Xalkori-dossier evaluation by IQWiG of 15 February 2013
Pfizer contradicts the dossier evaluation for lung cancer drug Xalkori by the Institute for Quality and Efficiency (IQWiG)
IQWiG method fails in lung cancer clinical reality and leads to misinterpretation
Xalkori (Crizotinib drug) is an innovative and effective drug in the treatment of previously treated advanced ALK-positive non-small cell lung cancer (NSCLC). 1,2,3,4 Pfizer believes that Xalkori provides a significant benefit for these critically ill patients. This view is consistent with a broad consensus in oncology research and practice, according to the Xalkori is seen as a significant step forward in personalizing the treatment of NSCLC patients. 5,6,7
Pfizer has the launch of Xalkori in November 2012 when the Federal Joint Committee (G-BA) filed a request for review of the value added by § 35a SGB V. On 15 February 2013 evaluation of the dossier published by the Institute for Quality and Efficiency (IQWiG) in the benefit assessment process provides an additional benefit to the appropriate comparison therapies when not occupied. Pfizer shares this view explicitly. The evaluation by IQWiG shows that the method is not suitable in this case, neither of the special requirements for the benefit assessment of personalized cancer medicine, yet the enormous needs of lung cancer patients to new and better treatment options needs.
The assessment of the IQWiG is a decision memo for the G-BA and therefore no decision about the extent of the value added represents the decision is made by the G-BA. Pfizer will present in the now adjoining the IQWiG review opinions from the process in detail his arguments, which are mentioned among others the following aspects:
The European Medicines Agency (EMA) is the recognized experts in oncology therapeutic potential of Xalkori 5,6,7 worn under the invoice approval process. Therefore, the European Commission Xalkori issued in October 2012 a "" conditional approval "" to seriously ill cancer patients in the European Union, instant access to this innovative drug. The dossier submitted by Pfizer benefits for Xalkori is based on the same data used for the license is based. 1,2,3,4 In the Institute's methodology, in this month's review of the Xalkori dossier is based on these data, however, were only a small portion considered. The Institute's methodology is therefore in this case not in a position to reflect the specific situation of a conditional approval, and the associated immediate access of seriously ill cancer patients in an innovative therapy.
Also fails to understand is that the efficacy data on progression-free survival (progression-free survival or PFS) and objective response rate (objective response rate, ORR) were Xalkori in the IQWiG report as "" not relevant to patients "seen" and therefore not in the review have been received. This is contrary to the clinical and scientific reality in cancer. PFS Example: The life time of the cancer does not progress can for the patient to reduce the burden of disease, mean avoiding complications and hospitalization. So the EMA provides expressly in its December 2012 updated guideline for the evaluation of anti-cancer drugs (Guidelines on the evaluation of anticancer medicinal products in man) the relevance of a PFS extension for a patient benefit fest.8 Xalkori has significantly in clinical trials, the PFS extended and guided in most patients to a significant reduction of the tumor. This was, among other things, the basis for positive admission decisions and the recommendations for Xalkori in numerous international and national treatment guidelines oncological societies 1 -. 7
Pfizer will present in the now adjoining the Institute's published opinions available to the process of these and other arguments, the G-BA in detail. The company is confident that the G-BA will appreciate this argument and the special circumstance of "" conditional approval "" in his assessment of the value added of Xalkori.
Camidge R et al., Lancet Oncol. 2012, Oct, 13 (10) :1011-9.
. Kim DW, et al, ASCO 2012, Abstract 7533
Xalkori ® prescribing information, as of October 2012
ClinicalTrials.gov. An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene. Link
DGHO guideline lung carcinoma, non-small cell (NSCLC). Link
S. Peters et al. Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up † † Annals of Oncology 23 (Supplement 7): vii56 - vii64, 2012
NCCN Clinical Practice Guidelines in Oncology. Version 2.2012. Non-Small Cell Lung Cancer 2012th link
European Medicines Agency updates guideline on evaluation of anticancer medicines: Link
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