1st evaluation of benefits, harms of Alzheimer’s screening on patient’s family

With the support of a new $3 million, five-year National Institute on Aging grant, researchers from the Regenstrief Institute and Indiana University Center for Aging Research are conducting the first evaluation of the benefits and harms of Alzheimer’s disease screening for family members of older adults.

A majority of individuals with Alzheimer’s receive care from family members –most commonly spouses or adult children or siblings — but the effect of early identification of Alzheimer’s by screening on these caregivers has never been determined.

“Does early identification of Alzheimer’s by screening prepare family members for a future caregiving role or does it depress them?,” queries Regenstrief Institute and IU Center for Aging Research investigator Nicole Fowler, Ph.D., the principal investigator of the new study. “We know that a delayed dementia diagnosis may perpetuate family beliefs that changes in cognition are part of ‘normal aging’. These are beliefs that have been shown to aggravate caregivers’ stress, burden and sense of isolation.

“But what we don’t yet know is — if by identifying possible Alzheimer’s early — if we can better prepare family members for a caregiving role and reduce their burden.”

The new study is enrolling 1800 adults age 65 and older who have not been diagnosed with Alzheimer’s or other dementias or serious mental illness. Additionally, the family member who each older adult indicates would be most likely to be a caregiver if needed (a total of 1800 potential caregivers) will be enrolled in the study, which is known as COADS, short for Caregiver Outcomes of Alzheimer’s Disease Screening.

Each pair of older adult and family member participants will be randomized into one of three groups and tracked for 24 months.

The older adults in Group I will not receive Alzheimer’s screening. The family members will not be given any information about their older adults’ cognition.

The older adults and family members in Group II will be randomized to Alzheimer’s screening and will be told about the older adults’ Alzheimer’s screening results. For example, they may be advised that based on screening test performance it appears that the older adult may have memory issues and that they should follow up with their doctor. The older adult’s physician will be made aware of the screening results.

The older adults and family members in Group III will be randomized to Alzheimer’s screening and will be told about the older adults’ Alzheimer’s screening results. If the older adult has screened positive for cognitive impairment, a referral will be given to the evidence-based Aging Brain Care (ABC) Program at Eskenazi Health for diagnostic evaluation and will be offered dementia collaborative care management if Alzheimer’s is diagnosed.

“You wouldn’t screen for any other condition and do nothing with a positive result,” said Dr. Fowler, who, in addition to the Regenstrief Institute is on the faculty of IU Center for Health Innovation and Implementation Science and IU School of Medicine. “Best practice is if you are going to screen, you also need to provide state-of-the-science diagnostic care and care management. That’s what we will offer the older adults and family caregivers in Group III to see if it makes a difference for caregivers.

“We can’t stop the train from leaving the station, but we can help the journey for both the older adults and their families. This study will answer the question of how screening for Alzheimer’s affects that crucial individual — the family caregiver.”

Source:

https://www.regenstrief.org/article/first-study-benefits-risks-dementia-screening-family-members-older-adults/

https://www.news-medical.net/news/20180920/First-evaluation-of-benefits-harms-of-Alzheimers-screening-for-family-members-of-older-adults.aspx

Healthcare spending growth bounces back

Post-recession spending growth is climbing towards pre-recession levels and is largely driven by brand-name drugs, ER visits, and outpatient surgeries.

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KEY TAKEAWAYS

Employer-sponsored insurance claims saw annual average growth rates of 4.1% over the past decade.

Spending growth has accelerated toward pre-recession levels over the past three years.

ER visits, outpatient services and brand-name presciption drugs account for nearly half the spending growth.

Private-sector healthcare spending grew by 44% over the past decade, rising from $3,752 per person with employer-sponsored insurance in 2007 to $5,394 in 2016, according to a study by the Health Care Cost Institute.

The recession, the Affordable Care Act, and strategic shifts in care delivery slowed spending growth but it’s since rebounded. Spending growth in 2015 and 2016 climb toward pre-recession levels seen in 2007 through 2009, according to the study, which was published online Wednesday in Health Affairs.

The study is the latest to suggest that healthcare spending is accelerating and straining budgets across the economy, from the federal government, to businesses and households.

HCCI researchers examined private employer-sponsored insurance claims for about 40 million people, and found the annual average growth rate was 4.1% over the decade, ranged from 6.3% in 2009 to 2.6% in 2014, and climbed to an average of 4.4% growth in 2015 and 2016.

“Retrospective studies like ours show that healthcare spending is cyclical,” study co-authors Amanda Frost and Kevin Kennedy said in an email to HealthLeaders.

“We observed a period of fast spending growth, followed by a period of much slower growth during the Great Recession. More recently, healthcare spending is up, and NHE predicts that we may be entering a period of faster growth.”

Adjusted for inflation, healthcare spending rose 23% from 2007 through 2016, the researchers said.

Brand-name prescriptions, ER visits, and outpatient surgery drove 48% of the per capita spending increase. Frost and Kennedy say these three high-cost growth areas “may be good targets for cost-saving measures.”

“Though, we did find that spending grew across all four main categories of health services: inpatient, outpatient, professional, and prescriptions,” they said.

The findings also provide more evidence of a fundamental shift by consumers away from inpatient settings in favor of lower-cost outpatient settings.

Per capita out-of-pocket spending on brand-name and generic prescription drugs declined, and researchers pointed to benefit design changes and patterns of service use.

“In the case of brand-name prescriptions, recent spending trends did not correlate with utilization trends,” Frost and Kennedy say. “Use of brand prescriptions has been falling each year, while spending has been increasing—suggesting price increases drove spending.”

In addition, per capita out-of-pocket spending increased by 43%, driven by outpatient and professional services. The largest increase was seen in spending for ER visits.

Frost and Kennedy conceded some limitations in their study. While the sample data represents more than 25% of the population with employer-sponsored insurance, they said it may not be representative of the larger employer-sponsored insured population.

The study also excludes spending trends for patients with public insurance, and does not track health insurance premiums paid by employers and employees or information on drug rebates and coupons.

https://www.healthleadersmedia.com/clinical-care/healthcare-spending-growth-makes-comeback

Vanda announces HETLIOZ patent listing in FDA Orange Book

Vanda Pharmaceuticals announced that a HETLIOZ patent, number 10,071,977, is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The ‘977 patent was issued by the United States Patent and Trademark Office on September 11, 2018 and expires in February 2035. Prior to this newly listed ‘977 patent, the HETLIOZ Orange Book listed patent with the latest expiry date was set to expire in May 2034.
https://thefly.com/landingPageNews.php?id=2793511

As San Francisco Real Estate Prices Spiral, Some Biotechs Look to the ‘Burbs

The two biggest areas for biotech startups in the U.S. are Cambridge in Boston and the San Francisco Bay Area. They’re also the locations of astonishingly expensive real estate. But they’re where biotechs seem to want to be because they’re close to talent, academic research institutions, and the attention of venture capital.

In the Bay Area, at least some startups are thinking about moving outside the area, at least a little bit, in order to control costs. The San Francisco Chronicle reports on several biotech companies that are settling some or all of their operations in Pleasanton, a suburb of San Francisco in Alameda County about 25 miles east of Oakland.

One of those companies is 10X Genomics, which has headquarters in Pleasanton, and decided to quadruple the company’s space to 200,000 square feet in the city rather than move it somewhere else. “Pleasanton is the sweet spot where you get the talent from all across the Bay Area and rents aren’t quite as expensive as San Francisco or the Peninsula,” said Serge Saxonov, co-founder and chief executive officer of 10x.

10x has a manufacturing plant in Germany, which it plans to keep, but the new site in Pleasanton will manufacture its products end-to-end, not just components, as in the German facility. This allows company executives to be more hands-on while having access to the region’s workforce that has the necessary specialized backgrounds in chemistry, biology, hardware and software.

This falls into the part of the Bay Area dubbed the East Bay, and it’s no stranger to biopharma companies. Others in the region include Roche Molecular, Bio-Rad Laboratories, and IntegenX, now owned by Thermo Fisher. The San Francisco Chronicle reports, “Lately, the region — though it doesn’t have the biotech cache of South San Francisco or the newness of San Francisco’s Mission Bay — has also been drawing smaller, newer and fast-growing firms that make critical hardware, software and technology used by biotech companies.”

Pleasanton is part of what is dubbed the Tri-Valley, which includes the cities of Pleasanton, Danville, Dublin, Livermore and San Ramon. From 2006 to 2016, these cities had a 35-percent job growth, higher than San Francisco’s 31 percent and Silicon Valley’s 19 percent.

Others in the area include Unchained Labs, which is a subsidiary of 10x, and Gritstone Oncology. Gritstone is located in Emeryville and in August, inked a collaboration deal with Cambridge, Massachusetts-based bluebird bio. It recently filed for an initial public offering (IPO) with plans to raise up to $91 million.

“We chose Pleasanton because I’ve been in life sciences for more than 20 years, and the whole time I was doing the crazy commute to the valley (Sunnyvale and Santa Clara),” Tim Harkness,founder and chief executive officer of Unchained Labs, told The San Francisco Chronicle. “I wanted to stop that craziness, and I didn’t think I was alone.”

The Chronicle writes, “It was risky to base the company in Pleasanton three years ago, said Harkness, who is also a founding partner at Tri-Valley Ventures, a venture fund created last year to back early-stage technology, IT and life sciences firms. But it turned out to be a competitive advantage, he said, because the location made it easier to recruit employees from Tracy and the Central Valley, where many Bay Area residents are seeking more affordable housing.”

For comparison, office space in San Francisco runs around $74 per square foot. Silicon Valley’s office space is about $52 per square foot, but the Tri-Valley real estate runs about $32 per square foot. In Cambridge, Massachusetts, the average is $65.35 per square foot as of 2017, with laboratory space typically running higher than the office space. For example, in mid-Cambridge, office space averaged $59.69 per square foot, but laboratory space averaged $76.08 per square feet, according to Lincoln Property Company’s Cambridge Office & Lab Market Report, Second Quarter 2017.

Does this mean the hotspots of South San Francisco, Oyster Point and Kendall Square, Massachusetts are no longer the places to be? Probably not. But for the more budget conscious biotechs, the suburbs may be looking more attractive.

https://www.biospace.com/article/jc1n-as-san-francisco-real-estate-prices-spiral-some-biotechs-look-to-the-burbs/

Medicare hospice payment model fails its first year

A Medicare model meant aimed at patients who wanted hospice as well as curative care did not do well in its first year because hospice providers fled the program and doctors were disinterested in participating in it, according to a new federal evaluation.

The CMS five-year experiment, known as the Medicare Care Choices Model launched in January 2016. The model was created because Medicare previously didn’t pay for hospice—which includes pain management, nursing care, counseling and respite care—until patients stopped treatment to slow or cure their illness, such as chemotherapy or radiation therapy.

Under the initiative, hospices receive a monthly payment of $200 to $400 per patient per month. Meanwhile, other providers can still bill Medicare for curative services.

The model immediately began to face problems once it launched and by the end of its first year, 37 hospices, or more than a quarter of those that agreed to participate in the model, exited the effort, according to the report released Wednesday.

Hospices found the $400 payment offered by the CMS to not be enough to cover their costs and they had difficulty finding beneficiaries who met all the eligibility criteria to get treatment under the model. Hospice providers historically have had trouble being properly paid for their services.

Criteria to be covered under this program included beneficiaries not being enrolled in a Medicare managed care organization and participation in a Part D plan. They also needed to be living at home, not in a nursing facility and they had to have had at least two hospital admissions during the prior 12 month period for a set list of diagnoses that included AIDS, heart failure, chronic obstructive pulmonary disease or cancer.

The CMS thought there would be interest in the model given as many as 150,000 patients chose to receive care under the initiative. However, only 5,022 beneficiaries were referred to the program by June 2017 and 60% of those patients turned out not to be eligible to participate. Of the remaining 2,002 patients, 1,092 ultimately chose to enroll.

Hospice staff also encountered physicians who failed to refer patients to the model. The clinicians viewed it as “adding another thing in their to-do list,” according to the report.

Low enrollment made it impossible for the CMS to determine if the model slowed Medicare spending in its first year, the report said.

Edo Banach, president and CEO of the not-for-profit National Hospice and Palliative Care Organization said he is still optimistic the model can help seniors in its remaining years. He noted the report indicated that hospice staff in the model was highly satisfied in the program, as were referring providers, enrollees and their families.

“Hospice providers in the model have demonstrated how to provide beneficiaries and their caregivers with a seamless continuum of services through their serious illness and into hospice,” Banach said. “With valuable lessons learned, NHPCO is looking forward to working with CMS to build upon [the model] in the years ahead.”

Another reason for optimism is that the CMS has gradually reduced eligibility requirements for the program which hospices say will lead to an increased enrollment, according to Liz Fowler, CEO of Bluegrass Care Navigators, a hospice and palliative care agency in Lexington, Ky. that’s still involved in the model.

Fowler is convinced patient word of mouth will be positive, given patients and caregivers receive round the clock care management support.

“We often hear people say no one has ever listened to me like this before,” Fowler said. “They can call someone at 2 a.m. and talk to someone they know and trust.”

http://www.modernhealthcare.com/article/20180920/TRANSFORMATION04/18092998

Stop Saying Social Media ‘Addiction’

Recently, the CEOs of Facebook and Twitter came before the Senate Intelligence Committee, which held hearings on attempts by foreign adversaries to use social media to manipulate elections, proliferate “fake news,” and sow discord among Americans. Senators also brought up the issue of social media addiction. There are fears that manipulative efforts by malevolent hackers might have greater impact on people whose addiction compels them to face constant exposure to this content.

But the American Psychiatric Society does not consider “social media addiction” also called “internet addiction disorder” to be a behavioral disorder. In the current Diagnostic and Statistical Manual of Mental Disorders (DSM) it’s listed as a “condition for further study.” Researchers have yet to approach a consensus as to whether perceived excessive time spent on the internet and engaged with internet-based social media is an addictive behavioral disorder. One of the leading researchers on the subject stresses that most reports on the phenomenon are anecdotal and peer-reviewed scientific research is scarce. As a result, most “internet addiction” rehab programs in the U.S. are not covered by health insurance.

The public perception that social media is addictive is no small matter. Legacy media is threatened by the “creative destruction” they face from social media platforms that bypass them to provide access to news and viewpoints that might not otherwise get through their gates. In the U.K., for example, where freedom of speech is not constitutionally guaranteed, media companies are urging the government to intervene to “counteract all potential online harms, many of which are exacerbated by social media.” Politicians are motivated to regulate social media platformsto protect the integrity of the election process, but also to assure that their political positions are presented in what they consider to be the “proper light” and are not misrepresented. These examples of privilege-seeking are nothing new.

But regulation of the internet and social media content has serious implications for freedom of speech, freedom of the press, and freedom of association. In some countries, tech companies have collaborated with the government in efforts at social conditioning. Last year police in Berlin raided the homes of 36 people accused of “hateful postings” on social media. German law prohibits a range of postings with punishments of up to 5 years in prison for inciting racial hatred.

The U.S. Constitution stands in the way of laws like those in many European Union countries. So do American sensibilities. But those cultural sensibilities might be changingas younger people appear more open to limitations on speech deemed “hateful.” Right now it is difficult to imagine the public supportive of such interventions.

But the fear of addiction to social media might conceivably reach the level of today’s fear of addiction to opioids. It is not a stretch to see social media platforms like Twitter and Facebook demonized as purveyors of addictive content, making them as unsympathetic as the opioid pharmaceutical companies or “Big Tobacco.” If this happens, resistance to intrusive regulations of internet content will erode.

The American Society of Addiction Medicine defines addiction as “chronic disease of brain reward, motivation, memory and related circuitry … characterized by the inability to consistently abstain, impairment in behavioral control, [and] craving” that continues despite the resulting destruction of relationships, economic conditions, and health. Addiction has a biopsychosocial basis with a genetic predisposition and involves neurotransmitters and interactions within reward centers of the brain. The interaction of these factors has not been established with respect to social media use.

In a recent Pew study, a majority of users overall stated it would not be difficult to give up visiting social media sites, although among those younger than 24, 51% stated it would be difficult. In another survey of Facebook users, 42% said they had taken a break from the platform for several weeks or more, and 26% had deleted the Facebook cell phone app altogether.

While excessive time on the internet and social media has been correlated with depression and even suicide, causation has not been established.

It is not nitpicking to push back on talk of social media addiction. Medical professionals should correct, not enable politicians and pundits when they misspeak.

Before people see their rights infringed or are otherwise harmed by unintended consequences, it would do us all a great deal of good to be more accurate and precise in our terminology. It would also help if policymakers knew more about the matters on which they create policy.

Jeffrey A. Singer, MD, practices general surgery in Phoenix and is a senior fellow at the Cato Institute.

https://www.medpagetoday.com/psychiatry/addictions/75194

Array BioPharma says EU approves BRAFTOVI, MEKTOVI combo

Array BioPharma announced that the European Commission has approved BRAFTOVI in combination with MEKTOVI for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test. This approval is applicable to all 28 European Union member states, as well as Liechtenstein, Iceland and Norway. “With an even greater number of patients with advanced BRAF-mutant melanoma in Europe than in the U.S., we are delighted BRAFTOVI + MEKTOVI will be available to these patients who are in critical need of additional options that delay disease progression and improve overall survival,” said Ron Squarer, Chief Executive Officer. “Our European partner, Pierre Fabre, has a strong legacy in oncology, and with over a thousand employees dedicated to this therapeutic area, we are very pleased they have made BRAFTOVI + MEKTOVI a top priority for their team.” https://thefly.com/landingPageNews.php?id=2793387