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Friday, April 5, 2019

Ways to cut debilitating complications for frail elderly trauma patients

A standardized interdisciplinary clinical pathway to identify and manage frailty in older patients has reduced the rate of one of the most debilitating complications for older patients–delirium–and kept patients from returning to the hospital within 30 days of treatment for traumatic injury. The pathway is being adapted for other surgical services as trauma surgeons from Brigham and Women’s Hospital, Boston, focus attention on the specific needs of elderly surgical patients. A study describing the pathway and its effects on outcomes appears as an “article in press” on the Journal of the American College of Surgeons website in advance of print publication.
As the U.S. population continues to age, increasing numbers of elderly patients will have a need for trauma surgery. By 2050, 40 percent of all trauma patients will be over age 65. While the elderly are at increased risk for morbidity and mortality after trauma, age itself is not the sole reason for poor outcomes. Frailty is a major contributor. Frail patients are more likely to have complications and loss of function after hospital care and require readmission for repeat trauma than more robust patients. As many as 50 percent of older trauma patients are frail, and 78 percent are functionally impaired.
Interdisciplinary inpatient care protocols involving consultation with geriatricians have improved outcomes for elderly hospitalized patients. However, there is a nationwide shortage of geriatricians.
“It’s just not feasible to have a geriatrician available for consultation all the time. We needed to become better equipped to provide dedicated geriatric-focused care on our own. So we put some processes in place to screen elderly trauma patients for frailty and stratify and direct our resources to provide the best possible care for them,” said Zara Cooper, MD, FACS, an associate professor of surgery, Harvard Medical School, and corresponding author of the study.
Since Brigham and Women’s Hospital’s trauma surgery service hired a geriatrician to consult on the care of elderly injury victims in 2014, it documented fewer complications, mortalities, readmissions and extended hospital stays. However, the surgeons noticed gaps in care when the geriatrician was not available and lack of overall uniformity in the way recommendations from the geriatric team were instituted.
The pathway for frail elderly trauma patients was created in 2016 to standardize processes of care a geriatrician would typically recommend: early ambulation, bowel and pain regimens, non-pharmacological delirium prevention, nutrition, physical therapy, and geriatric assessments.
Surgeons at Brigham and Women’s Hospital developed the Frailty Identification and Care Pathway over a six-month period with input from geriatrics, nursing, nutrition, physical and occupational therapy, speech and language pathology, social work, and care coordinators. The pathway makes use of the five-item FRAIL scale to identify vulnerable elderly trauma patients, a standardized set of orders for geriatric-focused care and consultations, family meetings, and fall prevention education.

In the present study, researchers compared outcomes for frail elderly trauma patients before and six months after implementation of the pathway. In addition to overall mortality, the investigators analyzed whether the pathway could prevent or quickly recognize and treat delirium (one of the most common causes of increased hospital length of stay), transfer to a nursing facility, and mortality within six months of hospital care.
In addition, the investigators tabulated the 30-day hospital readmission rate, which serves as an indicator of quality hospital care and effective use of resources.
Researchers reviewed the care of 125 patients who were treated before the pathway was implemented and 144 after it was in place for six months and found lower rates of delirium, in-hospital mortality, and readmission. Patients who were managed according to the pathway had a 9 percent less risk for delirium, 3 percent reduced risk for mortality, and 7 percent lower risk for readmission.
Interdisciplinary protocols represent a shift in perspective for trauma surgeons. “Trauma centers are primarily focused on hemorrhage and complications that are typical for young patients. The elderly, especially frail elderly, have very different needs. Innovative models for geriatric trauma patients are emerging in parts of the country that have a significant proportion of older adults,” Dr. Cooper said.
The pathway at Brigham and Women’s Hospital is fairly straightforward and makes use of resources that are readily available in other trauma centers and surgical services. The standardized approach is being expanded for pre- and post-operative elective operations for frail elderly patients. “We have to adapt the protocol here and there, but the basic framework relies on getting patients mobile and managing medications, nutrition, and communication with families,” Dr. Cooper said. “This is the type of care that matters to patients and should be universal.”
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‘Heart, lung transplants from hepatitis-C infected donors considered safe’

A recent trial has shown that heart and lungs from donors infected with hepatitis C can be safely transplanted, without recipients becoming infected with the virus.
https://www.youtube-nocookie.com/embed/O6uTOIHQLvU
A four-week course of direct-acting antiviral agents prevented the establishment of infection in all recipients and those who have been followed for six months are still infection-free.
The study, which has been published in the New England Journal of Medicine, is the largest of its kind to assess the safety of transplanting the organs from donors infected with the hepatitis C virus (HCV).

Solving organ shortages

Lead author Ann Woolley, (Brigham and Women’s Hospital, Massachusetts, US) estimates that the ability to safely transplant hearts and lungs from HCV-infected donors could increase supply of the organs by at least one-quarter.
In the US, more than 5,000 patients are currently awaiting a lung or heart transplant, but the shortage of donor organ availability means around one thousand patients die each year while they wait for the replacement organs.
In the wake of the current opioid crisis, an increasing number of donated organs now come from IV drug users. However, the donation of HCV-infected organs has historically been associated with high transmission rates to recipients and they are not typically used for transplant.
Usually, organs are discarded if donors are even suspected of having HCV infection, which is the most common type of chronic blood infection in the US.

Antivirals have led to high cure rates for hepatitis C

However, the advent of a new antiviral regimen in 2014 that has proved well-tolerated and to have high cure rates for chronic HCV has laid the foundations for a new trial that started enrolling patients in March 2017. The usual criteria were used to screen potential donors, with the exception that they were not disqualified for having a current or past HCV infection.
Forty-four patients received HCV-positive hearts or lungs, 35 of whom were followed up for at least six months. Antiviral treatment was initiated within a few hours of surgery and the treatment regimen was continued for four weeks.
Immediately after transplantation, all recipients had hepatitis C viral loads proportional to those of the donors. The majority cleared the virus within a few days and all patients had undetectable viral loads by around the two-week mark, reports Woolley.

Hepatitis C was ‘undetectable’ in transplant recipients

Of the 35 patients who completed 6 months of follow-up, all had excellent graft function and an undetectable viral load, with no treatment-related serious adverse events reported.
In an associated editorial, professor of Medicine at the University of Pennsylvania, Emily Blumberg, says that at least in the short-term, transplants from HCV-positive donors offer a very promising way to get people transplanted faster and expand the donor pool.
The authors conclude:
The advent of direct-acting antiviral agents to treat hepatitis C virus (HCV) infection has raised the possibility of substantially increasing the donor organ pool by enabling the transplantation of hearts and lungs from HCV-infected donors into recipients who do not have HCV infection.”
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LivaNova price target lowered to $100 from $115 at Stifel

Stifel analyst Rick Wise lowered his price target on LivaNova to $100 after its soft Q1 pre-announcement driven by “more intense FX headwinds”, challenges in the U.S. Neuromodulation segment, and the ongoing execution issues at Perceval pressuring the company’s Heart Valves sales by 11.4%. Longer term, the analyst is keeping his Buy rating on LivaNova however, citing its “dramatic and positive transformation” over the past 18 months with the divestiture of the lower-margin Cardiac Rhythm Management business and the hiring of a new and experienced management team. Wise believes that the company has the “solid foundation” to grow its revenue and earnings while supporting its “growth-enhancing pipeline investments.”
https://thefly.com/landingPageNews.php?id=2889327
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Coherus sees up to $38M in Q1 Udenyca sales; shares up 5% after hours

On a preliminary basis, Coherus BioSciences (NASDAQ:CHRS) expects Q1 sales of Neulasta biosimilar UDENYCA (pegfilgrastim-cbqv) to be $36M – 38M, well above consensus of $2.8M.
The company will provide additional details during its Q1 conference call on May 9.
The European Commission approved the product in September 2018 followed by the FDA in November 2018.
Shares are up 5% after hours.
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Cancer Patients Who Smoke Cost Nation Billions

Cancer patients who continue to smoke cost the healthcare system billions of dollars annually, thanks to smoking’s contribution to first-line treatment failures, a modeling study found.
The model estimated the cost of continuing to smoke to be nearly $11,000 per patient in treatment costs after failure of the initial cancer treatment protocol, or $2.1 million per 1,000 cancer patients (smokers and nonsmokers), reported Graham Warren, MD, PhD, of the Medical University of South Carolina in Charleston, and colleagues in JAMA Network Open.
Multiple variables were used to determine smoking-related costs, including expected first-line treatment failure rates in nonsmoking patients, smoking prevalence, and the cost of cancer treatment after first-line treatment failure.
“We know that smoking is bad for patients undergoing cancer treatment,” Warren told MedPage Today, citing a 2014 Surgeon General’s report concluding that smoking increases the risk for overall mortality, cancer-related mortality, cancer-treatment toxicity and developing a second primary cancer.
“With the increasing focus on value-based care in the treatment of cancer, we started to think about how to put a cost on this,” he said.
The researchers noted that widely discussed principles for value-based care in cancer include “patient-centered solutions, optimal care, and cost-containment strategies that do not limit patient access or innovation.”
Drug costs have been a focus, but a recent analysis suggested that many widely used drugs do not meet survival goals.
“Whereas drug cost and efficacy have been the primary focus for considering value in cancer care, relatively little consideration has been given to other potentially modifiable factors that could affect cancer treatment costs, including health behaviors such as smoking,” they wrote.
The model Warren and colleagues developed did not directly quantify the potential financial savings associated with smoking cessation; at this stage, it only addressed the extra costs incurred with treatment failures associated with smoking.
Specifically, using data from the 2014 U.S. Surgeon General’s report, it considered expected failure rates of first-line cancer treatments in nonsmoking patients, smoking prevalence, odds of first-line cancer treatment failure attributed to smoking, and cost of cancer treatment after such failure.
In the model, smoking-attributable failures peaked when expected cure rates among nonsmoking patients were high, in the range of 50% to 65%.
“Under the [2014 Surgeon General report] conditions of a 30% expected treatment failure rate among nonsmoking patients, 20% smoking prevalence, 60% increased risk of failure of first-line cancer treatment, and $100,000 mean added cost of treating a first-line cancer treatment failure, the additional incremental cost per 1,000 total patients was estimated to be $2.1 million, reflecting an additional cost of $10,678 per smoking patient,” the researchers wrote.
They added that extrapolation of the cost to 1.6 million patients in the U.S. with a cancer diagnosis annually “reflects a potential $3.4 billion in incremental costs.”
“By providing estimates across smoking prevalence rates, risk of failure among smokers vs nonsmokers, and expected cure rates, this model may be applied to estimate outcomes across a breadth of potential cancer conditions and their associated costs,” the researchers wrote.
In an editorial published with the study, Cara Petrucci, MBA, MPH, and Andrew Hyland, PhD, of Roswell Park Comprehensive Cancer Center, Buffalo, New York, wrote that analysis models like the one developed by Warren and colleagues will be more and more relevant as healthcare “is increasingly focused on delivering value-based care that accounts for both clinical effectiveness and cost of treatment.”
“The effects of continued smoking during cancer treatment have been well documented, but resources for smoking cessation services remain inadequate,” they wrote. “Coverage for smoking cessation by insurance companies is limited and tends to disproportionately favor medical interventions, such as smoking cessation medications, compared with evidence-based interventions.”
Because the economic benefits of smoking cessation have been hard to quantify, smoking cessation interventions do not “attract the attention of systems and clinicians who, although concerned with the health of their patients, operate within the constraints of an increasingly tight financial environment,” they added.
“To show the clinical association of smoking with first-line cancer treatment failure in financial terms places continued smoking during cancer treatment alongside surgery and chemotherapy as a significant contributor to cancer treatment costs.”
Researcher Michael Cummings, PhD, reported receiving personal fees from Pfizer during the conduct of the study and receiving personal fees from plaintiff law firms outside the submitted work.
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Ladenburg Bullish on Zynerba: ‘FDA Clarifies Views’ on Nonprescription CBD

The FDA has started looking into how it might legalize CBD-laced food products, and this is good news for Zynerba (ZYNE) investors.
This week, the agency announced it will hold its first public hearings on CBD, as it weighs rules allowing companies to add the popular cannabis-based compound to food. The hearing will be taking place on May 31. In reaction, Zynerba stock skyrocketed nearly 20% in Tuesday’s trading session.
Ladenburg analyst Michael Higgins believes “the FDA will be taking further steps in 2019 to remove any non-prescription products being sold that include THC and CBD, while allowing the “…production and marketing of hemp, defined as the plant Cannabis sativa L.” This would support the market adoption of Zynerba’s Zygel, a CBD gel treatment for children and adolescents with Fragile X syndrome, the most common form of inherited learning disability and attention deficit disorder.
As a result, Higgin reiterates a Buy rating on ZYNE stock, along with a price target of $26.
Higgin commented, “We believe the removal of current CBD-containing foods, lotions, snacks, oils and other embodiments containing CBD favors the market adoption of Zynerba’s Zygel (CBD gel via a sachet). We have long expected the availability of OTC CBD products during Zygel’s marketing (assuming positive pivotal data in Fragile X patients in 2H’19 and approval in 2H’20), but the stance of the agency suggests less availability of CBD-containing products for which consumers to choose from. From our research, today’s CBDinfused products deliver substantially lower levels of CBD with some containing other active ingredients from the marijuana plant, including THC. We believe this morning’s publication reflects the agency’s loss of patience with these products as the number of and marketing of these products have become more ubiquitous and aggressive. While 33 states allow “medical” marijuana the FDA lists marijuana as, “…Schedule I of the CSA (Controlled Substances Act) due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use for marijuana in the United States” (today’s Fed Reg). In our view, the agency is not relenting, rather, it is leaning on the regulatory statutes several times in this morning’s publication.”

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Plan to End Drug Rebates Adds Protections for Insurers

The Trump administration on Friday said the federal government would reimburse health insurers for financial losses caused by the administration’s plan to ban certain pharmaceutical-industry rebates in Medicare.
The backstop on most of insurers’ losses could help prevent premiums from rising significantly as a result of the rebate-rule changes, while making taxpayers responsible for a greater share of cost overruns in Medicare’s prescription-drug program.
The offer to assume most of the financial risk for the loss of the discounts is a sign the administration is likely to move ahead with its push to end rebates and could address some critics’ concerns. The idea has faced heated criticism from some Democrats, with House Speaker Nancy Pelosi saying last month that such a move would raise premiums and do little to lower drug costs.
The drug-rebate proposal is a marquee part of the administration’s push to lower drug prices. The rule would halt billions of dollars in discounts that drugmakers give insurers and companies such as CVS Health Corp. and UnitedHealth Group Inc. that administer Medicare prescription plans.
Health and Human Services Secretary Alex Azar has said it would spur manufacturers to pass discounts directly on to patients and bring new transparency to prescription drug markets.
But how the change will affect the complex financial structure of the Medicare drug program known as Part D is hard to predict. The government’s plan to protect companies that administer Medicare’s drug benefit could help minimize disruption to a program that insures more than 40 million people during an election year.
Federal spending is projected to increase by $196.1 billion over a decade as a result of the rebate-rule change, according to estimates by the CMS Office of the Actuary done prior to Friday’s announcement. Premiums paid by beneficiaries would rise by $58 billion over the same period, but beneficiaries taking high-priced drugs would see their out-of-pocket costs decline by around $83.2 billion. Medicare is a federal health insurance program for people age 65 and older and the disabled.
Drug makers, meanwhile, would save $39.8 billion over the decade because mandatory discounts they provide during a gap in Medicare coverage known as the “donut hole” would be reduced, according to the actuary.
These estimates don’t reflect the new risk-sharing program announced Friday.
Rebates are a little-known but important part of the U.S. drug pricing system. Drugmakers set list prices. But then many also offer rebates, or discounts, that reduce the amount that companies and the federal government actually pay.
The rebates can shape decisions about what drugs are offered and how much patients pay out-of-pocket. Drugmakers say the practice has led them to raise list prices to keep up with demands for greater rebates by companies that administer drug plans — which seldom use the money to reduce out-of-pocket patient costs. That view has been adopted by Mr. Azar, a former Eli Lilly & Co. executive.
Critics also say they lead to higher prices without passing savings on to consumers.
But health insurers and businesses that administer Medicare drug plans say the rebates keep down premiums for all beneficiaries, a contention many experts agree with. The base monthly premium for Medicare drug benefits has declined for the past two years.
The administration in January revealed a proposal to end rebates that go to insurers and companies that run drug plans in Medicare and Medicaid by Jan. 1, 2020. Instead, the Trump administration said it would create a protection for discounts offered to directly to patients.
Insurers and companies that set up prescription drug plans have balked. They also were concerned because they would have to submit bids to offer drug plans in Medicare in early June without knowing the fate of the rule or how drug prices could change.
Now the Centers for Medicare and Medicaid Services is saying it will shoulder most of the risk, if the rebate rule is finalized. After the first 0.5% of unforeseen profits or losses experienced by insurers or others that administer drug plans, the federal government would cover 95% of extra losses or get back of 95% of extra profits. The risk sharing would be optional for companies and last for two years.
“They are trying to deal with the uncertainty,” said Tricia Neuman, who heads the Medicare policy program at the Kaiser Family Foundation, a nonprofit that focuses on health information.
Changes to the rebate system in Medicare could have a trickle-down effect in the health system. Because the program represents such a big market, rebates could also fade in the private sector if they are ended in Medicare, some health analysts aside.
Steps in that direction are already under way. Sen. Mike Braun (R., Ind.) introduced legislation last month that would also end such rebates in the commercial sector.
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