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Friday, August 2, 2019

As Dems Debate Single Payer, Humana’s Medicare Advantage Enrollment Soars

Against the backdrop of the political debate over whether the U.S. government should administer Medicare for all Americans, health insurance companies are reporting record growth in their privately run Medicare Advantage businesses.
On Wednesday, Humana increased its full-year projections for Medicare Advantage growth to a “range of 480,000 to 500,00 members,” or 16% growth for 2019. That compares to a previous range of 415,000 to 440,000, the insurer reported.
Humana is the latest health insurer to tout solid profits thanks in part to seniors flocking to Medicare Advantage. Centene, WellCare Health Plans, UnitedHealth Group and Anthem have already reported record Medicare Advantage enrollment as well and Cigna will release its updated second-quarter figures on Thursday.
Medicare Advantage plans contract with the federal government to provide extra benefits and services to seniors, such as disease management and nurse help hotlines, with some even providing vision and dental care and wellness programs. And the federal government has changed rules to allow private health insurers to offer more supplemental benefits in Medicare Advantage plans they sell.
At a debate Tuesday night among half of the Democrats running for President, a divide emerged among candidates who want to preserve the private healthcare system — including Medicare Advantage — and U.S. Sens. Elizabeth Warren and Bernie Sanders who want to see the health insurance industry uprooted. The remaining candidates for the Democratic party’s 2020 nomination will debate Wednesday night including former Vice President Joe Biden and California U.S. Sen. Kamala Harris, who has a new healthcare plan out that would preserve the ability of seniors to keep their Medicare Advantage plans.
Humana CEO Bruce Broussard said seniors are attracted to the insurer’s “relentless focus on creating a simple and personalized healthcare experience.”
“As the number of seniors choosing Medicare Advantage plans continues to rise, we will continue to work collaboratively with partners across the industry to advance a consumer-centric system that focuses on improving both health outcomes and the affordability of care,” Broussard said on Humana’s second-quarter earnings call with analysts Wednesday morning.
The increase in Medicare Advantage members helped Humana’s earnings jump more than $1 billion, or $6.05 per share. Revenues rose 14% to $16.25 billion in the quarter.
As of June 30, Humana’s individual Medicare Advantage enrollment was 3.48 million, which was up 15% from the year-ago period.
Humana also raised its earnings forecast for the rest of this year due largely to the growth in its Medicare Advantage business. Humana raised its 2019 earnings-per-share guidance to $17.97, which the company said represented 21% growth for the year.
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Florida declares public health emergency over ballooning Hepatitis A cases

With 56 new cases of Hepatitis A reported statewide in the week since the last reporting period, the Florida Surgeon General declared a public health emergency on Thursday, allowing health officials to test and treat people suspected of carrying the virus.
“I am declaring this Public Health Emergency as a proactive step to appropriately alert the public to this serious illness and prevent further spread of Hepatitis A in our state,” Florida Surgeon General Dr. Scott Rivkees said. “The best way to prevent hepatitis A is through vaccination. It is important that we vaccinate as many high-risk individuals as possible in order to achieve herd immunity.”
The number of reported Hepatitis A cases in Florida in 2019 rose to 2,034 as of July 27, up from the 1,978 cases reported on July 20, the Florida Department of Health said.
The critically impacted counties are Brevard, Citrus, Glades, Hernando, Hillsborough, Lake, Liberty, Manatee, Marion, Martin, Okeechobee, Orange, Pasco, Pinellas, Sumter, Taylor, and Volusia. Most of that area is in Central and Western Florida.

EXPLOSION OF CASES

The number of Hepatitis A cases in Florida has exploded in 2019, with this year’s 2,034 cases nearly four times the 548 cases reported in all of 2018, according to the Health Department. And there are five more months to be accounted for in 2019.
In 2014, just five years ago, there were only 106 cases in the state, the health department’s figures show.

THOSE MOST AT RISK

Groups who are most at risk, according to the Centers for Disease Control and Prevention, include:
▪ People over 60 years old
▪ People with chronic liver disease, including cirrhosis, hepatitis B, or hepatitis C
▪ People with compromised immune systems, including people with HIV or AIDS
▪ People who have unstable housing or are homeless
▪ Drug users
▪ Inmates
Symptoms can include yellowing skin, fever, diarrhea, fatigue and loss of appetite. According to the Centers for Disease Control and Prevention, hepatitis A is “usually transmitted person-to-personthrough the fecal-oral route or consumption of contaminated food or water.”

NATIONAL OUTBREAK

Florida’s outbreak coincides with a national surge in cases.
Since the Hepatitis A outbreak was first identified in 2016, there have been 22,566 reported cases in 25 states as of July 26, the CDC reports. Of those, 13,352 cases, or 59 percent, resulted in hospitalizations and 221 people died.
According to the CDC, the five states with the highest number of cases are:
Kentucky: 4,793 (As of July 13)
Ohio: 3,220 (As of July 22)
West Virginia: 2,528 (As of July 3)
Florida: 2,220 (As of June 30)
Tennessee: 2.022 (As of July 19)

PREVENTION

“All individuals should wash their hands with soap and water for at least 20 seconds,” the Florida Health Department advisory said.
Hand sanitizers do not kill the virus, the Health Department said, and private showers and restrooms should also be consistently sanitized.
In addition to hand washing, health officials urge people to get vaccinated.
One dose of single-antigen hepatitis A vaccine provides up to 95% protection in healthy individuals for up to 11 years, the CDC reports.

WHO SHOULD GET VACCINATED

The CDC recommends the following groups should be vaccinated:
▪ All children at age 1 year
▪ Travelers to countries where hepatitis A is common
▪ Family and caregivers of adoptees from countries where hepatitis A is common
▪ Men who have sexual encounters with other men
▪ People who use injection and non-injection drugs
▪ People with chronic liver disease
▪ People with clotting-factor disorders
▪ People experiencing homelessness
▪ People who work with HAV-infected primates or with HAV in a research laboratory setting
▪ People with direct contact with others who have hepatitis A
▪ Anyone wishing to obtain immunity (protection)
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Removing the need for anti-rejection drugs in transplant recipients

For decades, immunologists have been trying to train the transplant recipient’s immune system to accept transplanted cells and organs without the long-term use of anti-rejection drugs. New University of Minnesota preclinical research shows that this is now possible.
For many patients with end-stage organ failure, transplantation is the only effective and remaining treatment option. To prevent transplant rejection, recipients must take medications long-term that suppress the body’s immune system. These immunosuppressive drugs are effective at preventing rejection over the short term; however, because anti-rejection drugs suppress all of the  nonspecifically, people taking these drugs face the risk of serious infections and even cancer. Additionally, non-immunological side effects of immunosuppression, such as hypertension, kidney toxicity, diarrhea, and diabetes diminish the benefits of transplantation. Finally,  are much less effective at preventing  over a long period of time, thereby leading to graft loss in many recipients.
Because a growing population of chronically immunosuppressed transplant recipients face that impasse, which might adversely affect their survival, generations of immunologists have pursued immune tolerance as the primary goal in the field of transplantation medicine. Inducing tolerance to transplants would eliminate the need for chronic immunosuppression and enhance transplant and patient survival. Proof that immune tolerance of transplants can be achieved was first demonstrated in mice by Peter Medawar in his Nobel Prize-winning Nature article more than 65 years ago. Yet, despite its immense significance, transplant tolerance has been achieved in only a very few patients.
This new study capitalizes on the unique attributes of modified donor , which were infused into transplant recipients one week before and one day after the transplant, thereby recapitulating nature’s formula for maintaining the body’s tolerance of its own tissues and organs. Without the need for long-term antirejection drugs, islet cell transplants could become the  of choice, and possibly a cure, for many people burdened by type 1 diabetes.
“Our study is the first that reliably and safely induces lasting  of transplants in nonhuman primates,” said senior author Bernhard Hering, MD, Professor and Vice Chair of Translational Medicine in the Department of Surgery at the University of Minnesota, who also holds the Jeffrey Dobbs and David Sutherland, MD, Ph.D., Chair in Diabetes Research. “The consistency with which we were able to induce and maintain tolerance to transplants in nonhuman primates makes us very hopeful that our findings can be confirmed for the benefit of patients in planned clinical trials in pancreatic islet and living-donor kidney transplantation—it would open an entirely new era in transplantation medicine.”
Journal information: Nature Communications
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FDA OKs Daiichi’s pexidartinib for rare synovial cancer

The FDA approves Daiichi Sankyo’s (OTCPK:DSNKY +0.2%) Turalio (pexidartinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations that cannot be improved with surgery.
TGCT is a rare benign cancer that occurs in the synovium, bursae and tendon sheath. Synovium is the thin membrane that covers the surface of joint spaces.
Small molecule pexidartinib inhibits a cell surface protein called colony stimulating factor-1 receptor (CSF1R) which is the primary growth driver of abnormal cells in the synovium.
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US News Releases Latest Top Hospitals List

For the fourth consecutive year, the Mayo Clinic in Rochester, Minnesota, claimed the number one spot in the annual honor roll of best hospitals published today by US News & World Report.
Massachusetts General Hospital in Boston holds the number two spot this year (up from number four last year) in the magazine’s annual honor roll, which highlights hospitals delivering “exceptional treatment across multiple areas of care.”
Johns Hopkins Hospital in Baltimore, Maryland, holds the number three spot again this year, while the Cleveland Clinic in Ohio falls two spots from number two to number four on the list.
NewYork-Presbyterian Hospital–Columbia and Cornell in New York City made the biggest jump this year, grabbing the number five spot on the ranking, up from number 10 in last year’s ranking. UCLA Medical Center, Los Angeles and UCSF Medical Center, San Francisco flipped positions this year, with UCLA at number six and UCSF at number seven.
Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; NYU Langone Hospitals, New York City; Northwestern Memorial Hospital, Chicago, Illinois.
2019–2020 Best Hospitals Honor Roll
1. Mayo Clinic, Rochester, Minnesota
2. Massachusetts General Hospital, Boston
3. Johns Hopkins Hospital, Baltimore, Maryland
4. Cleveland Clinic, Ohio
5. NewYork-Presbyterian Hospital–Columbia and Cornell, New York City
6. UCLA Medical Center, Los Angeles
7. UCSF Medical Center, San Francisco
8. Cedars-Sinai Medical Center, Los Angeles
9. NYU Langone Hospitals, New York, New York City
10. Northwestern Memorial Hospital, Chicago
11. University of Michigan Hospitals-Michigan Medicine, Ann Arbor
12. Stanford Health Care-Stanford Hospital, Palo Alto, California
13. Brigham and Women’s Hospital, Boston
14. Mount Sinai Hospital, New York City
15. UPMC Presbyterian Shadyside, Pittsburgh
16. Keck Hospital of USC, Los Angeles
17. University of Wisconsin Hospitals, Madison
18. (tie) Hospitals of the University of Pennsylvania-Penn Presbyterian, Philadelphia
18. (tie) Mayo Clinic-Phoenix
20. (tie) Houston Methodist Hospital, Texas
20. (tie) Yale New Haven Hospital, New Haven, Connecticut

New Methodology

“In the three decades since US News began evaluating hospitals, we periodically have revamped our measures to enhance the decision support our rankings and ratings provide to patients,” Ben Harder, managing editor and chief of health analysis at the magazine, said in a statement. “This year we revised the methodology to incorporate new measures of patient-centered care and to enhance how we account for differences in hospitals’ patient populations. The new model provides a more comprehensive assessment that is useful to patients, families, and their medical professionals.”
Due to the changes in methodology this year, US News advises against making comparisons to past numerical ranks.
The 2019–2020 rankings compared more than 4500 hospitals across 25 specialties, procedures, and conditions. This year, 165 hospitals were nationally ranked in at least one specialty (compared to 158 last year) and 569 hospitals were ranked among the best regional hospitals in a state or metro area based on their performance in delivering complex and common care.
In the 2019–2020 Best Hospitals: Specialty Rankings, as was the case for the prior 3 years, the University of Texas MD Anderson Cancer Center holds the number one spot in cancer, the Cleveland Clinic is number one in cardiology and heart surgery, and the Hospital for Special Surgery is number one in orthopedics.
Top Five for Cardiology and Heart Surgery
1. Cleveland Clinic, Ohio
2. Mayo Clinic, Rochester, Minnesota
3. Cedars-Sinai Medical Center, Los Angeles
4. NewYork-Presbyterian Hospital–Columbia and Cornell, New York City
5. Massachusetts General Hospital, Boston
Top Five for Cancer
1. University of Texas MD Anderson Cancer Center, Houston
2. Memorial Sloan Kettering Cancer Center, New York City
3. Mayo Clinic, Rochester, Minnesota
4. Johns Hopkins Hospital, Baltimore, Maryland
5. Dana-Farber/Brigham and Women’s Cancer Center, Boston, Massachusetts
Top Five for Orthopedics
1. Hospital for Special Surgery, New York City
2. Mayo Clinic, Rochester, Minnesota
3. Cedars-Sinai Medical Center, Los Angeles, California
4. UCSF Medical Center, San Francisco, California
5. NYU Langone Orthopedic Hospital, New York City
The full report is available online.
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Frailty Not a Normal Part of Aging

It’s something everyone fears will happen to them as they age: sapped strength, slowed walking, weight loss and an inability to perform daily tasks with ease.
But it’s not just a byproduct of aging: Frailty is a standalone medical condition, researchers report.
Sadly, the condition is associated with a lower quality of life and a higher risk of death, hospitalization and institutionalization, they noted.
And while frailty is most common among older adults, young people can become frail if they have one or more disabling chronic diseases.
In their study, the researchers analyzed 46 studies of more than 120,000 people aged 60 and older living without assistance in 28 countries. They concluded that 4.3% of people in that age group develop frailty each year, and that women are more vulnerable than men.
The findings “suggest that the risk of developing frailty in older people is high. This is a worldwide problem and highlights a major challenge facing countries with aging populations,” said study co-leader Richard Ofori-Asenso. He’s from the School of Public Health and Preventive Medicine at Monash University in Melbourne, Australia.
More than 20% of the world’s population will be older than 60 by 2050, so the number of people with frailty is expected to rise.
There is no firm definition of frailty, but it’s typically diagnosed when people meet three of the following five criteria: low physical activity, weak grip strength, low energy, slow walking speed, and non-deliberate weight loss.
Luckily, interventions such as strength training and protein supplementation may help prevent or delay the progression of frailty, according to the researchers. A previous study found that it may even be possible to reverse frailty.
In a university news release, Ofori-Asenso and his colleagues called for “regular screening to assess older people’s vulnerability to developing frailty so that appropriate interventions can be implemented in a timely manner.”
The study was published Aug. 2 in JAMA Network Open.
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Medicines Co. awaits Sept. 2 pivotal results report

Investors in The Medicines Company have Sept. 2 circled in red on their calendars. That’s the day the company plans to report the first pivotal results from late-stage studies of its experimental cardiovascular drug, inclisiran.
Success would test the Parsippany, New Jersey-based biotech’s all-in bet that it can compete in a market currently led by larger drugmakers Amgen and the team of Sanofi and Regeneron.
Wall Street analysts are expecting inclisiran to perform at least as well in lowering cholesterol as similarly acting drugs Repatha and Praluent, with the added benefit of twice a year dosing compared to once- or twice-monthly for the two approved products.
Falling short of that mark, or detecting a safety signal, would be devastating for The Medicines Company, which shed itself of a portfolio of drugs primarily used in hospital settings to finance the clinical program for inclisiran.
Along with selling off marketed lines like Angiomax and Kengreal, The Medicines Company raised at least $650 million from investors in the past three years to get inclisiran over the finish line, including a $150 million share sale in June 2019.
The setting for the big reveal will be the European Society of Cardiology meeting, where results of a trial called ORION-11 will be part of a session on cardiovascular prevention. That trial enrolled 1,600 patients with a history of heart disease or at high risk, testing inclisiran or a placebo on top of other lipid-lowering therapies. The trial’s primary comparison measures low-density lipoprotein, or “bad cholesterol,” 15 months after the first dose.
Executives said topline results will probably be available before the Sept. 2 presentation in Paris, although it will likely only state whether inclisiran was able to show a statistically significant reduction in LDL. Officials declined BioPharma Dive’s request for an interview for this story.
Like Amgen’s Repatha and Sanofi and Regeneron’s Praluent, inclisiran targets a protein called PCSK9 that is essential to LDL metabolism in the liver. The difference is that the marketed products, which are a type of biological called a monoclonal antibody, do so by binding to PCSK9. By contrast, inclisiran blocks the expression of genes that encode PCSK9.
The two antibodies have set a high bar for inclisiran. In this same population with atherosclerotic cardiovascular disease or risk factors, Repatha lowered LDL by an average of 57% more than placebo after 72 weeks in the FOURIER cardiovascular outcomes trial. Praluent performed similarly, leading to a 55% drop after 48 weeks in the ODYSSEY study.
The Medicines Company is confident inclisiran can come through. Long-term data from Phase 2 trials has detected LDL-lowering of more than 50% up to three years after treatment, with no safety signals. Based on those LDL reductions, the company predicted that in the ORION-11 population the risk of cardiovascular events would be reduced 31%, although that will likely need to be proven through a long-term outcomes study, as Amgen did with FOURIER and Sanofi and Regeneron did with ODYSSEY.
Repatha and Praluent both reduced the risk of cardiovascular death and complications by 15%, similar to the combination of Zocor and Zetia, now off-patent drugs that reduced the risk of heart attacks by 13% and strokes by 21% in the IMPROVE-IT trial. The modest improvement is one of the reasons the prices of both Repatha and Praluent have been cut from their initial prices of about $14,000 to around $6,000 a year.
The Medicines Company may have two advantages. The first is that inclisiran, a type of drug called an oligonucleotide, may be cheaper to produce than antibodies, and thus may be profitable at a lower price.
“They talk about how they have a lot more flexibility around pricing,” Dara Lundon, an analyst with Evercore ISI, said in an interview with BioPharma Dive.
Inclisiran also would not need to be refrigerated as antibodies are, potentially reducing distribution costs.
The second is the dosing frequency, which is twice a year once patients hit the maintenance phase. In the past, executives have said this could easily correspond with visits to cardiologists, meaning patients would not have to remember to take the drug as they do with PCSK9s or statins.
The exact value of twice a year dosing to patients, physicians or payers is an unanswered question, though.
Ethan Weiss, a cardiologist at University of California-San Francisco, told BioPharma Dive: “I don’t see taking 24 injections a year as a significant problem for my patients. In some ways, the cadence of it is good and they can remember it.”
Price could emerge as the most compelling factor. “With everything else, cost ends up being the big or final arbiter, and in this case it probably will be as well,” he added.
The track record of Repatha and Praluent prove Weiss’ point well. Both drugs launched to blockbuster sales expectations, yet struggled with resistance from insurers on price and low patient uptake. Even now, four years on from the drugs’ market arrival and after multiple price adjustments, revenue earned from each remains modest.
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