Table 2.
List of different Stakeholder groups increasingly involved in the appraisal stage of HTA with dedicated contribution, special needs (to understand and capture a drug's mechanism, effect, role, or impact) and example of how mechanistic modeling can help to address this need and fill persistent gaps.
| Stakeholder group | Contribution to HTA | Needs | Role of mechanistic models for increasing stakeholder involvement |
|---|---|---|---|
| Individual patients or disease-specific citizen and/or patient organizations/associations or caregiver and family member groups | First-hand experiential knowledge of living with a particular health condition; experience with the health technology under assessment, or currently available technologies, the use of associated health services, and associated benefits, risks, and side effects | Needs to understand the impact of a new MP on personal and individual health status, personal risks, and benefits | Establish plausibility and interactivity of clinical decision-making Highlight potential individual consequences from clinical decision making Highlight individual patient contribution to outcomes (e.g., compliance) |
| Citizen and health system user organizations not specific to any condition or disease. Public in general | May lack knowledge about disease or health technology in question but can assess transparency, legitimacy, and fairness in decision making (61) | Needs to understand reasoning in the decision-making process | Establish plausibility and interactivity of the policy decision-making |
| Healthcare professionals Organizations of healthcare professionals | Gather expertise on clinical aspects regarding: the disease/condition; medical needs; available therapies; the technology under assessment | Needs to be convinced about the new health technology being the best therapeutic approach to be delivered to a patient. | Provide clinically relevant scenarios of HT impact on outcomes, among other comparator approaches |
| Identify clinically relevant patient population (and/or subgroups), comparators, thresholds for improvement | Needs to decide, diagnose, or prescribe based on large and complex scientific knowledge | Provide a comprehensive view of all the available scientific knowledge | |
| Gather information on clinically relevant outcomes including possible neglected outcomes | |||
| Gaining further information on the importance of outcomes from a healthcare professional point of view (62) | |||
| Policymakers | Can judge the expected benefit for healthcare on a national or regional level given the specific political background (63) | Need to estimate a new treatment impact on a national or regional level | Provide trustworthy estimation of a new treatment benefit on a specific population where little data is available |
| Payers | Contribute expertise on reimbursement/coverage decisions Can highlight specific national or regional economic background |
Need to estimate a new treatment impact on a national or regional level | Provide trustworthy estimation of a new treatment benefit on a specific population where little data is available |
| Companies and associations producing health technologies | Technology manufacturers can take part (as peers) in all discussions and meetings about contributed data to clarify concerns and provide additional information to support coverage of their products (64). | Needs to understand and rationalize questions and concerns vs. specific available data | Show how technology manufacturer's data fits into the overall evidence Highlight technology and product specific properties with respect to reference |
| Academics | Provide cross-disciplinary scientific feedback from public health, economics, ethics, and social sciences | Needs to understand the bigger picture of HT | Provide information for other models and assessments |