Search This Blog

Friday, November 15, 2019

Oklahoma judge lowers J&J’s opioid epidemic tab by $107M

Saying he miscalculated the cost of treating babies addicted to opioids, Oklahoma judge Thad Balkman has reduced Johnson & Johnson’s (JNJ +2.9%) financial commitment over its role in the opioid crisis in the state. The company will now be on the hook for $465M, $107M lower than the initial settlement of $572M, citing an initial estimate of $107M to develop a program which should have been $107K.
He declined a request by the defendants for a more significant reduction considering the $355M settlement with Purdue Pharma and Teva Pharmaceutical Industries (TEVA +8.4%).
Related tickers: AmerisourceBergen (ABC +1.9%), Cardinal Health (CAH +2.8%), McKesson (MCK +2.6%), Endo International (ENDP +9%), Mallinckrodt (MNK +4.3%)

Amazon Pharmacy debuts branding

PillPack gets a name change to “PillPack by Amazon (NASDAQ:AMZN) Pharmacy,” the first public reference to Amazon Pharmacy.
CNBC sources say PillPack CEO TJ Parker was promoted over the summer to a VP position reporting directly to Doug Herrington, SVP for North America.
Amazon purchased PillPack last year for $750M in one of its largest healthcare pushes.

Qiagen shares halted pending news

The NYSE has suspended trading in QIAGEN (QGEN +0.3%) pending the release of news. Thermo Fisher Scientific (TMO +1.7%) is rumored to be a suitor.
Update: In a statement, the company says it has received several conditional “non-binding indications of interest” and has begun the process of reviewing strategic alternatives, including talks with interested parties.
Update: Shares resumed trading at ~3:39 pm ET and are up 9% approaching the close.

Lower cost hospitals patient outcomes similar to higher cost counterparts: JAMA

  • A new study in JAMA Network Open finds that Medicare patients with heart failure or pneumonia likely had more costs associated with the hospital where they were receiving treatment than their acuity.
  • The researchers randomly studied 1.22 million patients discharged between July 2013 and June 2016, and further isolated them to 1,615 patient pairs who were admitted twice for the same conditions to hospitals with high and low payment profiles.  The median payments up to 30 days after admission when divided by upper and lower quartile ranged from $13,789 to $16,651 for heart failure and $13,606 to $18,382 for pneumonia.
  • Spending on heart failure patients treated at lower-cost hospitals was $2,118 lower than at higher-cost hospitals. Spending on pneumonia patients was $2,907 less at the low-cost hospitals than the high-cost hospitals. Mortality rates and other outcomes were similar for both groups.

There has been a long-held assumption in the hospital sector that case acuity, socioeconomic stratification and many other factors greatly affect overall healthcare costs. However, a new study by researchers from Yale University, Harvard University and Yale-New Haven Hospital found lower cost hospitals — which tended to be smaller and non-teaching facilities than their high-cost counterparts — treated the same patients at less cost with virtually the same outcomes.
“We found marked differences in payment depending on which hospital the patient received care at. No evidence was found that lower-payment hospitals had higher mortality rates,” the study concluded.
There were some variations in care. According to the study, heart failure patients were less likely to receive percutaneous coronary intervention or an implantable cardiac defibrillator.
Yet the study’s authors suggested heart failure patients actually had lower readmission rates at the lower cost hospitals, which in turn may have helped keep those costs even lower. Heart failure patients at the lower cost facilities also had lower overall hospitalization and post-acute care costs. Pneumonia patients also had significantly lower hospitalization costs at the low-cost facilities.
As a result, the authors observed that the “lower-cost hospitals may represent achievable benchmarks and identify opportunities for reducing cost.” And while they concluded “research is needed to identify and address cultural and financial factors in resource use that might affect these different payment profiles,” they also noted “the idea that lower costs are achievable may provide the impetus to investigate new strategies rather than simply resist the possibility that efficiencies can be achieved.”

Lots of Worry, Little Discussion of Future Dementia Risk

Nearly half of Americans in their 50s and early 60s think they’re likely to develop dementia, according to National Poll on Healthy Aging data released today.
The online survey showed that 48.5% of people ages 50 to 64 believed they were somewhat or very likely to develop dementia in their lifetime, reported Donavan Maust, MD, MS, of the University of Michigan’s Institute for Healthcare Policy and Innovation in Ann Arbor, and colleagues in JAMA Neurology.
Only 5.2% said they had discussed dementia prevention with their doctor. About a third used fish oil or omega-3 or took other vitamins or supplements to prevent memory loss.
“A lot of people report doing things to maintain their memory that are not supported by any good science, while they are not talking to clinicians about things they could actually do,” Maust told MedPage Today.
These survey findings are important for two reasons, Maust noted. “First, given the lack of dementia treatments, interest has moved more to prevention earlier and earlier in the disease process,” he said. “But the patients who engage in prevention would probably be motivated by their perceived risk of dementia, so it is important to understand more about how people understand their risk.”
“Second, there is growing evidence that some prevention strategies already exist,” he added. “We were interested in what people report they are doing and how that compares to what evidence suggests is effective.”
In this survey, researchers interviewed 1,019 people from a probability-based online panel of the U.S. population. Respondents provided demographic and health information and reported whether they thought they were very, somewhat, or not likely to develop dementia in their lifetime. They also answered yes-or-no questions about whether they had ever discussed ways to prevent dementia with their doctor and about four specific strategies to “maintain or improve” their memory — fish oil or omega 3, ginkgo, other vitamins and supplements, and crossword puzzles.
Overall, 44.3% (95% CI 41.1%-47.5%) thought they were somewhat likely to develop dementia, and 4.2% (95% CI 3.1-5.8%) thought they were very likely.
Non-Hispanic black Americans were significantly less likely to think they may develop dementia than white people (OR 0.51, 95% CI 0.32-0.81; P=0.01), even though they have a higher prevalence of dementia than other racial or ethnic groups. People who rated their physical health as fair or poor also did not think they might have a higher likelihood of dementia than people with excellent or very good health (OR 1.46, 95% CI 0.93-2.28; P=0.10).
“There may be a mismatch between how people perceive their risk of dementia,” Maust said. “In other words, the people at highest risk — those with poor physical health and non-Hispanic African-Americans — did not perceive their risk as high compared to other respondents.”
Overall, 31.6% of respondents said they took fish oil or omega 3 to prevent memory loss; 39.2% used other vitamins or supplements. Less than 10% used ginkgo and more than 50% did crossword puzzles to maintain or boost memory.
How do these perceptions of dementia risk stack up against reality? “Given how the question is worded, it is hard to translate ‘very’ or ‘somewhat’ likely into what science tells us about actual risk,” Maust noted.
“But recent work by Brookmeyer and Abdalla suggests the lifetime risk for a 60-year-old woman is 24.4% and man is 17.6%,” he said. “So you might say that 50% of poll respondents aged 60 to 64 saying they are somewhat or very likely to develop dementia is high.”
Disclaimer
This research was supported by AARP, Michigan Medicine, and grants from the National Institute on Aging.
Researchers reported relationships with the National Institute on Aging, the National Institute on Drug Abuse, the Department of Veterans Affairs, AARP, See Change Health, Health Mine, Kaiser Permanente Washington Health Research Institute, the Robert Wood Johnson Foundation, the American Diabetes Association, AbleTo, Inc., Kansas City Area Life Sciences Institute, the Veterans Health Administration, and VA Health Services Research and Development Service.

Amarin enters the home stretch

After an overwhelmingly positive adcom, the outstanding question around Vascepa is just how big the product might become.
This time six years ago a heavily indebted Amarin, whose market cap had been crushed to a tiny $250m, was waiting for the FDA to turn down its application to market Vascepa to a bigger patient population. Fast forward to 2019, and the picture could not look more different.
A unanimous vote by an FDA advisory panel yesterday almost guarantees a broader label for the purified fish oil product, and the big remaining question is just how many patients the regulator is prepared to include in any new indication. With a decision due just before the end of the year, the wait to find out will soon be over.
The use of mineral oil as a placebo was considered one of the big issues heading into the adcom but in the event the panellists judged it unlikely to have influenced the findings of the Reduce-It study (Vascepa’s future could hinge on next week’s panel, November 5, 2019).
The main focus of the assembled experts was instead whether Vascepa’s new indication should be restricted to a secondary prevention setting, meaning only patients with established cardiovascular disease. Less than a fifth of the 8,000 subjects recruited into Reduce-It fitted a primary prevention description – those considered at risk of future cardiac problems – and the benefit of Vascepa was much less pronounced in this cohort.
As such, the FDA could have reason to err on the side of caution. Even so, the panel was not particularly concerned about safety flags like atrial fibrillation or bleeding, with some panelists advocating an all-encompassing label.
 For now, most sellside analysts are modelling revenues in a restricted population, with peak numbers sitting at around $4bn. This implies a net present value for Vascepa of around $8bn, according to EvaluatePharma’s NPV Analyzer, pretty much where Amarin’s market cap is today.
Shares in the company, which have surged more than sevenfold since Reduce-It surprised by reading out positively, edged 6% higher this morning.
How exactly Vascepa bestows its cardioprotective qualities remains unanswered, and perhaps this is another reason why the FDA might decide against a very broad label. Amarin has not announced any plans to study the drug in a primary prevention setting, and with Vascepa patents only running to around 2029 in the US there is probably little reason for a commercial company to run such a trial.
A small academic study being presented as a late-breaker at the American Heart Association’s annual meeting over the weekend will make interesting reading, however. The Evaporate trial looks at Vascepa’s ability to stabilise artery plaques, having recruited statin-treated patients with atherosclerosis, and is measuring changes in plaque volume in subjects treated with Vascepa or placebo.
A strong finding here would only add to the Vascepa story, which has provided biopharma watchers with a riveting ride over the past decade. It’s not over yet, though it certainly no longer looks like a disaster movie. Indeed, many will be hoping that the tale has the ultimate happy ending: a buyout.

Apple to ban all vaping apps after 42 EVALI deaths

Apple removed 181 apps related to vaping from the App Store Nov. 15 in a vaping app ban, according to CNBC.
The ban comes after the CDC reported 2,172 cases of e-cigarette or vaping product use-associated lung injury — or EVALI — Nov. 14, along with 42 EVALI deaths.
The removed apps include store apps, games, and hardware companion apps that let users regulate lighting and heating of vaping products. Users who have already downloaded the apps will still be able to use them.
“We’ve updated our App Store review guidelines to reflect that apps encouraging or facilitating the use of these products are not permitted,” Apple told CNBC in a statement. “As of today, these apps are no longer available to download.”
Apple stopped accepting new apps promoting the use of vape products in June, CNBC reports.