Good clinical studies are the most important piece of data to have to present in a dossier (portfolio) to the payer. These studies are published as full-text in peer-reviewed journals, with study subjects that represent the beneficiaries covered by the payer, outcomes that show improvements in health benefits of their members and representing a large enough patient population for statistically significant and clinically meaningful outcomes. FDA regulatory approval is a must. This environment requires that a reimbursement plan be fully vetted, with clinical study and regulatory planning, so outcomes for reimbursement purposes are identified early and can be incorporated into overall planning. This strategy will accelerate time-to-market while maximizing the financial resources invested in all three development areas.
The best approach to communicating with payers is based upon an educational process, not a sales process. There is a big difference. A sales process is designed to impress, to convince a buyer that the technology is better than competing wares by presenting the features and benefits in a way that will sway the buyer to purchase. But payers are not buyers or purchasers in the usual marketplace definitions. Rather, they objectively evaluate and assess technologies based on specific criteria and within a preset framework. Approach payers to educate them about the technology, speaking from an understanding of their perspective. Payers care about significant changes in clinical outcome that are demonstrated by statistically significant, objective outcomes in clinical studies. Compare and contrast the new technology/therapy to existing treatments. Present how it is as beneficial as, or more beneficial than, existing therapies. Just stick to the facts. This educational approach begins with a clinical dossier, built on the foundation of good clinical data. The dossier presents the disease state or unmet health need as the basis for why the technology was developed. When it comes time to present your new medical device to insurers to obtain coverage, it is best that you compile a dossier which contains all the information they want to hear, not what you think they may want to hear. Include an algorithm of care, or a continuum of care, that outlines the current treatment path. Explain the technology and how this medical device or procedure fits into the treatment path. Describe the benefits for the patient, the provider, and the healthcare system in general.