The FDA recently achieved two significant firsts in one approval. On April 21, the FDA licensed infliximab-abda (Renflexis; Samsung) for marketing. While this product represents the fifth biosimilar approved in the United States, it is the first one licensed without the FDA conducting an advisory committee hearing prior to final endorsement. It is also the first time that a second biosimilar was approved for the same reference product infliximab (Remicade; Janssen Biotech).more...
Given the challenge of achieving agreement on any issue in Washington, D.C., especially on topics involving health care, we should pause and celebrate situations where bipartisan behavior may be taking hold.more...
In my experience on the contracting side of pharmacy, I have yet to see an industry landscape quite as volatile and intriguing as the one we currently find ourselves navigating. As such, Vizient goes to great lengths to predict what’s coming down the pike in terms of trends, marketplace fluctuations and pricing variations, not just for our own organization, but to illuminate the landscape for our members as well.more...
The U.S. is in the midst of a national crisis. In the past two decades we have seen increasing use, abuse and deaths associated with opioid medications.
Here are a few disconcerting trends*:
Prescribing opioids is on the increase. Approximately 20 percent of patients receive an opioid prescription for non-cancer-related symptoms or pain-related diagnosis in America. This 20 percent translates to approximately 259 million prescriptions or an equivalent of one bottle of opioids for every adult...more...
While attending the National Nuclear Security Administration 2016 Mo-99 conference in St. Louis last week, I learned of a report from the National Academies of Sciences, Engineering, and Medicine (NAS) citing the 50 percent likelihood of a shortage of molybdenum-99 (Mo-99). Mo-99 is used to produce technetium-99m (Tc-99m), which is used in millions of diagnostic procedures annually.more...
One of the areas of greatest concern for pharmacy practice, in terms of both cost and impact on patient care, is the increasing development of pharmaceuticals that could be classified as “specialty.” While there is no universally accepted definition of a specialty drug, most characterizations include attributes such as:
• High cost
• Limited extent of use
• Technical complexity of delivery and/or administration
• Treatment of complex and/or...more...
A recent blog by Vizient’s Jodi Eisenberg shared insights about maintaining perspective on accreditation surveys in order to keep staff focused on delivering care to patients. The post included several recommendations, two of which I would like to dig into more deeply: using sources of truth and conducting mock surveys.more...
In December I blogged about the long, slow journey biosimilars are taking toward mainstream market adoption in our country. I am excited to now be able to blog about another important step forward!
On March 31, I received an email notification from the U.S. Food and Drug Administration (FDA) announcing the publishing of their long-awaited draft guidance, “Labeling for Biosimilar Products.”more...
It wasn’t that long ago when the accepted explanation for the high cost of medications was the extensive research and development necessary to get it successfully into the market. Recent media scrutiny and unscrupulous investors like Martin Skreli have shown that “R&D” isn’t the culprit we believed it to be.more...
In early January, the JPMorgan Healthcare Conference was held in San Francisco and more than 20 major health care organizations were present: Cleveland Clinic, Boston-based Partners Healthcare, Geisinger Health System, Northwestern Medicine of Chicago, Advocate Healthcare, to name a few.
The news coming out of this conference confirmed that change is inevitable to survive in the new health care environment, but now execution of strategies would be the new expectation for 2016. Leaders from...more...