Adtalem Global Education price target raised to $56 at First Analysis. First Analysis analyst Corey Greendale raised his price target on Adtalem Global Education to $56 and kept his Overweight rating, saying his recent meetings with the management highlight the company’s “portfolio management approach to deploying capital and its opportunities to create value across all segments”. Greendale notes the stock is attractive at current levels as the compay attempts to boost its revenue and margins in the technology and business segment.
Tuesday, May 29, 2018
Another drug to prevent migraines shows promise
Migraine sufferers could soon turn to a number of new medications to avoid their crippling headaches.
Earlier this month, the U.S. Food and Drug Administration approved Aimovig (erenumab), the first migraine prevention drug ever developed.
On its heels comes a successful trial of the migraine prevention drug galcanezumab.
Galcanezumab cut in half the number of days that most patients suffered from a migraine in a month, and did so without significant side effects, researchers reported.
“In contrast to what we currently have available to prevent migraine, they seem very well tolerated,” said study co-author Dr. David Dodick, a neurologist with the Mayo Clinic in Phoenix, Ariz. “There are no unique side effects to these treatments.”
Dodick expects that both galcanezumab and a third migraine prevention drug will be approved by the FDA in the coming months.
“I expect that, barring any unforeseen issues, there will be two more antibodies approved in 2018,” Dodick said, adding that an additional drug delivered by IV should be ready in 2019.
This could be good news for cost-conscious migraine patients, said Dr. Noah Rosen, director of Northwell Health’s Headache Center, in Great Neck, N.Y.
Right now, the estimated cost of Aimovig is $7,000 a year, a price it can ask as the only approved drug on the market, according to published reports.
“We do hope that competition drives pricing because, as a specialist, that’s one of our greatest fears, as to whether we’re now going to have what seems to be an effective treatment that we can’t actually give to anyone,” Rosen said. “Hopefully, more medications on the market will provide that accessibility.”
Both Aimovig and galcanezumab are injectable antibodies that target calcitonin gene-related peptide (CGRP), a signaling protein that has been linked to migraine and cluster headaches.
Aimovig targets the pain receptor that CGRP activates, but galcanezumab targets the CGRP protein itself, Dodick explained.
“It’s the protein that activates the receptor. Once the key fits into the lock, you open the door to pain transmission,” Dodick said. “You can’t open the door without having the key or opening the lock.”
The galcanezumab trial involved 858 patients who were randomly assigned to receive monthly doses of either the drug or an inactive placebo. To be included, people had to have a history of four to 14 migraines per month.
Patients who received galcanezumab had their number of monthly migraine days reduced by 4.7 days, on average, compared with 2.8 days for those who received a placebo, according to the report.
Side effects were so minimal that fewer than 5 percent of patients dropped out of the trial, a rate “really unheard of and not really seen before in migraine prevention studies,” Dodick said.
The findings were published online May 29 in JAMA Neurology.
The real promise of these drugs comes in their breadth of potential use, Rosen said.
Right now, doctors have to tailor their migraine prevention strategies to the specific health issues of each patient, as well as whether they suffer occasional or frequent headaches, he explained.
“One of the big advantages of this new class is they seem to work regardless of whether the migraine is intermittent or chronic,” Rosen said. “We don’t have to split hairs with trying to define the frequency of the headache. It becomes easier to prescribe an appropriate preventative treatment.”
Explore further: FDA approves first drug aimed at preventing migraines
More information: David Dodick, M.D., neurologist, Mayo Clinic, Phoenix, Ariz.; Noah Rosen, M.D., director, Northwell Health’s Headache Center, Great Neck, N.Y.; May 29, 2018, JAMA Neurology, online
The U.S. Department of Health and Human Services has more about migraines.
NY Presbyterian CEO Corwin on flirting with Amazon, telemedicine and AI
NewYork-Presbyterian CEO Steven Corwin has patient access on his mind.
The academic health system late last month opened the doors to an ambulatory care center including outpatient surgery, interventional radiology and diagnostic imaging services. The 740,000-square-foot center is the latest in NYP’s efforts to rethink how to engage patients.
Among the other efforts: NYP this month expanded its mobile stroke treatment unit to encompass three of the five New York boroughs. In December, the provider partnered with Walgreens to improve access to telemedicine services.
“Unless we get care to the ambulatory setting and more convenient settings, we’re not going to be able to reduce the cost of care in the country,” Corwin told Healthcare Dive in an interview while on a recent visit to Washington, D.C. He called out prices of care services, pharmaceuticals and devices as the main culprits for the rise of healthcare spending in the U.S.
“I’m responsible for hospital pricing. If I can move care to less expensive settings, that’s really what my role should be,” he said.
Corwin, CEO since 2011 and a member of NYP’s management team since 1998, echoes hospital CEOs around the nation who are rethinking their business models. In the past decade, NYP has experienced a 40% increase in inpatient days while outpatient visits have increased by 53%. Emergency visits have increased by about 66% since 2008.
“Emergency departments are very expensive [and] very crowded. If we can off-load the emergency department, patients would be much happier if we do it responsibly,” Corwin said. “There’s no question more and more care is [going] ambulatory and I think that’s better for the patients.”
In the interview, Corwin discussed NYP’s flirtation with Amazon for supply chain engagement, the organization’s telemedicine efforts and whether artificial intelligence will replace the human factor in care delivery.
Here are the highlights.
1) Artificial intelligence will have big wins for administration, but clinical use still needs oversight
Corwin isn’t ready to concede human oversight to the machines in a clinical setting just yet, but believes there will be significant disruption in the area in the next five years to get to advanced predictive analytics.
“I do think that the doctor can be aided in making the decision,” Corwin said, adding doctors will be more willing to accept AI and machine learning if they help them, as opposed to replace them. “Physicians want to be aided in diagnosis and treatment,” he said.
Hospital margins have tightened. Last month, Moody’s reported that median operating margins for nonprofit hospitals sunk to 8.1% in 2017, a 10-year low.
In addition to rethinking patient engagement and asset management, some organizations are looking at artificial intelligence and machine learning to help with administrative tasks. Corwin name-checked the automation of finances and virtual assistant chatbots as “big win” technology investments for care delivery organizations.
Easing repetitive tasks for employees to improve operations can help manage a hospital, Corwin said. NYP is currently using nudges generated by machines to help schedule social work consults or MRI scans to manage patients’ length of inpatient stay. The organization is finding positive results initially, but the effort will need to be studied, Corwin added.
For Corwin, larger issues over AI and machine learning include validating value sets and removing any unintended biases from AI systems as well as what the technology means for healthcare jobs over time.
“Certainly there’s going to be retraining,” he said. “We have to have more emphasis on STEM education for people coming into hospitals. Some of the lower-level jobs may be replaced and we’ll have to find new jobs for those employees to do. If we can’t convince our employees that there’s a net benefit to them, then we’re going to have difficulty getting them to adopt [such technologies].”
2) Amazon didn’t get better pricing for part of NYP’s supply chain
Corwin disclosed that NYP worked with Amazon on a supply chain deal, with tepid results.
“We gave them a piece of our supply chain to see whether they could get us better pricing and the answer to that was no,” Corwin said.
A recent Reaction Data survey found 62% of healthcare executives are hoping Amazon can shake up the industry’s supply chain. A Wall Street Journal report from February said the e-commerce giant had been piloting a supply chain program with a large Midwestern hospital system using Amazon Business, its business-to-business marketplace, for a portion of its outpatient facilities.
The healthcare supply chain space is already dominated by Cardinal Health, McKesson and AmerisourceBergen, so it’s currently unclear how seriously Amazon will pursue the space.
“The general rule of thumb is you’re looking at the stock market and Amazon is getting into a business, [stocks will sell],” Corwin said.
Still, he added: Amazon is “brilliantly led and I wouldn’t underestimate them.”
3) Hospitals need to rethink patient engagement strategies
“We’ve got to move outside the [hospital’s] walls,” Corwin said. “It’s part of the movement toward getting away from being responsible for the acute care episodes to having a more holistic view of healthcare.”
The American population is getting older, and younger generations don’t want to wait around to schedule doctors appointments. That’s changing the dynamics of patient volumes for hospitals.
Corwin sees sicker patients entering hospitals in the future, forcing organizations to re-imagine intensive therapy and what inpatient hospital care looks like. Bed complements for ICU units and staffing levels are administrative considerations needing to be reviewed over the next 10 to 20 years.
It’s part of grander industry sea change. More patients are choosing outpatient services for less intensive care. Moody’s Investor Service this month said health systems overall will need to be flexible with business strategies going forward, stressing a balance of both inpatient and outpatient investments.
To Corwin, that translates to more in-home visits, school-based clinics and on-demand care capabilities in various settings — such as kiosks — so patients interact with the provider.
“The convenience factor for patients makes a difference,” Corwin said, adding the registration time at the new ambulatory building is about 90 seconds. Patients check in with a kiosk and can be located if needed via RFID bands while at the facility.
It’s part of the reason he believes consumer-based principles will be more important for providers than a topic such as behavioral economics. “Healthcare has been the last [industry] to be disrupted but it has to be,” Corwin said. “If we can do it in such a way where people feel we’ve maintained the human connection and made it easier, that’s the holy grail. Right now I think people think that consumers think we’re too hard to access.”
4) Telehealth could be a big part of that strategy but ROI is still a question
NYP made a decision a few years ago to go deep into telemedicine on the assumption it provides better access and reduces costs.
The effort includes the mobile stroke units as well as telepsychiatry and urgent care kiosks in the emergency department. Altogether, NYP has found patients have taken to the service. The organization conducted 1,600 visits in 2016 and did 12,000 the next year. Corwin expects that NYP will conduct 100,000 televisits this year.
However, when it comes to ROI, Corwin said the jury is still out.
“I think it’s the question,” he said. Providers are currently questioning if the service offers a value-add. Medicare and other payers are concerned if healthcare costs will go up initially because patients and providers will have the ability to engage with teleservices, potentially driving up the number of claims to process.
“I don’t think we have enough data,” Corwin said. “You have to take a look over a long period of time. In the more chronic conditions, proving ROI … is going to be a more difficult challenge. You have to show outcomes are better, costs are down and access is better.”
Still, Corwin is a big believer in the service, pointing to its ability to treat patients quickly and triage with multiple care team members.
He gave an example of a follow-up office visit for a congestive health failure patient, which he said is typically between 15 and 20 minutes. A sick patient with heart failure could take eight to 10 minutes to get undressed and redressed, giving the physician limited time with the patient. That offers little time to review diet, medications and social situations in the patient’s home. Telemedicine triaging can help, he said.
“If you start to imagine it somewhat differently, if you had a pharmacist, social worker [and] nutritionist available and you can stack the work so that these people could be covering multiple sites simultaneously, then you fundamentally change the nature of the visit,” Corwin said.
Use cases, in this view, become varied over time, he said. The organization is now working on getting disparate workflows to align as a team via telemedicine.
WellCare to buy privately held Meridian Health for $2.5 billion
WellCare Health Plans Inc. WCG, +0.49% said late Tuesday it had agreed to buy privately held Meridian Health Plan of Michigan, Meridian Health Plan of Illinois, and MeridianRx, a pharmacy benefit manager, for $2.5 billion in cash. The transaction is expected to close by the end of the year, subject to closing conditions and regulatory approvals, WellCare said in a statement. Through the deal, “WellCare will diversify its Medicaid portfolio through the addition of Michigan, where Meridian has the No. 1 Medicaid market position; deepen its Medicaid business in Illinois; and acquire an integrated (pharmacy-benefit manager) platform,” the company said in a statement. Shares of WellCare rose 0.2% in late trading after ending the regular session up 0.5%.
Pfizer’s Xalkori gets FDA ‘breakthrough’ tags in lung cancer, lymphoma
Under new pressure from Roche’s Alecensa, Pfizer’s Xalkori has picked up two FDA breakthrough designations, one for certain lung cancer patients and another in a rare form of lymphoma.
Xalkori won FDA breakthrough-therapy designations in metastatic NSCLC with MET exon 14 alterations, as well as for patients with ALK-positive relapsed or refractory systemic anaplastic large cell lymphoma, the drugmaker said in a release.
MET 14 alterations occur in about 3% of NSCLC cases, Pfizer says, while anaplastic large cell lymphoma cases make up 2% of non-Hodgkin lymphomas.
The FDA grants breakthrough designations for drug candidates that treat serious and life-threatening diseases when data demonstrate they can significantly improve patient care over existing options. The program is designed to speed up the regulatory process.
If approved in the indications, Xalkori would have two new growth avenues as it comes under threat from Roche’s Alecensa in ALK-positive non-small cell lung cancer. In November, Alecensa picked up a first-line nod for the patient group, stepping up to challenge Xalkori and Novartis’ Zykadia. Novartis’ med won its approval in the indication in May 2017.
Alecensa boasts Xalkori-besting data that Dietmar Berger, Roche’s global head of clinical development in hematology and oncology, previously said will make it “the new standard of care for first-line” treatment. In a phase 3 trial, Roche reported that median progression-free survival was 25.7 months for Alecensa patients, compared with 10.4 months for Xalkori patients.
Alecensa cut the risk of disease worsening or death by 47% compared to Xalkori, according to Roche.
The breakthrough designations further demonstrate how oncology is shifting into increasingly targeted biomarker identification and treatment, boosting patient outcomes. In a statement, Pfizer oncology chief development officer Mace Rothenberg said the designations “exemplify our commitment to precision medicine development and delivering medicines that have the potential to transform the lives of patients whose cancers carry these genomic alterations.”
Xalkori pulled in $594 million last year, or 6% growth from 2016.
Exelixis: FDA accepts filing for liver cancer med
Exelixis announced that the FDA has accepted for filing the company’s supplemental new drug application, or sNDA, for Cabometyx tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma, or HCC. The FDA has completed its filing review and has determined that the application is sufficiently complete to permit a substantive review. The filing has been assigned a Prescription Drug User Fee Act, or PDUFA, action date of January 14, 2019. Exelixis announced they submitted the sNDA for the treatment of previously treated advanced HCC to the FDA in March 2018 based on results from the CELESTIAL phase 3 pivotal trial of Cabometyx in patients with advanced HCC who received prior sorafenib.
Robots are better than doctors at diagnosing some cancers
Artificial intelligence is better than doctors at diagnosing some cancers, research has shown.
The international study involved machines that were trained to detect signs of skin cancer before being tested against 58 dermatologists.
It comes after the Health Secretary, Jeremy Hunt, said extra funds for the NHS must be used to expand the use of artificial intelligence to diagnose patients.
The computer network was taught by being shown 100,000 images of malignant melanomas and benign moles marked with a diagnosis. It was then pitted against senior doctors to diagnose 100 of the most difficult lesions.
The machines correctly diagnosed the malignant cases in 95 per cent of cases – significantly more than the 87 per cent accuracy achieved by dermatologists, the study found.
The artificial intelligence also misdiagnosed fewer benign moles as malignant melanoma, meaning fewer patients would be forced to endure needless surgery.
Researchers from Germany, the United States and France used a form of artificial intelligence known as a deep learning convolutional neural network (CNN). This is an artificial neural network inspired by the biological processes at work when nerve cells in the brain are connected to each other and respond to what the eye sees.
The CNN learns from images that it “sees” and teaches itself to improve its performance in a process called machine learning.
Prof Holger Haenssle, the study lead author, from the University of Heidelberg, Germany, said: “The CNN works like the brain of a child. To train it, we showed the CNN more than 100,000 images of malignant and benign skin cancers and moles and indicated the diagnosis for each image.
“With each training image, the CNN improved its ability to differentiate between benign and malignant lesions.”
Once the machines had been trained, they were tested against 58 dermatologists from 17 countries across the world.
More than half the specialists had at least five years’ experience.
The dermatologists were asked to first make a diagnosis of malignant melanoma or benign mole just from the dermoscopic images, and to decide if surgery was required.
Four weeks later they were given the same tests, this time with clinical information about the patient, including their age, sex and position of the lesion.
When doctors were given simply the images, they accurately detected 86.6 per cent of melanomas, rising to 88.9 per cent when they also had information about the patient. The artificial intelligence made a correct assessment in 95 per cent of cases based on images alone.
“The CNN missed fewer melanomas, meaning it had a higher sensitivity than the dermatologists,” said Prof Haenssle. “And it misdiagnosed fewer benign moles as malignant melanoma, which means it had a higher specificity.
“This would result in less unnecessary surgery.”
The computer was more accurate even when compared with the most experienced doctors, the study, published in the Annals of Oncology, found.
“These findings show that deep learning convolutional neural networks are capable of out-performing dermatologists, including extensively trained experts, in the task of detecting melanomas,” Prof Haenssle said.
Researchers said such technology could be used to screen for skin cancer, meaning cases could be diagnosed far earlier. But they said the technology was likely to be used in conjunction with skilled doctors, rather than replacing them.
Malignant melanoma is the most deadly type of skin cancer. In the UK cases have more than doubled since the Nineties, with more than 15,000 cases annually.
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