Table 1 Initial judgement on the acceptability of evidence and complexity of evidence generation for each value domain in the core evaluation framework

Method of data collection

Source

Value domains

Unmet medical need

Health gain (measured by health care professionals)

Patient reported outcomes

Burden on households

Burden on health care systems

Extending treatment options in new indication with unmet medical need

Individual needs/special needs of patient (sub)population

Efficacy/ effectiveness

Patient safety and

tolerability

Patient experience related to the therapy

Adherence and Persistence

Quality of life

Patient’s economic burden

Economic and health burden on informal caregiver

Health care resource utilization, costs or efficiency

Technological improvement with logistical considerations