- Nevada’s health insurance exchange boosts enrollment assistance funding as federal government scales back in other states (thenevadaindependent.com)Nevada Exchange Continues Broker /Agent and Navigator /In -Person Assister Grant Program for Plan Year 2019 (d1q4hslcl8rmbx.cloudfront.net)Statement from Nevada Exchange Executive Director , Heather Korbulic on Centers for Medicare & Medicaid Services Navigator budget cuts (d1q4hslcl8rmbx.cloudfront.net)
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.”
- July 20 Pharmacy Week in Review: Valsartan Recall, Drug Approval for Smallpox (pharmacytimes.com)
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.
- EMA Report: Clinical Data Published on 50 Medicines in One Year (raps.org)European Medicines Agency Clinical Data: Online Access to Clinical Data for Medicinal Products for Human Use (clinicaldata.ema.europa.eu)Clinical data publication ( Policy 0070) report Oct 2016 - Oct 2017 (ema.europa.eu)
The European Medicines Agency...published its first report on implementing its policy on the publication of clinical data whereby researchers, academics and others can access data from clinical reports submitted by pharmaceutical companies to EMA for new medicines as of 1 January 2015...The 27-page report covers one year from the launch of EMA’s clinical data website on 20 October 2016, and lists the 50 medicines for which clinical data were published...EMA is the only regulatory authority to provide open access to clinical data submitted by companies in support of their marketing authorisation applications...The report unveils the documents published, the amount of commercially confidential information redacted and the anonymization techniques used...EMA accepted about one third of CCI redactions proposed by pharmaceutical companies, though only 0.01% of 1.3 million pages published contained CCI redactions...anonymization techniques to protect personal data, the report suggests conducting a “proper assessment” of the impact of the anonymization technique on data utility and improving the quality of the anonymization reports...
- Clinical technology is broken, so what is being done to fix it? (outsourcing-pharma.com)
The need to improve visibility, enable faster study execution, and improve study quality, is driving the industry to unify its "broken" clinical trial operating environments, according to a report...nearly all respondents reported a need to unify clinical trial operating environments, and 87% said they have or plan to have, an initiative in motion to fulfill this need and improve trial performance...The main challenge of siloed applications and processes is integrating multiple applications...The top drivers for unification are to improve visibility (75%), enable faster study execution (61%), and improve study quality (60%)...The majority of respondents (84%) reported “significant deficiencies” with their current clinical trial management system (CTMS) applications, with more than 85% citing the inability to fully support functions such as governance and oversight, resource management, as well as issue and task management...industry is recognizing the need for key performance metrics (KPIs) and reporting capabilities “to learn about how they operate so that they can improve...recognizing they need a unified technology...
- Blood Pressure Medicine Is Recalled (nytimes.com)
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...
- Doctors say pharmaceutical firms are top cause of high medical costs (healthcarefinancenews.com)
...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.
- FDA looks at incentives, manufacturing ‘interventions’ to solve drug shortages (fiercepharma.com)
The FDA will consider creating a list of “essential drugs” and financial incentives to drugmakers that manufacture them as it continues to grapple with the drug shortages that plague U.S. hospitals and caregivers...FDA Commissioner Scott Gottlieb, M.D...announced the formation of a new Drug Shortages Task Force and named Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives to lead it...“I’m charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge,” Gottlieb said. “The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages.”...The FDA is already taking steps to support new technologies that can improve manufacturing and help reduce the chance that supply disruptions will occur...the FDA may want to consider “more significant interventions” than it currently employs. “We want to make sure we aren’t discouraging investment for manufacturing drugs that are more likely to go into shortage, and thus working against our own goals." One suggestion is to grant the FDA authority to require applicants of certain drugs to conduct a “risk assessment to identify the vulnerabilities in their drug supply that could cause a shortage," and to establish risk mitigation plans in advance to address those weaknesses...
- Bowing to Trump, Novartis Joins Pfizer in Freezing Drug Prices (nytimes.com)
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...
- Evidence to support ‘breakthrough’ drugs often very limited: study (reuters.com)
The 46 medicines given approval through 2017 as part of the Food and Drug Administration’s Breakthrough Therapy program have often been sent to patients without a large double-blind study, direct measurement of benefit, or comparison with a placebo or existing treatment, according to a new analysis...“FDA approval of these breakthrough therapies is generally based on shorter and smaller clinical trials than those that support FDA approval of non-breakthrough therapy drugs,” coauthor Dr. Joseph Ross....expediting drug approvals raises concerns that important safety or effectiveness information will be missed, potentially heightening risk of patient harm...The study, published in the Journal of the American Medical Association, did not examine whether the drugs were actually as effective and safe as pre-approval testing suggested. In some cases the FDA doesn’t require such post-marketing studies for “breakthrough” drugs...people, when they hear ‘breakthrough designation,’ assume the ‘breakthrough’ is based on great clinical trial evidence but it’s actually more of an expectation that this is promising...My expectation is that this is what the public and clinicians (and Congress!) wants - more novel therapies coming to market as quickly as is reasonably possible, while still assuring drug safety and efficacy...questions persist on whether a larger trial will produce a different result, whether the benefit will fade as treatment continues, whether a drug will prove to be dangerous over the long term and whether a drug will really make a difference in long-term quality of life or survival...
- Experts weigh in on CMS’ big changes to clinical documentation, EHRs and interoperability (healthcareitnews.com)
Industry groups like easier quality reporting and advance applications of telehealth, but some say docs shouldn't have to make expensive EHR upgrades for 2019..."historic changes" announced...by the Centers for Medicare & Medicaid Services, promising big adjustments to its policies around the Physician Fee Schedule and the Quality Payment Program, already have the healthcare industry talking...CMS says it wants to incentivize the use of and access to virtual care and telehealth, to ease the quality reporting burden on physicians by focusing on the most important and impactful measures...also wants to spur better information sharing among healthcare providers, regardless of what electronic health record vendor they happen to use...CMS notes that these proposals will modernize Medicare payment policies to promote access to virtual care, saving Medicare beneficiaries time and money while improving their access to high-quality services no matter where they live...the new proposal would "help shift the nation’s electronic documentation away from overly long, form-driven, hard-to-read documents written primarily to satisfy billing requirements to what it was originally intended for – providing high- quality care to patients."...