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Challenges With Including PROs in Oncology Product Labels
The debate over including patient reported outcomes on oncology drug labels continues. The FDA expects well-defined and validated measurement tools and the patient community wants patient experiences to find their way to the label.
Industry, the FDA, and patient groups agree that patient-reported outcomes (PROs) should be included in labeling for oncology products, but there is not consensus on how to do so.
The various stakeholders met in a panel discussion last year at the plenary session of the annual Accelerating Anticancer Agent Development and Validation Workshop in Bethesda, MD, where frustrations were aired and frank views were exchanged.
A report of their discussion was published recently in JAMA Oncology. PRO-based claims are now included in the labeling of as many as 25% of new drug products in the United States, but only 1 of 43 oncology products approved by the FDA between 2006 and 2013 carry such claims.
Read the complete article at Cancer Therapy Advisor: http://bit.ly/1ApmQBf
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Higher Life’s Essential 8 Scores Associated With Reduced COPD Risk
November 21st 2024Higher Life’s Essential 8 (LE8) scores, especially those reflecting lower nicotine exposure and better sleep health, are inversely associated with chronic obstructive pulmonary disease (COPD) risk, emphasizing the importance of cardiovascular health (CVH) in disease prevention.
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