Introduction
What is the secret to a successful drug launch? One crucial factor is establishing a cross-functional team that effectively integrates market access strategy with evidence development. Successful drug launches rely on the seamless coordination of diverse activities across multiple disciplines and geographies. It is essential to harmonise expertise between central departments, including regulatory, clinical/medical, value and access, and supply chain, as well as local affiliates or partners who provide critical stakeholder knowledge and nuanced insights necessary for informed decision-making.
In a previous discussion, we explored the pivotal role of Pricing and Market Access (PMA) teams in guiding decisions from early product development through post-marketing phases. The success of these teams depends on their ability to integrate and communicate effectively across all stages of the process to develop evidence that resonates with all stakeholders. The strategy for evidence generation is vital in unlocking a drug’s market access potential, and achieving this requires the collaboration of all key players. Without proper integration, misaligned strategies can lead to delays in market access and potential revenue loss.
This article will explore the importance of integration, the key players involved, and best practices for aligning these activities in evidence generation.
Why integration matters
Pharmaceutical companies must align clinical and commercial objectives during a drug launch for several reasons:
- Maximising market success: aligning clinical and commercial strategies ensures that the drug meets both regulatory requirements and payer needs. This alignment results in a product that satisfies the expectations of patients, healthcare providers, and payers, ultimately maximising market success
- Efficient resource utilisation: coordinating PMA, clinical, and commercial goals streamlines development processes and optimises resource use, leading to quicker time-to-market and more effective budget allocation.
- Improved patient outcomes: collaboration between clinical and PMA teams fosters a better understanding of patient needs, resulting in improved outcomes. This approach not only facilitates market entry but also enhances adoption and adherence rates
Key Areas of Integration
1. Early collaboration in clinical development
Market access teams play a critical role in orchestrating the drug development lifecycle by creating an integrated market access plan that translates payer value into the design of clinical trials. Early collaboration between clinical development and market access teams ensures that trial designs generate data meeting both regulatory and payer needs.
This is particularly important in fields such as oncology and orphan drugs, where nuanced input can significantly impact the development process. Key considerations include selecting appropriate treatment comparators, determining relevant endpoints, understanding single-arm trial data implications, and preparing for challenges like indirect treatment comparisons. Identifying these success factors early helps recognise, mitigate, and address potential risks in the evidence generation plan.
2. The role of Real-World Evidence (RWE)
Companies often face challenges in translating evidence across different markets and healthcare settings. Payers increasingly demand proof of a product’s value within their specific contexts, making Real-World Evidence (RWE) essential in supporting clinical trial data. While RWE is often generated in later stages, it is crucial that the RWE plan is informed by insights from PMA teams throughout the product development process. Whether utilising electronic health records (EHRs), patient registries, claims/billing data, or patient-generated data, RWE plays a pivotal role in demonstrating value and meeting stakeholder needs, particularly for payers.
Best practices for successful integration
1. Cross-functional teams and regular communication
Establishing cross-functional teams that include members from market access, sales, marketing, regulatory, and medical affairs is essential for successful integration. Regular communication within these teams ensures alignment on market access strategy and messaging, enabling them to address challenges promptly and collaboratively.
2. Use of integrated data systems
Implementing integrated data systems that facilitate seamless information sharing across departments is crucial. These systems provide real-time access to market research, clinical trial data, and post-launch performance metrics, enabling informed decision-making and better alignment with market access goals.
3. Continuous training and development
Keeping teams updated on the latest PMA trends and regulatory requirements through continuous training is vital. Awareness of changes in payer policies, competitive dynamics, and access reforms ensures that the overall product strategy remains relevant and effective.
Consequences of not integrating
- Misaligned strategies and wasted resources: without integration, departments may operate in silos, leading to strategies that do not align. This misalignment results in inefficiencies, duplicated efforts, and missed opportunities to optimise market access
- Delayed Market Access and revenue loss: failure to coordinate efforts can cause delays in obtaining market access, negatively impacting revenue and diminishing the drug’s competitive advantage in a rapidly evolving market
- Inability to adapt to market and regulatory changes: siloed operations hinder a company’s ability to respond swiftly to changes in payer policies, regulatory requirements, or market conditions, potentially compromising the drug’s success and market positioning
Conclusion
To optimise their success, pharmaceutical companies must adopt an integrated approach to market access. Remap Consulting assists companies in navigating global market access, securing early payer scientific advice to inform clinical development, and crafting evidence-based value propositions that resonate with payers. Additionally, we provide PMA training and gather critical insights to support pricing strategies and product launches. By integrating market access strategy with evidence development, companies can enhance their market positioning, streamline operations, and ultimately improve patient outcomes.
Sources:
- Robson A. What does the right market access organisation structure look like? Remap Consulting. Available at: https://remapconsulting.com/pma-trends/what-does-the-right-market-access-organisation-structure-look-like/ Accessed August 27, 2024.
- Dang, A. Real-World Evidence: A Primer. Pharm Med 37, 25–36 (2023).
- Foxon G. What is real-world evidence? Remap Consulting. Published June 11, 2020. Available at: https://www.remapconsulting.com/articles/what-is-real-world-evidence. Accessed August 27, 2024.