The small incremental improvements to existing drugs that make up the majority of new drug approvals by the FDA each year provide important health benefits to patients.
The small incremental improvements to existing drugs that make up the majority of new drug approvals by the Food and Drug Administration each year provide important health benefits to patients, especially elderly patients, according to a study conducted by the Center for Pharmaceutical Health Services Researc h at Temple University in Philadelphia, in cooperation with the Reston, VA-based National Pharmaceutical Council.
The study showed that newer drugs in a therapeutic class often have fewer side effects, have improved drug safety and effectiveness, and are used more easily, which facilitates compliance with prescribed treatments. Plus, a wide variety of product alternatives permits treatments to be better tailored to individual patient needs. "By giving physicians a broad range of medicines, we provide them with a 'tool chest' to treat each patient with precision and provide options when particular agents have less than optimal effectiveness or are poorly tolerated," said Albert Wertheimer, director of the Center for Pharmaceutical Health Services Research at Temple University and the lead researcher on the study. "Even choices in dosage form - tablets versus liquids, or once- versus twice-daily dosing - can benefit elderly patients who may have special needs or preferences regarding chewing, swallowing or remembering to take their medications."
In addition to improving health outcomes, products entering the market that represent incremental innovations over their predecessors are often less expensive than existing agents in a therapeutic class. The result is less expensive alternatives long before generic products are available.
Some incremental innovations have been shown to save overall healthcare costs as well. For example, a study by the National Institute for Neurological Diseases and Stroke found that patients treated with tPA had shorter hospital stays than other patients and were more often discharged to their homes rather than to institutional care. Although hospital costs for treated patients increased by $1,700 per patient, rehabilitation and nursing home costs were reduced by $6,200, a net savings of $4,500.
Wertheimer commented, "Most of the top 10 prescription drugs sold in the United States in 1999 were incremental improvements on existing products. Policies that foster incremental innovations stimulate research, broaden access to important therapies and help to promote a competitive market.
"Individual physical and medical differences increase as people age," said Wertheimer. "As a result, multiple drug options are necessary for safe, effective and individualized therapy, especially for the fastest-growing portion of our elderly population, those 86 years old and older. In the current debate over the details of drug programs for the elderly, it is important to keep focused on one key concept - the need to provide a range of incremental drug therapies necessary for appropriate care." PR