Dementia care plans delay nursing home admits, cut Medicare cost: JAMA

A comprehensive, coordinated care program for people with dementia and their caregivers significantly decreased the likelihood that the individuals would enter a nursing home. The study also shows that the program saved Medicare money and was cost-neutral after accounting for program costs.

The research, conducted at the UCLA Alzheimer’s and Dementia Care Program, was designed to evaluate the costs of administering the program, as well as the health care services used by program participants, including hospitalizations, emergency room visits, hospital readmissions and long-term nursing home placement.

“The findings of this study show that a health care system-based comprehensive dementia care program can keep persons with dementia in their homes and in the community without any additional cost to Medicare,” said the study’s senior author, Dr. David Reuben, Archstone Professor of Medicine and chief of the UCLA Division of Geriatrics at the David Geffen School of Medicine at UCLA.

The study was published Dec. 21 in JAMA Internal Medicine.

The research focused on the UCLA Alzheimer’s and Dementia Care Program. In the program, people with dementia and their caregivers meet with a nurse practitioner specializing in dementia care for a 90-minute in-person assessment and then receive a personalized dementia care plan that addresses the medical, mental health and social needs of both people. The nurse practitioners work collaboratively with the patient’s primary care provider and specialist physicians to implement the care plan, including adjustments as needs change over time. A total of 1,083 Medicare beneficiaries with dementia were enrolled in the program and were followed for three years. The study compared them to a similar group of patients living in the same ZIP codes who did not participate in the program.

“The most striking finding was that patients enrolled in the program reduced their risk of entering a nursing home by about 40 percent,” said lead author Dr. Lee Jennings, assistant professor at the University of Oklahoma College of Medicine. Jennings began the project while on faculty at the Geffen School and finished it after arriving at Oklahoma.

There were no differences between the two study groups in hospitalizations, emergency room visits or hospital readmissions. However, cost was another important element of the study. Participants in the program saved Medicare $601 per patient, per quarter, for a total of $2,404 a year. However, after program costs were factored in, the program was cost-neutral and might result in savings in other settings, such as at other health care systems. That was good news to the study’s authors.

“We found the study to be very exciting,” Jennings said, “because it showed that an intensive intervention can delay nursing home entry without adding costs. The intervention isn’t going to reverse dementia, but it allows us to provide high-quality care to help patients cope with the progression of this disease and stay in their homes for longer.”

Jennings added that individuals with dementia typically have not received good-quality care. “Part of the reason,” she said, “is that the care takes a significant amount of time, which primary care physicians don’t have in abundance. In addition, pharmacologic treatments for dementia are limited, which makes community resources all the more important for both patients and caregivers. However, community programs tend to be underutilized.”

The intervention featured in the study addresses those issues directly. The assessment looks not only at what the patient and caregiver need, but also at their strengths, such as financial security, family assistance and proximity to community resources. It is designed to be interdisciplinary and to address the needs of both patients and caregivers.

“This study aligns with similar studies of collaborative care models for other chronic diseases, such as heart failure,” Jennings said. “It underscores that we need to be thinking differently about how we provide care to persons with chronic illnesses, like dementia. This study shows the benefit of a collaborative care model, where nurse practitioners and physicians work together to provide comprehensive dementia care.”

 Explore further: Setting personal goals for dementia care

More information: Lee A. Jennings et al. Health Care Utilization and Cost Outcomes of a Comprehensive Dementia Care Program for Medicare Beneficiaries, JAMA Internal Medicine (2018). DOI: 10.1001/jamainternmed.2018.5579

https://medicalxpress.com/news/2018-12-dementia-nursing-home-admissions-medicare.html

TCR2 Therapeutics Files for IPO

Immunotherapy company TCR2 Therapeutics Inc. plans to go public to fund several clinical trials of cancer therapies.

TCR2, which is developing novel T cell receptor (TCR) therapies for patients suffering from cancer, filed registration documents for an initial public offering, Securities and Exchange Commission records show. The company’s filing Friday with the SEC lists an amount of up to $100 million.

The Cambridge, Mass.-based company has applied to be listed under the symbol TCRR in the Nasdaq Global Market. The company didn’t list an initial public offering price, the filing shows.

The company hasn’t generated any revenue from product sales and has no products licensed for commercial sale, the filing said. That’s because the company is in the early stages of development of product candidates and has yet to start its first clinical trial, according to the filing. Because of that, the company will “continue to incur significant research and development and other expenses” related to its operations, and it also expects to “incur significant losses for the foreseeable future,” it said.

TCR2 posted losses each year since it was founded in May 2015. The company reported losses of $9.9 million in 2016 and $13.1 million in 2017. As of Sept. 30, the company had a $75 million deficit and $131 million in cash, cash equivalents and short-term investments.

The company plans to use the IPO proceeds for development and manufacturing to support the clinical trials of: TC-210, which is meant to targets mesothelin-positive solid tumors such as lung cancer, ovarian cancer; TC-110, which targets CD19-positive B-cell hematological malignancies; and TC-220 for the treatment of patients with MUC16-positive ovarian cancer. The remaining proceeds would be used to fund new and ongoing research and development, working capital and other general corporate purposes.

TCR2 was founded by private equity firm MPM Capital’s executive partner Dr. Patrick Baeuerle, an immunologist who previously developed the first commercial bi-specific antibody at Micromet Inc., which was later acquired by Amgen Inc.

Stockholders of TCR2 are MPM Capital, F2 Capital, UBS Oncology Impact Fund L.P., 6 Dimensions Capital, and Curative Ventures. As of Dec. 15, TCR2 had 45 full-time employees and one part-time.

https://www.marketscreener.com/AMGEN-4847/news/Amgen-TCR2-Therapeutics-Files-for-IPO-27805774/

Rerouting Nerves Reduces Post-Amputation Pain

Rerouting severed nerves in below-knee amputations into surrounding muscle prevented symptomatic neuromas and reduced phantom limb pain, researchers reported.

None of 22 amputation patients who underwent the nerve reassignment procedure — known as targeted muscle reinnervation (TMR) — developed symptomatic neuromas over an average of 18 months, according to Ian Valerio, MD, of the Ohio State University Wexner Medical Center in Columbus, and co-authors.

And of 18 patients who had TMR performed concurrently with their amputation surgery, only 13% reported phantom limb pain at 6 months, they wrote in Plastic and Reconstructive Surgery.

While previous studies have shown TMR can reduce phantom limb pain and peripheral neuropathy months or years later, this is the first major paper to show it can produce successful results when performed concurrently with below-knee amputation, Valerio said.

TMR involves transferring transected peripheral nerves of an amputated limb to motor nerves of residual muscle. Attaching cut nerve endings to nerves in a nearby muscle helps re-establish neural circuitry and “gives the peripheral nerve somewhere to go and something to do,” Valerio told MedPage Today.

Targeted reinnervation originally was developed in 2002 to allow patients better control of prosthetics; that it also improved post-amputation pain was a later, incidental finding. The technique differs considerably from the traction neurectomy often performed in below-knee amputations in which “you would pull the nerve, cut it, and let it retract into the limb, then cover it while you close the amputation stump,” Valerio explained. With conventional neurectomy methods, up to 25% of patients with major limb amputations can develop chronic localized pain from symptomatic neuromas, he noted.

Since 2015, Valerio and co-authors have performed 22 TMR surgeries on patients with below-knee amputations, including 18 primary TMR (performed concurrently with amputation) and 4 secondary (performed months or years later) procedures. Over a mean of 18 months post-surgery, no patient developed symptomatic neuromas. In the primary TMR cohort, 72% reported phantom limb pain in the first month; this dropped to 19% at 3 months and 13% at 6 months — a substantial difference from other reported long-term phantom limb pain rates, which range up to 80%.

TMR patients who experienced phantom limb pain also reported lower pain scores and used less pain medication than patients who did not have the procedure, Valerio added.

“Targeted muscle reinnervation completely reshapes everything we thought we knew about nerve endings,” said Gregory Dumanian, MD, of Northwestern University’s Feinberg School of Medicine in Chicago, who recently led a randomized clinical trial which showed that secondary TMR improved phantom limb pain.

“TMR can revolutionize treatment for the limb pain that affects and often debilitates millions of amputees around the world,” Dumanian told MedPage Today. “There are low barriers to adoption. The ability to perform TMR is everywhere, but surgeons just need to know how to do the procedure.”

Why TMR reduces pain is not clear. It may be because the technique “has the advantage of preservation of longer peripheral nerve length than traditional traction neurectomy, permits rapid nerve ingrowth and reinnervation of target muscle, and potentially permits greater neuroplasticity to possibly alter the pain circuits and central pain upregulation,” Valerio and co-authors hypothesized. Their paper provides a surgical description of primary TMR in below-knee amputations in detail.

This study had no funding, and no authors reported disclosures.

LAST UPDATED 12.27.2018

• Primary Source

  Plastic and Reconstructive Surgery

  Source Reference: Valerio I, et al “Targeted muscle reinnervation technique in below-knee amputation” Plast Reconstr Surg 2018; DOI: 10.1097/PRS.0000000000005133.

https://www.medpagetoday.com/neurology/generalneurology/77131

Edge analysts say Amazon may buy Henry Schein

Analysts at The Edge believe the separation of its animal-health unit makes Henry Schein (HSIC) an acquisition candidate for Amazon.com (AMZN), according to Bloomberg. Amazon is considering a move into healthcare distribution and an acquisition of Henry Schein would bring instant leadership of the U.S. dental distribution market and access to the company’s intellectual property, Bloomberg adds, citing The Edge.

https://thefly.com/landingPageNews.php?id=2841912

What happens when DNR is ignored

A New Mexico woman suffering from Dercum’s disease (adiposis dolorosa) — which causes painful fatty tumors — is suing a Santa Fe hospital and an emergency physician, claiming she was the victim of two negligent acts in 2016.

First, according to the Albuquerque Journal, she told hospital personnel she was allergic to hydromorphone (Dilaudid), but went into cardiac arrest after receiving an injection of the drug.

Second, despite the presence of a lawfully executed “do not resuscitate” (DNR) advance directive, she was successfully resuscitated and now faces continued pain and medical bills.

The staff had been aware of her DNR order and had even issued her a purple bracelet labeled “DNR.” Since the cardiac arrest was allegedly caused by an allergic reaction to Dilaudid, the staff may have felt her problem was not related to her illness and would likely result in a successful resuscitation.

While researching this subject, I found several instances of patients or families suing hospitals and doctors for failing to heed a DNR order or what some have called “wrongful life.”

However, I found only one major case that had gone to conclusion. A Georgia woman had both an advance directive and a healthcare proxy — her granddaughter. She was admitted to a hospital for a cough and eventually required a thoracentesis. The healthcare proxy agreed to allow the procedure to be done but specifically said her grandmother did not want intubation or mechanical ventilation.

A 2017 paper in the Journal of Clinical Ethics said the patient was temporarily intubated and ventilated during the thoracentesis. She was extubated, but a bout of respiratory distress was treated with intubation and mechanical ventilation again without consulting the granddaughter. The patient died 2 weeks later.

The granddaughter sued, and the hospital settledfor $1,000,000. I believe this is the first such case settled for that much money. The biggest problem was failure of the doctor to communicate with the healthcare proxy.

But many issues in medicine are not black or white. Here’s the other side of the story. An elderly Boston man suffered a cardiac arrest in a hospital CT scanner and was resuscitated. The resident who treated him wrote that during the code, a nurse discovered a 6-year-old advance directive saying he did not want to be resuscitated in his chart.

But the code team noted that he had walked into the hospital for the test and felt certain they could save him. They contacted his son and healthcare proxy who said: “My father would want everything done to save his life.” The code was successful. He was weaned from mechanical ventilation and extubated after a few hours. He thanked his doctor and was discharged from the hospital 2 days later.

Some take-home points:

A DNR order and an advance directive may not necessarily be the same. For more information, read an interview with the plaintiff’s lawyer in the Georgia case.

Whether to resuscitate a patient or not may depend on the circumstances (e.g., whether an event is likely reversible or not), the wording of an advance directive, and/or the wishes of the healthcare proxy.

If possible, explain the possible scenarios and outcomes of resuscitation and DNR to your patients and their families well before a cardiac arrest occurs.

Communicate with patients and their healthcare proxies.

https://www.medpagetoday.com/blogs/kevinmd/77137

Antimicrobial Drugs in Food-Producing Animals: Downtrend Holds; 10 Year Low

On Dec. 18, 2018, the Center of Veterinary Medicine (CVM) of FDA  announced the publication of its 2017 Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals.  This report is required by the Animal Drug User Fee Amendments of 2008.  Under that law, every sponsor of an approved or conditionally approved new animal drug application containing an antimicrobial active ingredient must annually report to FDA the amount of each such ingredient in these drug products sold or distributed for use in food-producing animals.  FDA must summarize this information and make it available to the public in annual summary reports.  The data on antimicrobial drugs sales and distribution information are intended to assist FDA in its evaluation of antimicrobial resistance trends as well as its analysis of other issues that may arise relating to the safety and effectiveness of antimicrobial drugs approved for use in food-producing animals.

The first report was published in 2010.  Since that time,  FDA has taken several measures to reduce the use of antimicrobials in food-producing animals.  Notably, FDA issued Guidance for Industry (GFI) #213,  New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209.  Based on recommendations in this guidance, all production uses (i.e., non-therapeutic uses) of medically important antimicrobials were eliminated.  As CVM mentions in its press release, this guidance was fully implemented early 2017.  Since that time, medically important antimicrobial drugs can only be used for therapeutic purposes under veterinary oversight.

The graph below suggests that FDA’s efforts are paying off.

According to the report, between 2016 and 2017, the sale and distribution of medically important antimicrobials approved for use in food-producing animals that have an approved indication for production use decreased from 5,770,655 kg to 0 kg and the sales and distribution of medically important antimicrobials approved for use in food-producing animals that are sold over-the-counter, decreased from about 8 million in 2016 to 217,280 in 2017.  Overall the reduction in sale and distribution of the relevant drugs decreased by 33% from 2016 through 2017 and by 43% from its peak year (2015).

Scott Gottlieb issued a statement that he was pleased with the report, but said more work is needed to fight antibiotic resistance.  He pointed to CVM’s 5-year action plan published in September 2018 for additional steps that the FDA plans “to continue fostering our momentum in antimicrobial stewardship across veterinary settings.”

In its press release, CVM also stressed that the primary goal of its programs is no to reduce antimicrobial sales but “to support the implementation of good antimicrobial stewardship practices . . . to slow the development of antimicrobial resistance” and preserve the effectiveness of antimicrobial drugs.

The importance of stewardship is recognized by the animal production industry.  On the same day that FDA published its report, major food animal companies from across the supply chain—including retailers, livestock producers, and trade and professional associations such as Elanco Animal Health, Hormel Foods, Jennie-O Turkey Store, McDonald’s Corporation, National Milk Producers Federation, National Pork Board, National Pork Producers Council, National Turkey Federation, Smithfield Foods, Inc., Tyson Foods, Walmart Inc., and Zoetis —announced the publication of a “Framework for Antibiotic Stewardship in Food Animal Production.”  Apparently, these companies came together as a result of a two-year dialogue moderated by the Pew Charitable Trust and the Farm Foundation.  The framework is meant to apply across the animal supply chain.

http://www.fdalawblog.net/2018/12/report-on-antimicrobial-drugs-for-sale-in-food-producing-animals-downward-trend-holds-10-year-low/

QurAlis Spins out Med Device Company EnClear to Target ALS

EnClear Therapies, a new medical device company spun out from QurAlis, will focus its developmental programs on targeting neurological diseases, including amyotrophic lateral sclerosis (ALS) and progressive supranuclear palsy (PSP).

EnClear’s devices have a goal of continuously clearing toxic proteins from cerebrospinal fluids to treat these diseases. With its devices, EnClear said its mission is to halt the progression of the diseases with its devices and extend the lives of patients with ALS and PSP. The company plans to do so by removing the toxic proteins that build up in the brain and spinal cord, significantly impacting neurodegeneration.

Parent company QurAlis is developing three therapeutics targeting subsets of ALS. The company is developing treatments that include: a transformative device to remove toxic proteins; a drug that mediates overactive neurons and prevents them from dying; and a drug that restores a dysfunctional waste clearance system in cells.

Kasper Roet, chief executive officer of QurAlis and Co-Founder of EnClear, said that during the discovery process of causative gene mutations in ALS, company researchers realized that “some of the mutated proteins transcribed from these genes cause not only loss of function issues but that the mutations make them in fact specifically toxic and that this toxicity spreads through the brain and spinal cord causing neuronal death.” When looking at ways to clear the toxic proteins, Roet said the company decided that a device that continuously circulates the cerebrospinal fluids would filter those proteins.

“This device is the basis for the formation of EnClear and will hopefully be able to help not only ALS patients but also patients with many other neurological diseases,” Roet said.

ALS is a progressive neurodegenerative disease that affects neurons in the brain and the spinal cord. The disease is usually fatal within two to five years of diagnosis. Patients with ALS eventually lose the ability to control muscle movement, which eventually leads to total paralysis and then death. Currently, there is no known cure for the disease, but multiple companies are working on treatments, hoping to be the first to provide a viable option for patients. The Centers for Disease Control and Prevention estimates that approximately 12,000 to 15,000 Americans have ALS, with about 5,000 to 6,000 diagnosed annually.

The new company will be helmed by Anthony R. DePasqua, who has more than 20 years’ experience in the medical device industry. EnClear will be located at LabCentral’s Kendall Square laboratory facility in Cambridge. Mass. William B. Gormley, director of the Neurosurgical Critical Care at Brigham and Women’s Hospital, will serve as the company’s chief medical officer. Gormley is also a cofounder of the company.

EnClear CEO DePasqua, also a company co-founder, noted that patients who have been diagnosed with ALS have few therapeutic options. Not only is the disease a virtual death sentence, but it is also costly to treat, which creates financial burdens on families and society, DePasqua said.

“Our understanding of these diseases has improved exponentially in recent years thanks to the identification and study of the human genome and related biology. QurAlis has been at the forefront of these new discoveries and EnClear has been spun out to create therapeutic devices based on this knowledge,” DePasqua said in a statement. “A device that can continually access CSF and clear it of toxic proteins has the potential to help numerous patient populations in a safe and effective manner.”

Although EnClear has just launched, the company will present at the Biotech Showcase 2019 conference in San Francisco next month.

https://www.biospace.com/article/quralis-spins-out-medical-device-company-enclear-to-target-als-and-other-neurological-diseases/