FluMist Quadrivalent could become the first self-administered flu vaccine in the United States; the American Society of Reproductive Medicine updates its definition of infertility to be more inclusive; the Environmental Protection Agency moves to ban the use of a cancer-causing chemical .
AstraZeneca's FluMist Quadrivalent Seeks FDA Approval for Self-Administration
The FDA has accepted AstraZeneca’s its application for review, seeking approval for patients or caregivers to administer its nasal flu vaccine, FluMist Quadrivalent, according to Reuters. If approved, this vaccine could mark the first self-administered flu vaccine that does not require a health care practitioner for administration. AstraZeneca anticipates an FDA decision in the first quarter of 2024 and, if approved, plans to make the vaccine available for self-administration during the 2024-2025 flu season in the United States. The application is supported by data from a usability study that confirmed individuals over 18 years of age could self-administer the vaccine with instructions, benefiting eligible patients aged 2 to 49 years.
Revised Definition of Infertility Broadens Inclusivity and Access to Reproductive Medicine
The American Society for Reproductive Medicine (ASRM) has issued a revised definition of infertility that aims to be more inclusive, according to CNN. Under the new definition, infertility includes anyone needing medical interventions to achieve a successful pregnancy, whether as an individual or with a partner. The updated definition also explicitly considers those who require medical assistance to build their families, including individuals who are single or in same-sex relationships. This change is intended to ensure equal access to infertility treatment and care for all, regardless of marital status, sexual orientation, or gender identity. The new definition seeks to remove one of the excuses insurance companies have used to deny coverage for necessary medical care related to infertility.
EPA Proposes Ban on Trichloroethylene, a Cancer-Causing Chemical Found in Consumer Products
The US Environmental Protection Agency (EPA) has proposed banning the use of trichloroethylene (TCE), a cancer-causing chemical found in consumer products, according to The Associated Press. TCE is known to cause sudden death or kidney cancer at high exposure levels and neurological harm even at lower exposures over an extended period. The EPA's risk evaluation studies indicated that up to 250 million pounds of TCE are still produced in the United States each year. The move aims to address TCE's toxic legacy in communities and protect people from exposure to this hazardous chemical. The decision comes after years of battling to ban TCE, which has been associated with contaminated drinking water in various locations, including the city of Woburn, Massachusetts.
Public Hospitals More Likely to Extend Unprofitable Services After 340B Participation, Study Finds
May 10th 2024Public hospitals were significantly more likely to sustain access to unprofitable services following 340B Drug Pricing Program participation, while nonprofit hospitals were mostly unaffected, according to a recent study.
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Frameworks for Advancing Health Equity: Urban Health Outreach
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Persistence Pays Off With Zanubrutinib: A Challenging CLL Case With a Prior BTK Inhibitor Failure
May 10th 2024The case of a 77-year-old woman with a long chronic lymphocytic leukemia (CLL) history illustrates the novel use of zanubrutinib as a potential option for some patients who have failed first-generation Bruton tyrosine kinase (BTK) inhibitors and venetoclax.
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CMS Medicare Final Rule: Advancing Benefits, Competition, and Consumer Protection
May 7th 2024On this episode of Managed Care Cast, we're talking with Karen Iapoce, senior director of government products and programs at ZeOmega, about the recent CMS final rule on Medicare Part D and Medicare Advantage.
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Looking Back on ISPOR 2024: Hot Policy Topics, Welcome Focus on Employers, and More
May 10th 2024Kimberly Westrich, MA, chief strategy officer of the National Pharmaceutical Council, reflects on the most valuable learnings from the 2024 meeting of ISPOR—The Professional Society for Health Economics and Outcomes Research, including lively discussions of the Inflation Reduction Act and workshops on value assessment.
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