Translation of a-t 2021; 52: 78
 

IN BRIEF

Intermezzo for the flu drug baloxavir marboxil (XOFLUZA)

In early October 2021, Roche ceased marketing of baloxavir marboxil (XOFLUZA) in Germany. The medicinal product was only introduced onto the market in February 2021 for the treatment and post-exposure prophylaxis of influenza. The step was taken because the Federal Joint Committee (G-BA) only attributed an additional benefit to baloxavir in a sub-population. Roche AG therefore feels that its "expectations based on the clinical data [are] not met and the patient benefit is not appropriately acknowledged". In the price negotiations there was "no mutual understanding" of the benefit of the product and the pricing (1). The G-BA sees no additional benefit of the antiviral substance, the mechanism of action of which deviates from that of a neuraminidase inhibitor, in the treatment of influenza for patients either with or without risk factors for influenza-related complications (2). In both authorisation studies, both baloxavir and oseltamivir (TAMIFLU, generics; see a-t 2010; 41: 4, 13-4 and 2012; 43: 17-8) reduced the duration of illness by around a day (3,4). The G-BA did identify a significant additional benefit as post-exposure prophylaxis compared to watching and waiting in exposed persons with no risk of complications caused by influenza, but not in persons with an increased risk (5). There are no comparison data with the neuraminidase inhibitors considered by the G-BA to be appropriate comparator treatment for this group. Ultimately, the decision to stop marketing baloxavir, for which Roche calculated a pharmacy retail price of EUR 117 or EUR 223 depending on the dose, was primarily a financial one - as was the case with Janssen-Cilag with the SGLT-2 inhibitor canagliflozin (INVOKANA; a-t 2015; 46: 89). The patient benefit of the substance, of which the company appears to be convinced, evidently plays a less significant role, -Ed.

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