Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases

Table 1 Inclusion vs exclusion of EBAs by therapeutic area

Therapeutic area	EBAs (n)	Assessments in analysis set (n)		Main reason for EBAs not being evaluable^a
Therapeutic area	EBAs (n)	Included	Excluded	No dossier submitted	Data on PEP acceptance by G-BA not evaluable	Newer assessment available (same medicine and indication)
Oncological diseases	47	36	11	2	6	3
Metabolic diseases	34	15	19	3	14	2
Infectious diseases	16	14	2	0	2	0
Total	97	65	32	5	22	5

^aEBAs were excluded from the analysis when no dossier was submitted by the PM, a newer assessment was available (same medicine and indication) or the G-BA’s viewpoint on the patient relevance of the PEP could not be discerned (due to incomplete dossiers or studies, use of inappropriate comparators, or inadequate indirect comparisons)
EBA Early benefit assessment, G-BA Federal Joint Committee, n Number of EBAs, PEP Primary endpoint, PM Pharmaceutical manufacturer

ISSN: 1472-6963