Case Study – Preparing a Biopharmaceutical Manufacturer to Launch a Drug into Federal Healthcare Programs

The Client Need

A small, investor-funded biopharmaceutical company with no commercial products was preparing for the launch of a pipeline drug in two years’ time. The company was uncertain of the steps to take to ensure appropriate coding, coverage, and reimbursement to successfully commercialize its drug in federal healthcare programs. The product also had unique characteristics that had the potential to address a critical public health need in Medicare.

K+A’s Solution

To ensure provision of a comprehensive approach to launch, we conducted a landscape assessment of federal healthcare program coding, coverage, and reimbursement parameters of relevance to the product. We provided the client with a detailed education on Medicare, Medicaid, 340B and VA/DoD programs, including recommendations of the actions the client should take to become a participant in those programs and a timeline of key deadlines before and after the launch of the product. We also assisted the client in considering mechanisms for outsourcing its price reporting functions and served as a liaison with the federal government on key launch issues.

To assist the company in considering potential opportunities for the product at launch given its unique characteristics, we conducted a full-scale assessment of the public health needs and initiatives of relevance in Medicare and provided the client with strategies for best positioning its product for success.

We provided ongoing health policy and reimbursement counseling as the launch approached to ensure the client remained apprised of developments that posed an impact on its strategy.

The Outcome

The client obtained knowledge that was shared across the company in ensuring strong understanding of federal programs, which enabled the company to make critical business decisions to prepare for its participation in advance of launch. The client also gained an understanding of the potential coverage and reimbursement challenges and opportunities for the product and mechanisms for advocating for its priorities in addressing a public health need in these programs.