Building a Commercialization Strategy for Medical Benefit Therapy

This guide addresses the complexities of market access for medical benefit therapies, emphasizing the importance of early planning for pharmaceutical companies. It outlines the necessity for manufacturers to engage in market access activities well before FDA approval, ideally 12-18 months prior, to ensure coverage, distribution, and reimbursement strategies are firmly established. The document details the significance of medical policies created by payers, which dictate coverage and reimbursement based on specific treatment requirements. It also explains the pre-certification process, highlighting that 35% to 40% of medical procedures require it. The guide emphasizes tracking distribution methods, including the buy-and-bill model and the implications of white bagging and brown bagging for high-cost specialty drugs. Furthermore, it discusses the importance of educating providers about pre-certification requirements and the medical exception process, which can significantly impact access to therapies. Overall, the guide provides a comprehensive framework for navigating market access challenges in the pharmaceutical landscape.