In an interview I did with Clinica in the UK (which they turned into an article "Device Reimbursement: Plan Early, Says US Compliance Consultant"), I made the case that firms need to incorporate reimbursement evaluation and assessments as early as possible, preferably toward the end of the preclinical stage.
Some points from the article:
- The sooner you can evaluate reimbursement potential, the better your return on investment in clinical trials
- Try to build a reimbursement evaluation into the stage gate review process for moving a new medicine from preclinical to clinical
- Early reimbursement evaluation allows you to determine what potential customers (prospective patients, physicians, hospital administrators, etc.) will need to see when it comes to efficacy and safety claims
- Early reimbursement evaluation gives you the time to better shape your marketing messages to different customers
- Early reimbursement offers you the chance to set better cost controls for production and the rest of development; it will hardly benefit you as the company if you are making a product that costs you more than you will earn back in reimbursement
Key tactics to help incorporate reimbursement planning early in development include stage gates, regulatory affairs road-mapping, and clinical regulatory strategic plans, all of which I discuss in detail in my forthcoming book, Get to Market Now!
Bringing in reimbursement considerations as early as possible in development help demonstrate an integrated, holistic compliance and development strategy - and show how compliance departments such as regulatory affairs and quality management drive value to a company's bottom line. And that's what I call Lean Compliance.
Are you ready?