Anticoagulant crowd feels squeeze

In this era of cost-consciousness, clinical efficacy may not be enough to convince hospitals and doctors to use new products, particularly in crowded fields such as anticoagulants for acute cardiovascular conditions, where the drugs already on the market are so cheap as to be virtually free.

Many of the factors driving the market sizes for these drugs are pushing in one direction - down - which means that the 13 products in development (see accompanying list) could be competing in smaller markets and at lower prices than the companies originally hoped.

The key drivers of market size come from the clinical area and the health care system. Companies need to prove that benefits outweigh risks amid growing pressures on the health care system to limit costs. These factors may work synergistically, if hospitals and reimbursers use narrow labels to limit the use of drugs to patients where the cost/benefit ratio is strongest.

Narrower indications

The need to demonstrate efficacy to the FDA, especially in indications where the death rate or rate of adverse events is low, may lead companies to target trials at high-risk groups. Targeting those groups also may be necessary to show that any side-effects are offset by health benefits. The need to show a cost-benefit also points in this direction. As a result, more drugs may be tested in narrow indications.