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Table 1 The core evaluation framework for value-added medicines

From: Development of a core evaluation framework of value-added medicines: report 1 on methodology and findings

Cluster name Domain name Definition
Unmet medical need Extending treatment options in new indication with unmet medical need Reduction of the unmet medical need for patients in a new indication due to additional therapeutical value
Individual needs/special needs of patient (sub)population Reduction of the unmet medical need in patients with special needs in the original indication (e.g., treatment resistant patients, vulnerable patients, etc.)
Health gain (measured by health care professionals) Efficacy/Effectiveness Improved clinical outcomes of a pharmaceutical treatment (e.g., extending survival, stabilizing disease, improving treatment response, etc.) in trial and real-world settings
Patient safety and tolerability Improved safety and/or tolerability of the pharmaceutical treatment
Patient Reported Outcomes Patient experience related to the therapy Improved patient's satisfaction, acceptance, convenience with the pharmaceutical therapy
Adherence and persistence Improved adherence and/or persistence of patients with the prescription guidelines (including duration, timing, dosage and frequency of medication use)
Quality of life Improved health-related quality of life reported by patients
Burden on households Patient's economic burden Improved productivity of patients and/or reduced health and non-health care resource use (such as travel time) covered by patients
Economic and health burden on informal caregiver Improved quality of life of family caregivers and/or reduced financial or non-financial burden on households
Burden on health care system Health care resource utilization, costs or efficiency Reduced utilization of health care cost and/or resources
Technological improvement with logistical considerations Improved stability and/or shelf life of pharmaceuticals through technological improvement
  1. VAM value-added medicine