SIVC stage	Theme	Considerations	Stakeholders involved
U/A	Unmet need	Elicit awareness and literacy of stakeholders with disease/treatment spectrum, and coping mechanisms to identify (in particular with leaders in the field and societies) gaps in pre-existing knowledge and current disease management—can include both clinical and non-clinical aspects.	Patients; Providers; NRAs; Payers
	Advocacy (agenda setting)	Determine which individuals and groups (e.g. medical review boards, policymakers, associations, societies) will support/oppose a new intervention, which value they seek, and the impact they will likely have on initial agenda-/priority-setting of other stakeholders/decision-makers—to gauge intervention potential and improve stakeholder utility.	Patient groups; Providers (+thought leaders and societies)
	Priorities	Determine priorities to, if possible, focus development on interventions that will more likely receive (expedited) marketing authorisation and market access: e.g. rare, severe, costly disease; no current or costly treatment.	NRAs; Payers
O	Disease and cost burden	Assess the overall/incremental burden and cost of the target disease for health systems—cost of treatment/no treatment—to gauge the potential of the market for proposed intervention. Cost feeds into evidence requirements (market access).
	Stratification	Identify, quantify and stratify stakeholders to determine intervention market potential, key value targets and sources/recipients of market intelligence. Criteria include: ‒ Patients: diagnosis, geographic location, and demographic and socioeconomic status (e.g. price sensitivity) ‒ Providers: leader in the field, decision-maker at decision interfaces, volume of patients/sales and experience, distribution across the market ‒ NRAs: institution(s) involved in regulation, their remits and jurisdictions ‒ Payers: type (public/private) and size, location, risk-pools ‒ Competitors: products, therapeutic area, market share	Patients; Providers; NRAs; Payers; Competitors
	Preferences	Identify stakeholder intervention preferences, align TPPs with stakeholder value accordingly, and co-develop and trial new interventions (primarily with leaders in the field) to further improve value and utility for stakeholders.	Patients; Providers; NRAs
	Advocacy (market introduction)	Determining which individuals and groups (e.g. payers, providers and patients) will support or oppose a new intervention, and the impact they will likely have on market introduction and on uptake—to address barriers and improve market introduction prospects.	Patient groups; Providers (in particular thought leaders and societies)
	Market exclusivity	Establish if development is first to market and which developments are or might be in competitor pipelines (now, in future). If not first to market, determine competitor sales volumes per product (or combinations thereof), and the implications for own development activities.	Competitors
	IP landscape	Determine potential competitors’ degree of IP protection and if market has and enforces protection policies to evaluate the overall feasibility of protecting IP and financial rewards, and if so, which strategy is most promising/adequate.	Competitors
D/P	Evidence requirements	Identify which safety and efficacy data are required for marketing authorisation (market introduction approval and post marketing data monitoring commitments), and which cost-effectiveness data and types of analyses are required for market access (formulary listing and reimbursement approval)—to reduce delays and prevent rejection of pertinent applications. In addition, conceive various approval scenarios and their impact on uptake to assess which quantity of data (and level of resources) is needed per scenario/for more favourable decisions.	NRAs (marketing authorisation); Payers (market access)
	Decision interfaces	Map journey of patients through health system to determine their decision points (and share of decision-making with providers) and thereby the appropriate placement and maximum stakeholder value of interventions.	Patients; Providers
	Communication and positioning	Identify concerns and information (evidence) needs, as well as the types of language and communication-style/presentation that resonate with stakeholders to align engagement (communication and positioning) strategies with stakeholder value. Concomitantly, assess competitor positionings.	Patients; Providers; Competitors
	Early/late adopters	Identify early and late adopters to determine who will (a) rapidly adopt and utilise intervention and (b) stabilise utilisation over time—both can have different information needs.	Providers
F	User experience	Elicit (dis-)advantages of (new) intervention and potentially existing alternatives to fine-tune product (development), positioning, engagement strategies and maximise user value.	Patients; Providers