Real-world data brings the ability to observe how treatments work in a real-world environment outside of a clinical trial setting, but there remain some key challenges, according to an article by Ambra Health's Morris Panner published on Forbes. Data collection, organization, sharing and storage […]
Survey Reveals Insights into State, Expectations of Health Care Industry
A recent survey by Managed Healthcare Executive (MHE) of 200 executives offers a look inside at the roadmap and expectations of the health care industry going into 2019. The survey was conducted during the third quarter of this year, and includes input from provider organizations, benefit […]
House Green Lights Bipartisan Drug Pricing Bill
The House this week gave the green light to a bipartisan drug pricing bill that targets practices by pharmaceutical companies that ultimately lead to higher costs for taxpayers. According to a Beckers Hospital Review report, the bill would give the Department of Health and Human Services that […]
Gottlieb Says New Guidelines Will Spur Insulin Competition
Food and Drug Administration Commissioner Scott Gottlieb says new rules that could roll out in 2020 will look to bolster competition in the insulin market, Managed Care magazine reports, which is currently dominated by three drugmakers: Eli Lilly, Novo Nordisk and Sanofi Aventis. A study conducted […]
Trump Administration Could Narrow Focus on Drug Prices
The Trump administration could begin zeroing in on Medicare Part B spending next year, according to a FierceHealthcare report. Bernstein analysts reportedly said recent spending data released by the Centers for Medicare and Medicaid Services, along with comments coming out of the agency, point to […]
Frakt Looks at Pros, Cons of Price Cutting Strategies
Partnered Evidence-Based Policy Resource Center Director Austin Frakt in a recent article published on the New York Times offers a look at some of the pros and cons of potential strategies to reduce drug pricing in the U.S. For example, Frakt writes, private insurers that drive "the hardest […]
Opinion: Outcomes-Based Pricing Holds Promise
Although outcomes-based pricing remains in its infancy, the Institute for Policy Innovation's Merrill Matthews writes in an article published on The Hill, it remains a promising solution to combating high drug prices. Matthews says the payment model could help address concerns about high-cost gene […]
Trump White House Touts International Pricing Index
The Trump administration is defending its push on a new pricing index that would look to align Medicare Part B drug prices with prices in other developed countries. In a recent blog post on the International Pricing Index proposal, Health and Human Services Senior Adviser for Drug Pricing Reform […]
Ohio Leading Push Against PBMs
Pharmacy benefit managers are facing a significant amount of scrutiny and criticism by a number of states, with Ohio being a key player after it was the first to comb through pricing data related to its two PBMs: CVS Caremark and Optum Rx. According to data collected by The Columbus Dispatch […]
Report: Generic ‘Cartel’ Probe Expands to 300 Drugs
An antitrust lawsuit levied by states in 2016 over two drugs has reportedly expanded into a full-blown investigation of alleged price-fixing of generic drugs, the Washington Post reports. Joseph Nielsen, an assistant attorney general and antitrust investigator, tells the Post the investigation […]
Report: Consumer Shouldering More Health Costs
While spending growth in the health care sector slowed to a post-recession rate of 3.9 percent in 2017, according to figures from the Centers for Medicare and Medicaid Services (CMS) published in Health Affairs, spending per capita grew 3.2 percent. Citing a report from the Commonwealth Fund, a […]
NPC Backs FDA’s RWE Framework, Says It’s a Step in Right Direction
The National Pharmaceutical Council (NPC) says the Food and Drug Administration's (FDA) recent real-world evidence framework is a step in the right direction. The FDA released the framework Thursday, Dec. 6, and lays out how the federal agency will assess potential uses for RWE in drug […]
FDA to Use 3-Step Approach in RWE Initiative
The Food and Drug Administration in a new framework says it will use a three-step approach to determining how to best use real-world evidence in drug approvals. According to a RAPS.org report, the agency says it will consider the following:Whether the real-world data are fit for use; Whether […]
FDA Creating Roadmap for RWE Integration
The U.S. Food and Drug Administration (FDA) is working to develop a roadmap for the implementation of real-world evidence (RWE) into the drug development arena, and as part of that effort released a framework for assessing its potential uses. According to a BioCentury report, the framework makes […]
Forbes Summit Spurs Robust Talks on Drug Prices, Innovation in Pharma
The 7th annual Forbes Healthcare Summit brought a dynamic conversation about the state of pharmaceuticals, drug pricing and innovation, BioSpace reports. Vertex Pharmaceuticals' Jeffrey Leiden said it's imperative that companies consider the entire "$3 trillion system" and search for important […]
2019 Could Spell Change for Pharma with Democratic House
While the pharmaceutical industry has been mostly untouched in the Trump administration's first 22 months, according to an MM&M report, a new Democratic House and shifting political landscape could mean change is on the horizon. Though little action has been taken against the industry, per the […]
More Hospitals in VBP Program to See Medicare Payment Increase
The Centers for Medicare and Medicaid Services (CMS) recently reported that more hospitals in the Hospital Value-Based Purchasing Program will see a higher Medicare payment next year. According to a RevCycleIntelligence report, the program adjusts Inpatient Prospective Payment System (IPPS) […]
ICR Report: NICE’s Efforts to Expedite Drug Pipeline Insufficient
The Institute of Cancer Research's recent report on innovative cancer therapies and access to such drugs suggests that the National Institute for Health and Care Excellence's efforts to reduce the time to patient has to date been insufficient. According to Pink Sheet, the report also says the […]
Proposal to Require Drug Prices in Ads Garners Opposition
The government's proposal that would require drugmakers to include a drug's list prices in television ads has drawn opposition from some, including the Association of National Advertisers (ANA) and two academics, FiercePharma reports. The ANA in a blog post and the academics in a New England […]
New Bipartisan Drug Pricing Bill Targets Bad Rebate Practices
A new bipartisan bill introduced by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Oregon) looks to tighten regulations around Medicaid rebates to stop drugmakers from overcharging U.S. taxpayers, The Hill reports. The proposed legislation would provide the Department of Health and Human Services […]
Report Analyzes Trends in Cancer Drug Innovation, Access
A new report by the Institute of Cancer Research (ICR) looks at the cancer drug pipeline, including trends in innovation and access between 2000 and 2016. The European Medicines Agency, according to the report, licensed 97 cancer drugs across 177 indications between 2000-2016. The rate of […]
Iqvia: FDA’s MyStudies is ‘Major Milestone’
The Food and Drug Administration's (FDA) new mobile app, MyStudies, marks a significant milestone for the collection of real-world data, Iqvia Senior Vice President and General Manager John Doyle tells Outsourcing-Pharma.com. "On the patient-centricity initiative, it amplifies the patient voice, […]
ISPOR Seeks Comments on CMS Notice
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is calling for comments on the Centers for Medicare and Medicaid Services' latest call for input on an advance notice of proposed rule making regarding an international pricing index for Medicare Part B drugs. In an […]
After Midterms, Door Opens for Bipartisan Action on Drug Pricing
Experts say Republicans and Democrats could set aside their partisan differences following the 2018 midterms to find some bipartisan compromises on drug pricing legislation, FierceHealthcare reports. Jennings Policy Strategies Founder and President Chris Jennings tells FierceHealthcare drug pricing […]
Trump Administration Seemingly Promotes Private Medicare Plans Via Email
President Donald Trump's administration has reportedly been sending emails to millions of Medicare beneficiaries, promoting private Medicare Advantage plans. According to the New York Times, the administration has been sending emails with subject lines such as "Get more money benefits for your […]
Former FDA Chief Califf Talks RWD, RWE
Robert Califf, People-Centered Research Foundation board chair and former Food and Drug Administration commissioner, recently discussed the benefits of using real-world evidence with real-world data garnered from electronic health records. "Part of the way the system of research worked before […]
AMCP Set to Host Webinar on Post-Midterm Health Care
The Academy of Managed Care Pharmacy (AMCP) is slated to host a Dec. 3 webinar on the direction of health care following the 2018 midterm elections. The online event, set to kick off 3 p.m. EST, will focus on how the 116th Congress could move on major health care issues, as well as the implications […]
CMS Proposal Aims to Modernize Medicare to Slash Drug Prices
The Centers for Medicare and Medicaid Services on Monday, Nov. 26, announced a new policy proposal for 2020 aimed at modernizing Medicare Part C and D programs. According to a press release, the proposal would provide Medicare Advantage and Part D plans with the necessary tools to negotiate lower […]
Report: Pharma, U.K. Reach Deal on Pricing, Access
The U.K. government and pharma have reportedly reached a deal to improve market access and broaden efforts to encourage innovation, STAT reports. According to the report, the agreement would deploy spending caps on brand drugs, as well as measures to speed up cost-effectiveness assessments. The […]
FDA Has Big Changes Planned for Medical Device Approval Pipeline
The U.S. Food and Drug Administration is reportedly looking to overhauling the pipeline for medical device approvals in a bid to modernize and streamline the pathway for high-tech innovations, FierceHealthcare reports. The agency is looking to make the changes to the 510(k) pathway, a process for […]
