Manufacturers of biopharmaceutical products and medical devices understand that the regulatory approval of their product will bring postmarketing challenges, requiring strategic and innovative solutions for continued surveillance of product safety and for demonstrating value and effectiveness based on real world evidence.
It is important that such evidence requirements are well understood and a strategic evidence gathering plan is in place even before product approval. UBC has compiled a list of reasons to begin planning pre-marketing and to conduct postmarketing research with the aim of demonstrating product value.
1. Disease natural history: Understand the characteristics of patients with the disease before product approval and evaluate the impact of a product in the overall treatment regimen once marketed.
2. Health services research: Understand the impact that health systems, plans, and provider organizations have on the delivery and outcomes of healthcare. Research payer priorities and address in studies.
3. Real-world effectiveness: Observe and document real world effectiveness in contrast to the efficacy measures documented in clinical trials.
4. Comparative effectiveness: Determine how a new product compares with the current “standard of care,” or with other competitors’ products in clinical practice.
5. Patient-reported outcomes: Evaluate patient (and/or caregiver) reported outcomes to inform or support market access, including health-related quality of life, impact of disease and treatment, satisfaction with treatment, and adherence.
6. Cost of care implications: Collect resource utilization and other relevant data to quantify the burden of illness and economic impact of disease and recognize how savings may be realized through alternative therapies. Measure and assess the differential economic impact of a novel product versus an alternative intervention or other healthcare service.
7. Prescriber and patient preferences: Identify the decision-making process related to reasons why prescribers and/or patients prefer certain treatment characteristics and why patients adhere (or not!) to prescribed medications.
8. Safety: Gather data on the adverse effects of a product versus other standard of care treatments as they are used in real-world populations.
9. Disease and patient heterogeneity: Understand how conditions, including orphan diseases, vary in terms of presentation and progression over time. Patients treated in actual clinical practice are considerably more varied than those included in clinical trials.
10. Longitudinal outcomes: Increase the duration of follow-up to better understand effectiveness and safety, cost, and patient-reported outcomes or to evaluate outcomes with long latency.
Planning can begin as soon as late Phase II or the beginning of Phase III to document disease natural history and the impact of the current standard of care and to understand payer priorities.
Interested in learning more about how postmarketing research can help document the ongoing value of your product? Contact us.
