Table 2.

Results of univariate beta regression models for ΔP

	No. of therapeutic indications	Mean ΔP (SE)		β coefficient (SE)		p-value
Overall	48	− 26.0%	(− 15.1%)
ICER before negotiation
≤ 25,000€ per QALY	11	− 16.8%	(− 27.5%)	Ref.
> 25,000 to < 40,000€ per QALY	11	− 21.5%	(− 26.0%)	0.302	(0.369)	0.413
≥ 40,000€ per QALY	26	− 30.1%	(− 15.9%)	0.757	(0.311)	0.015
Orphan designation
No	31	− 23.4%	(− 16.4%)	Ref.
Yes	17	− 27.9%	(− 20.9%)	0.236	(0.256)	0.361
Therapeutic indications
First indication	22	− 29.6%	(− 17.8%)	Ref.
Additional indications	26	− 21.1%	(− 17.9%)	− 0.454	(0.245)	0.064
Innovativeness status
Not innovative	26	− 23.1%	(− 17.9%)	Ref.
Full or conditional	22	− 27.3%	(− 18.5%)	0.223	(0.249)	0.370
Onco-immunological products
No	11	− 15.7	(− 28.0%)	Ref.
Yes	37	− 27.9%	(− 13.8%)	0.729	(0.303)	0.016
Advanced therapies
No	43	− 24.3%	(− 14.1%)	Ref.
Yes	5	NS		0.331	(0.395)	0.402
Expected expenditure (€)
< 50 million	27	− 22.0%	(− 17.5%)	Ref.
50 to < 200 million	17	− 26.9%	(− 20.7%)	0.265	(0.262)	0.312
≥ 200 million	4	NS		0.739	(0.433)	0.088
Potentially eligible patients
≥ 1200 patients	20	− 19.3%	(− 20.5%)	Ref.
< 1200 patients	28	− 29.1%	(− 15.8%)	0.538	(0.250)	0.031
Disease severity
Less severe	41	− 23.9%	(− 14.4%)	Ref.
More severe	7	NS		0.362	(0.342)	0.289
Monitoring registry
No	11	− 26.4%	(− 14.6%)	Ref.
Yes	37	− 20.4%	(− 27.4%)	0.335	(0.302)	0.267
Outcome-based MEA
No	44	− 24.3%	(− 13.9%)	Ref.
Yes	4	NS		0.404	(0.433)	0.351

ΔP outcome of price negotiation, ICER incremental cost-effectiveness ratio, MEA managed-entry agreements, NS not showed; cells with a frequency lower than 10 are blanked out due to confidentiality, QALY quality-adjusted life years