Walmart asks some beauty suppliers to consider sourcing outside of China

Walmart Inc has asked some beauty suppliers to consider sourcing products from outside China, as it looks for ways to mitigate the impact of a new set of tariffs on Chinese products proposed by the Trump administration.

In an email sent to some beauty suppliers on Aug. 7, seen by Reuters, the retailer asks if they have facilities outside China, and if not, whether they would consider investing in them, to broaden their sourcing ability.

Many cosmetics products like shampoos, lipsticks and makeup fall under the most recent list of proposed levies on Chinese goods.

Walmart spokesman Randy Hargrove did not comment on the letter. He directed Reuters to Chief Financial Officer Brett Bigg’s statement on the trade tariff issue when Walmart announced quarterly results on Thursday.

Biggs told Reuters the potential impact of tariffs is difficult to quantify. He also said that one of the mitigation strategies for the retailer is understanding what suppliers’ plans and alternatives are for sourcing.

“We are closely monitoring the tariff discussions and are actively working on mitigation strategies, particularly in light of potentially escalating duties,” he said.

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AstraZeneca Biopharma Spinout Entasis Files for IPO

Entasis Therapeutics Holdings Inc., a developer of antibiotics that spun out from AstraZeneca PLC (AZN, AZN.LN) in 2015, has revealed its plans for an initial public offering.

Entasis, which previously filed confidential IPO paperwork, said in its Form S-1 Friday it has applied to list on Nasdaq under symbol ETTX.

The Waltham, Mass., biopharmaceutical company filed to offer up to $86.25 million, but that is a placeholder amount likely to change.

AstraZeneca owns a 21.6% stake in Entasis. Other large shareholders include Clarus Ventures, which owns 14.7%.

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Many people take drugs that interfere with their blood pressure meds

People who take pills to lower their blood pressure often take other drugs that reduce the pills’ effectiveness, a recent study suggests.

Researchers studied data on 521,028 adults prescribed blood pressure pills for the first time and 131,764 people taking at least four different pills to lower their blood pressure.

Roughly 18 percent were also taking drugs that make blood pressure pills less effective, the study found. These include medicines like non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or hormones.

“In some cases, use of these blood pressure-interfering medications may be justified and the potential side effect of elevations in blood pressure may be acceptable to patients,” said study leader Andrew Hwang of the High Point University Fred Wilson School of Pharmacy in North Carolina.

“But in other cases . . . there may be significant opportunities to switch to alternative treatments or reassess the need for continuing the interfering treatment,” Hwang said by email. “If these drugs can be discontinued, it’s possible we can reduce the prescribing cascade – that is, reduce the need for using additional medication to treat a side effect of another medication.”

Patients may not realize the risks, the findings suggest.

Among people recently prescribed blood pressure medications for the first time, 58 percent later refilled prescriptions for drugs known to increase blood pressure, the study found.

Among people prescribed four or more blood pressure drugs, 65 percent refilled drugs known to increase blood pressure after stepping up their blood pressure treatment regimen.

Patients who need blood pressure medicine should ask their doctor if any of the other medications they’re taking might interfere, said Dr. Gunnar Gislason, a professor of cardiology at Copenhagen University Hospital Herlev and Gentofte and director of research at the Danish Heart Foundation.

And if blood pressure drugs are not working, it’s important to consider not just other drugs that might influence blood pressure but also herbal medications that often are considered harmless, Gislason, who wasn’t involved in the study, said by email.

The way different drugs can increase blood pressure varies, Hwang said.

“Some drugs, such as NSAIDs and hormones, elevate blood pressure mainly by causing the body to retain excess fluid,” Hwang noted. “This effect counteracts the mechanism of some blood pressure medications like diuretics (water pills), which cause the body to get rid of fluid.”

“Other drugs can cause blood pressure elevation by constricting the blood vessels, increasing heart rate, or by a combination of mechanisms,” Hwang added. “There are also some drugs, such as acetaminophen, that we know increase blood pressure, but we don’t know how.”

The study, published in the American Journal of Hypertension, wasn’t designed to prove whether or how certain prescription drugs might interfere with the effectiveness of blood pressure medicines or increase blood pressure.

Another limitation is that it focused only on patients who were taking prescribed medicines that can interfere with blood pressure drugs, and many painkillers like acetaminophen and naproxen are available over the counter without a prescription in the U.S., the study authors note.

“Although this study cannot tell us the reasons why the prescription rate of blood pressure-interfering medication is so frequent, it may explain why in (the) U.S. population blood pressure control is still very poor,” said Dr. Liffert Vogt of Amsterdam University Medical Center.

“Poorly controlled blood pressure (is) a major cause of heart disease and stroke,” Vogt, who wasn’t involved in the study, said by email. “For that reason, prescribing drugs that contribute to poor blood pressure control should be carefully considered.”

SOURCE: bit.ly/2OLgv0v American Journal of Hypertension, online July 25, 2018.

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Biomarkers Called Needed in Parkinson’s Research

Shared biobank samples and data sets can sharpen the search for Parkinson’s disease (PD) biomarkers and boost the therapeutic development pipeline, experts from 36 organizations proposed.

“Biomarkers to bolster our efforts to develop new therapies are urgently needed,” said Alice Chen-Plotkin, MD, of the Perelman School of Medicine at the University of Pennsylvania, lead author of a position paper published in Science Translational Medicine.

Of more than 550 open studies for PD on ClinicalTrials.gov, only about 10% are aimed at testing disease-modifying or neuroprotective therapies, Chen-Plotkin and colleagues noted; of those trials, only two are in phase III.

The position paper charts a course for developing clinical trial PD biomarkers. What’s unusual is that includes contributions from academic medicine, industry, foundations, and government, Chen-Plotkin noted.

“It’s hard to get these groups around a table, but since biomarkers are likely to be discovered by academics, then used by industry with help from foundations and government funding along the way, it’s helpful to have the perspective of all of these groups together from the outset,” she told MedPage Today.

While previous research focused on biomarkers that distinguish PD patients from healthy individuals or other patients with neurodegenerative diseases like Alzheimer’s disease, Chen-Plotkin and co-authors argue for a shift toward biomarkers within PD itself.

“Right now we consider all PD patients as a group,” Chen-Plotkin said. “However, if you look at what happens in terms of how severe motor symptoms become in PD patients over time, it’s easy to see that individual PD patients may be dramatically different from each other.”

“In fact, in the Parkinson’s Progression Marker Initiative cohort, which is a group of PD patients very similar to the type of group who would be in a clinical trial for a disease-modifying therapy, one-third of the people show almost no change in their symptoms over the first 2 years, which is the amount of time the usual clinical trial lasts,” she explained.

“If patients don’t change or progress, it’s going to be really hard to see the effect of the drug that is being tested in the clinical trial,” Chen-Plotkin added. “We don’t really have any good biomarkers that look within PD itself — at these differences between PD patients — which is why we are calling for efforts to develop them.”

Biorepositories may help take markers from concept to clinic, the authors suggested: the Parkinson’s Disease Biomarkers Program (PDBP) of the National Institute for Neurological Disorders and Stroke (NINDS), the Parkinson’s Progression Marker Initiative (PPMI), and the BioFIND collaboration between the Michael J. Fox Foundation and NINDS are potential resources.

And while biobank samples can streamline the discovery process, standardized validation can move biomarkers toward real-world use. The experience of the Alzheimer’s community — in which the Alzheimer’s Disease Neuroimaging Initiative (ADNI) help translate biochemical markers (cerebrospinal measures of amyloid-beta and tau) and imaging markers (PET ligands to assess amyloid-beta deposition) into clinical trial use — suggests standard sample collection protocols are crucial, the authors observed.

Biomarker enrichment trial designs have been proposed in oncology and may benefit Parkinson’s patients, too, they noted. If biosamples and data collected during clinical trials were made available for independent researchers to mine, they could “further strengthen our confidence in the biomarker candidates, possibly leading to their use in future clinical trial enrollment and helping to define specific phenotypes and subtypes of parkinsonism at the molecular level.”

This paper originated from a Biomarkers Discovery Workshop convened by the Michael J. Fox Foundation; it was further developed at the National Institute of Neurological Disorders and Stroke Parkinson’s Disease Biomarkers Program annual meeting in Washington, D.C., in August 2016.

Authors reported relationships with the Burroughs Wellcome Fund, the Benaroya Fund, the Michael J. Fox Foundation, the Parkinson’s Foundation, the Bigglesworth Family Foundation, the Gaucher Generations Program from Genzyme-Sanofi, Icon, Teva, Ionis, Biogen, 23andMe, Denali Therapeutics, ProPhase, Google Verily, Foresight, Caprion Biosciences, U.S. WorldMeds, Impax Pharmaceuticals, Acorda Therapeutics, Acadia Pharmaceuticals, Adamas Pharmaceuticals, Lundbeck LLC, Chaperone Therapeutics, AbbVie, Acumen Pharmaceuticals, Epiodyne, Lysosomal Therapeutics, Neuroinitiative, Pfizer, Sinopia Biosciences, Desitin, Boehringer Ingelheim, GE Healthcare, Bayer Schering Pharma AG, Roche, GlaxoSmithKline, and Orion Pharma.

• Primary Source

  Science Translational Medicine

  Source Reference: Chen-Plotkin A, et al “Finding useful biomarkers for Parkinson’s disease” Sci Transl Med 2018; DOI: 10.1126/scitranslmed.aam6003.

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Payers transition to government health plans despite risks

• Health insurance companies continue inching away from employer-sponsored plans to government-sponsored business. Medicaid managed care and Medicare Advantage plans now make up more than half of health plans’ premiums combined, A.M. Best said in a new report.
• Employer plans once dominated the private market, but they dropped to just 38% of total net premiums written (NPW) in 2017.
• Medicaid’s NPW grew the most of any health insurance sector over the past 10 years. The Affordable Care Act’s Medicaid expansion pushed Medicaid managed care’s NPW from $43.1 billion in 2007 to $224 billion last year, A.M. Best said.

Despite payers’ finding success in government plans, the move generally means lower margins with private insurers relying more on state and federal funding. That’s a potential downside.

A.M. Best said greater reliance on government payments “could lead to short-term liquidity pressure because of the timing of the receipt of funds and possible delays related to budgetary issues.”

Regulations and legislation could lead to unpredictability, especially in the ACA exchanges. “With healthcare remaining a controversial political issue, the regulatory regime is likely to remain volatile over the near to medium term, especially as it relates to the individual exchange segment,” A.M. Best said.

Nevertheless, private payers are increasingly embracing offering public plans. Medicaid’s NPW share increased from 10.2% in 2007 to 27.1% in 2017. Most of that growth came in 2014 and 2015 after states could expand Medicaid to 138% of the federal poverty line. Medicaid expansion added more than 14 million Medicaid recipients.

Medicare Advantage has grown from $69.9 billion in 2007 to $202.7 billion in 2017. It represented 24.5% of overall industry premiums in 2017. Both Medicaid and Medicare Advantage have seen flat business over the past few years, A.M. Best said.

However, more payers are interested in testing the Medicare Advantage market. One reason is that aging Baby Boomers are a fresh market for MA payers.

UnitedHealthcare and Humana still make up the two largest Medicare Advantage payers, but Aetna, Anthem, WellCare and Centene have all grown MA membership this year. Oscar Health also announced this week that it’s expecting to expand to MA in 2020.

Commercial premiums still make up the largest percentage of single sector premiums. That’s dropped from 58% in 2007 to 38% in 2017.

Things aren’t all negative in the commercial market, though. In fact, insurance companies’ cost-containing policies and benefit design have brought stability. Payers have been able to maintain low single-digit annual premium increases in the employer market this decade. Mercer’s recent National Survey of Employer-sponsored Health Plans said those plans’ premiums have increased about 3% yearly since 2012.

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Move to electronic transactions could save Medicaid plans over $4.8B /year

• A new Council for Affordable Quality Healthcare (CAQH CORE) report said that Medicaid could save more than $4.8 billion annually if it moved to fully electronic transactions.
• CORE said more than half of Medicaid enrollees are in plans without electronic prior authorization. Only 44% of Medicaid recipients are in currently in plans with the automated claims processes.
• In comparison, 78% of commercial plans and 75% of Medicare Advantage plans have electronic transactions, according to the report. Efficient operational systems such as electronic transactions can reduce administrative costs and improve patient care by providing quicker approvals.

CAQH CORE is a group of more than 130 public and private healthcare companies that created operating rules for electronic sharing of administrative data almost a decade ago. CORE Certification includes four phases of operating rules that deal with a different set of administrative transactions.

George Conklin, CAQH CORE board member and CIO of CHRISTUS Health in Irving, TX, said in a statement that CHRISTUS has found working with CORE-certified Medicaid plans to be “more efficient and predictable.”

The report, published Monday, said Medicaid payers can reduce overhead by adopting all four phases of operating rules for electronic transactions. At the state level, Florida payers could save $177 million annually, Illinois could save $294 million and California $655 million if their Medicaid claims processes were to go fully electronic.

Payers are increasingly turning to electronic transactions such as prior authorizations. Manual prior authorizations can create administrative issues, lost productivity and result in delayed or avoided care. CAQH estimates that electronic transactions can save $6.84 per transaction alone.

Doctors have also spoken out about the hassle of prior authorizations. The American Academy of Family Physicians called the practice family physicians’ “number one administrative burden.”

An American Medical Association survey earlier this year found that 92% of physicians said prior authorizations hurt patient clinical outcomes. Also, at the time of the survey, one-third of reporting doctors noted they had waited at least three business days in the last week for the payer to give the OK, delaying necessary patient care.

Multiple efforts involving both payers and providers are looking at ways to improve prior authorization processes. One notable coalition involves stakeholders like the AMA, American Hospital Association and America’s Health Insurance Plans, and recently wrote a consensus statement highlighting their shared commitment to industry-wide improvements to prior authorization and patient-centered care.

Proponents of the automation argue that helps patients along with healthcare companies. A recent case study of Milwaukee area nonprofit Aurora Health Care’s electronic prior authorization system from Surescripts found that patients were able to receive their drugs more quickly with less administrative work for providers.

Plus, Luke Forster-Broten, manager of product innovation at Surescripts, recently told Healthcare Dive that Surescripts has seen a 1% increase in first-fill adherence for patients where electronic prior authorization is available. In Milwaukee, Aurora enjoyed an 8% first-fill adherence after a few months.

https://bit.ly/2vLL5QP

UnitedHealth, AARP hit with another lawsuit over co-branded Medigap plans

A lawsuit filed this week accuses UnitedHealth and AARP of violating state insurance laws and charging consumers artificially inflated premiums.

It’s the third such lawsuit filed against the two companies this year and adds to ongoing litigation in several states. A class-action lawsuit filed in a Connecticut U.S. District Court in May alleged that UnitedHealth and AARP siphoned off $400 million in illegal rebates through Medigap plans.

The most recent lawsuit, filed in the U.S. District Court in Eastern Pennsylvania, similarly claims UnitedHealth and AARP “orchestrated an elaborate scheme” in which the senior citizen lobbying group took a 4.95% commission on Medigap plans that were added to member premiums.

A Florida plaintiff filed a similar class-action complaint in February. Last year, the 9th Circuit Court of Appeals overturned a lower court’s decision to dismiss a lawsuit filed in 2014 alleging similar violations involving commission payments.

UnitedHealth and AARP categorize the payments as a “royalty” for the use of AARP’s intellectual property to sell AARP-branded plans. But the lawsuit alleged the term allows AARP to avoid oversight by insurance regulators and avoid paying taxes on that income.

The complaint (PDF) says AARP generated $704 million in revenue from royalties in 2012, three times what it generated from membership dues. Nearly two-thirds—$458 million—came from UnitedHealth insurance products.

The plaintiffs—two Pennsylvania residents who purchased Medigap policies—also claim AARP acted as an authorized insurance agent for UnitedHealth even though it wasn’t licensed by the state.

“Ultimately, Defendants’ deceptive and unlawful scheme takes advantage of unsuspecting senior citizens and the disabled who, unfortunately, put their trust in the AARP name,” the complaint stated.

The plaintiffs are seeking to recoup the royalty payments and are asking the court to issue a permanent injunction on the practice.

Medigap, or supplemental Medicare, plans are purchased through private insurers to pay for healthcare costs that aren’t covered by traditional Medicare. Supplemental plans are a big business for UnitedHealth, accounting for $66 billion in revenue in 2017. The insurer owns a 34% market share of supplemental plans, the most of any major insurer, according to an analysis by the Mark Farrah Associates.

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