Eisai has temporarily suspended commercial distribution of its anti-epileptic drug, Fycompa, in Germany after regulators issued an assessment that would sharply limit what Eisai could charge for the drug there.

The company says that the committee “failed to appropriately assess the value of Fycompa” in an additional benefit assessment conducted after it was granted German marketing approval in 2013.

Drugmakers have been watching the German market closely ever since the nation rolled out its Act on the Reform of the Market for Medical Products, also known as AMNOG. The act placed new requirements on pharmaceutical companies to provide justification for their pricing and put in place the new value assessment process carried out by the German Federal Joint Committee.

AMNOG launched in January 2011 and was designed to generate savings of $2.2 billion (€1.7 billion) in 2011 and annual savings of $2.6 billion (€2 billion) thereafter by tying a drug’s price to the value it provides.

The additional benefit assessment for Fycompa, conducted by the German Institute for Quality and Efficiency in Health Care, compared a year of treatment with the drug to a year of treatment with lamotrigine, a drug GlaxoSmithKline sells as Lamictal in Europe, and topiramate, which is sold by several companies in Europe. It found that the annual treatment costs per patient for Fycompa would be $3687 (€2,842) more than lamotrigine and $3046 (€2,348) more than topiramate, without providing any additional benefit.

Eisai plans to submit Fycompa for reassessment at its earliest opportunity, according to PMLive. Meanwhile, the company says that once it suspends sales of Fycompa, it will continue to work with patients who need the drug to enroll them in its patient access program.