A manufacturer with a unique product that appeared to be a drug-device partnered with the GIRS Value Discovery Landscape Assessments® team to develop US market access strategies. The manufacturer contracted with GIRS to determine the appropriate coding, coverage, payment, payer-desired clinical outcomes and marketing strategies. They also needed to determine whether their drug-device product would be reimbursed under the pharmacy or medical benefit.
Our Value Discovery Landscape Assessments® team developed integrated reimbursement strategies that created the foundation strategies for the follow areas for this unique product:
- Coding, coverage and payment
- Payer market strategies
- Payer-desired clinical outcomes and study design
- Marketing
- Sales
This unique technology could potentially help 35% of the US population with an immune related disorder. It had no direct competitor products, and the only competition was from over-the-counter (OTC) and prescription drugs. To perform this extensive work, the GIRS Value Discovery Landscape Assessments® team included certified coders, senior reimbursement specialists, a Medicare Part D policy consultant, a reimbursement lawyer and current medical directors from the GIRS Technical Expert Panel (TEP). The TEP included:
- All lines of business – commercial, Medicare Advantage, and Medicaid managed care
- Pharmacy Benefit Managers (PBM) and Health Plans, with sizes ranging from 735,000 – 22+million covered lives
- A geographic reach which spanned nationwide
Our team developed effective coding, coverage and payment strategies for the device for the Medicare and commercial payer markets. We also were able to identify payer-desired criteria for coverage, a payer-desired study design and dossier, and we verified with payer input that using the NDC number under the pharmacy benefit would be the most appropriate for this product to be covered and paid.
We also found that this novel technology would not qualify to be covered under the Medicare Part D plans because it does not meet the FDA definition of a drug. Based upon this, we recommended working with private payers on the coding, coverage and formulary placement. The Client was provided with an appropriate pricing range for the product and now understands how to get favorable formulary placement for this and future products. Most of all, we were able to introduce this unique technology to private insurers, therefore opening the door to future discussions.
Our Client is now equipped to develop sound marketing, reimbursement and clinical outcomes strategies for market uptake.
Are you looking for market access strategies for your novel product? Are you struggling to overcome coverage and payment barriers? Contact us and we can strategize the best plan for your medical technology!