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Tuesday, July 23, 2019

CVS to trial knee replacement program for Aetna beneficiaries

  • CVS Health will trial a coordinated care pilot for knee replacements in Aetna beneficiaries later this summer, CVS CEO Larry Merlo said at a Medicare Advantage conference in Washington on Tuesday.
  • In the pilot, pre- and post-operative care for Aetna MA and commercial members undergoing a knee replacement procedure will be managed by a clinical team in the home, at CVS pharmacy locations and via telehealth.
  • The trial is the first in a series of initiatives CVS and its payer arm Aetna are working on, Merlo said, and will be available for as many patients as possible according to a spokesperson.

As CVS Health jockeys with Amazon and more traditional rivals like Walgreens, the retail pharmacy giant is looking to leverage two of its biggest assets going into the second half of the year — 10,000 brick and mortar locations and reams of claims data from its merger with Aetna.
The model aims to cut costs by reducing hospital readmissions amid a broader push to move care outside the hospital setting.
The volume of total joint replacements, like the knee or hip, has risen continuously over the past few decades as the population skews increasingly older. By 2030, total knee replacement is projected to grow by up to 189%, according to the American Academy of Orthopaedic Surgeons, and 90% of people who receive one report less pain from chronic conditions such as arthritis.
According to the Agency for Healthcare Research and Quality, more than 600,000 knee replacements are performed each year in the United States. The number and relative safety of the procedure likely drove CVS’ interest in the space fresh off its November closing of the Aetna merger.
In a video touting the approach showed at the conference Tuesday, an elderly knee replacement patient meets with a CVS case manager to make sure her surgeon is in-network, gets a home assessment to ensure safety post-operation and has a CVS representative help her pick out a cane and coordinate prescriptions.
“It’s not just getting home from the hospital,” Merlo said. “It’s what happens in subsequent days and weeks in terms of a follow-up appointment with a physician or with physical therapy if it can’t be provided in-home.”
Though the CVS-Aetna integration isn’t technically complete until a federal judge signs off on the settlement pact, the two companies have been joining their business operations for some time now.
“I’m really pleased with how the assimilation, the integration is going as we become one company,” Merlo said, holding up the new trial as just one example of a “series of broad-based initiatives we’re working on.”
The company has been expanding its CVS HealthHUBs, retail locations that devote roughly 20% of their floor space to health services with a focus on preventive care and wellness. CVS plans to open 1,500 HealthHUBs by the end of 2021 as part of its enterprise growth strategy, and has already seen increased traffic and higher margins in the locations compared to regular CVS stores.
Though a CVS spokesperson declined to say where CVS would be trialing the knee replacement model, the Dallas/Houston area — where CVS opened its flagship HealthHUB stores —​ could potentially be fertile ground for the healthcare company. East Texas has one of the country’s highest rates of healthcare spending, according to the Health Care Cost Institute, and some of its worst health outcomes.
Wherever the knee replacement pilot will run, CVS will look for opportunities to expand to other conditions and procedures, the spokesperson confirmed.

People Don’t Know What ‘Medicare For All’ Means. Democrats Want It That Way

Next week, Democrats will convene their second round of presidential debates. As during last month’s debate, health care is sure to be a focus.
The candidates have sharpened their differences on the issue in recent days. Frontrunner Joe Biden released his vision for health reform—a sort of Obamacare on steroids—last week. He went to great pains to emphasize that people would be able to keep their private insurance under his plan. “If you like your health care plan, your employer-based plan, you can keep it,” he said.
Senator Bernie Sanders continues to beat the drum for Medicare for All—a government takeover of the country’s health insurance sector. “At the end of the day, you’ve either got to be on the side of the people or the side of the health insurance companies,” he said. “I know which side I’m on.”
Polling data seem to indicate that only Democrats with a political death wish will get behind Medicare for All. Once voters learn what Sanders-style health reform entails, support for it plummets.
Let’s look at three things most of the public believes about Medicare for All: that they’ll be able to keep their private health plans, that doctors and hospitals will be paid enough to stay in business, and that ordinary Americans will save lots of money.
None is true.
Take the first—that Medicare for All will coexist with private health insurance. A recent Kaiser Family Foundation poll found that 55% of Americans believe they’ll be able to keep their plans under Medicare for All. Sixty-eight percent of Democrats say workers would be allowed to keep their private employer-sponsored plans; 65%  think those with individual-market coverage could do the same.
But the plan Sanders has introduced in the Senate is clear—it would be, “unlawful for a private health insurer to sell health insurance coverage that duplicates the benefits provided under this Act.” And because Medicare for All would cover just about every medical service known to man, private health insurance would effectively become illegal.
Everyone who has a private plan—whether through work, or one they bought on the individual market, or a plan their unions negotiated on their behalf—would lose it. So too would the 22 million retirees with Medicare Advantage plans. Only those who receive their health care through the Veterans Health Administration or the Indian Health Service would be able to keep their pre-Medicare for All coverage.
Or consider the second big misperception—that doctors and hospitals will be paid adequately. The Kaiser poll found that 58% of Democrats and half of independents were unaware that doctors and hospitals would be paid less under Medicare for All.
The plan’s architects claim it will provide comprehensive, first-dollar coverage to everyone residing in the United States—including undocumented immigrants—and still cut national health spending by trillions of dollars. The only way to do that without directing virtually the entire federal budget toward health care is to pay providers less. Reimbursements for doctors and hospitals under the Sanders plan would be roughly 40% less than what private insurance pays.
Those kinds of pay cuts would be catastrophic. Hospitals would lose up to $151 billion in annual revenues under Medicare for All, according to an article published in the Journal of the American Medical Association.
Paying doctors less would also exacerbate the existing physician shortage. The United States is projected to be short more than 120,000 doctors by 2032, according to the Association of American Medical Colleges. That shortage would balloon further under Medicare for All. Some older doctors would probably prefer to retire than work for lower pay. America’s best and brightest students, meanwhile, would decline to pursue careers in medicine, if they’d be looking at long hours and low pay.
Finally, there’s the notion that Medicare for All will save everyone money. It’s a big part of Senator Sanders’s sales pitch. “People who have healthcare on the Medicare for All will have no premiums, no deductibles, no co-payments, no out-of-pocket expenses,” he said during last month’s Democratic presidential debate. “Yes, they will pay more taxes but less in healthcare for what they get.”
“More taxes” will certainly be needed to cover the plan’s cost—between $30 trillion and $40 trillion over ten years, according to estimates Sanders released last week.
Among those taxes? A new payroll tax on employers, new taxes on individuals, and higher taxes on investment income. An analysis of the tax plan Sanders advanced during his last bid for president, which has a lot in common with the ideas he’s proposed for paying for Medicare for All this time around, estimated that average post-tax income for all taxpayers would fall by about 12.84%, when factoring in reduced GDP as well.
Families today have some measure of control over their own health costs under the current system—they can opt for cheaper health plans, or shop around for lower-cost services. But they’d lose any measure of control over their health expenditures under Medicare for All. They’d have no choice but to pay whatever taxes the government socks them with.
Medicare for All may play well in the Democratic primary. But it’ll be a liability during the general election, when health care promises to be among the most important issues for voters. At next week’s presidential debate, we’ll see if Democrats can get wise to that reality.

Study quantifies smoking’s strong link to peripheral artery disease

A new study led by researchers at the Johns Hopkins Bloomberg School of Public Health found that cigarette smoking boosts the risk of peripheral artery disease, and this elevated risk can persist up to 30 years after smoking cessation. The study also found that the link between smoking and peripheral artery disease was even stronger than that for coronary heart disease and stroke.
The study found that compared with never-smokers, those who smoked for more than 40 pack-years had roughly 4 times more risk for peripheral artery disease, versus 2.1 times and 1.8 times more risk for coronary heart disease and stroke, respectively. A pack-year is a parameter of smoking: 10 pack-years can mean 1 pack per day for 10 years or 2 packs per day for 5 years or some other combination.
Similarly, participants who reported currently smoking more than a pack per day had a relative increased risk–5.4 times more for peripheral artery disease versus 2.4 for coronary heart disease and 1.9 for stroke–compared to those who had never smoked.
The study, published July 22 in the Journal of the American College of Cardiology, is the first comprehensive comparison, in a large population moving through time, of the smoking-elevated risks of peripheral artery disease, coronary heart disease, and stroke. The analysis was based on a sample of 13,355 Atherosclerosis Risk in Communities (ARIC) cohort participants, including 3,323 current smokers and 4,185 former smokers, who were tracked for a median period of 26 years.
Peripheral artery disease features the atherosclerotic buildup of cholesterol-laden deposits in arteries serving the legs. The reduction of blood flow leads to limb pain, poor wound healing, and other signs and symptoms. The U.S. Centers for Disease Control and Prevention estimates that about 8.5 million people in the U.S. have peripheral artery disease, including more than 10 percent of people older than 69, though most cases go undiagnosed and there is relatively little public awareness of the disorder.
“Our results underscore the importance of both smoking prevention for nonsmokers and early smoking cessation for smokers. The study also suggests that campaigns about smoking’s health risks should emphasize the elevated risk of peripheral artery disease, not just coronary heart disease and stroke,” says senior author Kunihiro Matsushita, MD, PhD, associate professor in the Department of Epidemiology at the Bloomberg School.
The study was an offshoot of the ARIC study, which began in the late 1980s with funding from the National Heart, Lung, and Blood Institute. The ARIC study initially enrolled cohorts totaling 15,792 participants aged 45-64 years from four U.S. communities, and over three decades has included periodic follow-ups to record their health, as well as potential health risk factors such as smoking and diet. The main goal of the ARIC cohort study was to identify and quantify risk factors–such as smoking–for coronary heart disease, heart attacks, and stroke. But Matsushita and colleagues in the new study were able to use the large ARIC dataset to examine the links between smoking and peripheral artery disease.
The effect of smoking on peripheral artery disease risk was not just stronger; it was also longer-lasting. Only after 30 years of smoking cessation did the peripheral artery disease risk for former smokers return to the baseline level seen in never-smokers. By comparison, coronary heart disease risk took about 20 years to return to baseline after smoking cessation.
The good news from the analysis is that quitting smoking appeared to bring a meaningful drop in peripheral artery disease risk fairly quickly. “We observed a lower risk for peripheral artery disease, coronary heart disease, and stroke within five years of smoking cessation,” says Ning Ding, MBBS, ScM, a data analyst at the Bloomberg School and first author of the study. Smoking cessation for 5 to 9 years was linked to a much greater drop in peripheral artery disease risk, 57 percent, compared to 30-40 percent for coronary heart disease and stroke.
Overall, the results suggest that public health campaigns against smoking should include reference to the elevated peripheral artery disease risk and should emphasize how long it takes to eliminate that risk.
“Smoking almost always starts in adolescence or early adulthood, and it’s very important that young people understand how long the elevated health risk persists even after they’ve quit,” Matsushita says.
The ARIC study is ongoing and may continue for another decade or two. To date, ARIC researchers have published more than 2,000 peer-reviewed papers on the project’s findings.
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“Cigarette Smoking, Smoking Cessation, and Long-term Risk of Three Major Atherosclerotic Diseases,” was written by Ning Ding, Yingying Sang, Jingsha Chen, Shoshana Ballew, Corey A. Kalbaugh, Maya J. Salameh, Michael J. Blaha, Matthew Allison, Gerardo Heiss, Elizabeth Selvin, Josef Coresh, and Kunihiro Matsushita.
The ARIC study has been funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, and Department of Health and Human Services (HHSN268201700001I, HHSN268201700003I, HHSN268201700005I, HHSN268201700004I, HHSN2682017000021). Matsushita’s work is supported by a grant from the National Heart, Lung, and Blood Institute (R21HL133694).

Earnings before Wednesday’s open: Alexion, Anthem, Boston Sci, Medco

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More Than 936 Million Have Obstructive Sleep Apnea Worldwide: ResMed

More than 936 million people have obstructive sleep apnea – the disease’s first prevalence update in more than a decade – according to The Lancet Respiratory Medicine, the world’s leading journal in its field. The Lancet published a multinational analysis by ResMed (NYSE: RMD) (ASX: RMD) and 12 academic leaders in sleep research. The results were first presented at the ATS 2018 International Conference in San Diego.
This figure is nearly 10 times greater than the World Health Organization’s 2007 estimate of more than 100 million, renewing calls for physicians to step up their efforts to screen, diagnose, and prescribe treatment for those who unknowingly suffer.
“More than 85 percent of sleep apnea patients are undiagnosed, meaning hundreds of millions repeatedly suffocate instead of getting healthy, restful sleep each night,” said Carlos M. Nunez, M.D., a study coauthor and ResMed’s chief medical officer. “This raises their risk of workplace and roadway accidents, and can contribute to other significant health problems, such as hypertension, cardiovascular disease, or even poor glucose control for diabetic patients. We know the risks, and now we know the size of the problem is nearly 10 times greater than previously thought. Addressing it starts with screening patients we know to be high-risk.” Why is sleep apnea mostly undiagnosed? Sufferers often don’t know they’re suffering. They’ll stop breathing for 10 seconds or more throughout the night – called an “apnea” – and repeatedly wake to breathe and prevent suffocation. They rarely remember waking, but the disruptive cycle causes chronic sleep deprivation.
“Many will attribute the resulting tiredness to aging or stress,” said Nunez. “Others will mention the problem to their doctor, only to be misdiagnosed with insomnia, migraines, chronic fatigue, or other conditions. Misdiagnosis is especially common with women, since sleep apnea was long thought to be much more common in men.”
Today, women account for 40 percent of newly diagnosed sleep apnea patients.
Another reason many suffer unknowingly can be blamed on cultural ideas of what constitutes good sleep.
“For instance, some believe snoring may simply be a normal feature of how some people sleep, when in fact it’s one of the most important signs for the risk of having sleep apnea,” Nunez said. “With a global prevalence that approaches 1 billion people, patients and physicians need to consider the risks and ask the questions that may ultimately help them sleep and live better. This is no longer a problem that can be treated lightly or ignored.” Who is at risk for sleep apnea? More than half of all people with obesity, heart failure, stroke or transient ischemic attack (TIA), atrial fibrillation, or type 2 diabetes also have sleep apnea, according to leading research.
Snoring is the number-one indicator of sleep apnea in men and women, though not everyone who snores has it – and not everyone who has it snores.
People told they stop breathing for long periods during sleep are also at a higher risk for the disorder.
“The bottom line is: If you’re constantly tired or have other conditions linked to sleep apnea, it never hurts to ask your doctor about it,” said Nunez. “Don’t settle for being tired all the time. Sleep apnea is 100 percent treatable. You can improve your sleep, your mood, your relationships at work and home, your health, perhaps even other medical conditions you’re managing. But first, you have to find out.”

FDA OKs Merck’s Humira biosimilar

The FDA has approved Merck’s (NYSE:MRK) HADLIMA (adalimumab-bwwd), a biosimilar to AbbVie’s (NYSE:ABBV) top seller Humira (adalimumab).

Ligand Acquires Ab Initio Biotherapeutics, Antigen-Discovery Firm

Strengthens and expands its OmniAb platform offering
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces the signing of an agreement with Ab Initio Biotherapeutics whereby Ligand will acquire Ab Initio for $12 million in cash. Ab Initio was a privately held antigen-discovery company based in South San Francisco, California. Antigen design and preparation are the first steps necessary for the discovery of therapeutic antibodies. Some antibody targets are particularly difficult and require a specialized approach to design, prepare and deliver an antigen to enable the successful discovery of an antibody drug candidate. This transaction will have minimal impact on Ligand’s future cost structure.
Ab Initio brings to Ligand a patented antigen technology that is synergistic with Ligand’s OmniAb® therapeutic antibody discovery platform. This new technology will provide Ligand’s current and potential new partners enhanced capabilities for the discovery of therapeutic antibodies against difficult-to-access cellular targets. In addition, Ab Initio has a collaboration agreement with Pfizer Inc. to discover novel therapeutic antibodies against an undisclosed target in the G-protein coupled receptor (GPCR) superfamily. GPCRs comprise the largest class of therapeutic drug targets, with key regulatory roles ranging from cardiovascular biology to metabolic health. Under the agreement, Ligand is eligible to receive potential milestones and tiered royalties on potential future sales. Ab Initio also currently has two unpartnered preclinical programs focused on hematological malignancies and solid tumors.
“The Ab Initio technology is highly complementary to our OmniAb platform. Antigen generation is a required step in the antibody discovery process and some targets are very complex with the initial work of antigen design and preparation being difficult. By bolting on the proprietary antigen technology, Ligand will be able to more fully meet the needs of our partners,” said John Higgins, Chief Executive Officer of Ligand. “Since Ligand’s acquisition of OmniAb in 2016, we have continued to augment the platform through additional internal R&D, partnering and supporting acquisitions such as OmniChicken and now Ab Initio. Ligand is providing a cutting-edge antibody discovery platform that provides considerable value to our current partners.”