Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified?

Table 3 Categories of missing data for conditional appraisals^a and PAMs

	Conditional appraisals (N = 35 categories) n ^b	PAMs (N = 54 categories) n ^b
Category
Efficacy	13	22
Safety	10	22
Effectiveness	5	2
Pharmacology	0	8
Reference to EMA^c	7	–

PAM post-authorisation measure
^a19 products with 20 conditional appraisals, 33 products with 34 EPARs
^bNumber of data requests for each category. More than one category of data request was permissible for each PAM or conditional appraisal, but each category was only counted once for each PAM or conditional appraisal
^cReference to EMA only applicable for G-BA restrictions. All other G-BA data requests (efficacy, safety, effectiveness and pharmacology) were unique to the respective appraisals and were not reflected by EMA requests

ISSN: 2191-1991