Outline Regulatory and Clinical Reimbursement
Why is this Important? You have to understand what regulatory approvals you will need and how that will impact payment from payers, providers, and patients.
| Key Actions | Things to Consider | Tool Kit |
|---|---|---|
| Find professional consultants with relevant clinical & regulatory expertise | Find a consultant with domain expertise (e.g. oncology, inflammation, infectious disease, etc.) | |
| Outline initial indications for use for the TPP | Expanded indications may require additional expensive and/or lengthy clinical trials to establish safety & efficacy | |
| Outline regulatory requirements and action plan | Seek multiple opinions on clinical development and regulatory strategy
Consider holding a FDA pre-IND meeting to clarify pathway |
FDA Guidance Documents |
| Outline clinical trials required and timing | What evidence will be needed for FDA and European Medical Agency (EMA) approval and/or reimbursement? | |
| Formulate preliminary post-approval pricing strategy | How are similar products priced and reimbursed?
Keep in mind your value proposition as it relates to pricing. |
LSWI Health Economics Consultation |