BioCentury
ARTICLE | Clinical News

Signifor pasireotide regulatory update

December 10, 2012 8:00 AM UTC

Germany's Federal Joint Committee (G-BA) issued a final assessment that said Cushing's disease drug Signifor pasireotide from Novartis provides a "marginal" degree of additional benefit for patients with Cushing's disease for whom surgery is not an option or has failed - its approved indication. Novartis will now negotiate a price for the Orphan drug, a somatostatin analog, with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband).

Under drug pricing law AMNOG, the additional benefit of Orphan products is regarded as having been demonstrated by the marketing authorization. Orphan products with an annual cost of less than €50 million ($65.1 million) to the German statutory health insurance funds (GKV) do not undergo a formal benefit assessment through the Institute for Quality and Efficiency in Health Care (IQWiG), though G-BA still determines the extent of the additional benefit. In an assessment issued in September, IQWiG said the cost of Signifor to GKV would be between €8.6-€19.3 million ($11.2-$25.1 million) pear year (see BioCentury, Sept. 24). ...