Germany Issues Benefit Assessment For InterMune’s Esbriet, Despite Orphan Drug Status

Germany’s senior health technology assessment body, the G-BA, has said that InterMune’s Esbriet is beneficial, but says it is unsure to what extent. However, such added value assessments for orphan drugs could be illegal.

The German Joint Federal Committee’s (G-BA’s) decision on March 15 to give the go-ahead for price negotiations to begin for InterMune Inc.’s idiopathic pulmonary fibrosis product Esbriet (pirfenidone) comes as no surprise. However, its assessment, mirroring an earlier judgment from the Institute for Quality and Efficiency in Health Care (IQWiG), that Esbriet offers an “unquantifiable benefit” to patients has rattled the some in the pharmaceutical industry.

The confirmation is a worrying development in the sense that IQWiG’s initial decision to assess the added benefit of an orphan drug may not have

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