US market access plan for antibody launch

Challenge:

A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by the EMA, and was therefore expecting to launch in the US within 12 months. 

Although the company was quite advanced in developing its market access strategy in Europe, the US was expected to be the first and largest market for the product. The company was interested in better understanding the process for obtaining reimbursement in US hospitals, the decision makers involved, potential obstacles and how to mitigate them. This included feedback on the proposed business model of pricing per course of treatment. In this regard, Alacrita was asked to conduct an assessment of US payers to enable a market access strategy to be implemented in support of the US product launch.

Solution:

Alacrita conducted a payer landscape assessment for the therapeutic in the US market, with focus on its use first and second line in the pediatric population in the hospital. Alacrita recommended covering other future indications that included outpatient treatment.

We covered the items:

• Identification of key value messages for US payers based on feedback on clinical data in the context of the proposed price range;
• Critical steps and decision points for formulary inclusion and reimbursement;
• Key success factors and potential obstacles in obtaining pricing per course, feasibility comparison with alternative approaches;
• Coding considerations; 
• High-level insights into key success factors and potential obstacles for establishing access to routine diagnostic procedures for the indication.

In-depth one-hour interviews with US hospital medical and pharmacy directors were conducted in different regions of the US. The insights were complemented as needed by literature research. 

New Product Planning

The payer environment for innovative therapies is becoming increasingly competitive. Leverage our team’s industry experience in pharmaceutical market access, market research and strategic planning. We will work with you to map a clear path towards optimized access and value-based pricing for your new products. Alacrita’s expert network also offers you access to senior Medical Affairs experience, which we have used to help clients drive alignment at the commercial and medical interface.