Germany's G-BA issues final assessment for Cell Thera's Pixuvri

USA-based Cell Therapeutics (Nasdaq: CTIC) says that Germany's Federal Joint Committee (G-BA) has issued its final benefit assessment report for Pixuvri (pixantrone), which is indicated as a monotherapy for the treatment of adult patients with aggressive B-cell non-Hodgkin lymphoma (NHL) who have failed two or three prior lines of therapy.

In an early benefit assessment under Germany’s Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) concluded that no additional benefit could be determined for Pixuvri versus the comparator therapies assigned by the G-BA (The Pharma Letter March 4).

Now, the G-BA confirms that additional benefit could not be determined for Pixuvri versus the comparator therapies assigned by G-BA, the ultimate authority in determining reimbursement for drugs in Germany. Pixuvri is the first medicinal product approved in the European Union for patients with aggressive B-cell NHL who have failed two or three prior lines of therapy; as such, there was no approved standard of care.