TABLE 1.

Cross comparison of the empirical and theoretical reimbursement decision-making criteria

Empirical assessment through a closed-ended survey among four stakeholder groups						Theoretical assessment as defined in the current official reimbursement legislation
Reimbursement decision-making criterion	Medical professionals (n=10)	Patients (n=10)	Health authorities (n=10)	Industry (n=10)	Overall agreement percentage (median)	Reimbursement decision-making criterion	Weight (actual points given)
Reimbursement criteria of 80% and more overall agreement
Health benefits	100%	90%	100%	100%	100%	Clinical effectiveness	45
Efficacy/effectiveness	100%	70%	100%	90%	95%	Clinical effectiveness	45
Strength of evidence	100%	70%	80%	100%	90%	Currently not considered	n/a
Population effect	90%	70%	90%	80%	85%	Public health effect	20
Safety	80%	70%	80%	90%	80%	Safety	30
Individual effect	80%	90%	80%	70%	80%	Clinical effectiveness	45
Disease burden	90%	60%	70%	100%	80%	Currently not considered	n/a
Treatment alternatives	80%	80%	80%	100%	80%	Therapeutic alternative	20
Need	70%	80%	80%	100%	80%	Currently not considered	n/a
Budget impact	90%	40%	70%	100%	80%	Pharmacoeconomics	40
Reimbursement criteria of 90% and more agreement in at least one of the stakeholder groups
Life-saving	80%	90%	70%	70%	75%	Currently not considered	n/a
Cost-effectiveness	100%	40%	80%	70%	75%	Pharmacoeconomics	40
Clinical guidelines and practices	90%	70%	70%	60%	70%	Currently not considered	n/a
Access	70%	70%	90%	60%	70%	Currently not considered	n/a
Disease severity	60%	30%	90%	30%	45%	Currently not considered	n/a

n/a: not applicable