A new strategy produced by European regulators considers future challenges for the European drug regulatory network, The Pink Sheet reports. The plan, per the report, looks to position the regulatory network to endure an uncertain future. To read the report, click here. […]
Study Finds Inconsistent Reimbursement Assessments Across EU Markets
While some modifications in the HTA process for orphan drugs have had some positive impacts, manufacturers still face key hurdles due to inconsistent reimbursement assessments in the EU markets, the authors of a recent study suggest. The authors, Chales River Associates' Steven Kelly, Ioanna […]
Report: FDA Mandates 50% Efficacy for COVID-19 Vaccines
Vaccine candidates must be at least 50 percent more effective than a placebo to be considered for Food and Drug Administration approval, according to a FiercePharma report. However, some experts have expressed concerns about that guidance, according to the report, with some suggesting that level […]
Proposed Medicaid Changes Aim to Foster Innovative Contracts
The Centers for Medicare and Medicaid Services (CMS) is hoping to encourage greater use of innovative contracting models in a recently-proposed package of changes to Medicaid. Washington University in St. Louis associate law professor Rachel Sachs in a recent Health Affairs blog post writes that […]
Legislation Aims to Prevent Pharma From Price-gouging During Pandemic
Two new bipartisan bills introduced by House Democrats aim to prevent the pharmaceutical industry from engaging in price-gouging on COVID-19 treatments, according to a Common Dreams report. The legislation was introduced following a recent poll that found a whopping 88 percent of Americans fear […]
Report Reveals Racial Disparities in COVID-19 Outcomes
New data released by the government on Monday suggests black Americans under Medicare were roughly four times more likely as white Americans to be hospitalized for COVID-19, Reuters reports. The data was released by the Centers for Medicare and Medicaid Services. "The disparities in the data […]
Hahn: Some COVID-19 Changes to Remain
Food and Drug Administration (FDA) Chief Stephen Hahn recently said some changes made to address COVID-19 will remain in place, Medical Design & Outsourcing reports. Hahn made the comments June 19 during a meeting with members of the Medical Device Innovation Consortium, according to the […]
Blog Post Touts VA, ICER Partnership as ‘Highly Beneficial’
The partnership between the Department of Veterans Affairs (VA) and the Institute for Clinical and Economic Review (ICER) has provided benefits across a number of fronts, according to a Health Affairs blog post by representatives of the agency and drug pricing watchdog. Despite concerns that the […]
Report: EMA Considers Big Data Network ‘Priority’
The European Medicines Agency (EMA) says the development of a big data network is a "priority" project, according to a Pink Sheet report. According to the report, the agency's 2019 report offered some insight into plans for a new data network. To read the full report on The Pink Sheet, click […]
Report: Hospitals Paid CEO Millions While Laying Off Thousands
Despite having received billions in emergency funds through the CARES Act, some of the nation's top hospital systems have been laying off thousands while paying their top executives millions, The New York Times reports. The New York Times combed through tax and securities filings by the top 60 […]
OptumRx: Payers Should Monitor Three Key Drugs
OptumRx in its latest drug pipeline update recommends payers to keep an eye on risdiplam, viltolarsen and trodelvy, FierceHealthcare reports. OptumRx's chief medical officer, Sumit Dutta, says orphan drugs could account for roughly 40 percent of approvals by the Food and Drug Administration this […]
Trump Administration Picks Five Companies in Operation Warp Speed
The Trump administration has selected five drugmakers as being most likely to develop a coronavirus vaccine, The New York Times reports. According to the report, the five companies are Moderna, a partnership between Oxford University and AstraZeneca, Johnson & Johnson, Merck and […]
A Look at How Germany Structures Drug Purchasing
James Robinson in a recent perspective piece published in NEJM looks at how Germany purchases medicines. Germany's system, he writes, not only incentivizes agreements but also restricts price increases if there exists no evidence-based justification. To read the write up, click here. (Paid […]
FDA Chief Vows to Permanently Adopt COVID-19 Measures to Accelerate R&D
Food and Drug Administration (FDA) Commissioner Stephen Hahn in a recent speech said the agency will work toward permanent adoption of COVID-19 measures aimed at accelerating research and development, FierceBiotech reports. "To the extent that innovations and adaptations we implemented during the […]
CMS Implements Harsher Penalties for Nursing Homes Amid Pandemic
The Centers for Medicare and Medicaid Servicies (CMS) is implementing stiffer penalties for nursing homes which are repeatedly caught violating infection control protocol, FierceHealthcare reports. According to the report, as of May 24, some 26,000 COVID-19 deaths were individuals in nursing […]
EMA Calls for Transparency, Collaboration in COVID-19 Studies
The European Medicines Agency (EMA) is urging transparency and collaboration on COVID-19 studies to facilitate more robust results. "High-quality observational research of real world data collected during the pandemic can be an important complement to the results of randomised clinical trials in […]
A Look at Phlow CEO’s Track Record
STAT in a recent report takes a look at the track record of Phlow CEO Eric Edwards, who the Trump administration tapped to manufacture generic drugs in short supply. According to the report, Kaleo, which was founded by Edwards and his brother, hiked the price of its opioid overdose drug, Evzio, […]
Will Expanded Access to Telehealth Services Stay Put?
While the Trump administration's sweeping reimbursement changes led to expanded telehealth services and access, some are concerned about their longevity, Fierce Healthcare reports. "We are concerned about what will happen post-COVID if changes prevent us from providing telehealth at patients' […]
Putting a Dollar Amount on Human Life
Austin Frakt in a recent article published in the New York Times outlines how governments have tackled the issue of applying a dollar figure to human life. "There has always been a limit to how much we are willing to spend to protect life and health," he writes. "After all, no society can spend a […]
EMA Reportedly Preparing Q&A Guidance on Big Data
The European Medicines Agency (EMA) is reportedly preparing new guidance on the application of EU data rules for secondary use of health data, according to a Regulatory Affairs Professionals Society report. According to the report, EMA is working to finalize the guidance next year. "The aim is […]
Article: Health Jobs No Longer Recession Proof
While health care jobs have been generally considered recession-proof, the COVID-19 pandemic is breaking that trend, according to a recent article published in The New York Times. Job losses in the health care industry, according to the article, reached 1.4 million in April. "This is a […]
Article Highlights FDA Decisions that Involved RWE
A recent article published on Aetion looks at three recent decisions by the Food and Drug Administration (FDA) that included real-world evidence. The article outlines how RWE supported the approval of Pretomanid, Zolgensma and Lutathera. "The U.S. Food and Drug Administration (FDA) is […]
Aetion Launches FDA Decision Alerts
Aetion announced the launch of a new library of FDA submissions that used real-world data and real-world evidence, the FDA Decision Alerts. "To enable our partners to learn from the growing empirical evidence base of regulatory decisions, Aetion is systematically assessing drug and biologic […]
SCOTUS Rules in Favor of Payers in Risk Corridors Case
The Supreme Court on Monday ruled that commercial health plans are owed billions of dollars under the Affordable Care Act's risk corridor program, Healthcare Dive reports. According to the report, the court reversed a 2018 decision by the U.S. Court of Appeals for the Federal Circuit. The case […]
Report: Providers Can Earn MIPS Credits by Participating in Data-Sharing Program
The Centers for Medicare and Medicaid Services (CMS) last week urged providers to use a data-sharing program through which they can earn Merit-Based Incentive Payment System credits, Modern Healthcare reports. According to the report, the Quality Payment Program could help in the fight against […]
A Look at Cummings’ Drug Pricing Law
While the Elijah Cummings Lower Drug Costs Now Act would reduce drug prices, The Commonwealth Fund says the impact on prices would hinge on several key components. A significant drop in prices, according to The Commonwealth Fund, would depend on: The specific choices implemented in detailed […]
Preparing for a COVID-19 Vaccine
A recent Health Affairs blog post considers the challenges that lie ahead of a potential COVID-19 vaccine. The rollout of a vaccine, the authors, Cecelia Thomas and Amy Pisani, write, "will require massive preparation and precise coordination." "While state and local public health immunization […]
AMCP’s Andel Talks Drug Pricing Proposals Ahead of Election
Melissa Andel, Applied Policy vice president of health policy, discussed during an AMCP eLearning Days presentation drug pricing proposals in the U.S. as the 2020 election nears. According to an eLearning Days post, Andel highlighted how Trump has acted on drug pricing during his presidency, […]
Supreme Court Delays Arguments on Arkansas’s PBM Law
The Supreme Court has pushed back arguments in a case involving an Arkansas law that regulates the rates at which PBMs reimburse pharmacies. According to a Law360 report, arguments have been delayed until sometime in October. To read more on Law360, click here. […]
Article Highlights State of HTA
A recent article published in Value & Outcomes Spotlight looks at the health technology assessment (HTA) landscape across the globe. The article was published in the March/April edition. "With a consistent stream of innovative new therapies, HTA organizations are challenged to determine […]
