A Comparison of G-BA’s additional benefit score to NICE ICERs


      G-BA and NICE are two influential HTA agencies: both are large markets for pharmaceuticals, many countries look to Germany for reference pricing, and NICE decisions are referenced in other agencies’ assessments. Both agencies review clinical efficacy versus a comparator. NICE also evaluates the cost-effectiveness. The output of a G-BA review is the “additional benefit” score, while for NICE it is an incremental cost-effectiveness ratio (ICER). Because both outcomes are dependent on the clinical evaluation, we hypothesize that G-BA’s additional benefit score and NICE’s ICER is inversely related. The relationship between NICE and G-BA is useful for manufacturers trying to predict reimbursement in these markets and globally. Our objective is to examine how G-BA’s additional benefit decision correlates to NICE’s reimbursement decision and to the most probable incremental cost-effectiveness ratio (ICER).


      G-BA assessments were matched to NICE final guidances. G-BA’s additional benefit was extracted and compared to the NICE reimbursement decision (categorized as positive or negative) and the ERG’s most probable ICER. In instances where there were multiple ICERs reported (e.g. due to different comparators), the lowest ICER was used. If a drug “dominated” the comparator, an ICER of 0 was used.


      138 G-BA additional benefit decisions were compared to 34 NICE final guidelines. 56% the G-BA assessments resulted in a “no additional benefit” score and the second most prevalent score was “minor additional benefit” (20%). 82% of NICE decisions were positive. There was no difference in the distribution of additional benefit scores by NICE decision. There was not a strong correlation between additional benefit and the ICER (r=0.09).


      There does not appear to be a trend for G-BA to issue better additional benefits to drugs with a positive NICE decision and for drugs with a better additional benefit decision to have a lower ICER.