Contrast Enhanced Ultrasound (CEUS) and Off-label Use (in Children)

Prescribing pharmaceuticals for unapproved indications, or off-label use, is essential to therapeutic innovation, but it also raises questions about increased liability and pharmacovigilance. In Germany, an expert committee introduced the Statutory Health Insurance (SHI) Modernization Act of 2004 [1–3]. Two addendums were introduced in 2006; Annex 9 defines drugs that are eligible for off-label use, and Annex 10 lists drugs that will be eligible for prescription following assessment by the Institute for Quality and Efficiency in Health Care (IQWiG). The expert committee has also defined rules governing the Social Health Insurance (SHI)-financing and prescription of oncology therapeutics for unlicensed use, based upon a ruling from the Federal Social Court [2].

Despite these efforts, numerous problems regarding funding and other critical issues remain unsolved in the off-label use of drugs and imaging modalities, including ultrasound and ultrasound contrast agents (UCA) [1, 2].

The off-label use of contrast enhanced ultrasound (CEUS) illustrates the need to deal with unresolved legal issues and balance with the need for diagnostic innovation in the daily clinical routine [3]. CEUS has a number of distinct advantages over CT and MRI. It can be performed immediately, without any preliminary laboratory testing, and it can be carried out in a variety of settings (bedside, operatory room, CT suite, etc.). CEUS operates in real time, so that rapid changes can be captured, and without radiation exposure [4].