Clinical Endpoint Strategies and Deliverables
Step II Comparative Effective Endpoints: It is imperative that the manufacturer initiate clinical, market and reimbursement assessments with a strategic plan of action regarding positive coverage, coding, and reimbursement early in the product development cycle. I.e. Phase II or Phase III.
Reimbursement Strategies can guide you in what clinical and economic endpoints are important to payers. Clinical-effectiveness and cost-effectiveness must now, more than ever be justified in order to compete successfully to acquire appropriate coverage and reimbursement. Most insurers will focus on patient and economic outcomes.
Comparison of several medical or surgical modalities
- Which treatment is best? For what population? Age? Gender?
- What works in clinical practice
- Will this technique solve health care issue? Will further surgery be necessary?
- Will utilization of this technique reduce need for other treatment modalities? E.g. drugs, surgical interventions?
- If expensive, what are costs in comparison to other treatments?
- Over time, will economic impact justify price to the patient, insurer and health care system?
By including and providing this information in the clinical trial and peer-reviewed literature can decrease insurer questions and potentially increases patient access in a more judicious timeframe. Our firm can help establish an environment conducive to the adoption of your technology in the marketplace.