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It may be a cross between the Eurovision Song Contest, a papal conclave and a social club raffle but a ballot among EU ministers...could hurt Europe’s pharmaceutical industry and the health of millions...It will fix the new home of the European Medicines Agency, which must leave London by 2019 when Britain leaves the European Union; most of its 900 staff may refuse to move to many of the 19 cities in the running, the EMA warns. Replacing them would delay drug approvals and patient safety checks...Yet the result, diplomats agree, is utterly unpredictable; months of horse-trading on issues unrelated to healthcare will end up in hours of haggling between secret ballots in Brussels...It could even come down to drawing lots...Senior officials liken the process to Europe’s annual TV music schlock-fest, when the winner of the Eurovision Song Contest is often determined by viewers phoning in votes for acts from like-minded neighbouring states and historic allies...British bookmaker Ladbrokes has Milan the 2-1 favorite to secure the EMA...seasoned diplomats hesitate to quote odds: “The most likely result is one that will be perverse,” said one, recalling previous upsets behind closed doors...Another referred to closeted cardinals electing popes at the Vatican: “In the end,” he said, “We will get the white smoke.”

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The American Hospitals Association and other organizations have made good on their promise to sue the federal government in an effort to halt a major cut planned for the 340B Drug Pricing Program...The hospitals are arguing the reimbursement change exceeds the authority of the HHS secretary and is "arbitrary and capricious." They ask the court to force HHS to delay implementation or strike the cut entirely...HHS released a final rule earlier this month that changes the amount 340B hospitals will be paid for most drugs to 22.5% less than the average sales price starting at the beginning of next year. Currently those hospitals are paid the average price plus 6%...The cut of about 30% would hurt nonprofit hospitals' margins, according to a recent report from Moody's. The CMS has argued the change would reduce out-of-pocket costs and improve patient-provider relationships. The agency has calculated the 340B cut would save about $900 million next year...AHA has been strongly critical of the cut, saying it threatens patient care, particularly for vulnerable populations that are most likely to use safety net hospitals benefiting from the drug payment program...A recent report found 340B hospitals had a larger decrease in charity care spending than other hospitals, but AHA said the study was misleading and incomplete.

According to the Harvard Business Review, several big-name hospitals reported significant declines and, in some cases, net losses to their FY 2016 operating margins...How did some of the biggest brands in care delivery lose this much money? The problem isn’t declining revenue...Part Of The Problem Is Rooted In The Past...From the late 19th century to the early 20th, hospitals were places the sick went to die. For practically everyone else, healthcare was delivered by house call. With the introduction of general anesthesia and the discovery of powerful antibiotics, medical care began moving from people’s homes to inpatient facilities. And by the 1950s, some 6,000 hospitals had sprouted throughout the country...By the time Medicare rolled out in 1965, healthcare consumed just 5% of the Gross Domestic Product. Today, that number is 18%...Hospitals have contributed to the cost hike in recent decades by: (1) purchasing redundant, expensive medical equipment and generating excess demand, (2) hiring highly paid specialists to perform ever-more complex procedures with diminishing value, rather than right-sizing their work forces, and (3) tolerating massive inefficiencies in care delivery...Most hospital leaders acknowledge the need to course correct, but very few have been able to deliver care that’s significantly more efficient or cost-effective than before. Instead, hospitals in most communities have focused on reducing and eliminating competition. As a result, a recent study found that 90% of large U.S. cities were “highly concentrated for hospitals,” allowing those that remain to increase their market power and prices...

Fentanyl billionaire John Kapoor is set to plead not guilty this morning on charges of racketeering, mail fraud, wire fraud and conspiracy to violate the anti-kickback law...The founder and former CEO and chairman of ...Insys Therapeutics, Kapoor became a billionaire in 2013 because of the skyrocketing sales of that company’s Subsys, a form of the powerful opioid fentanyl that is sprayed under the tongue. He was arrested and charged on October 26 for allegedly leading a conspiracy to use fraud and bribes to market the drug and is set to appear in federal court in Boston...for his arraignment...Prosecutors...allege that Kapoor and six other executives...were arrested and charged...as part of a superseding indictment, offered bribes and kickbacks to doctors and nurses to get them to write large numbers of Subsys subscriptions to patients, most of whom did not have cancer.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Amazon.com Inc.'s filings with state pharmaceutical regulators reveal the company is not looking to sell drugs on its marketplace...The filings to distribute to at least 12 states from three facilities in Indiana reveal Amazon could distribute medical devices, supplies, gas or pharmaceuticals from the warehouses. However, to distribute drugs the company would likely also have to pursue a deal with a pharmaceutical benefits manager...In correspondence with regulators in Tennessee and Indiana, Amazon explicity (explicitly) said it would not "store or ship drugs," tempering rumors that the company would move into the pharmacy business in the near term...Spinners have spread rumors Amazon will soon disrupt the pharmaceutical supply chain, but it turns out the opposite is true: drugs, at least, are safe from e-commerce — but medical distributors are not so lucky...Companies like McKesson Corp. and Cardinal Health Inc. have long had a stranglehold on the medical supply distribution market, serving as middlemen between countless suppliers and the dozens of hospitals and clinics they serve. As healthcare providers continue to consolidate, so does suppliers' opportunities to sell to big clients...pharmaceutical companies and healthcare providers alike should watch the e-commerce giant's healthcare experiment with interest, as its success will likely anticipate further expansions — either in distribution or logistics.

The thought of lab-grown organs conjures up Frankenstein-like imagery. The reality however, is somewhat less visually dramatic, with the term ‘organoids’ used to describe tiny 3D structures of human tissue, a millimeter or so in diameter...these tiny lumps of cells are creating a lot of excitement in the world of medical research...Cells in dishes and animal models have been used for preclinical testing of drugs for decades. Success in these experiments is a key hurdle for any new medicine to overcome before being given the green light for all-important human clinical trials...Organoids are most commonly made either from a small sample of tissue needled out of a person or from stem cells cultured in a cocktail of nutrients intent on pushing them towards becoming a particular tissue type. So far, organoids have been made resembling several tissues including lung, liver, brain, kidney and intestine...as a relatively new innovation they are being used to investigate dozens of conditions from infectious diseases to cancer.... A study published last year in Science Translational Medicine by scientists at the University Medical Centre, Utrecht generated organoids formed from the rectal tissue of 71 people with cystic fibrosis and exposed them to experimental drugs. By observing changes in the organoids, the scientists accurately predicted which patients would respond to the therapies in just one week at a cost of around $1200 per patient. The results were so convincing that a positive organoid test is now considered sufficient evidence for insurance companies to fund the new therapies in the Netherlands...

New guidelines lower the threshold for high blood pressure, adding 30 million Americans to those who have the condition, which now plagues nearly half of U.S. adults...High pressure, which for decades has been a top reading of at least 140 or a bottom one of 90, drops to 130 over 80 in advice announced Monday by a dozen medical groups...The change means an additional 14 percent of U.S. adults have the problem, but only an additional 2 percent will need medication right away; the rest should try healthier lifestyles, which get much stronger emphasis in the new advice. Poor diets, lack of exercise and other bad habits cause 90 percent of high blood pressure...The guidelines were announced Monday at an American Heart Association conference in Anaheim...WHAT THE CHANGES MEAN

• The guidelines set new categories and get rid of "prehypertension":
• Normal: Under 120 over 80
• Elevated: Top number 120-129 and bottom less than 80
• Stage 1: Top of 130-139 or bottom of 80-89
• Stage 2: Top at least 140 or bottom at least 90

Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue...The progress comes as Food and Drug Administration Commissioner Scott Gottlieb...indicated that the agency will expand which abbreviated new drug applications will see priority reviews..."Earlier this year we made changes to how we prioritize the agency’s generic drug submissions. The goal was to prioritize the review of generic applications until the FDA has approved three generic versions of each particular drug," Gottlieb said in a statement. "Today we’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine."...The shift could accelerate generic competitors to market more quickly and help bring down costs, and comes a day after the Federal Trade Commission held a workshop on drug competition.