have tremendous potential: A neurologist can view a patient by video to see if lopsided facial movements suggest a stroke. A patient with an irregular heart rhythm could send in digital tracings to see if a new prescription drug is working. But the tangible benefit of many other virtual services offered is less certain. Some people may like receiving feedback about their sleep from an Apple Watch, but I’m not sure that’s medicine.
And if virtual medicine is pursued in the name of business efficiency or just profit, it has enormous potential to make healthcare worse.
My doctor’s nurse is far better equipped to answer a question about my ongoing health problem than someone at a call center reading from a script. And, however thorough a virtual visit may be, it forsakes some of the diagnostic information that comes when you see and touch the patient.
A study published recently in Pediatrics found that children who had a telemedicine visit for an upper-respiratory infection were far more likely to get an antibiotic than those who physically saw a doctor, suggesting overprescribing is at work. It makes sense: A doctor can’t use a stethoscope to listen to lungs or wiggle an otoscope into a kid’s ear by video. Similarly, a virtual physical therapist can’t feel the knots in muscle or notice a fleeting wince on a patient’s face via camera.
More important, perhaps, virtual medicine means losing the support that has long been a crucial part of the profession. There are programs to provide iPads to people in home hospice for resources about grief and chatbots that purport to treat depression. Maybe people at such challenging moments need — and deserve — human contact.
Of course, companies like those mentioned are expecting to be reimbursed for the remote monitoring and virtual advice they provide. Investors, in turn, get generous payback without having to employ so many actual doctors or other health professionals. Livongo, for instance, has raised a total of $235 million in funding over six rounds. And, as of 2018, Medicare announced it would allow such digital monitoring tools to “qualify for reimbursement,” if they are “clinically endorsed.” But, ultimately, will the well-being of patients or investors decide which tools are clinically endorsed?
So far, with its new so-called skill, Alexa will be able to perform a half-dozen health-related services. In addition to diabetes coaching, it can find the earliest urgent care appointment in a given area and check the status of a prescription drug delivery.
But it will not provide many things patients desperately want, which technology should be able to readily deliver, such as a reliable price estimate for an upcoming surgery, the infection rates at the local hospital, the location of the cheapest cholesterol test nearby. And if we’re trying to bring healthcare into the tech-enabled 21st century, how about starting with low-hanging fruit: Does any other sector still use paper bills and faxes?

HCA redeems, sells secured notes at favorable rate differentials

On June 5, 2019, HCA Healthcare, Inc. (the “Registrant” or the “Parent Guarantor”), HCA Inc., a wholly owned subsidiary of the Registrant (the “Issuer”), and certain subsidiary guarantors of the Issuer entered into an underwriting agreement (the “Underwriting Agreement”) with BofA Securities, Inc., Citigroup Global Markets Inc., and J.P. Morgan Securities LLC as representatives of the several underwriters named therein, for the issuance and sale by the Issuer of $5,000,000,000 aggregate principal amount of senior secured notes (collectively, the “Notes”) in the following tranches:
     •   $2,000,000,000 aggregate principal amount of 41/8% Senior Secured Notes
         due 2029;




     •   $1,000,000,000 aggregate principal amount of 51/8% Senior Secured Notes
         due 2039; and




     •   $2,000,000,000 aggregate principal amount of 51/4% Senior Secured Notes
         due 2049.

The Notes will be guaranteed on a senior unsecured basis by the Parent Guarantor and on a senior secured basis by certain of the Issuer’s subsidiaries, and will be issued and sold pursuant to the Registrant’s Registration Statement on Form S-3 (File No. 333-226709) and a related preliminary prospectus supplement dated June 5, 2019.
The description of the Underwriting Agreement is qualified in its entirety by the terms of such agreement, which is incorporated herein by reference and attached to this report as Exhibit 1.1.
On June 5, 2019, the Issuer provided notice of its election to redeem (the “Redemption”) all $600 million aggregate principal amount outstanding of its existing 4.25% Senior Secured Notes due 2019, all $3.000 billion aggregate principal amount of its existing 6.50% Senior Secured Notes due 2020 and all $1.350 billion aggregate principal amount of its existing 5.875% Senior Secured Notes due 2022 (collectively, the “Redeemed Notes”). The Redeemed Notes will be redeemed on July 5, 2019 (the “Redemption Date”). The Issuer’s obligation to complete the Redemption is conditioned upon the receipt prior to the Redemption Date by the Issuer of at least $4.500 billionin net proceeds from the sale and issuance of the Notes pursuant to the Underwriting Agreement. This Current Report on Form 8-K does not constitute a notice of redemption of the Redeemed Notes.

Cancer genomics platform Personalis sets terms for $100 million IPO

Personalis, which provides a genome sequencing platform for cancer research, announced terms for its IPO on Friday.
The Menlo Park, CA-based company plans to raise $100 million by offering 6.7 million shares at a price range of $14 to $16. At the midpoint of the proposed range, Personalis would command a fully diluted market value of $479 million.
Personalis was founded in 2011 and booked $48 million in sales for the 12 months ended March 31, 2019. It plans to list on the Nasdaq under the symbol PSNL. Morgan Stanley, BofA Merrill Lynch and Cowen are the joint bookrunners on the deal. It is expected to price during the week of June 17, 2019.

Drugstores Often Don’t Have Opioid Antidote in Stock

Even though the drug naloxone can be a lifesaving antidote to an opioid overdose, researchers in Philadelphia report that only a third of drugstores in that city carried it.
What’s more, although Pennsylvania’s standing order law for naloxone (common brand name: Narcan) allows pharmacists to dispense the drug without a doctor’s prescription, many pharmacies refused to give the nasal spray without a doctors’ OK, the study authors said.
The intent of the law was to encourage pharmacists to give the drug to anyone who asked for it. The impetus for the law was to try to curb the growing number of deaths from opioid overdoses.
Not implementing these laws puts unnecessary barriers in the way of those who need this medicine most, said study co-author Dima Qato, an associate professor of pharmacy systems, outcomes and policy at the University of Illinois at Chicago College of Pharmacy.
“Efforts to strengthen the implementation of naloxone access laws, including statewide standing orders, which are considered the least restrictive, are warranted,” Qato said in a university news release. “Particularly for pharmacies located in communities with the highest rates of death due to opioid overdose.”
For the study, researchers surveyed Philadelphia drugstores by phone in 2017.
Of the more than 400 drugstores surveyed, only 34% had naloxone available. Chain pharmacies were more likely to stock it than independent ones.
Naloxone was also less likely to be found in minority neighborhoods than in white neighborhoods. It was also not likely to be found in areas with the highest number of drug overdose deaths, the researchers noted.
In addition, of those stores that did stock naloxone, 40% asked for a doctor’s prescription and many would not give the drug to those under 18.
Laws are not enough, according to Qato. “Policies need to be enforced and pharmacies need to be aware of and held accountable for implementing them,” she said.
A new law now requires pharmacies to “stock naloxone and to post a sign notifying shoppers that it is stocked,” said researcher Jenny Guadamuz, also from the University of Illinois.
“Pharmacies can be fined $250 for each day they are not in compliance of the law. Now, the question is, will the city enforce the law?” Guadamuz said.
The report was published online June 7 in the journal JAMA Network Open.
More information
The U.S. National Institute on Drug Abuse has more information on naloxone.
SOURCE: University of Illinois at Chicago, press release, June 7, 2019

Biohaven up 16% on sale hopes

The company has been exploring a sale, and reports that it’s decided not to attend Goldman’s annual healthcare conference next week has animal spirits stirring.
BHVN +16.2%

Rewalk Robotics suits up

Europe and the US approvals of the ReStore device have arrived within a week; now the company must deliver commercially.
US FDA clearance for Rewalk Robotics’ second powered exosuit, ReStore, will have come as a relief to the group’s investors after the troubles that have dogged the company’s first system. The group’s stock closed up 122% yesterday.
Analysts had not expected the approval until the second half, so Rewalk is ahead of schedule. But this is a new kind of technology in an unproven market, and early adoption of the system will be closely watched.
ReStore is designed to help in the rehabilitation of stroke survivors with mobility problems. The battery and motor part of the system is worn on the waist, and transmits power to a fabric leg brace and a foot plate under the shoe. This helps the patient lift their feet and move their legs. It also includes sensors worn on both shoes to enable the movements to be synchronised with the patient’s natural gait.
The system also tracks the patient’s performance, and rehab therapists can analyse the data to monitor improvements, tweaking the settings as necessary.
Commercial strategy
The company says this is the first soft exosuit approved in the US, as indeed it was in Europe when it was CE marked at the end of last month. The device will be priced at $28,900, and the company believes that it will fall into existing gait training reimbursement codes.
In Europe ReStore will cost €28,500 and it is set to be launched this month. Rewalk plans to use its own sales force in Germany and the UK as these two countries have reimbursement policies in place for post-stroke rehabilitation. The group is expected to sign up distributors for France and Italy.
As well as selling the suit outright, the company intends to offer a leasing option, potentially allowing rehabilitation centres to limit their up-front capital investment. Investors will now want to see decent early adoption rates.
The company already sells the ReWalk exoskeleton for personal use by patients with spinal cord injury; it also sells the system to rehabilitation centres. ReWalk Personal reached the US five years ago, but was the subject of FDA warnings and skated close to being withdrawn from market (Rewalk draws the FDA’s ire, March 3, 2016).
Rewalk placed 85 of these systems in 2018, giving total revenues of $6.5m. But sales seem to be falling; in 2017 it had sales of $7.8m from 107 systems. Perhaps ReStore’s market debut will help reverse this apparent decline.

VTV’s diabetes reinvention gains some ground

After crashing on a late-stage Alzheimer’s failure last year VTV Therapeutics has taken a small step forward in type 1 diabetes.
VTV Therapeutics looked dead and buried after the Alzheimer’s project azeliragon flopped in its pivotal study last year, but the company’s reinvention as a diabetes drug developer gained some ground today.
Still, VTV still has a long way to go. Data from a phase II trial of the group’s oral glucokinase activator TTP399 in type 1 diabetes look promising, but the results so far are in just a handful of patients, and it might take more to convince the markets.
VTV’s shares initially opened up 14% today, but these gains had soon faded, perhaps as investors took the opportunity to sell on the news. And the company’s current market cap of $84m is well off what it was before the azeliragon blowup (VTV pivots to diabetes after Alzheimer’s flop, 10 April 2018).
Insulin add-on
If VTV does get TTP399 to market in type 1 disease, it is likely to have little competition – insulin is the only option for these patients, and they often still struggle to keep glucose levels under control.
The Simplici-T1 trial tests TTP399 on top of insulin. Its primary endpoint is 12-week change in glycated haemoglobin, or HbA1c, a measure of blood sugar levels.
The first part of the study found a mean 0.6% reduction in HbA1c in eight patients receiving TTP399, versus a 0.1% rise in the 11 given placebo; the difference was significant, with a p value of 0.03.
VTV hopes to replicate these results in part two of the study, in a broader population; results are due in the first quarter of 2020.
TTP399 also reported positive data from a phase II trial in type 2 diabetes in 2016, but things have gone quiet since, which led Bernstein analysts to suggest a lack of enthusiasm at VTV for this indication.
The type 2 space is much more crowded, which could explain any reluctance from the company to move forward here.
The only other glucokinase activator in active development, according to EvaluatePharma, is Hua Medicine’s dorzagliatin, also known as HMS5552, which is in phase III trials in China. The company has said it will look to partner the project outside the country after the pivotal data report in the second half of this year.
Other glucokinase activators have been discontinued owing to lack of efficacy and side effects including hypoglycaemia and liver steatosis.
VTV has another mid-stage candidate in the form of its small-molecule GLP1 agonist TPP273, for type 2 diabetes; however, even if this progresses it could have a hard time competing against Novo Nordisk’s oral semaglutide.
And, remarkably, VTV has not given up on azeliragon, with plans to start a phase II trial in mild Alzheimer’s and type 2 diabetes this month.
TTP399 looks at present to be the group’s best shot at success, but it still has a lot to prove.
VTV’S PIPELINE
ProjectDescriptionIndicationStatus
TTP399Glucokinase activatorType 1 & 2 diabetesPhase II
TPP273Oral GLP-1 receptor agonistType 2 diabetesPhase II
AzeliragonRage antagonistMild AD and type 2 diabetesPhase II imminent
HPP737PDE 4 inhibitorCOPDPhase I
HPP593/REN001*PPAR-delta agonistMitochondrial diseasesPhase I
UnnamedNrf2/Bach1 modulatorUndisclosedPhase I
*Licensed to Reneo Pharmaceuticals. Source: EvaluatePharma & company website.