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Thursday, July 4, 2019

A look at Cigna’s international NGO health plans

Cigna has more than 15 million members in the U.S. But plenty of people might not realize an additional 1.5 million of the insurance giant’s members live abroad—some of whom are in some of the most dangerous regions of the world.
This growing market is where Angela Rooney, who is Cigna’s nongovernmental organizations (NGOs) director, specializes.
Cigna has been in the business of insurance for NGOs doing humanitarian work worldwide for 60 years, Rooney said in an interview with FierceHealthcare in June during an NGO workshop hosted by the insurer in Washington, D.C. That includes being available to meet the needs of NGO workers around the clock.
Cigna’s NGO team could be assisting a member with a snakebite one day and helping with another group in a war zone the next, Rooney said.
“Their missions are very important to us,” Rooney said.
Because the circumstances NGOs are operating in can be so varied, Rooney said that Cigna builds benefits packages for each that are tailored to the region they’re working in. For example, a group in a remote location with limited or no internet access may not be able to fully take advantage of telehealth.
The healthcare infrastructure in these regions can also be quite different, she said. Cigna builds a coverage network around where NGOs are located when they contract for benefits.
“It’s duty of care at its extreme,” Rooney said. “Everyone who works at Cigna for our NGOs thinks it’s so fulfilling because you’re helping people in desperate need and doing some good for the world.”
The insurer operates such plans in more than 100 countries and provides local case managers to NGOs in Kenya, South Africa, Chile, Belgium, Spain and Malaysia. Stateside case managers are also based in Miami, Florida.
Cigna also operates an international medical board in several countries and is directly contracted with more than 1,550 providers in Africa alone. The continent is a key growth target for the insurer, Rooney said; Cigna has offered insurance products in Africa since 2008 but significantly expanded its scope with the launch of Hollard Cigna Health in 2016, which is a partnership with Hollard Insurance Group, another payer active in Africa.
Cigna’s membership on the continent has grown to more than 200,000 people.
A crucial focus for Cigna’s NGO team is the mental health of workers in the field, Rooney said. Burnout is a risk, she said, and many of these workers are in dangerous situations. A key solution is including video counseling visits in benefits packages, which can be easier for workers to keep up with than in-person therapy.
Mental health checks are also built into the onboarding and offboarding processes, both for Cigna’s plan specifically and within most NGOs, Rooney said.
“They’re so committed that they don’t really want to break assignment to leave,” Rooney said. “So, the more we can offer support and tech processes, they can remain in that location.”
Pre- and post-international work also includes routine physicals and health checks. Cigna deploys physicians who specialize in tropical diseases where needed and works with local specialty doctors as well when possible.
Rooney said she and her team never know when they’ll get that call about an emergency situation—but they’re always ready.
“This is when NGOs need you and you’ve got to be there,” she said.

Post-Shire buy, Takeda investors want execs to return pay if performance lags

Takeda wrapped up its $60 billion Shire takeover early this year with massive support from shareholders, despite previous resistance. But the weight on the deal’s mastermind, Takeda CEO Christophe Weber, is far from over.
At the company’s general meeting last week, the majority of Takeda investors backed a proposal that would allow Takeda to claw back executive pay should the Shire deal not live up to expectations.
Though 52.2% of attending shareholders voted in favor of the new clause, it fell short of the two-thirds majority needed to move through, according to a securities filing posted on Tuesday. Still, it’s a clear sign that investors intend to keep members of management responsible for their major decisions.
The proposal didn’t specifically name Shire, but it referred to “excessive investment in the past” in general. If an impairment loss arises later that renders the compensation amount under the long-term incentive plan incorrect, or if the indicators for performance-based pay are erroneous, the pay package should be recalculated and the difference be returned, it says.
In the previous fiscal year that ended in March, Weber racked up 1.76 billion yen ($16.3 million) in total pay, with about half from long-term incentives, according to Takeda’s just-filed annual report. Those figures are on par with Celgene CEO Mark Alles’ $16.2 million for the 2018 calendar year.

Unlike its Western peers, Takeda doesn’t lay out the details of how it calculates compensation for executives. A separate proposal that asks Takeda to disclose the logic and math behind each individual executive’s pay was also defeated, even though it racked up almost half of all votes in favor.
Influential proxy advisers Institutional Shareholder Services (ISS) and Glass Lewis previously backed both proposals and likely influenced foreign investors, who own 50.7% of the Japanese pharma, Nikkei Asian Review reported. The financial newspaper also said that Takeda will consider increasing transparency behind executive pay and adding a clawback provision in its internal rules rather than making them formal revisions to the articles of incorporation.

Weber’s efforts to take in Shire ended with his victory in January after 88% of votes supported the deal a month before. But the French-born CEO had to fight hard. Descendants of the Takeda founding family, including former Takeda chairman Kunio Takeda, openly objected to the buyout, citing high risks as the company took on a $31 billion loan to fund the deal. Concerns also pointed to competition to Shire’s hemophilia franchise, which made up about 20% of the Irish company’s revenue.
ISS and Glass Lewis previously both recommended that investors vote to approve the gigantic deal. “The deal diversifies the company in terms of products and geographies, and provides strong cash flow generation that, combined with divestments, allows for relatively rapid deleveraging, despite maintaining top of the range leverage in the mid-term,” ISS said in a report to clients, as quoted by Reuters in November.
To help pay down debt, the company recently sold Shire’s eye drug Xiidra to Novartis for $3.4 billion upfront and up to $1.9 billion in potential milestone payments. As of March, Takeda’s net debt was 4.7 times its adjusted earnings. The plan is to sell some noncore assets worth $10 billion and bring down the ratio to 2x within three to five years.

Grifols Gets FDA OK for Xembify® for Primary Immunodeficiencies

– Xembify® is Grifols’ first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies
– Grifols is a frontrunner in disease treatment with immunoglobulins, and this approval will enable the company to further expand its portfolio of plasma-derived medicines to benefit of patients and healthcare professionals
– Xembify® represents a significant R+D+i milestone for Grifols and an important step forward in its long-term sustainable growth strategy
– The company plans to launch Xembify® in the United States in the last quarter of the year and is working to obtain additional approvals in Canada, Europe and other global markets

Hanging in the Balance: Reports Aim to Propel Obesity Care Forward

Two brief “cutting edge reports” in the July issue of Obesity propose training competencies for medical students and care standards for practitioners for treating patients with obesity, which one expert hopes will help drive the field forward.
“Hopefully, the prescribed standards of care and training competencies in this issue of Obesity will result in reformation of our systems for obesity healthcare delivery and medical education,” W. Timothy Garvey, MD, professor of medicine, Department of Nutrition Sciences, University of Alabama at Birmingham, writes in a commentary that accompanies the two reports.
The first report outlines a set of 32 obesity-focused competencies to be taught and assessed in medical education programs for graduate and undergraduate medical students and for advanced practice nurses and physician assistants.
The second report is a proposed standard of obesity care for all providers and payors.
The two articles, says Garvey, “constitute landmarks that will impel the evolution of healthcare for patients with obesity.”

32 Obesity Care Competencies to Be Taught in Medical School

The first article is by Robert F. Kushner, MD, Northwestern University Feinberg School of Medicine, Chicago, Illinois, and colleagues, on behalf of the Obesity Medicine Education Collaborative (OMEC) — an intersociety initiative spearheaded by three societies, The Obesity Society (TOS), American Society for Metabolic and Bariatric Surgery (ASMBS), and OMA, involving 15 medical societies* overall and endorsed by 20 societies.**
OMEC’s aim is to develop obesity-focused competencies and benchmarks for medical education programs.
A task force of representatives from the 15 medical societies developed 32 competencies in obesity care, internally reviewed them, adjusted them after a consensus-building process, and then sent them for external review and feedback from 16 other societies.
The competencies were developed to “standardize the process of evaluating obesity-related competencies across medical school, residency, fellowship, advanced practice nursing, and [physician assistant] training programs,” according to Kushner and colleagues.
There is a need for such a document because “a major challenge facing medical educators today is adequately training current and future healthcare providers in the prevention and treatment of obesity,” said Kushner, past president of TOS, in a statement from the organization.
The competencies, he said, “provide the framework to improve provider education and thus also improve patient care in the treatment of obesity.”
The 32 competencies cover six areas: practice-based learning and improvement (5 competencies), patient care and procedural skills (5), system-based practice (4), medical knowledge (13), interpersonal and communication skills (3), and professionalism (2).
Examples of competencies that students need to master are:
  • “Elicits comprehensive obesity-focused medical history.”
  • “Applies knowledge of obesity treatment guidelines to the development of comprehensive, personalized obesity management care plan.”
  • “Uses appropriate language…that is nonbiased, nonjudgmental, respectful, and empathetic when communicating with patients with obesity.”

Charting a Course for the Training of Healthcare Professionals

Ethan Lazarus, MD, FOMA, a weight loss physician at the Clinical Nutrition Center, Denver, Colorado, and vice president of the OMA, says a 2016 American Medical Association report showed obesity training is neither consistent nor comprehensive.
“OMEC represents a big step forward in filling these significant educational gaps and is provided as a free tool*** that can be used at all levels of medical education,” he notes in a statement from OMA.
Wendy Scinta, MD, FOMA, OMA president, agrees, noting: “For years, obesity has been misunderstood,”
“The goal of our multidisciplinary and multisociety effort is to remove bias and ensure obesity is appropriately understood as a disease by healthcare professionals in medical school, residencies, fellowships, and beyond. These competencies set the bar for obesity education and will immensely benefit patients with obesity and their providers,” she emphasizes.
Garvey writes in his commentary that the OMEC’s “groundwork provides a formidable stimulus” and “charts a course for the training of physicians, physician assistants, and advanced practice nurses in obesity medicine” that is “much needed.”
And although these competencies are aimed at MDs, doctors of osteopathy, nurse practitioners, and physician assistants, “this structure could readily be adopted in the training of other important professional members of the obesity care team including dietitians, educators and behavioralists, exercise therapists, and clinical psychologists,” he adds.
He also notes that the reader is referred to a website for access to the proposed evaluation scheme for all stated competencies.

STOP: Proposed Standards of Obesity Care Represent “Quantum Leap”

The second article is by William H. Dietz, MD, PhD, and Christine Gallagher of the Milken Institute School of Public Health, George Washington University, Washington, DC, representing the Strategies to Overcome and Prevent (STOP) Obesity Alliance, which aims to provide health professionals, payors, community organizations, policymakers, and those affected by obesity with guidance on foundational components of evidence-based obesity care.
STOP has members from business, consumer, government, advocacy, and health organizations. It held three roundtable meetings to develop the standards of care for treating adults with obesity in the community and in a clinical setting.
“Our goal,” Dietz said in the TOS statement, “was to develop a practical, tangible, measurable, and simple standard of care for the treatment of adult obesity across care settings and representing practices that positively impact the health of people impacted by obesity.”
The standards are intended to augment published guidelines developed for obesity care providers, according to Dietz and Gallagher, and “to be implementable and acceptable to payors.”
“The core principles…include shared decision-making,” which includes the involvement of patients in developing treatment plans, and help on “when to use adjunctive therapies and when to move patients to higher intensity treatments, as well as providing assurance that patients have access to appropriate levels of care, regardless of when they enter the healthcare system.”
The standards further state, “Obesity should be treated as a chronic disease” and providers “should be sensitive to bias and language” and “be trained to initiate the conversation about weight.”
Dietz and Gallagher add that clinical providers should recommend an evidence-based dietary strategy and appropriate levels of physical activity for patients with obesity, minimize the use of medications that may cause weight gain, and when appropriate, discuss and/or prescribe obesity medications and/or refer to bariatric surgery.
Garvey does find some fault with the proposed standards.
“For one thing, [they] do not address obesity prevention. Secondly, they seem to exclude patients with overweight (BMI 25-29.9 kg/m2) from the treatment paradigm,” he observes.
Thirdly, in treating obesity as a disease, “there could be more explicit integration of the presence and severity of obesity-related complications into therapeutic decisions, so risk stratification can serve as a strategy to target more intensive interventions to those at highest risk.”
Nevertheless, “the recommended standards represent a quantum leap forwarding in guiding the formulation of high-quality and evidence-based care of patients with obesity,” he stresses.

Critical First Steps: “Much Hangs in the Balance”

Garvey summarizes in his commentary, “At the heart of this issue is the bias that obesity is a lifestyle choice and not a chronic disease that merits the full force of a medical model for prevention and treatment.”
“This bias is in abject contradistinction to scientific evidence but, nevertheless, is prevalent among the lay public, many healthcare professionals, and regulators. The result is a lack of access by patients to evidence-based therapies in our healthcare systems.”
Taken together, “the two papers do not even begin to address what will be necessary to promote the prepared patient, nor efforts needed for obesity prevention requiring changes in the built environment, food supply, and messaging for a healthier lifestyle.”
Nevertheless, “these are critical [first] steps in the evolution of a comprehensive care model for obesity treatment and prevention.”
“Much hangs in the balance,” he concludes.
*American Association of Clinical Endocrinologists (AACE), American College of Obstetricians and Gynecologists, American Association of Nurse Practitioners (AANP), American Academy of Physician Assistants (AAPA), American College of Lifestyle Medicine, American College of Preventive Medicine, American Osteopathic Association, American Association of Colleges of Osteopathic Medicine, American Society for Nutrition, Endocrine Society, Society of Behavioral Medicine, and Society of General Internal Medicine.
**The obesity competencies for medical education were endorsed by the AAPA, AACE, AANP, American Board of Obesity Medicine, ASMBS, American College of Surgeons, Association for Bariatric Endoscopy, American Medical Woman’s Association, AND, American College of Osteopathic Pediatricians, American Society for Gastrointestinal Endoscopy, Endocrine Society, Obesity Action Coalition, OMA, Society of General Internal Medicine, Society of Behavioral Medicine, Society of Teachers of Family Medicine, TOS, World Obesity Federation, and Obesity Canada.   
***More information about adopting OMEC competencies can be obtained by contacting: omec@obesitymedicine.org
The authors of the report on “obesity competencies for medical education” have no relevant financial disclosures. The report on the “proposed standard of obesity care for all providers and payors” was funded through a research grant from Novo Nordisk. Dietz has reported serving on the scientific board for Weight Watchers. Gallagher has reported no relevant financial relationships. Garvey has reported receiving personal fees from Sanofi, Novo Nordisk, Amgen, American Medical Group Association, BOYDSense, and Gilead, and grants from Merck, Pfizer, Novo Nordisk, Astra Zeneca, and Sanofi outside the submitted work
Obesity. 2019;27:1045-1047, 1059-1062, 1063-1067. Report 1Report 2Commentary

Medicare recipients may pay more for generics than brand-name counterparts

Medicare Part D enrollees may pay more out of pocket for high-priced specialty generic drugs than their brand-name counterparts, according to new research by health policy experts at Vanderbilt University Medical Center and the University of North Carolina at Chapel Hill.
Researchers examined differences in brand-name and generic or biosimilar drug prices, formulary coverage and expected out-of-pocket spending across all of the Medicare Part D plans available in the U.S. in the first quarter of 2018.
The study, published in the July issue of Health Affairs, found that current Medicare Part D beneficiaries can have higher out-of-pocket spending for generics than their branded counterparts if they use expensive specialty drugs and if the price differences between brands and generics are not large. This can be common for individuals prescribed specialty drugs typically used to treat rare or complex conditions such as cancer, rheumatoid arthritis or multiple sclerosis.
Ironically, even if we assume that generic drugs have lower list prices than brands, for Medicare beneficiaries with $20,000 to $80,000 in annual drug spending, using only brand-name drugs could actually save them money.
This is happening because branded drug manufacturers now pay a discount in the donut hole, which gets counted as out-of-pocket spending. This helps patients reach catastrophic coverage faster, where they pay 5% of the drug’s price instead of 25%. Generic drug makers do not pay these same discounts, so patients have to spend more of their own money to make it to the catastrophic phase of the benefit.”
Stacie Dusetzina, PhD, associate professor of Health Policy and Ingram Associate Professor of Cancer Research at VUMC, the study’s lead author
In 2019, this means people using brand-name drugs who reach the donut hole, or coverage gap, have to spend $982 to get to the catastrophic coverage phase. People using generic drugs have to spend $3,730 to reach that point. The study also notes policy changes set to take effect in 2020 will only make the situation worse by increasing patient out-of-pocket spending requirements for the catastrophic phase coverage from $5,100 to $6,350.
In response, the Trump administration and the Medicare Payment Advisory Commission (MedPAC) have included recommendations to exclude the manufacturer discount from out-of-pocket spending calculations.
“While this would level the playing field between generic drugs and brands, it would do so by making brand-name drugs more expensive instead of making generic drugs less expensive,” said Dusetzina. “Congressional committees have signaled interest in addressing this and other issues in Medicare Part D, including placing a cap on out-of-pocket spending.
“The Part D benefit needs a redesign so that it works for people needing expensive drugs. I hope Congress will take this opportunity to make changes to Part D, including making sure that generic drug users aren’t overpaying for these drugs.”

Quorn protein builds muscle better than milk protein

A study from the University of Exeter has found that fungus-derived mycoprotein, the protein-rich food source that is unique to Quorn products, stimulates post-exercise muscle building to a greater extent than milk protein.
The study evaluated the digestion of protein, which allows amino acids (the building blocks of protein) to increase in the bloodstream and then become available for muscle protein building in 20 healthy, trained young men at rest and following a bout of strenuous resistance exercise.
The young men performed the exercise and were then given either milk protein or mycoprotein.
Their muscle building rates were then measured using stable isotope labelled “tracers” in the hours following protein consumption.
Animal proteins like milk are an excellent source for muscle growth, so they provide a useful comparison for testing other protein sources.
The results showed that while those who ingested milk6 protein increased their muscle building rates by up to 60%, those who had mycoprotein increased their muscle growth rates (MGRs) by more than double this — showing that mycoprotein, the main ingredient in all Quorn products, is a more effective source of protein to promote muscle growth.
“These results are very encouraging when we consider the desire of some individuals to choose non-animal derived sources of protein to support muscle mass maintenance or adaptations with training,” said Dr Benjamin Wall, Associate Professor of Nutritional Physiology, University of Exeter.
“Our data show that mycoprotein can stimulate muscles to grow faster in the hours following exercise compared with a typical animal comparator protein (milk protein) — we look forward to seeing whether these mechanistic findings translate to longer term training studies in various populations.”
Tim Finnigan, Chief Scientific Adviser for Quorn Foods, said “We’re excited to see this data being presented by the University of Exeter at ECSS. In a world where many people are trying to cut back on their meat consumption, either for environmental or health reasons, we’re happy to be able to offer an alternative protein that can provide exceptional nutrition and muscle growth, all while being meat-free.”
Recent research has suggested that current recommendations for protein intake are too low — some scientists have calculated that minimum protein requirements could have been underestimated by as much as 30-50% in some populations.1
The British Nutrition Foundation already recommends mycoprotein as a good source of dietary protein, both for everyday life and for sport and exercise.
However, in the UK roughly a third of total protein consumption comes from meat products — and increasing meat intake may have serious consequences for public health and for the environment.
A pivot to “alternative” sources of protein therefore may be advisable — and mycoprotein is well placed to fill the gap.
Story Source:
Materials provided by University of ExeterNote: Content may be edited for style and length.

DOJ asks Congress to permanently classify fentanyl-like drugs

A temporary order classifying fentanyl-like drugs as controlled substances should be enacted into law, the U.S. Department of Justice is telling Congress.
The order—which was enacted in 2018 on an emergency basis and expires in February 2020—tightened controls on fentanyl-like drugs, which had skirted federal law because their chemical makeup is slightly different than the opioid fentanyl, which is about 100 times stronger than morphine, CBS News reported. Fentanyl-like drugs can be even stronger.
“From a policy and regulatory perspective, fentanyl-like substances need to be permanently scheduled as a class,” said Katie Crytzer, the acting deputy assistant attorney general in the Office of Legal Policy at the Department of Justice, CBS Newsreported. The  is an “urgent and necessary first step,” she told reporters Monday.
Of the more than 70,000  in the U.S. in 2017, nearly 48,000 were caused by opioids, and about 29,000 by fentanyl or fentanyl-like , according to U.S. Centers for Disease Control and Prevention data, said John Martin, assistant administrator of the Drug Enforcement Administration, CBS News reported.

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