PHARMACY

Austin College of Pharmacy researchers developing breathable, respiratory Ebola vaccine

BY Michael Johnsen

AUSTIN, Texas — A potentially breathable, respiratory vaccine in development has been shown to provide long-term protection for nonhuman primates against the Ebola virus, as reported this week in the online edition of the journal Molecular Pharmaceutics.
 
Results from a recent preclinical study represent the only proof to date that a single dose of a non-injectable vaccine platform for Ebola is long lasting, which could have significant global implications in controlling future outbreaks. A breathable vaccine could surmount the logistical obstacles of storing, transporting and administering injectable vaccines in parts of Africa most afflicted by the virus.
 
Professor Maria Croyle and graduate student Kristina Jonsson-Schmunk of The University of Texas at Austin’s College of Pharmacy, who co-authored the paper with Gary Kobinger and his team at the National Microbiology Laboratory in Winnipeg, will make a presentation on the newly published work in San Diego Nov. 5 at the 2014 American Association of Pharmaceutical Scientists Annual Meeting and Exposition.
 
 
The Ebola virus often is a fatal illness that is spread among the human population via direct contact with blood or bodily fluids from an infected individual. The current Ebola outbreak in Western Africa is the largest and most complex epidemic since the virus was first discovered in 1976, according to the World Health Organization. With a fatality rate currently as high as 70%, officials are declaring this outbreak a public health emergency of international concern.
 
Croyle, Jonsson-Schmunk and colleagues worked over seven years to develop a respiratory formulation that improved survival of immunized nonhuman primates from 67% to 100% after challenge with 1,000 plaque forming units of Ebola Zaire 150 days after immunization.
 
This improvement is statistically significant because only 50% of the primates given the vaccine by the standard method of intramuscular injection survived challenge.
 
Ebola causes devastating outbreaks with fatality rates of 25% to 90% in Africa and Asia. Although progress has been made in understanding the virus’ biology, no licensed vaccines or treatments currently exist, the researchers noted.
 
“There is a desperate need for a vaccine that not only prevents the continued transmission from person to person, but also aids in controlling future incidences,” said Jonsson-Schmunk.
 
“The main advantage of our vaccine platform over the others in clinical testing is the long-lasting protection after a single inhaled dose,” added Croyle. “This is important since the longevity of other vaccines for Ebola that are currently being evaluated [are] not fully evaluated. Moreover, this immunization method is more attractive than an injectable vaccine given the costs associated with syringe distribution and needle safety and disposal.”
 
The next stage of research for Croyle’s team is a phase I clinical trial that tests the effectiveness of their vaccine in human subjects. They will also further explore preliminary data they have collected for administration of the vaccine as a thin film under the tongue in nonhuman primates.
 
This work was supported by a grant from the National Institutes of Health.
 

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Cardinal Health blog: Only 1% of eligible Medicare Part D beneficiaries get MTM services

BY Michael Johnsen

DUBLIN, Ohio – Healthcare leaders are being pushed hard across the board to lower costs while raising quality. Medication Therapy Management has been hailed by many, including the federal government, as one way to accomplish this important goal, especially in Medicare Part D. In fact, the Center for Medicare & Medicaid Services states that MTM is a "cornerstone" of Part D's future and a practice that will "serve as a model for achieving quality."
 
So, then, why do only 1% of eligible Medicare Part D beneficiaries get MTM services today? And what must health insurance plans do to reap the MTM benefits in CMS' Five-Star Quality Ratings System and in what other ways?
 
In a new blog post on Cardinal Health's online thought leadership website, Essential Insights, Brad Tice shared his perspective on why more patients aren't receiving MTM services, and how health plans can maximize the benefits of MTM services in both the short and long term. 
 
"Today, only a small share of Medicare Part D beneficiaries receive MTM services because health plans identify only 10% of members as eligible and, of these, only 10% get a Comprehensive Medication Review," Tice wrote. "That means only 1% of Part D beneficiaries — 10% of 10% — get this 'cornerstone' benefit of Part D's future. This large disconnect between health plans and CMS cannot last."
 
According to Tice, the following are four steps health plans can take to ensure more eligible beneficiaries receive this important Medicare Part D benefit:
 
  1. Improve your reach. Reach members where they receive care. Partnerships with providers who see patients frequently — retail pharmacies and long-term care facilities, for example — are crucial for connecting to the high-risk Part D patients whom CMS wants to receive MTM services;
  2. Find new allies. When incentives are properly aligned, pharmacists have a proven ability to improve patient care in a cost-effective way. Properly structuring payments will dramatically improve outcomes. View the pharmacist as a Star Ratings ally;
  3. Measure and maximize ROI. A lot of focus has been on the question, "What is the ROI on MTM services?" First ask, "What is the cost of inappropriate medication use?" The answer is about $300 billion annually. Then ask, "What is the ROI on a physician visit? On other forms of care?" If a medication is not used correctly, most of these costs will have gone to waste, not to mention the savings that will be missed from the prevention of disease progression; and
  4. Leverage data to find new models of care. While payers need to manage their populations across often broad geographies, individual care for these populations occurs at a local level. Therefore, collaborating with providers, who have the local reach, is key to innovation. These collaborative initiatives — electronic data sharing, business models that incorporate pharmacists, MTM consultations on specialty medications, care across distribution channels and so on —are the waves of the future.

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RAND Corp. projects that biosimilar drugs will save $44.2 billion by 2024

BY Michael Johnsen

NEW YORK — The RAND Corp. projected that the introduction of biosimilar drugs in the United States will reduce direct spending on biologics by $44.2 billion from 2014 to 2024, the firm announced Monday.  
 
"The Cost Savings Potential of Biosimilar Drugs in the United States," published by RAND and sponsored by Sandoz, highlights the promise of biosimilars in the biopharma marketplace.
 
"We predict that biosimilars will lead to a $44.2 billion reduction in direct spending on biologic drugs from 2014 to 2024, or about 4% of total biologic spending over the same period, with a range of $13 billion to $66 billion," RAND noted on its webpage. "While our estimate uses recent data and transparent assumptions, we caution that actual savings will hinge on the specifics of the final FDA regulations and on the level of competition."
 
The introduction of biosimilars is expected to reduce prices, albeit to a lesser degree than small-molecule generics, according to the report.
 

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