Introduction
The landscape of launching new medical products presents significant challenges, with a staggering 66% of launches falling short of consensus expectations. Half of these failures are attributed directly to poor market access. Recognizing this, companies are increasingly turning to early engagement with payers during the clinical development phase to glean crucial insights into payer evidence requirements. By doing so, they can tailor their evidence-generation strategies to align with payer expectations, thereby enhancing their chance of securing favorable coverage decisions.
Securing regulatory approval alone is no longer sufficient for successful market access. Payers demand robust evidence that goes beyond clinical trial data, emphasizing the product’s ability to address unmet needs, its comparative value against existing treatments, and its economic viability. Consequently, a comprehensive, successful market access strategy requires a strategic evidence-generation plan that involves cross-functional collaboration. This approach ensures that all stakeholders within the healthcare ecosystem, including payers, providers, value analysis committees, and health technology assessment (HTA) organizations, are presented with compelling evidence of the product’s value proposition.
Top Considerations for a Successful Evidence-Generation Plan
- Have different healthcare decision-makers been engaged early on?
Start discussions early in the clinical development process to understand evidence requirements and preferences of all relevant decision-makers, including payers, providers and value analysis committees. This understanding helps in designing studies and evidence-generation strategies that align with payer needs, thus increasing the likelihood of positive coverage decisions. Receiving early feedback on study design, endpoints, and overall evidence-generation strategies, enables adjustments before significant resources are invested. More broadly, early discussions can prove invaluable in strategic planning. This includes anticipating potential barriers to coverage and devising a comprehensive access strategy that goes beyond clinical data. - Does the clinical trial data meet payer needs outside of regulatory requirements?
Clinical trials need to show efficacy and safety according to regulatory body standards for a product to be approved. Comparisons to current standard of care may be lacking in regulatory clinical trials, which is a strong barrier to achieving favorable market access as payers and other stakeholders want to understand whether the product is better, safer and more cost-effective than what they are currently covering. Answering these questions is an essential step in obtaining market access. An early consideration in formulating the evidence strategy should be to conduct a detailed landscape assessment of the data available for competitor products, as this will likely set the benchmark for future data needs. Comparative effectiveness data can sometimes be sufficiently obtained through real world evidence (RWE) sources; but limitations can exist, such as lack of data on certain outcomes. In such instances, indirect treatment comparisons (ITC) including network meta-analysis or matched-adjusted ITCs (MAIC) of published clinical trial data can be used to indirectly compare products. Globally, HTA bodies are increasingly using these methods to compare relevant products. - Can data be developed or enhanced for subpopulations that are better responders?
Oftentimes, coverage and reimbursement are restricted to specific patient-level criteria to help control costs. The cost burden of a product may be high relative to its incremental benefit. Demonstration of efficacy and safety for specific subpopulations can help to create a clear pathway to support successful launch and market access given today’s environment of payer restrictions. It can also serve to expand criteria imposed by payers should restrictions be too narrow. Real world evidence can reveal unmet treatment needs and unique effectiveness patterns in patient subgroups. Furthermore, post-hoc clinical trial analyses of responders vs. non-responders, and predictive variables of response, can serve the same purpose. For example, payers may limit use of a diagnostic device to patients with a threshold for obesity (e.g., >40 BMI). If trial or RWE data can show incremental benefit with lower BMI thresholds, this may serve to expand criteria for coverage and reimbursement. - Can clinical expert input help fill gaps and increase credibility?
Even with the plethora of experimental and observational study design options available, a full-fledged study may be insufficient or sometimes not even necessary to obtain the evidence that is needed. In such cases, in-depth discussions with clinical experts, combined with the synthesis of existing evidence, may suffice. For example, in the medical device field, treatment options may rapidly evolve, and standard of care may vary across time and settings. Strategies such as a Delphi Panel to achieve rapid consensus in a validated and systematic manner, may not only be a cost-effective solution but also the most appropriate one to accurately understand and support product place in therapy. Furthermore, expert opinion may be required to understand healthcare resource use patterns in more depth and detail where public sources such as claims databases may provide incomplete data. Lastly, expert feedback and Delphi panels on the use of an intervention in the real-world can provide interim evidence while waiting on longer-term data to become available. - Have different teams across the organization collaborated on evidence plans?
A successful market access strategy requires the involvement of a cross-functional team to ensure it can address the needs of diverse stakeholders in our complex healthcare system. In most companies, the Commercial team will serve as the quarterback of this cross-functional initiative. While each function contributes specific expertise, collaboration across teams is required during the entire strategy development process. For example, the design of clinical trials that will provide evidence for product approval, market access, and promotional messaging requires the close collaboration of Clinical Development, Regulatory Affairs and Commercial teams. Beyond clinical trials, evidence-generation plans require the collaboration of Health Economics, Commercial, Regulatory and Medical Affairs, as well as Market Access expertise. The overall market access strategy may also require the collaboration of each of the above-mentioned functions plus other functions such as Finance, Legal, Contracting, and Analytics given factors such as investment requirements and patient privacy laws.
Conclusion
Securing regulatory approval alone is no longer sufficient for successful market access. Payers demand robust evidence that goes beyond clinical trial data, emphasizing the product’s ability to address unmet needs, its comparative value against existing treatments, and its economic viability. Consequently, a comprehensive market access strategy hinges on a well-coordinated evidence-generation plan that involves cross-functional collaboration. This approach ensures that all stakeholders within the healthcare ecosystem, including payers, providers, value analysis committees, and health technology assessment organizations, are presented with compelling evidence of the product’s value proposition, ultimately facilitating market entry and uptake.
Author
Nicole directs U.S. and global projects to support multi-stakeholder medical device adoption and reimbursement. Nicole has more than 20 years of experience in health economics and research methods within academic, industry, and consulting roles.…
Tim is bringing a global perspective to life sciences product launches and end-to-end commercialization. With more than 20 years in the pharmaceutical industry, his career has included numerous executive-level positions at leading industry companies.…
Megan is a Director at EVERSANA, leading HEOR projects involving health economic modeling, value communications, literature reviews and reimbursement submission strategy. Megan has extensive research and writing experience in both academic and commercial applications,…