| Cluster | Core considerations |
| Stakeholders and target mapping | Landscape assessment (Payer-mix) Are healthcare costs primarily financed/covered by public or private entities and who specifically are the payers? Can be insurances, single-payers (e.g. government), patients (out-of-pocket). |
| Stakeholder decision drivers | Priorities/awareness Are the political climate and economy stable? Which populations/disorders have been given priority status (e.g. minorities, age brackets, disease rarity, severity, EoL stages, etc.)? Are price moratoria in place and might there be funding delays (reimbursement)? |
| Exclusivity/affordability What is overall cost of the disease? Will step or incremental cost-increase be required to cover new intervention for indication/target population? Step increases considerably higher hurdle. Do new interventions fit into overall budget; which are the competing budgets of one entity; are existing alternatives already covered by budgets of different entity? Which buying mechanisms/arrangements exist in the market? E.g. for hospitals/buying consortia: bundled payments, exclusive basket of drugs per manufacturer, etc. | |
| Need/preferences (value-fit) Does intervention provide step improvement regarding (cost-)effectiveness?—Increasingly required for branded products; downward price pressures compelling payers to prefer generics. Is it possible to demonstrate short- and/or long-term benefit/ROI for payer? Are payers requiring milestone-based reimbursement/payment models for e.g. novel staged interventions, such as genetic therapies? Which are the most meaningful efficacy and cost data points overall? Post-launch: effectiveness data sourced in phase 4 clinical trials. What are the incremental costs for specific levels of effectiveness? | |
| HTA/formulary status/reimbursement (decision-points) As HTA is key to formulary listing and pricing/reimbursement level: which are essential cost-effectiveness data, is the payer perspective (society, health system), and are the parameters/weightings used in market. Which is the likely formulary status (outcome of HTA) and thus reimbursement level? Are complementary products/services, e.g. companion diagnostics, covered, too? How might the regulatory label impact on HTA? E.g. indication, target population, dosing, etc. Has the formulary status been “pre-negotiated” by previous HTAs?—Will determine data requirements. Has variation across countries/jurisdictions been taken into account?—E.g. evidence requirements, reimbursement levels, forecasting worst/best case Which impact might patient advocacy groups have on payers and prices? Use similar technologies for HTA if no direct comparator exists (if applicable, also those already introduced in other specialties). | |
| Stakeholder engagement | Relationships Has a relationship with payers been established and if so, how good is the relationship? |