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Tuesday, August 21, 2018

Medtronic: Injected Treatment vs. Oral Med Aids Post-Stroke Quality of Life


Medtronic plc (NYSE:MDT) today announced the online publication of ‘Effect of intrathecal baclofen on pain and quality of life in post-stroke spasticity: a randomized trial (SISTERS)’ in Stroke: A Journal of Cerebral Circulation (Stroke).
These results, secondary endpoints of the ‘Spasticity In Stroke-Randomised Study’ (SISTERS) trial, demonstrate Intrathecal Baclofen Therapy (ITB Therapy(SM)) with Lioresal Intrathecal (baclofen injection) reduces spasticity-related pain and improves quality of life more than conventional medical management (CMM) with oral antispastic medications.
‘Despite its known benefits, ITB Therapy continues to be underused when it comes to treating severe spasticity in post-stroke patients,’ said lead author and study investigator Michael Creamer, D.O., of Central Florida Pain Relief Centers in Orlando, Fla. ‘These secondary study results demonstrate that, in addition to treating excessive muscle tone associated with spasticity, ITB Therapy also addresses spasticity-related pain and quality of life and should be considered when assessing treatment options for post-stroke spasticity.’
Stroke can result in a number of physical, emotional, and daily living problems as well as pain.1 Spasticity, a condition where certain muscles are constantly being contracted, is a relatively common long-term complication of stroke, with up to 13 percent of post-stroke patients suffering from severe disabling spasticity.2 Patients with post-stroke spasticity (PSS) tend to experience a higher incidence of pain and lower health-related quality of life (QoL) compared to patients with normal muscle tone.3
Results of the study show ITB was more effective than CMM over six months using Numerical Pain Rating Scale (NPRS) scores for actual and least spasticity-related pain. Further, a majority of ITB patients (73 percent vs. 48 percent of CMM patients) reported satisfaction with spasticity reduction at month 6. Demonstration of greater improvements in pain and QoL with ITB compared to CMM in this trial enhance existing data associated with ITB’s impact on spasticity.
SISTERS is the first randomized, controlled, open-label, multicentre study to evaluate the efficacy and safety of ITB Therapy versus CMM with oral antispastic medications for treatment of PSS after six months’ active treatment. The study randomized 60 patients in Europe and the United States. Primary outcomes results were published in January 2018 in the Journal of Neurology, Neurosurgery & Psychiatry. In this new paper, the results are presented for other pre-specified secondary outcomes of SISTERS, including assessment of pain and QoL measures and patient satisfaction with therapy.
More patients reported adverse events in the ITB group (24/25 patients, 96 percent; 149 events) compared to CMM (22/35, 63 percent; 77 events), although events were generally consistent with the known safety profile of ITB Therapy. Around half of the drug, device and procedure related adverse events occurred during implant and titration phase. No patient discontinued ITB Therapy due to treatment related adverse events.4
‘Spasticity-related pain is a common and often overlooked after-effect of stroke that can also negatively impact quality of life, especially in patients experiencing post-stroke spasticity,’ said Charlie Covert, vice president and general manager, Targeted Drug Delivery, Medtronic Pain Therapies. ‘At Medtronic, we’re committed to raising awareness of ITB Therapy as an effective treatment for severe PSS. We are pleased these results show that additional improvements are possible with improved spasticity management.’

UAE to build first-ever ‘medical mall’ in Pakistan


A prominent UAE-based MBF Group has announced to establish an integrated medical city that will also feature a first-ever medical mall of the country in Islamabad.
The agreement of MBF with Ibchez Housing and Nixon, according to the report, will include the construction of a hospital that will provide medical services at international standards.
The founder and owner of MBF Group Shaikh Mohammad Bin Faisal Al Qasimi ,in an interview with the Gulf news said the project will include a 400-bed university hospital that will offer the most advanced levels of healthcare services.
The medical city will also feature the country’s first medical mall, therapeutic and recreational areas, a regional cardiology centre, and an orthopedic centre, he added.
He noted that the city will include a nursing college and is expected to serve some one million patients and clients on a monthly basis. There is a need for such advanced hospitals to serve Pakistan’s growing population, he stressed.
Shaikh Mohammad pointed out that the investment provided for the medical city has reached US$970 million (Dh3.52 billion), while noting that its land has been purchased, as well as the desire of all parties to complete the project on time, in a bid to answer the growing demand for medical services in Islamabad and provide specialist health services that are in short supply.
He informed that the group will manage the city’s 1,000 medical, technical and administrative staff, who will all be Pakistanis, and is responsible for providing medical equipment and beds.

Monday, August 20, 2018

100 days in, Azar says drug blueprint has helped curb prices


HHS Secretary Alex Azar and his top lieutenants marked the first 100 days of their drug pricing blueprint with a report they said showed the plan has curbed pharmaceutical costs.
Compared with the same time period last year, the report said there have been 60% fewer brand drug price increases and 54% more generic and brand drug price decreases since the Trump administration’s drug pricing strategy was laid out in May.
“It’s unprecedented to ever see any action like that,” said John O’Brien, adviser to the secretary for healthcare policy, in a Monday call with reporters. “We are tracking from the day of the launch of the blueprint up to Aug. 15, and we see a direct correlation to the blueprint.”
The HHS analysis did not break down the magnitude of the drug price increases that did occur, nor did officials compare those increases to last year’s. The report by Dan Best, Azar’s senior adviser on drug pricing reform, did not cite data to support the numbers.
Azar has found himself defending the administration’s blueprint against Washington skepticism, and he heralded these numbers as the start of a major change.
“The pharmaceutical industry has responded with real changes, not out of altruism but because they’re skating to where they see the puck going,” Azar said.
He emphasized that 15 companies offered concessions on the pricing front this summer. In July, Pfizer said it would delay planned increases until the blueprint was fully implemented, and Merck announced it would lower the price of a hepatitis C drug by 60% and cut prices of six older drugs with low sales volume by 10%. Thirteen additional manufacturers have promised to freeze increases for the rest of the calendar year and four have canceled planned hikes.
Azar also called on Congress to act, specifically on the blueprint’s core plan to merge Medicare Parts B and D to allow negotiations for Part B. He plugged a bill against so-called gag-clauses by lawmakers including Sens. Susan Collins (R-Maine), Bill Cassidy (R-La.), Claire McCaskill (D-Mo.) and Debbie Stabenow (D-Mich.). The legislation would block insurers from instructing pharmacists not to tell consumers if they could buy a drug that would be cheaper out-of-pocket than under their plan.
But he emphasized that he wants to see more action from the drug supply chain, noting that “nothing is stopping” pharmacy benefit managers from revamping their business model of guaranteed rebate structures or drugmakers from revealing drug prices in their advertisements.
Azar has promised to roll out demonstrations to push policies such as the integration of Medicare Parts B and D to drive more price negotiation, but officials didn’t provide a timeline for any announcements.

Mission Health may donate as much as $90M to rural communities in HCA deal


Mission Health says it will give $30 million to $90 million to foundations in five rural Western North Carolina communities plus an Asheville-based one if its proposed sale to HCA Healthcare goes through.
Some of the gifts would benefit communities where residents have expressed concerns that the potential sale of Mission Health could cause local hospitals to close or make cutbacks.
Money would go to foundations that support hospitals in Brevard, Highlands and Spruce Pine that are part of Mission Health plus one that helps Asheville-based CarePartners, a provider of home health, rehabilitation and other health services in WNC. In addition, a foundation would be formed in Franklin, the other rural WNC town where Mission has a hospital, to receive up to $15 million.

Funds would come from sale proceeds

Mission announced on Monday its intention to make the gifts, which could amount to $15 million to each foundation over a three-year period. The money would come from proceeds of the sale of Mission Health to HCA, a Nashville, Tennessee, based company that is the largest for-profit operator of hospitals in the United States.
The foundations were formed primarily to support various facilities that are part of Mission Health. Federal tax law would make it difficult for the foundations to give money directly to the hospitals once they become part of a for-profit company, meaning the foundations will have to find new ways to spend to benefit their communities.
Mission’s announcement says they would be expected to use the money it gives the foundations to improve residents’ health.
Mission announced in March that it had agreed to be sold to HCA if the two sides could agree to terms of a deal. Those discussions are going on now.
“Throughout the due diligence process, Mission Health’s board has discussed various way to provide additional support for the communities served by our member entities,” said Dr. John Ball, chairman of the Mission Health board. The money will “benefit (rural) communities directly and locally,” he said.
There has been no announcement of the amount HCA would pay for Mission, but past statements by Mission officials suggest the amount is likely to be between $1 billion and $2 billion. Mission’s accountants gave the system’s value as $1.7 billion as of Sept. 30 last year.

Money tied to Dogwood goal

Dogwood Health Trust, a nonprofit, has been formed to receive whatever amount HCA ultimately pays. Mission officials say it will use earnings on the money to improve social determinants of health, a range of factors like poverty, access to healthy food and availability of places to exercise that affect people’s health.
The amount of money the foundations around WNC would get would depend on how well they pursue that goal.
Mission’s announcement says each foundation would get an initial $5 million. Subsequent gifts of $5 million in the second and third years after the sale would be dependent on each foundation’s “previous year’s progress and its commitment to continue to develop community capacity to improve the health and well-being of its citizens … including a focus on the local social determinants of health.”
Mission Health System Foundation, which supports Mission Hospital and the health system, is not one of the intended recipients. Donors will be given the option of rolling over any unspent gifts made to that foundation to Dogwood Health Trust or having the money returned to them, said Rowena Buffett Timms, senior vice president for government and community relations at Mission Health.
That foundation listed net assets of $25.8 million as of September 2016.

It’s not just the uninsured — it’s also the cost of health care


We still have an uninsured problem in the U.S., but we have a far broader health care affordability problem that hits sick people especially hard.
Why it matters: It’s time to think more broadly about who’s having trouble paying for the health care they need. The combination of lack of insurance and affordability affects about a quarter of the non-elderly population at any one time, but almost half of people who are sick.
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Now that the Affordable Care Act has expanded health coverage, the percentage of the non-elderly population that is uninsured is now just under 11%, the lowest level ever recorded. But as the chart shows:
  • Another 15.5% who have insurance either skipped or delayed care because of the cost or reported that they or someone in their family faced problems paying their bills in 2017.
  • That brings the total percentage of non-elderly people with insurance and affordability problems to 26.2%.
More striking: nearly half of all people in fair or poor health — 46.4% — are uninsured or have affordability problems despite having coverage.
  • That includes 13.5% who were uninsured and in fair or poor health — arguably the worst off in the entire system — and another 32.9% percent who have insurance but said they or a family member have had a problem affording care in the last year.
It’s not surprising that people who are sicker and need more care would have more problems paying for it. But arguably an insurance system should work best for people who need it the most.
All this says a lot about current health care politics.
  • It helps explain why so many people name health their top issue, despite the progress that has been made in covering the uninsured. And everyone who’s sick and can’t afford medical care has family members and friends who see what they are going through, creating a political multiplier effect.
  • It is also why health care is substantially an economic issue as well as an issue of access to care. When people have trouble paying medical bills, it’s a hard hit to their family budgets — causing many people to take a second job, roll up more debt, borrow money, and forego other important family needs.
For as long as I have been in the field, we have used two measures more than any others to gauge the performance of the health system: the number of Americans who are uninsured and the percentage of GDP we spend on health. Both measures remain valid today.
The bottom line: If we want a measure that captures how people perceive the system when the number of uninsured is down and overall health spending has moderated, we need better ways of counting up the much larger share of the population who are having problems affording care.
And whatever big policy idea candidates are selling, from single payer on the left to health care choices on the right, the candidate who connects that idea to the public’s worries about paying their medical bills is the one who will have found the secret sauce.

Investors have misdiagnosed Amazon’s push into the pharmacy business


Companies everywhere, in every business, are paranoid about Amazon.com. This sort of paranoia is healthy for the long-term well-being of our investment portfolio, as it is creating interesting buying opportunities.
A case in point: My firm spent a lot of time thinking about pharmacies when we were analyzing investments in McKesson and other drug distributors. We struggled with a question: How will the retail pharmaceutical industry look in the future? Or more precisely, how will Amazon’s entrance into the retail pharmacy business change this industry?
Our inability to answer this question kept us away from retail pharmacies. Then we had a small but important insight that shifted our thinking on Walgreens Boots Alliance WBA, +0.00%  : The preponderance of drugs in the U.S. is consumed by an older population, whose habits change slowly or not at all. Accordingly, it’s likely that Amazon’s AMZN, -0.29%  online pharmacy will not significantly impact the existing drug industry.
Here’s why: Americans currently spend $450 billion a year on drugs. WalmartWMT, -1.89%  is the fourth-largest pharmacy in the U.S., with sales of $21 billion, or 4.6% of the company’s total sales. Let’s say that over the next five years Amazon gets to Walmart’s sales level of $21 billion. If the U.S. pharmaceutical industry grows 2% a year over that time, total drug sales will have increased by $45 billion, or the equivalent of two Walmarts (we are ignoring compounding here), to $495 billion. Walgreens, with its pharmacy selling about $70 billion a year, would barely notice Amazon’s presence.
I’ve made this point before, but it is important to repeat: 10 years ago Amazon was not taken too seriously. Giants like Google, now Alphabet, GOOG, +0.57% and Microsoft MSFT, -0.66%  ignored Amazon’s entry into cloud hosting, thinking “What does a bookseller know about the cloud?” They have regretted it ever since.
Everyone is taking Amazon too seriously
Nowadays everyone is taking Amazon too seriously, bestowing CEO Jeff Bezos with walk-on-water-like superpowers. Boardrooms today are filled to overflowing with chatter about Amazon. There‘s admittedly a lot Corporate America can learn from Bezos (for instance, about ignoring short-term results), but Bezos is not superhuman and Amazon cannot bend the laws of economic gravity.
Walgreens’ U.S. business, which is about 75% of its total sales, is impressive. A single stand-alone store produces revenues of about $10 million a year — $7 million in the pharmacy and $3 million in front-end sales (milk, candy bars, T-shirts, etc.) A single store fills about 121,000 scripts a year (up from 97,000 four years ago). Walgreens has one of the highest sales-per-square-foot numbers in the retail industry, at around $1,000 per-square-foot (compared to Walmart’s $450, Kroger’s KR, +0.16%  $550, and Target’s TGT, +0.34%  $300). (Note that Tesco’s TSCO, -0.23%   U.K. stores have sales per square foot of $1,100 — this is why we like the U.K. grocery business more than ones in the US).
Walgreens also has an underutilized asset: the front end of the store. Think about it: The pharmacy takes up 20% of the floor space but generates 70% of revenue. In other words 80% of the store (the front end) brings in only 30% of revenue. Walgreens is experimenting with different ways to optimize this underutilized asset — it’s opening medical clinics and bringing LabCorp LH, -1.74%  into its stores, for instance.
In 2018 Walgreens bought 1,900 stores from Rite Aid RTA, -3.03%  , bringing its total U.S. store count up to around 10,000. Store-count growth days are behind Walgreens, but the scripts-per-store-growth will continue, since baby boomers are not getting any younger. Accordingly, total sales growth will continue at a level of at least 2%-3% a year. When retailers mature and cannot open new stores, their free cash flows explode. Which begs the question, what will Walgreens do with its cash?
Already Walgreens is taking a quite different approach than its largest counterpart, CVS Health Corp. CVS, +1.28%  CVS owns one of the largest pharmacy benefit management (PBM) companies (a business that has a lot of political risk, as it’s ridden with conflicts of interest), and CVS is doubling down on complexity and buying Aetna , a health insurance company. CVS is trying to become an integrated healthcare provider. We don’t know if CVS will be successful in this endeavor, but the historical odds of success with acquisitions of this complexity clearly do not favor CVS.
Walgreens is run by Stefano Pessina, who owns 13% of the company; and thus 13 cents of every dollar spent is his. Walgreens has therefore been deleveraging its business, buying back stock, and paying a dividend. Walgreens is expected to earn $6 a share in 2018. My estimate is that earnings, helped by the Rite Aid acquisition, same-store sales growth, and share buybacks (WBA repurchased 8% of its shares in 2018 and has an authorization to buy another 13%), will exceed $8 per share in 2021.
If Walgreens shares trade at 13 times its $8 earnings per share in three years,, then the upside from here is about 70%; if it trades at 15 times then it’s a double (Walmart trades currently at 18 times estimated 2018 earnings, while Target is at 15 times). We bought Walgreens at a little over 10 times estimated 2018 earnings in July 2018. Walgreens is a better business than Target and at least as good a business as Walmart. At this valuation, heads we win, tails we win — the only question is by how much.
So, how does one invest in this overvalued market? Our strategy is spelled out in this fairly lengthy article.

Sepsis: 3 innovations to know


Best practices and innovations in sepsis can drop mortality rates and lead to earlier detection.


KEY TAKEAWAYS

Remote monitoring helped Nemours Children’s Hospital drop its sepsis rate to zero.
Emory’s AI device in development predicts sepsis 4—12 hours prior to clinical recognition.
New test may detect sepsis earlier by measuring body’s immune response rather than detecting pathogens.
Sepsis is deadly, it’s expensive, and there are abundant initiatives under way that could lead to earlier detection, lowering costs, and saving lives.
In May 2016, the Healthcare Cost and Utilization Project (HCUP) and the Agency for Healthcare Research and Quality released a report about the impact of sepsis on U.S. inpatient hospital costs. As published by The Sepsis Alliance, the study, which analyzed billings from 2013, revealed:
  • Sepsis accounts for nearly $24 billion in annual costs, making it the most expensive condition to treat in the U.S. healthcare system
  • Sepsis was responsible for 6.2% of all hospital costs across the country
  • Sepsis also was the most expensive hospital condition billed to Medicare, accounting for 8.2% of all Medicare costs
  • The condition accounted for nearly 1.3 million hospital stays
The Sepsis Alliance estimates that 258,000 patients die from the condition each year in the U.S. To save lives and improve the bottom line, hospitals across the nation are trying different approaches to reduce sepsis morbidity and mortality. At the same time, innovators strive to create ways to identify the condition earlier.

Below is a look at best practices from Nemours Children’s Hospital in Orlando, which instituted a program that reduced its pediatric morality rate to zero, as well as two promising innovations on the horizon.

1. NEMOURS DROPS MORTALITY TO ZERO WITH REMOTE MONITORING

In 2015 Nemours Children’s Hospital decided to take an aggressive, multifacted approach to sepsis that dropped sepsis mortality rates from 12.5% in 2016 to zero during the first six months of 2018. While there were numerous factors that contributed to the decrease, remote monitoring was one of the primary drivers behind the improvement, according to one of the physicians involved in the project.
Jennifer Setlik, MD, pediatric emergency physician at Nemours Children’s Hospital, says, “The way we have improved our sepsis results is through a bundle of care. We’ve educated nurses on administering IV fluids in a faster way. We also worked on pharmacy processes to have antibiotics delivered faster to a patient with sepsis. There are many different mechanisms we have used to help this process, but the key starting point—or the gun that starts the race—is [remote monitoring from] the Logistic Center. Logistics really gives us a head start in the race to treat patients with sepsis.”
The initiative began in November 2015 in the emergency department, then rolled out to the rest of the hospital. Nemours also participates in a national collaborative with the Children’s Hospital Association, which is working to reach consensus on appropriate mechanisms of action related to sepsis.
How It Works
  • The Nemours Clinical Logistics Center, a facility located in the hospital, provides 24/7 remote monitoring by paramedics who observe all patients in the emergency department and every bed in the hospital, except the NICU, which uses separate protocols
  • Vital signs and other data are aggregated into a shock/sepsis score
  • Nemours designed the scoring system, which contains a unique feature that gives greater weight to blood pressure changes
  • The team tweaks the scoring system over time to further improve its sensitivity
  • If the score reaches a threshold value of 25 or more points, paramedics receive a visual cue and prompt a bedside nurse (who also receives the score on her monitor) to gather additional information
  • Additional inputs include assessments for a shock/sepsis state, which may raise the score
  • If the child has a score of 45 points or higher, a rapid response team is deployed as the child is at an elevated risk of shock, a precursor to sepsis
Results
  • Average length of stay dropped from 10 days in 2016 to 7 days throughout 2017 and the first six months of 2018
  • Mortality rates decreased from 12.5% in 2016, to 4.5% in 2017, to zero through June 2018 (However, physicians note that figures can be artificially inflated due to the small size of the 100-bed hospital)
  • Mortality rates for medically complex children saw a similar decline from 21% in 2016, to 6% in 2017, and zero in 2018 through June

ON THE HORIZON

There are numerous innovative approaches to sepsis in development. Here’s a look at two:

2.  ARTIFICIAL INTELLIGENCE TOOL IN DEVELOPMENT AT EMORY

Predictive analytics already play a role in early sepsis detection in models introduced by Mayo ClinicPenn Medicine, and other places. But it’s only a matter of time before artificial intelligence speeds up the detection process even further.
Using real-time data, Emory University innovators are testing their Artificial Intelligence Sepsis Expert. It already can accurately predict the onset of sepsis in an ICU patient four to 12 hours prior to clinical recognition, according to an articlepublished April 2018 in Critical Care Medicine.
The accuracy rate is 85% to 90%, says Timothy Buchman, MD, PhD, FACS, FCCP, MCCM, professor of surgery and anesthesiology at the Emory University School of Medicine, who also serves as director of the Emory Critical Care Center and chief of critical care services at Emory Healthcare.
In addition to predicting sepsis, the developers want the model, which is still in development, to explain why the patient is likely to become septic.
“The novelty of this algorithm is that it [will tell clinicians] that among hundreds of tests, you need to pay attention to these five labs right now,” says Shamim Nemati, PhD, assistant professor of biomedical informatics at Emory University’s School of Medicine. This information will not only help providers build trust in the device, it will offer more precise opportunities for action.
It may be up to five years before the device is commercially available, although initial forms of the Sepsis Expert may be available for testing in academic health environments as soon as next year.

3.  TEST IMMUNE RESPONSE RATHER THAN PATHOGENS

Seattle-based Immunexpress has taken a different approach to the sepsis battle. Currently, no definitive test exists to diagnose sepsis.
Clinicians rely on detecting pathogens in blood cultures, a process that takes time and still doesn’t offer a conclusive diagnosis. Minutes are precious in the sepsis battle; each hour without treatment increases mortality by 8%, says Rolland Carlson, PhD, CEO of Immunexpress.
Rather than passively chasing pathogens, Immunexpress developed a test to measure the body’s specific immune response to infection by examining biomarkers in the patient’s blood.
According to Carlson, these biomarkers may hold the key to the early and accurate detection of infection, as well as assist in guiding the use and timing of drugs and other therapies.
“SeptiCyte is the first FDA-cleared diagnostic to test for a gene signature that differentiates between positive systemic inflammation, which would be sepsis, or negative systemic inflammation, which would be indicative of SIRS (systemic inflammatory response syndrome),” says Carlson.
The latter diagnosis is treated much differently from sepsis and usually doesn’t require admission to the ICU. Up to 43% of patients treated for sepsis were unlikely to have had a sepsis infection, according to a study published September 7, 2015, in Critical Care.
SeptiCyte has received FDA approval and conducted some of its clinical trials at Seattle Children’s Hospital in Seattle, Washington. The company is now testing SeptiCyte on a different platform that could produce results in less than 90 minutes. Immunexpress expects to have a product commercially available during 2019.

LEARN MORE

  • Hospital sepsis scores are now publicly available on Medicare’s Hospital Compare website (select a hospital, then “Timely & Effective Care,” then “Sepsis Care”).
  • Learn how the U.S. Department of Health and Human Services aims to accelerate sepsis innovation.
  • Preliminary findings from an Intermountain Healthcare study found no difference in 30-day mortality among sepsis patients treated as inpatients versus outpatients.