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Vandetanib in thyroid cancer: No proof of added benefit
Date:11/9/2012

whom the course of the disease was not "aggressive and symptomatic" were also enrolled. This applied to a total of about 44% of the study participants. This means that the study population - in contrast to the statements made by the manufacturer - was much wider than just the approval population. A benefit assessment pursuant to AMNOG should, however, only be undertaken for patients for whom the drug is actually approved. But the analysis of the study presented by the manufacturer did not allow for this.

Separate analysis would have been possible

The pharmaceutical company did not provide a separate analysis of the data with regard to patient-relevant outcomes (mortality, morbidity, quality of life) for patients treated in accordance with the approval status. However, comments of the EMA from the approval process prove that this group of patients is clearly distinguishable within the study and therefore the company could have presented a separate analysis for the benefit assessment.

The incompleteness of the dossier does not allow a reliable assessment of the new drug. An added benefit of vandetanib compared with "best supportive care" is therefore not proven.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure, which provides further information and can result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.


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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
0049-221-356-856
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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