BioCentury
ARTICLE | Clinical News

Rapiscan regadenoson regulatory update

January 23, 2012 8:00 AM UTC

The German Institute for Quality and Efficiency in Health Care (IQWiG) said Rapiscan regadenoson from Rapidscan Pharma Solutions Inc. (Los Altos, Calif.) provides "no additional benefit" over adenosine for use as a pharmacological stress agent in myocardial perfusion imaging (MPI) in adults unable to undergo adequate exercise stress to diagnose coronary artery disease (CAD). The health technology assessment agency made the determination because it did not receive any data for the product. Under the AMNOG pricing scheme, the price of a new drug in Germany is set based on a government assessment of cost-effectiveness. If the assessment finds no clinical benefit beyond available treatments, the drug will be added to the reference pricing system, which gives the same base price to all comparable drugs.

Previous data showed Rapiscan was comparable to adenosine for use as a pharmacologic stress agent in cardiac perfusion imaging studies (see BioCentury, Dec. 11, 2006). ...