Mid-Sized Pharma Prepares a Successful Launch of Prostate Cancer Therapy in Europe

Client Challenge

A mid-sized pharmaceutical company was conducting a Phase III trial designed to support registration and launch of a radiopharmaceutical therapy in the United States (US) for prostate cancer. As the next step, they wanted to identify a strategic path forward to successful registration, pricing, and reimbursement in France, Germany, Italy, Spain (EU4), and the United Kingdom (UK). To leverage the data generated from the US trial in these other markets, the client sought support to rapidly assess and identify gaps in their evidence generation strategy and develop a mitigation plan.

The company trusted Alira Health in this type of project based on a prior successful experience in market access strategy for another innovative asset.

Our Approach

The client was conducting a multi-center, open-label, randomized Phase III trial comparing the safety and efficacy of their treatment versus hormone therapy. The study was designed to support registration and launch of the treatment in the US. Alira Health’s Regulatory, Medical Strategy, Biostatistics, and Market Access teams worked together to identify potential evidence gaps and provide recommendations on the feasibility of registration and launch in the EU4 and UK.

Working cross-functionally, Alira Health experts performed the following activities: 

• Identified relevant regulatory pathways and requirements prior to filing in the EU4 and UK
• Assessed the suitability and relevance of the current evidence package, based on the Phase III clinical trial and a retrospective RWE study, for EU4 and UK registration, Health Technology Assessment and pricing negotiations. The team also tested payers’ willingness to pay (gross-to-net) and HCPs’ willingness to prescribe
• Explored the potential differences between the intended regulatory label and the clinical trial population in the US that may impact the label indication, reimbursed population and/or pricing ambition in the EU4 and UK
• Conducted numerous interviews with HCPs, ex-agency experts, and payers’ experts to consolidate Alira Health’s findings and provide the most relevant, realistic, and up-to-date recommendations for the client
• Presented a list of gaps and remediations to consider optimizing the overall strategy from a clinical, regulatory, statistical, and market access aspects
• Provided potential mitigation strategies to fine tune key recommendations for an optimal launch in the EU4 and UK
• Proposed a unique differentiation strategy for the client’s asset versus competitors to emphasize added-value services that could drive stakeholders’ preference for the treatment

Outcomes

Alira Health’s multidisciplinary teams exceeded the client’s expectations in identifying evidence gaps and proposing remediations to close those gaps. Alira Health also provided final key recommendations for an optimal launch in the EU4 and UK on the clinical, regulatory, statistics and market access aspects.   The client gained clarity in their strategy moving forward and a strong business case to present to internal decision-makers.

Key Success Factors

The client appreciated the diversity of expertise and can-do attitude found in Alira Health’s Regulatory, Medical, Biostatistics, and Market Access teams, which enriched the outcome of the project. The multidisciplinary teams showed resilience to the tight timeline by rapidly mobilizing and coordinating their taskforce to provide deliverables on time. The teams established effective and clear communication by engaging one point of contact with all stakeholders. Alira Health’s extensive track record of over 30 projects in nuclear medicine in the past five years was vital to the project’s success.

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