France versus Germany: differences and similarities in determining the added therapeutic value of medicines

Although Germany and France implement ordinal scaling when assessing medicines and follow a relative effectiveness approach, there are procedural and methodological differences. All G-BA and HAS decisions from 2011 to March 2023 were compared after assigning corresponding subgroups to harmonized added benefit categories. Descriptive statistics and dichotomous and ordinal agreement analyses by (weighted) Cohen’s Kappa were performed for procedures and subgroups. Logistic regression was calculated to identify explanatory variables for (dis-)agreement. 475 G-BA and 465 HAS identified decisions led to 907 considered subgroup-pairs. G-BA granted an added benefit in 59% of procedures (39% subgroups) and HAS in 43% (48% subgroups). Mean time difference of decisions depending on therapeutic area varied strongly between both countries (-337–318 days). In 37% of subgroups comparators were identical. Overall (p < 0.001) and for some therapeutic areas, statistically significant differences in added benefit between G-BA and HAS revealed. Dichotomous agreement was slight for procedures (subgroups slight) and increased after excluding orphan drugs to moderate (subgroups fair). Subgroups had a fair ordinal agreement (unweighted kappa 0.370, 0.317–0.423) that increased after weighting to moderate (linear: 0.438, 0.387–0.490; quadratic: 0.507, 0.417–0.597). Some subgroups reached substantial agreement. In the regression models orphan designation showed a strong impact for Germany and PFS for France. Though the HTA systems of both countries appear similar, differences emerged regarding added therapeutic value of medicines. This is reflected in the agreement results. Differences in methods and processes led even to different evaluations of the same evidence.