This week, the top managed care stories included President Donald Trump's plan to drive down drug prices; the FDA approved the first biosimilar of the year; a study found rapid uptake of PD-1 agents after FDA approval.
Trump goes after rebates to drive down drug costs, FDA approves the first biosimilar of the year, and a study finds anti PD-1 agents reach patients quickly.
Welcome to This Week in Managed Care, I’m Laura Joszt.
Trump's Drug Pricing Plan
President Donald Trump vowed to drive down drug prices last week as he and HHS Secretary Alex Azar outlined a plan they say will go after manufacturers’ rebates and an upside-down incentive structure that works against consumers.
The plan, called America’s Patients First, has 4 key parts:
In follow-up appearances, Azar pushed back at criticism that the plan goes easy on drug companies by not having Medicare negotiate with them directly. Azar said the plan would stop having Medicare overpay for drugs in protected classes, and would end the gamesmanship that keeps generics and biosimilars from reaching the market.
In a speech to HHS staff, Azar said, “The president has called on us to merge Medicare Part B into Part D, where negotiation has been so successful on so many drugs… This is how we follow through on his promise to do smart bidding and tough negotiating for our seniors.”
FDA Commissioner Scott Gottlieb, MD, who helped craft the president’s drug pricing plan, is expected to name drug makers who have refused to provide samples to companies for testing of generics and biosimilars.
First Biosimilar of 2018
Within days of the pricing plan, the FDA approved the first biosimilar for 2018.
Epotein-epbx, to be sold by Pfizer as Retacrit, is a biosimilar to Epogen, a drug used to treat anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV. Retacrit will be used before surgery to reduce the need for red blood cell transfusions.
FDA’s Leah Cristl, PhD, noted the significance of the approval, and said, “It is important for patients to have access to safe, effective, and affordable biological products, and we are committed to facilitating the development and approval of biosimilar and interchangeable products.”
Access to PD-1 Agents
A new study finds that a large number of patients with melanoma gained access to anti PD-1 agents following their approval.
The study, published in JAMA Oncology, noted that it can take 10 years for traditional innovations to change patient care, but this was not the case after nivolumab and pembrolizumab received breakthrough designations from FDA.
Researchers looked at back at patients who received either drug for previously treated or untreated melanoma, non-small cell lung cancer, or nivolumab for renal cell carcinoma between January 2011 and August 2016.
More than 60% of the patients eligible for treatment in each group received an anti PD-1 drug within 4 months of FDA approval. By the end of the study period:
had been treated with an anti PD-1 agent.
Connecting Gut Bacteria to the Brain
Knowledge of how the human microbiome develops and its impact on our health has expanding greatly in the past decade, according to an expert who appeared at the Society of Biological Psychiatry meeting in New York City last week.
Elaine Hsiao, PhD, of the University of California, Los Angeles, discussed how the microbiome affects brain function and behavior, starting with the differences that happen at birth, when a baby inherits its microbiome from his or her mother. She said some believe there is a connection between the rise in chronic disease and the increase in cesarean births, since this alters gut bacteria.
Dr Hsaio’s work has led to the study of the role of microbes in autism, multiple sclerosis, and depression.
For more on her talk and the rest of AJMC’s coverage of the meeting, visit the conference page.
Upcoming Conference Coverage
AJMC will bring you coverage from coast to coast this week.
Starting Sunday, we will be in San Diego for the American Thoracic Society (ATS) International Conference, featuring news about the IMPACT study and single inhaler triple therapy in COPD.
Then it’s off to Baltimore for the 23rd meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), featuring research in real-world evidence and healthcare decision making.
You can also register to receive conference emails, which will bring you coverage from this weekend’s meetings and our upcoming coverage of the American Society of Clinical Oncology Annual Meeting in June.
For all of us at the Managed Markets News Network, I’m Laura Joszt. Thanks for joining us.