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Wednesday, August 1, 2018

Wait Times for Obesity Surgery Are Growing


People who want to have weight-loss surgery are facing much longer wait times now than a decade ago, a new study finds.
Among weight-loss surgery patients in Michigan, the typical wait time almost doubled between 2006 and 2016 — from 86 days, to 159 days, researchers reported.
Delays were especially common for patients on Medicaid, the government health insurance program for low-income Americans. These patients were three times more likely than people with private insurance to be among those with the longest delays — typically waiting for over 200 days.
The study authors said that Medicaid’s pre-surgery requirements put up unnecessary obstacles. The program mandates, for example, that patients first go through a medically supervised weight-loss program for at least six months.
But there’s no evidence that that requirement improves patients’ long-term success after surgery, said senior researcher Dr. Oliver Varban, an assistant professor of surgery at the University of Michigan.
Private insurers vary in what they require, but some say patients have to document they’ve complied with a weight-loss program.
Insurers may also require extensive pre-operative evaluations — of patients’ heart, lung and kidney function, for example, according to Varban.
That all adds up to multiple doctor visits before the surgery can happen — which can be a particular burden for disadvantaged patients, Varban pointed out.
“We’re especially concerned this sets up more barriers for low-income, Medicaid patients,” he said. “They may be working three different jobs, or have transportation issues, for example.”
Weight-loss surgery is medically known as bariatric surgery. It’s done in different ways, but essentially involves altering the digestive tract to limit the amount of food a person can eat, and to change the way nutrients are absorbed.
According to the U.S. National Institutes of Health (NIH), weight-loss surgery can be an option for people with a body mass index (BMI) of 40 or higher — about 100 pounds or more overweight. BMI is a measurement based on height and weight.
People with less severe obesity (a BMI of at least 35) may be candidates if they have conditions such as type 2 diabetes or sleep apnea.
On average, surgery costs between $15,000 and $25,000, depending on the type of procedure, the NIH says. There are surgical risks, including bleeding and infection. In the longer term, there’s a risk of nutritional deficiencies — especially if people don’t take their prescribed vitamins and minerals.
But the benefits can be substantial, Varban noted: Surgery can improve or cure conditions like type 2 diabetes and high blood pressure.
“This is not about making people thin,” he said. “It’s about managing these medical conditions.”
The findings, published recently in the Annals of Surgery, come from a registry covering most people who had weight-loss surgery in Michigan between 2006 and 2016 — almost 61,000 patients.
Overall, Varban’s team found, the one-quarter of patients with the longest delays waited 204 days. The one-quarter with the shortest wait times typically had surgery within 67 days.
In the end, both groups saw similar success — losing an average of 57 to 59 pounds within a year, the findings showed.
“The people who waited longer didn’t lose any more weight,” Varban noted.
The delay did not harm those patients, either. But the concern is that long delays, with insurance-mandated hurdles, will deter many patients from ever having surgery, said Dr. Ivania Rizo, a spokesperson for The Obesity Society.
“There’s a risk of them dropping out — particularly those patients from disadvantaged backgrounds,” she said.
Some patients do need more time to get certain health conditions under better control before surgery. But any delays should be based on medical needs, rather than insurance mandates, Rizo added.
Varban noted that the study included only patients in Michigan, and wait times may be different in other states.
But Rizo pointed out that insurance requirements do affect patients broadly.
Part of the issue, according to Varban, is the way in which weight-loss surgery — and obesity — are viewed, even by doctors.
“Surgery is seen as a last resort, even though it’s the most effective treatment for severe obesity,” he said. “And obesity, itself, is often seen as the patient’s ‘fault.’ ”
More information
The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more on bariatric surgery.
SOURCES: Oliver Varban, M.D., assistant professor, surgery, University of Michigan, Ann Arbor; Ivania Rizo, M.D., endocrinologist, Boston Medical Center, and spokesperson, The Obesity Society; May 23, 2018, Annals of Surgery

Sensus Healthcare initiated with a Buy at Roth Capital


Roth Capital analyst David Solomon initiated Sensus Healthcare with a Buy rating and $12.50 price target, as he sees the company being able to sustain its revenue growth as it capitalizes on the resurgence of superficial radiation therapy for nonmelanoma skin cancer and intra-operative radiation therapy for solid tumors.

First Patient Enrolled In Biohaven’s Phase 2/3 Mild-To-Moderate Alzheimer’s Trial


Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven” or the “Company”) announced today that it has enrolled the first patient in a Phase 2/3 clinical trial of trigriluzole (BHV-4157), a novel glutamate modulator for the treatment of mild-to-moderate Alzheimer’s disease (AD). The trial is a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of trigriluzole in patients diagnosed with AD of mild-to-moderate severity (Mini-Mental State Examination scores of 14-24 at screening), and is being conducted in collaboration with the Alzheimer’s Disease Cooperative Study (ADCS) at sites throughout the U.S.
Howard Feldman, MD, FRCP, Director of the ADCS and Professor of Neurosciences at University of California San Diego School of Medicine added, “We are excited that the first patient has been enrolled into this innovative clinical trial that we are conducting with Biohaven. The preclinical evidence for the active metabolite of trigriluzole to modulate glutamate and confer neuroprotective effects in patients with AD is compelling, and the new formulation of trigriluzole should improve its pharmaceutical properties with potential for efficacy in AD.”
Alzheimer’s disease is a progressive, fatal neurodegenerative dementia that accounts for 60 – 80 percent of dementia cases. Alzheimer’s disease currently has no cure. Although there are FDA-approved medications for symptomatic treatment of AD, their clinical benefits are generally limited. Novel therapeutic approaches aimed at normalizing synaptic and extra-synaptic glutamate levels, such as trigriluzole, may offer the potential for symptomatic benefit in AD by improving cognitive function, as well as the potential for disease modification by preventing the loss of synapses.
Irfan Qureshi, M.D., Executive Director of Neurology at Biohaven, commented, “Biohaven is committed to efficiently developing novel therapies for severe neurological diseases so this is an important clinical milestone for the company. Based on compelling preclinical research, trigriluzole represents a promising therapeutic option for patients and families suffering from mild-to-moderate Alzheimer’s disease and we look forward to collaborating with the ADCS.”
Vlad Coric, M.D., CEO of Biohaven, added, “We are excited to advance trigriluzole in another late-stage clinical trial that reflects the broad therapeutic potential of trigriluzole in neurologic conditions. The trial, if positive, may contribute to the regulatory package necessary to establish the effectiveness of trigriluzole for the treatment of Alzheimer’s disease.”

QIAGEN to Collaborate with Japan’s Largest Clinical Lab Testing Firm, SRL


QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a collaboration with SRL, Inc. the largest clinical testing laboratory company in Japan, to prepare for introduction of new companion diagnostics simultaneous with new drug approvals. The non-exclusive master collaboration agreement for clinical laboratory research services will enable rapid implementation by SRL of QIAGEN´s companion diagnostic workflows upon approval of the drugs and tests by Japan’s Pharmaceutical and Medical Devices Agency (PMDA). Several tests QIAGEN is co-developing with pharmaceutical partners are expected to enter registration in Japan in the coming years.
QIAGEN’s Day-One Lab Readiness initiative with SRL includes strategic planning for market access to companion diagnostics, filing for reimbursement, and alignment of medical communication by SRL, QIAGEN and pharmaceutical partners. The agreement will cover a range of QIAGEN companion diagnostics, including real-time polymerase chain reaction (PCR) and next-generation sequencing (NGS) solutions for Personalized Healthcare. Initial projects involve QIAGEN companion diagnostics paired with new drugs under development in Japan for solid tumors and leukemia.

Piper recommends Biogen shares after meeting with management


After hosting investor meetings with Biogen investor relations this week, Piper Jaffray analyst Christopher Raymond continues to recommend purchase of the shares. The analyst came away feeling like the “all-important” high-dose APOE4 subset analysis of the BAN2401 results “may be provided sooner than later.” If shown to have little impact on the overall placebo-adjusted ADCOMS benefit, this should be an important event, Raymond tells investors in a research note. Coupling this with “continued solid commercial momentum and a host of other value-enhancing catalysts,” the analyst continues to like the risk/reward on shares of Biogen. He keeps an Overweight rating on the name with a $400 price target.

United Therapeutics reports Q2 EPS $4.36, consensus $3.16


Reports Q2 revenue $444.5M, consensus $368.58M.

Incyte risk/reward remains compelling, says Barclays


Barclays analyst Geoff Meacham continues to see “compelling risk/reward profile” for Incyte shares following the company’s Q2 results. Despite signs of commercial strength and the recent positive Reach1 data readout, Incyte shares have remained flat since the end of Q2, Meacham tells investors in a research note. The analyst continues to see upside given the “strong base business” as well as the company’s “attractive and diverse” late-stage pipeline set to begin providing near-term catalysts. He keeps an Overweight rating on Incyte with an $85 price target