Launch planning in an ever-evolving policy and regulatory landscape
Case Study:
Strategic Launch Planning Amidst Policy and Regulatory Changes
This case study demonstrates how Magnolia Market Access supported a development-stage biopharma company in navigating the complexities of the Inflation Reduction Act (IRA) and related regulations for a multi-indication product launch.
Key highlights include:
- Challenge: Understand the IRA’s impact on product development and navigate the Medicare Drug Price Negotiation Program (MDPNP) alongside other regulations.
- Approach: Magnolia developed a comprehensive strategy addressing packaging, licensing, and pricing considerations. Key activities included:
- Unpacking federal regulations, including MDRP and NCPDP guidelines, to optimize launch planning.
- Strategizing around the 7-year MDPNP “clock” to align launch timing and evidence generation with negotiation criteria.
- Exploring innovative life cycle management approaches, such as licensing NDAs and strategic global launches.
- Outcome: The strategy enabled the company to plan effectively for regulatory complexities, maximize pricing flexibility, and mitigate future risks.
Download the case study to explore how regulatory insights can shape effective launch planning.
