Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

G-BA Issues Final Assessment Report for PIXUVRI®

Published: Tuesday, May 21, 2013
Last Updated: Tuesday, May 21, 2013
Bookmark and Share
Pricing negotiations to begin in June.

Cell Therapeutics, Inc. (CTI) has 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:

• the chosen comparator arm differed from the G-BA selected appropriate comparative therapy, and

• 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.

Bianco continued, "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.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

CTI Opens Enrollment for PERSIST-2 Phase 3 Trial of Pacritinib for Myelofibrosis Patients
This trial, together with PERSIST-1, to support registration in the U.S. and Europe.
Tuesday, March 04, 2014
CTI Announces UK NCRI AML Cooperative Group Phase 2 Trial Evaluating Pacritinib for AML Patients
Trial sponsored by Cardiff University and supported by Cancer Research UK.
Tuesday, February 04, 2014
CTI Announces GOG Completes Patient Enrollment in GOG-0212
Patient enrollment in Phase 3 clinical trial of Opaxio™ as maintenance therapy in ovarian cancer.
Thursday, January 30, 2014
CTI Reaches Agreement with Novartis
Agreement to reacquire rights to two anti-cancer compounds.
Monday, January 13, 2014
CTI Announces Removal of the Partial Clinical Hold on Tosedostat
Company has received notification from the U.S. Food and Drug Administration.
Thursday, January 02, 2014
CTI and GKV-SV Reach Agreement on Pricing of PIXUVRI® (pixantrone) in Germany
Decision applies to patients with aggressive B-cell non-Hodgkin lymphoma who have failed two or three prior lines of therapy.
Wednesday, December 04, 2013
CTI Announces Data Presentations at the 55th ASH Annual Meeting
Pacritinib phase 2 analysis of myelofibrosis patients with thrombocytopenia (low platelets) accepted for oral presentation.
Monday, November 11, 2013
Cell Therapeutics Announces Agreement with the FDA on SPA for PERSIST-2 Trial
PERSIST-2 trial expected to initiate in fourth quarter of 2013.
Tuesday, October 08, 2013
Market Access Granted in France for Aggressive NHL Treatment, PIXUVRI®
CT will reassess the ASMR rating for PIXUVRI within two years.
Wednesday, August 21, 2013
CTI Announces Results from Sub-Set Analyses of Data from Phase 3 EXTEND Clinical Trial
Results presented at 18th Congress of the European Hematology Association.
Monday, July 15, 2013
Market Access Granted in Italy for PIXUVRI®
Access granted by AIFA for the aggressive non-Hodgkin lymphoma treatment.
Monday, July 08, 2013
Comprehensive Summary of Preclinical and Clinical Data for Pacritinib Published
Comprehensive article was published in the journal Drugs of the Future 2013.
Thursday, July 04, 2013
Cell Therapeutics Announces Resignation of Chief Medical Officer
Resignation of Steven E. Benner for personal reasons.
Monday, July 01, 2013
CTI Secures $15 Million Loan Financing Agreement
Company has entered into loan agreement with HTGC.
Tuesday, May 28, 2013
Tosedostat OPAL Study in Acute Myeloid Leukemia Published in Lancet Oncology
Lancet Oncology has published results from the OPAL Phase 2 study of tosedostat.
Tuesday, March 05, 2013
Scientific News
Liquid Biopsies: Utilization of Circulating Biomarkers for Minimally Invasive Diagnostics Development
Market Trends in Biofluid-based Liquid Biopsies: Deploying Circulating Biomarkers in the Clinic. Enal Razvi, Ph.D., Managing Director, Select Biosciences, Inc.
Study Questions Presence in Blood of Heart-Healthy Molecules from Fish Oil Supplements
A new study from the Perelman School of Medicine at the University of Pennsylvania questions the relevance of fish oil-derived SPMs and their purported anti-inflammatory effects in humans.
Experimental MERS Vaccine Shows Promise in Animal Studies
A two-step regimen of experimental vaccines against Middle East respiratory syndrome (MERS) prompted immune responses in mice and rhesus macaques, report National Institutes of Health scientists who designed the vaccines.
Young South African Women can Adhere to Daily PrEP Regimen as HIV Prevention
NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.
Key Player in Diabetic Kidney Disease Revealed
Discovery could lead to new and better diagnostic marker for chronic kidney disease.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Santhera Announces First Patient Dosing with Omigapil in CMD
Company announces full patient recruitment of CALLISTO study.
Study Shows Promise of Precision Medicine for Most Common Type of Lymphoma
The study appeared online July 20, 2015, in Nature Medicine.
HIV Control Through Treatment Durably Prevents Heterosexual Transmission of Virus
NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.
Adaptimmune's Novel Cancer Therapeutics Show Positive Clinical Trial Results
The company has announced that positive data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!