Comparing the approval and coverage decisions of new oncology drugs in the United States and other selected countries

Abstract

BACKGROUND: Global pharmaceutical sales for anticancer drugs were $74.4 billion in 2014, ranking first for drugs by therapeutic class. Countries may differ substantially in the approval and coverage decisions for anticancer drugs. OBJECTIVE: To compare the approval and coverage decisions for new anticancer drugs between the United States and 4 other countries: the United Kingdom, France, Australia, and Canada. METHODS: We identified all new anticancer drug indications approved by the FDA between January 1, 2009, and December 31, 2013. For each country, we reviewed the organizations, processes, criteria, and special considerations used to make approval and coverage decisions for the drug ..