Tuesday, May 10, 2011

Merck's Ezetimibe Faces Reimbursement Threat In Europe

Merck & Co. Inc.'s cholesterol agent ezetimibe will likely see reimbursement cuts in Germany unless persuasive public arguments are offered against them by May 31.
And the product may also run into trouble in the U.K. this summer when the National Institute for Clinical Excellence is set to revisit its favorable 2007 guidance on coverage in England and Wales.
In Germany - where ezetimibe is marketed as Ezetrol and Inegy (in combination with simvastatin) by MSD Sharp & Dohme GmbH - the Institute for Quality and Efficiency in Health Care (IQWiG)gave a thumbs down to the product in a preliminary report published on May 3.
The report is now open to public comments until May 31, but a confirmation of the preliminary report after the consultation period has closed could spell trouble for reimbursement of ezetimibe by the statutory health insurance funds.
IQWiG, which undertakes health technology assessment at the behest of Germany's senior health care decision-making body, the Joint Federal Committee (G-BA), said that there was no evidence that ezetimibe - either alone in combination with a statin - offered greater benefits or fewer side effects than other lipid-lowering agents and non-pharmaceutical based treatments.
The institute even said it could find no evidence that ezetimibe offered more benefit or caused less harm to patients with hypercholesterolemia than treatment with placebo