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

Regulatory Questions Worksheet

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