After publishing The Diagnostics Reimbursement Compass: A 90-Minute Guide to Define, Demonstrate and Capture Diagnostics Value Confidently we have also created some short “explainer” videos.
Check out: #5 – How to secure coverage
Securing coverage is a long-term strategic play. Ideally, it starts with an early access assessment, identifying the likely reimbursement setting and key stakeholders involved.
Once the key stakeholders are identified, their decision-making criteria and processes should be further explored.
The key questions leading to coverage are unmet need, disease burden, medical and laboratory benefits, value for money, budget impact, consequences of not funding and in which patient subgroups does the test have the highest impact.
A market access plan is a useful tool to discover hurdles, set reimbursement objectives, milestones and resources required. Alignment with regulatory, clinical, and commercial plans is pivotal.
Seeking early scientific advice is valuable to pressure-test key working assumptions and to validate access and clinical development plans.
When developing the clinical and economic evidence base, conference presentations and publications in scientific journals help to increase the chances of making a successful reimbursement case.
It is vital to assess if the manufacturer can directly submit a reimbursement request to the respective payers or can only play an indirect role. If it is the latter, engaging medical or laboratory associations and KOLs is important to secure the buy-in and help advocate for the test post submission. Lead time should be planned in for engagement efforts. After the submission, developers should explore potential ways to be at least partially involved in the process.
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