A Multinational Pharma Targeting Myasthenia Gravis Garners Payer Advice on Market Access

Client Challenge

A multinational pharmaceutical company was evaluating an investigational asset for the treatment of myasthenia gravis (MG). The client’s goal was to launch in the United States (US), France, Germany, Italy, and Spain (EU4), and the United Kingdom (UK). Price erosion risk added complexity to the project, since the client anticipated launching the same asset for multiple sclerosis (MS) one year prior to the MG indication launch.

In preparation for submitting the Phase III protocol for MG to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the client sought support to incorporate early payer advice on the MG clinical trial design, identify evidence gaps, and provide insights on the overall development program for the asset. The client also sought recommendations to strengthen the perceived value of the product for MG use and the implications for coverage decisions in the US and future benefit assessments in the EU4 and the UK.

Our Approach

To provide perspectives from the target markets, including varied US payer types, Alira Health’s Market Access team proposed to focus on working with payer experts.

After aligning with the client’s cross-functional global team on the project objectives and plan, Alira Health carefully selected payer experts from the different geographies, including a Pharmacy Benefit Manager (PBM) and a Managed Care Organization (MCO) in the US and national and regional payer experts in the EU4 and the UK.

In the US, PBMs work on behalf of insurers to negotiate with drug manufacturers and create and maintain formularies of covered drugs. To optimize formulary placement and ensure optimal drug pricing patient access through effective management of pharmacy benefits and utilization controls, the team found it crucial to include a PBM’s perspective.

MCOs play a significant role in determining which drugs are reimbursed in the US and included in formularies. The criteria for these decisions include clinical effectiveness, health resource utilization, and overall value to the enrolled population. Therefore, an MCO’s perspective was also vital.

Alira Health’s Market Access team carefully crafted in-depth market-specific interviews, working with the client’s cross-functional teams including Global Access, Health Economics and Outcomes Research, Medical, Clinical and Market Access affiliates, to ensure that the conversation with payers addressed all the key topics necessary for successful protocol finalization and launch in the target markets:

• Clinical development program
• Coverage decisions (US) and benefit assessment (EU4 and the UK)
• Target population
• Evidence generation
• Pricing and access implications

To ensure full alignment with their goals, the client was involved at every step of the project and in the interviews. In preparation for the finalization of the Phase III clinical trial development, Alira Health also developed high-level key takeaways with recommendations for the Phase III protocol and mitigation strategies for evidence gaps.

Outcomes

The Alira Health Market Access team crafted a robust market access strategy, including an indication extension strategy, that effectively met the client’s goals and would minimize price erosion. Leveraging combined insights from payer experts and Alira Health consultants, the client was able to refine the Phase III clinical trial design to better align with payer expectations and enhance the product’s perceived value ahead of future assessments. The Alira Health team also pinpointed evidence gaps in the clinical development program and recommended strategies to bridge these gaps.

Key Success Factors

Thoughtful collaboration between the client and the Alira Health team ensured that the payer expert consultations achieved maximum value because they reflected the latest strategic thinking and targeted the client’s key questions and uncertainties. Alira Health leveraged their global network of experts and selected the appropriate payers with a variety of perspectives, including two different types of US payers, the PBM and MCO. Alira Health’s knowledge of the healthcare ecosystem and the needs of different stakeholders proved vital. The client also benefited from Alira Health’s expertise in developing and commercializing orphan drugs in multiple markets.

Learn more about our capabilities in rare diseases like Myasthenia Gravis.