Table 2.

Example scenario of the trade-off exercise

Example scenario	Product K	Product L	Product M
Origin of FVIII	Plasma-free/recombinant (FVIII made completely in a laboratory with DNA technology)	FVIII made from human blood plasma	Plasma-free/recombinant (FVIII made completely in a laboratory with DNA technology)
Storage flexibility (temperature)	Can be stored anywhere outside the refrigerator at ≤30°C	Can be stored anywhere outside the refrigerator at ≤30°C	Needs to be stored in the refrigerator at 2°C–8°C (~10 min until it reaches room temperature before you can inject it)
Storage flexibility (shelf life)	≤12 months	≤6 months
Reconstitution device (mixing FVIII powder with solvent)	Mix FVIII powder with a solvent in a prefilled syringe. The syringe is connected with the vial containing FVIII	Mix FVIII with two connected vials. One vial contains FVIII powder, and the other contains solvent. Then, take the mixed factor in a syringe connected with the vials	FVIII in a prefilled syringe with both powder and solvent enclosed in separate chambers of the same syringe
Stability outside the refrigerator after mixing (in case of unexpected interruptions)	4 hours	3 hours	2 hours
Frequency of administration in prophylaxis	2×/week	3×/week	3×/week

Notes:

Question as framed to responders: “Please imagine that your FVIII product is no longer available. Your doctor presents and recommends three alternative products that are approved for the treatment of hemophilia A. Both efficacy and safety are absolutely identical and comparable with the product you currently use. All three products can be used for prophylaxis (on a regular basis) or on-demand (only occasionally as needed, depending on expected activity level or to treat bleeds)”

Abbreviations: DNA, deoxyribonucleic acid; FVIII, factor VIII.