Pricing, Regulatory

Greek health minister takes issue with Roche’s withdrawal of cancer medicine due to mandatory, retroactive discount

Drug prices are not just a US problem. Greece’s minister of health on Tuesday expressed dismay over Roche’s decision to withdraw a cancer medicine because of a new mandatory discount imposed by the country.

Greek health minister Andreas Xanthos called the move by Switzerland-based Roche “unacceptable” and said citizens’ access to innovative medicines should not be a business decision, according to a translation of a statement released Tuesday.

The cancer treatment that was pulled from Greece’s market by Roche is Cotellic (cobimetinib), which is used to treat melanoma in combination with Zelboraf (vemurafenib). Cotellic was approved in the US in 2015, and the combo is reportedly priced at $17,600 per month, or about $211,000 per year.

Roche spokesperson Anja von Treskow told Focus: “With the imposition of the mandatory 25% discount on new innovative products, which is added to a series of mandatory discounts, making Cotellic available in Greece at the reimbursed price has become unsustainable.

“We want to ensure that Greek patients continue to have access to innovative medicines and treatments now and in the future. At the same time, we need to protect our company from the extremely unfavorable environment created by the rebate and discount based pricing policy for pharmaceutical companies in Greece,” the drugmaker said.

According to news reports, the mandatory 25% discount has been applied retroactively to January 2017 in Greece and could cause other companies to withdraw products from the market.

James Love, director of Knowledge Ecology International, told Focus he thinks Greece should issue compulsory licenses on expensive cancer medicines and “this is a good candidate.”

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email for more information.

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Recursion Pharmaceuticals Salt Lake City, UT
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