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Tuesday, December 3, 2019

Pharmacy benefits manager Abarca inks discount deal for Amgen’s Enbrel

Abarca, a small Puerto Rico-based pharmacy benefits manager, said on Tuesday Amgen Inc had agreed to give its health insurer clients an additional discount on its blockbuster rheumatoid arthritis drug Enbrel, if patients discontinue taking it after three months.
Pharmacy benefits managers like Abarca act as middlemen in the drug supply chain, and negotiate discounts on drugs on behalf of health insurers. Depending on the discounts drugmakers are willing to provide, pharmacy benefits managers make decisions about which drugs to include in coverage plans.

Abarca said its new deal with Amgen will help health insurers save costs when patients discontinue the drug because of side effects or a lack of effectiveness. It did not disclose the size of the additional discount.
Last year, Abarca, which currently serves 2.5 million members, signed a similar agreement with Amgen over its cholesterol drug Repatha and with Biogen Inc over coverage of its medicines to treat multiple sclerosis.

Abarca’s Chief Operating Officer Javier Gonzalez estimates Enbrel costs the health insurance plans the company represents between $4,000 and $5,000 per patient every month.
The drug has been on the U.S. market since 1998 and is Amgen’s best-selling product, bringing in revenue of $1.37 billion in the third quarter.
While the U.S. Food and Drug Administration has approved biosimilars to Enbrel, including one from Novartis AG, they have not yet been launched because of ongoing patent litigation.
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U.S. regions hard hit by opioids to ditch class action, pursue own lawsuits

Local governments in regions hard hit by the U.S. opioid epidemic have opted out of massive litigation taking aim at the drug industry over the crisis, potentially weakening a novel legal mechanism created to help settle thousands of lawsuits.
Overall, 98% of some 34,000 local governments agreed to be bound by a class action against companies such as drug distributor McKesson Corp, drugmaker Johnson & Johnson and pharmacy chain Walgreens Boots Alliance Inc, according to a Monday court filing.
However, the 541 local governments that opted out included Florida’s Palm Beach County and counties in West Virginia, according to attorneys, raising the prospect that companies could face expensive trials even if they settled with the class. The two regions are among the hardest hit by the crisis, which has contributed to more than 400,000 deaths since 1997.
Officials from Houston’s Harris County, one of the largest U.S. counties, have said it would opt out, meaning they would pursue their own lawsuit and not receive funds from a nationwide settlement.
The court filing did not identify opt-outs.

U.S. Judge Dan Polster in Cleveland, who has been overseeing 2,600 consolidated opioid lawsuits, is pushing hard for a settlement to help get funds to those most in need in a timely fashion. He approved the novel “negotiation class” as a way to reassure companies that any deal to resolve the lawsuits would bind remaining governments and prevent them from filing a case.
The lawsuits generally allege that drugmakers improperly marketed opioids while distributors and pharmacy chains failed to stop suspicious orders. The defendants deny the allegations.
Typical class actions allow members to opt out after a settlement has been reached, but the negotiation class fixes the members first. Any settlement must be approved by 75% of the class.
Lawyers said towns and counties less affected by the crisis had little reason to opt out, while areas ravaged by opioids, like West Virginia, had more incentive to pursue and control their own lawsuit.
The number of opt-outs represented around 20% of those that have already sued and could be significant if it included large cities, according to Elizabeth Burch, a professor at the University of Georgia School of Law.

“If I’m trying to negotiate with a town of 80, that’s very different from Houston,” she said.
The negotiation class was opposed by some state attorneys general and drug distributors, and faces a legal challenge at the 6th U.S. Circuit Court of Appeals in Cincinnati.
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Roche wins FDA OK for immunotherapy cocktail against lung cancer

Roche’s Tecentriq immunotherapy mixed with chemotherapy won U.S. approval as an initial treatment for a form of lung cancer as the Swiss drugmaker seeks to establish its alternative to drugs from Merck and Bristol-Myers Squibb.
The U.S. Food and Drug Administration approved Tecentriq mixed with Celgene’s Abraxane and carboplatin chemotherapy to treat metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations, Roche said on Wednesday.
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Focused Ultrasound Ablates Tremor

Transcranial image-guided focused ultrasound was capable of targeting and ablating areas of the brain involved with tremors, and brought relief to individuals with Parkinson’s disease or essential tremor, researchers reported here.
In a study involving 39 patients with tremor, substantial improvement was reported in 37 individuals, and that improvement continued over the course of at least one year, said Federico Bruno, MD, of the University of L’Aquila in Italy, at the Radiological Society of North America’s annual meeting.
Bruno told MedPage Today, “We have continued to perform these treatments on patients since we submitted our abstract and now have treated more than 60 people. This is a second-line therapy, that differs greatly from deep brain stimulation. There is no brain incision or wire placement with magnetic resonance-guided focused ultrasound thalamotomy.”
After medical therapy fails or stops working, treatment options have included deep brain stimulation and laparoscopic or even open surgery to ablate tissues where tremors are thought to arise.
As a non-invasive approach, focused ultrasound has advantages over deep brain stimulation, including minimal risk of complications from bleeding and infections, Bruno said. “Another advantage is the immediate effect this treatment provides, unlike deep brain stimulation which requires a break-in period for the electrostimulation,” he said. “Additionally, treatment with magnetic resonance-guided focused ultrasound requires shorter hospitalization and is a fairly well-tolerated procedure even by more fragile patients.”
Michael Lev, MD, director of emergency radiology and professor of radiology at Massachusetts General Hospital/Harvard Medical School, Boston, told MedPage Today, “Focused ultrasound has been used in multiple medical fields, from cancer to tremors, and its extension here is to Parkinson’s disease. That is the new twist.”
“A problem with deep brain stimulation, aside from it requiring surgery, is that the wires and electrodes may make future imaging difficult because they case imaging artifacts.” He called it a “nice idea” to use a non-invasive method, with which radiologists are already somewhat familiar, and that avoids the artifact problem.
However, Lev cautioned, “These are always works in progress. You do a small series, you check for safety, but considering there is a track record with this treatment, I think this is promising.”
For the new study, Bruno and colleagues enrolled patients, average age 64.5, with disabling tremors that had not responded to standard treatment. The 39 patients included 22 men and 17 women enrolled from February to March 2018. Eighteen were diagnosed with essential tremor and 21 with Parkinson’s disease. They had experienced symptoms for an average of more than 10 years.
Temporary side effects and complications occurred in seven patients after treatment, with resolution at the 6-months follow-up in four patients. Instrumental imaging follow-up showed a progressive reduction of thalamotomy lesion size and perilesional edema in both groups.
Patients were evaluated using the Fahn-Tolosa-Marin (FTM) scale for tremor and the QUEST score for quality of life at baseline and then at 1-month, 6 months, and 1 year. In patients with essential tremor, FTM scores dropped from a mean of 36.2 at baseline to 13.8 immediately after treatment. At one month the mean score was 14.6; it was 14.3 at 6 months and 14.5 among patients evaluated at 1 year.
Among the Parkinson’s disease patients, FTM scores decreased from mean values of 27.5 before treatment to 11.6 immediately after treatment. At the 6-months follow up, mean FTM score was 15.5, due to mild recurrence of tremor in four patients, that remained stable at 1 year.
In the QUEST quality of life evaluation, Bruno said mean scores in essential tremor patients fell 73.2% and by 68% among the Parkinson’s disease patients.
“The study we present reports our experience of over a year in the treatment of tremor by thalamotomy with focused ultrasound,” Bruno said. “It is worth noting that we had a high number of patients with Parkinson’s disease in our series, compared to previously published data, where the procedure was used mainly in the treatment of essential tremor patients.”
Bruno disclosed no relevant relationships with industry.
Lev disclosed relevant relationships with GE and Takeda.
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Nutritional Deficiencies in Teens Seen at 5 Years After Bariatric Surgery

Target Audience and Goal Statement: Bariatric surgeons, endocrinologists, pediatricians, primary care physicians, family medicine specialists
The goal of this 5-year prospective cohort study was to determine the prevalence of, and risk factors for, nutritional deficiencies in adolescents who underwent bariatric surgery.
Question Addressed:
  • What is the prevalence of, and risk factors for, nutritional deficiencies in adolescents who underwent bariatric surgery at 5-year follow-up?
Study Synopsis and Perspective:
Adolescents who underwent bariatric surgery, particularly Roux-en-Y gastric bypass (RYGB), had an elevated risk for nutritional deficiencies at 5 years, according to results from a study by the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) consortium.

Action Points

  • Adolescents who underwent bariatric surgery — particularly Roux-en-Y gastric bypass, but also vertical gastric sleeve — had an elevated risk for nutritional deficiencies at 5 years, according to results from a study by the Teen Longitudinal Assessment of Bariatric Surgery consortium.
  • Understand that because adolescents have an anticipated longer lifespan, it is recommended that they be closely monitored for nutrient deficiencies in an ongoing manner and given supplements to treat these deficiencies.
Five years after surgery, 59% of RYGB recipients and 27% of vertical sleeve gastrectomy (VSG) recipients had two or more nutritional deficiencies, according to Stavra Xanthakos, MD, MS, of Cincinnati Children’s Hospital Medical Center, and colleagues.
Researchers enrolled; 161 patients had undergone RYGB and 65 had undergone VSG. The participants were 75% female and 72% white, with a mean age of 16.5 years and a mean body mass index (BMI) of 52.7 kg/m2 at the time of surgery. Mean BMI decreased by 23% at 5 years in both groups.
Following RYGB surgeries, serum concentrations of vitamin B12 significantly decreased, while serum levels of transferrin and parathyroid hormone increased. Ferritin levels decreased significantly after both RYGB and VSG: hypoferritinemia was diagnosed in 2.5% of patients before RYGB and in 71% at 5 years (P<0.0001), and in 11% of patients before VSG and in 45% at 5 years (P=0.002), the authors reported in Clinical Gastroenterology and Hepatology.
At baseline and once yearly for 5 years, researchers measured serum levels of vitamins A, D, B1, and B12; ferritin; red blood cell folate; and parathyroid hormone. General linear mixed models were used to examine changes over time and identify factors associated with nutritional deficiencies.
Higher multivitamin intake was associated with higher ferritin, vitamin B12, folate, vitamin A, and 25-hydroxyvitamin D levels and reduced odds of vitamin D deficiency. Vitamin D and calcium supplementation were not associated with parathyroid hormone levels or abnormality.
There were no significant changes in serum folate or vitamins A, B1, or D between baseline and 5 years after either procedure.
For both groups, risk factors associated with specific deficiencies included surgery type, female sex, black race, supplementation intake, weight regain, and pregnancy.
The authors noted that while bariatric surgery is an increasingly accepted treatment for severe obesity in young people, post-surgical nutritional deficiencies have been estimated largely from adult cohorts. “Yet, lower adherence to supplementation and anticipated longer lifespan with altered gastrointestinal physiology may increase risk of adverse nutritional outcomes in these youth,” they wrote.
The differential nutritional risk profiles associated with the two surgical procedures point to a need to monitor patients undergoing bariatric surgery, as the numbers of these procedures are likely to increase as the prevalence of childhood and adolescent obesity and associated morbidities grow. VSG is now the predominant bariatric surgery in adolescents and adults due to its limited anatomical alteration, lower operative risk, and presumed lower risk of nutritional deficits.
“Our results now provide critical evidence that VSG does in fact carry significantly lower nutritional risk than RYGB, but can still worsen iron status,” the authors wrote.
Study limitations included some missing data and the limited number of nutritional measures available, which prevented full characterization of iron and vitamin B12 nutriture. In addition, copper, zinc, and vitamin E were not assessed, and the self-reported supplement intake by participants was likely to entail appreciable error, possibly biasing findings towards the null. Data on dietary intake and non-recommended supplements were also lacking, the authors noted.
Source Reference: Clinical Gastroenterology and Hepatology 2019; DOI: 10.1016/j.cgh.2019.10.048
Study Highlights and Explanation of Findings:
The study authors noted that nutritional deficiencies associated with bariatric surgeries are “a significant concern” and may lead to morbidities including chronic anemia, osteoporosis, and/or permanent neurological problems if not diagnosed and managed. They noted that deficiencies found in the first year after surgery may not reflect what is found at 5 years.
“Lifelong micronutrient supplementation is therefore recommended,” the authors wrote. Nutritional deficiencies are an especially pressing concern for adolescents, given their anticipated longer lifespan and lower likelihood of adhering to supplementation regimens.
Because more is known about adult nutritional deficiencies, the authors designed this prospective study to determine what deficiencies exist among adolescents who have undergone RYGB or VSG procedures. Previous trials had been retrospective single-center studies, they noted.
This is the first study to evaluate nutritional deficiencies in adolescents after both types of bariatric surgery, examining longitudinal changes in iron status and vitamins A, B12, B1, D, albumin, folate, and calcium. The authors hypothesized that nutritional deficiencies would increase with time, particularly after RYGB.
The most widespread abnormality was hypoferritinemia, which affected nearly twice as many patients who had undergone RYGB compared with VSG at 5 years. Similarly, vitamin B12 status worsened disproportionately after RYGB.
Overall, RYGB was associated with a five-fold increase in two or more deficiencies, and a six-fold increase in three or more deficiencies by 5 years after surgery. VSG produced a four-fold — but not significant — increase in two or more deficiencies, “supporting a lower, but not negligible, nutritional risk,” the authors noted.
The iron and B12 deficiencies seen after RYGB mirror results from a 5-year Swedish cohort study of 81 teens who underwent RYGB surgeries, and also align with deficiencies found in adults undergoing this procedure, the authors wrote.
Adolescents and adults have high rates of vitamin D deficiency both pre- and postoperatively, which raises a red flag for fracture risk.
“Our findings underscore the importance of long-term nutritional monitoring in adolescents after bariatric surgery and the need to examine impact on health outcomes and quality of life as these youth advance into adulthood, including systematic assessment of anemia and bone health,” the researchers said.
The authors recommended that patients be monitored for nutrient deficiencies in an ongoing manner and given supplements to treat deficiencies.
Earlier this year, the Teen-LABS researchers reported that while weight loss was similar in teens to that in adults, at 26% and 29%, respectively, adolescents had a significantly higher rate of intra-abdominal reoperations within 5 years of initial surgery.
Asked for her perspective, Elizabeth Parks Prout, MD, MSCE, of Children’s Hospital of Philadelphia, who was not involved with the research, called the study “a wonderful follow-up, as the group’s prior publication on nutrition deficiencies after surgery did not include VSG.”
She added that while both procedures are safe and effective for treating obesity and serious comorbidities such as type 2 diabetes, obstructive sleep apnea, and high blood pressure, both surgeries do have complications.
“And it is a natural tendency for adolescents to decrease medication use during adolescence, so this study emphasizes the need for life-long follow-up,” Prout said. “After the 2-year visit, patients should have vitamin and mineral levels checked at least yearly. Adolescents with deficiencies prior to surgery are more likely to continue to have those deficiencies.”
She added that, surprisingly, the study did not find B1 deficiencies, which have been noted in adults after both surgeries. For example, a 2018 study by Tang and colleagues found a “troubling” higher risk of B1 deficiency in African Americans in the first 3 years.
“This study reinforces the pediatric follow-up and nutrition recommendations of the American Society for Metabolic and Bariatric Surgery published in 2018,” Prout said.
Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College
Primary Source
Clinical Gastroenterology and Hepatology
Source Reference: Xanthakos SA, et al “Nutritional risks in adolescents after bariatric surgery” Clin Gastroenterol Hepatol 2019; DOI: 10.1016/j.cgh.2019.10.048.
Secondary Source
MedPage Today
Source Reference: Swift D “Nutrient Deficits Persist Long-Term in Teens After Bariatric Surgery” 2019.
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Online grocery shopping leaves ‘food deserts’ behind

There’s a new path out of the “food desert,” and it’s as close as the nearest Internet connection.
A Yale University analysis found that most people in “” in eight states would increase their access to healthy,  if they purchase groceries online and had the  delivered as part of the federal government’s Supplemental Nutrition Assistance Program (SNAP).
The analysis showed that online  delivery systems already cover about 90% of food deserts—places where access to healthy food is limited—in the eight states: Alabama, Iowa, Maryland, Nebraska, New Jersey, New York, Oregon, and Washington.
“If you live in a food desert, online grocery delivery really stands out as way to get healthy food that potentially can save your life,” said Eric Brandt, M.D., a postdoctoral research fellow in the National Clinician Scholars Program at Yale and lead author of a study published online Dec. 2 in JAMA Network Open.
Earlier this year, SNAP began a  in which clients had the option of buying food via online grocery delivery services. The program was established by the 2014 Farm Bill; it may be considered for national implementation after the pilot ends in 2021.
Brandt’s inspiration for the study was a visit to an urban, East Coast neighborhood served only by small convenience stores. “I thought, “One of the grocery store chains must deliver here—wouldn’t that be a better option than trying to build a new brick-and-mortar store nearby or change the way local bodegas are run?'”
Brandt then learned the latest Farm Bill had just such a program.
For his study, Brandt identified food deserts in eight states by working with data from the U.S. Department of Agriculture and the U.S. Census Bureau. He also made use of a database of all stores that both sold and delivered groceries purchased online in the eight states (including department stores and big-box retailers) and also accepted orders from SNAP clients.
Brandt said the benefits of allowing SNAP families to buy  online are far-reaching and wide-ranging. In the short term, they provide nutrients and nourishment that reduce obesity, boost energy, and help heal patients recovering from serious physical ailments; in the long term, they promote better eating habits and behaviors, which can lower the risk for serious illnesses.
“When I see patients who have had a , the cornerstone of their recovery is making better lifestyle choices,” Brandt said. “Part of that has to do with the environment in which they live. It really influences the outcome.”

More information: Eric J. Brandt et al. Availability of Grocery Delivery to Food Deserts in States Participating in the Online Purchase Pilot, JAMA Network Open (2019). DOI: 10.1001/jamanetworkopen.2019.16444
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HealthEquity Soars Late On Strong Earnings, Guidance

HealthEquity (HQY) stock soared after hours after the firm posted a big earnings beat for the third quarter of fiscal 2020. The health savings account (HSA) provider also raised its outlook.
HealthEquity earnings per share jumped 52% to 47 cents, which was handily beat analyst expectations for an EPS decline to 22 cents. A 123% revenue increase to $157 million above estimates of $152 million.
The firm now has a total of 5 million HSAs, a 37% increase. The amount of total HSA Assets rose 48% to $10.5 billion.
The firm raised its full year EPS outlook to $1.46-$1.52, up from a prior view of $1.10-$1.16 and above the consensus for $1.33.
HealthEquity completed its acquisition of WageWorks on Aug. 30, and management said it has achieved an annual run-rate of approximately $15 million net synergies since then.
The company now expects to reach its goal of a run rate of $50 million of net synergies by the end of fiscal 2021, earlier than the 24-36 months from closing previously anticipated.
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