R&D Planning / Evidence Exploration

Decision Context

This service supports decisions about what evidence to generate, when to generate it, and how it will be used to support downstream market access, reimbursement, policy and commercial outcomes.

Early R&D and evidence decisions have long-term consequences. Choices made at this stage can either enable or constrain future PBAC, MSAC, Prescribed List and policy funding pathways.

Our Role

Pulse Economics works with pharmaceutical, biotech, medtech and diagnostics organisations to design forward-looking R&D and evidence strategies that are explicitly aligned to future decision requirements.

Our advice is grounded in first-hand PBAC and MSAC evaluation experience, giving us a clear view of how early evidence choices are later interrogated, stress-tested and challenged.

We help clients move beyond “what data can we generate?” to the more important question:
“What evidence will decision-makers ultimately need?”

What We Deliver in Practice

Our R&D planning and evidence exploration support includes:

HTA-aligned evidence gap assessments
Strategic advice on clinical development pathways and endpoints
Early health economic and value framework development
Evidence exploration to inform comparator selection and positioning
Burden of disease, resource use and outcomes scoping
Advice on integrating clinical, economic and real-world evidence plans

All work is tailored to product maturity, indication, funding pathway and uncertainty profile.

Our Approach

Our approach to R&D planning and evidence strategy is:

Evaluator-informed — shaped by experience assessing how early evidence decisions play out at PBAC and MSAC
Decision-led — focused on future reimbursement, funding and policy decisions, not just development milestones
Integrated — aligning clinical, economic and policy considerations from the outset
Pragmatic — recognising uncertainty, constraints and real-world development trade-offs

We focus on evidence that is decision-enabling, rather than technically impressive but strategically misaligned.

Managing Uncertainty Early

Early development is characterised by uncertainty — around clinical outcomes, comparators, endpoints, pricing and payer expectations.

We help clients:

Identify which uncertainties matter most for future decisions
Prioritise evidence generation where it will have the greatest impact
Avoid unnecessary data collection that does not change decision outcomes
Design flexible strategies that can adapt as evidence evolves

This ensures R&D investment is efficient, defensible and strategically aligned.

Where This Service Applies

This service is particularly valuable during:

Early development and feasibility assessment
Pre-clinical to Phase I/II planning
Early engagement with HTA and policy stakeholders
Portfolio and indication prioritisation decisions

We work with both early-stage innovators and established organisations, tailoring our advice accordingly.

Where This Service Applies

Study co-design: We help you plan your evidence generation activities to effectively launch your new medtech product and/or service.

Systematic and Targeted Literature Reviews: We meticulously review and synthesise published and grey literature to gather robust evidence, highlighting critical findings and knowledge gaps.

Epidemiological and Burden of Illness Studies: Our experts delve into epidemiological data to understand disease prevalence, incidence, and socioeconomic burden.

Utilisation Patterns: We analyse therapy utilisation trends to identify opportunities and challenges in the market.

Real-World Evidence Assessments: Leveraging real-world data, we assess the effectiveness and safety of therapies in actual clinical practice.

Utility Studies: We conduct utility studies to quantify the impact of interventions on patients’ quality of life, a crucial element in health economic modeling.

Clinician Surveys and Interviews, plus Advisory Boards: We conduct meticulously designed surveys and interviews that provide qualitative insights into disease management, treatment pathways, resource use and the real-world impact of therapies.