Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported 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 reported that additional benefit could not be determined for PIXVURI 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 (E.U.) 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 3 EXTEND study of PIXUVRI was found not to be sufficient to allow a conclusion of a 'proven additional benefit' because:
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the chosen comparator arm differed from the G-BA selected appropriate comparative therapy , and
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the pre-treatment of patients in the pivotal Phase 3 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 E.U.," said James A. Bianco , M.D., President and CEO of CTI. "PIXUVRI is the first medicinal product approved in the E.U. 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 3 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 authorization 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 3 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. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.pixuvri.eu. CTI is currently accruing patients into a Phase 3 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.
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