News In Germany – GBA finalizes additional benefit assessment of GSK’s Tafinlar

For GlaxoSmithKline’s Tafinlar (dabrafenib) the assessment was completed and the final resolution published on 3rd April 2014. Tafinlar received a “no additional benefit” rating in the assessment. This means that the drug will either be assigned to a reference price group (“Festbetragsgruppe”) which is effectively a price cap on the basis of the average price in the group.

If an assignment to a reference price group is not possible for lack of a sufficient number of comparable medicines Tafinlar will enter price negotiations with the payer groups (GKV-SV). However, by law in these negotiations there will be a price cap at the price level of the drug’s comparator therapy. Remarkably, in the case of Tafinlar two different comparator therapies have been taken into account in the GBA’s assessment.

During the first stage of the assessment Dacarbazine had been determined by the GBA as the appropriate comparator. Upon the hearing following the first stage of the assessment, GBA decided to change the comparator, naming Vemurafenib for the second stage of the assessment.

However, according to GBA Tafinlar did not show an additional benefit towards any of the two comparators used. In the price negotiations, the price cap will be determined on the basis of the more economical of the two comparators.

Tafinlar has been approved since August 2013 for the treatment of advanced melanoma. The drug is an option for adult patients with melanoma that has a certain abnormal protein (BRAF V600 mutation) and that is unresectable or has already formed metastases.

The GBA’s final resolution on Tafinlar can be found here (German only): https://www.g-ba.de/downloads/40-268-2758/2014-04-03_AM-RL-XII_Dabrafenib_2013-10-01-D-076_TrG.pdf.

Published 2. April 2014 in News Germany