Abstract
Abstract
Background
Although Germany and France implement ordinal scaling when assessing medicines and follow a relative effectiveness approach, there are procedural and methodological differences.
Methods
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.
Results
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
Conclusion
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.