Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) has declined to recommend Cell Therapeutics’ Pixuvri after deciding the cancer drug provides ‘no additional benefit’.
Pixuvri was approved in Europe in May as a monotherapy for the treatment adults with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) and was given a phased launch across the region.
But in its preliminary benefit assessment, IQWiG concluded that no additional benefit could be determined for Pixuvri versus the comparator therapies assigned by Germany’s Federal Joint Committee (G-BA), while it also noted there was no current standard of care.
The German health technology assessment (HTA) body’s assessment will now be passed to the G-BA,which will decide whether the drug should be reimbursed in Germany.
Cell Therapeutics issued a bullish response to IQWiG’s decision, noting that the decision “has no immediate impact on the reimbursement of Pixuvri or physician’s ability to prescribe this new treatment in Germany”.
The Seattle, US headquartered biopharmaceutical firm’s president and CEO James Bianco said: “Pixuvri is the first medicinal product approved in the EU for treatment of patients with multiply relapsed or refractory aggressive NHL that addresses an unmet medical need
“We believe Pixuvri offers patients suffering from aggressive NHL a safe and effective therapy, where there currently is no standard of care.”
Pixuvri has a conditional marketing authorisation from the European Commission (EC), based on results from the EXTEND, or PIX301, pivotal randomised phase III clinical trial.
This showed that more patients on Pixuvri achieved a complete response or unconfirmed complete response, and also survived for longer before their disease progressed, than participants taking other active single-agent treatments.
As part of its conditional approval, Cell Therapeutics is required to complete a post-marketing study aimed at confirming its clinical benefit. Results from the PIX306 trial, comparing Pixuvri and Roche’s MabThera (rituximab) to a regimen of Lilly’s Gemzar (gemcitabine) and MabThera, are expected by June 2015 as part of this post-marketing follow-up.
Conditional marketing authorisations are granted in the EU to speed access to products that address unmet medical needs and whose availability would result in a significant public health benefit.
There are about 37,000 new cases of aggressive B-cell NHL every year in Europe, and Cell Therapeutics will be looking to take a strong hold in a market where few treatment options are available and compensate for the problems it has had gaining a US licence. The FDA has twice knocked back Pixuvri, most recently last January.