Germany Snubs Cholesterol Drug

Germany’s Institute for Quality and Efficiency in Health Care has balked at reimbursing cholesterol drug Praluent — co-developed by Sanofi and Regeneron Pharmaceuticals — due to a lack of an added benefit.

IQWiG said none of the 12 submitted studies were relevant for benefit assessment. There were several studies in which some patients did not receive prior therapy with their maximum tolerated dose of statins — a prerequisite for treatment with Praluent — while other studies did not adhere to the appropriate comparator theory or were too short.

The UK’s National Institute for Health and Care Excellence previously gave a thumbs-down to reimbursing the drug, concluding that while the drug is effective at lowering bad cholesterol, the drugmakers had not conducted large-scale head-to-head trials of Praluent versus a combination of Zetia and a statin.