Table 1.

Determination of extent of added benefit—Ranked criteria according to the ANV plus amendments, as well as effect sizes for generation of thresholds^{a )}

		Outcome category
		All‐cause mortality	Serious (or severe) symptoms (or late complications) and adverse events	Health‐related quality of life	Nonserious (or nonsevere) symptoms (or late complications) and adverse events
Extent category	Major: sustained and great improvement in the therapy‐relevant benefit, which has not previously been achieved versus the appropriate comparator therapy	Major increase in survival time RR1 = 0.50	Long‐term freedom or extensive avoidance RR1 = 0.17	Major improvement RR1 = 0.17	Not applicable
	Considerable: marked improvement in the therapy‐relevant benefit, which has not previously been achieved versus the appropriate comparator therapy	Moderate increase in survival time RR1 = 0.83	Alleviation or relevant avoidance RR1 = 0.67	Important improvement RR1 = 0.67	Important avoidance RR1 = 0.33
	Minor: moderate and not only marginal improvement in the therapy‐relevant benefit, which has not previously been achieved versus the appropriate comparator therapy	Any increase in survival time	Any reduction	Relevant improvement	Relevant avoidance RR1 = 0.67

^aAmendments to ANV in italics.

ANV, Arzneimittel‐Nutzenbewertungsverordnung (regulation for early benefit assessment of new pharmaceuticals).