Cell Therapeutics, Inc. (CTI), a biopharmaceutical company, announced 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. The G-BA further reported 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 (EU) 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.

The Federal Joint Committee also decided that the prescribability for pixantrone should be limited to hematologists and oncologists and that this limitation might be of relevance for the GKV-SV, the Federal Association of Statutory Health Insurance Funds, with regard to the therapy cost, since the cost for Pixuvri was only marginally higher than the cost of the appropriate comparative therapy. CTI also reported that the company was notified by the GKV-SV that pricing discussions will begin in June.

The G-BA's decision was based on the assessment that the submitted phase III EXTEND study of Pixuvri  was found not to be sufficient to allow a conclusion of a 'proven additional benefit' because: the chosen comparator arm differed from the G-BA selected appropriate comparative therapy, and the pre-treatment of patients in the pivotal phase III study of Pixuvri  (PIX301) did not reflect the current treatment used in German health care practice with regard to previous therapies patients received.

"We recognize the challenge of quantifying the additional benefit for a therapy for which under AMNOG law there is no comparator because there was no approved standard of care for this stage of the disease, prior to the approval of Pixuvri  in the EU," said James A Bianco, MD, president and CEO of CTI. "Pixuvri  is the first medicinal product approved in the EU for the treatment of patients with aggressive non-Hodgkin B-cell lymphomas who have failed two or three prior lines of therapy, which was based on results from the only phase III study conducted in this patient population. We appreciate the Joint Committee recognizing this conundrum and providing CTI the opportunity to work with payors to arrive at an equitable price for Pixuvri, based on the cost associated with unlicensed agents or regimens currently being utilized by physicians in Germany."

CTI will begin pricing discussions in June with the GKV-SV, the Federal Association of Statutory Health Insurance Funds. Under AMNOG, the annual treatment costs must not exceed those of the appropriate comparator.

Pixuvri  is already available in Germany for healthcare professionals to prescribe in accordance with local guidance. In May 2012, the European Commission granted conditional marketing authorisation for Pixuvri  as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL based on the results of the EXTEND, or PIX301, pivotal randomized phase III clinical trial. The benefit of Pixuvri treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.

CTI is currently accruing patients into a phase III trial comparing Pixuvri  and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. Pixuvri  does not have marketing approval in the United States.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use has accepted PIX306, CTI's ongoing randomized controlled phase III clinical trial, which compares Pixuvri -rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B-cell NHL and who are not eligible for autologous stem cell transplant. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.

CTI is committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable.