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Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Drug regulators across Europe are hiring extra staff and increasing their workload as the role of British experts in the EU-wide system of medicines supervision winds down ahead of Brexit...Britain has already stopped taking on new projects that will extend beyond March 29, 2019 and is preparing to hand over existing drug review work to other countries...Despite a vote by UK members of parliament this week calling for Britain’s continued participation in the Europe regulatory network for medicines, there is no certainty that any such deal will be reached...That reflects the wider lack of clarity over Britain’s future relationship with the world’s biggest trading bloc after it leaves the EU next March...The Brexit-induced disruption also comes at a time when regulators are having to grapple with oversight of a range of new health technologies, such as gene therapy, and a slew of big data on health outcomes...Global drug companies, including UK-based GlaxoSmithKline and AstraZeneca, have been vocal in calling for continued close EU-UK ties after Brexit. The issue is also important to many Japanese drugmakers that have made Britain their European base.

The Food and Drug Administration has announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears about the safety of imported drugs...Three companies that sell the generic drug, valsartan, in the United States agreed to recall it after the F.D.A. said it might be tainted by N-nitrosodimethylamine (NDMA), considered a probable human carcinogen. The agency is still investigating, but said the contamination was believed to be related to changes in the way that valsartan was manufactured...All of the valsartan that is being recalled was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. Ltd. It is distributed in the United States by three companies: Major Pharmaceuticals; Teva Pharmaceutical Industries, Ltd.; and Solco Healthcare... Other companies that market the drug, not subject to the recall, are Sun Pharma, Mylan, Jubiliant, Aurobindo and Hetero...The safety of imported drugs has long been debated. The F.D.A. said it would continue to investigate the levels of NDMA in the recalled products, determine the possible effect on patients who have been taking them, and assess what measures can be taken to reduce or eliminate the impurity from future batches...

...high healthcare costs, most physicians claim they are not the ones to blame and instead pinpoint pharmaceutical and insurance companies, according to a new survey from University of Utah Health...members of the New England Journal of Medicine Catalyst Insights Council, who are clinicians, clinical leaders and executives involved with healthcare delivery...overwhelmingly believe pharmaceutical firms, followed closely by insurance companies, hospitals and health systems, have the biggest impact on costs...Other findings revealed by the survey showed that 86 percent believe physicians are not adequately trained to even discuss the cost of care, and 64 percent say there is not enough time to discuss the cost of treatments with patients. And 90 percent believe healthcare costs are too confusing for patients, while 78 percent feel the necessary tools are not available for patients to estimate those costs.

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

...the Governor’s Opioid State Action Accountability Task Force met in the Capitol building in Carson City, with the conference being teleconferenced to Las Vegas...The meeting provided status reports on the four tracks - prescriber education and guidelines, treatment options and third-party payers, data collection and intelligence sharing, and criminal justice investigations that were developed during the two-day Governor’s Prescription Drug Abuse Summit in 2016...meeting was the third time the opioid state action accountability task force came together, and opioid use has been steadily going down in Nevada since it peaked in 2011

Novartis...said...it would not raise prices on its products in the United States for the rest of 2018, joining Pfizer, which delayed its increases last week after President Trump singled out the company for criticism...Novartis’s chief executive, Vas Narasimhan, said during an earnings call with investors that the company had made the decision in June, amid escalating outrage over high drug prices. “We thought that was prudent, given the dynamic environment we’re currently in,” he said...Pharmaceutical companies are scrambling to stem the groundswell of criticism over steep drug pricing, as elected officials and the Trump administration have taken up the issue...

European drugmakers Roche, Bayer and Merck KGaA became the latest companies to freeze prices in the United States for the rest of 2018 following criticism by President Donald Trump over the cost of medicine...Roche did boost U.S. prices for nine key drugs by an average of 3 percent on July 1, but said it would hold off additional increases as discussions with the Trump administration continue over a longer-term solution to containing healthcare costs...The European announcements on Friday follow similar moves from Novartis, Pfizer and U.S. drugmaker Merck.

While most states are still grappling with the Trump administration’s decision earlier this month to slash funding for a program that helps people purchase health insurance on the exchange, Nevada is gearing up for open enrollment later this year by expanding the enrollment assistance it offers to consumers...Nevada’s health insurance exchange announced earlier this month that it would be nearly doubling the number of brokers, navigators and in-person assister organizations available to help walk people through the process of signing up for health insurance this year, calling the assistance program a “critical component” in an oftentimes “intimidating and complicated process.” That announcement stood in stark contrast to a decision by the Centers for Medicare and Medicaid Services a little more than a week later to scale back the navigator program for the fully federally facilitated marketplaces in 34 other states, saying that “the need for federally funded Navigators has diminished.”

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.