Table 2

Major themes and subthemes extracted from the included literature

Major themesSubthemes
AffordabilityPayer's budget
Therapy cost/price
Therapy payment/reimbursement
Assessment of valueCriteria
Non-patient related health benefit
Patient-related health benefits
Development of therapyIntellectual property
Manufacturing
Non-clinical
Positioning
Resources
Ethical/social factorsPatient's convictions
Patient's perception
Socioeconomical
Evidence generationTrial design
Trial conduct
Trial outcomes
Postauthorisation
Operational implementationInfrastructures
Patient burden
Healthcare professionals
Regulatory hurdlesMarketing authorisation application process
Quality standards
Pricing regulations
Parallel access