Common Pitfalls of Integrated Evidence Plans (Part 2)
Authored by Michael Ryan, PharmD and Rita Numerof, Ph.D.
In Part 1 of this series, we discussed Integrated Evidence Plans (IEPs) whose purpose is to identify and prioritize evidence gaps aligned with commercial goals to obtain regulatory approval in markets of interest, optimize access, and achieve a price that reflects the holistic value of a given asset. We noted that the creation of a formal IEP was essential to new product development and that it requires keen attention to planning and coordination across many internal functions to ensure efficiency and success. However, to deliver and execute IEPs that allow companies to realize the full holistic value of their products, several historical flaws or pitfalls of IEPs need to be addressed. The first of these pitfalls that we discussed focused on the timing of evidence development, the inclusion of all appropriate stakeholders, and the appropriate application of lower hierarchical study designs such as RWD, PRO and QoL, and need for budget and evidence prioritization.
Other potential IEP pitfalls that need to be addressed include:
Infrastructure: Pharmaceutical companies are often organized into siloed professional and regional departments, each of which is focused on responding to different evidence requirements. While regional and functional needs are important, unfortunately, they are far too often very different and even potentially conflicting. To address these differences and to better achieve cross functional and regional alignment on evidence generation requires a degree of dialogue and collaboration which is often difficult to achieve in the siloed organizational structures so often employed by biopharma companies.
Alignment of labeled and commercial target populations: Often the final Regulatory approved labeled indications are much broader than the patient enrollment criteria utilized in the phase 3 label generating clinical trial. Payers are especially tuned into these differences and often will attempt to limit the use of a newly launched medication to the phase 3 enrollment criteria. It’s essential that the IEP focuses on the potential gap between the labeled population and the population defined by the phase 3 clinical trial enrollment criteria. Failure to develop the evidence necessary to fill this evidentiary gap is a frequent cause of lower access and pricing from what was predicted in the product’s launch forecast.
Segmentation: Rather than a single payer system, the U.S. employs a diverse and highly segmented and multifaceted system of payer entities and providers to administer health benefits. Unfortunately, each player in the U.S. healthcare system sees “value” differently based on their individual role. It is essential that a highly trained Market Access specialist take this segmentation into consideration in the development of an IEP to ensure that the evidence necessary to meet the needs of all players in the U.S. healthcare system are met.
Benefit horizon: One of the primary drivers of HTA driven cost effectiveness and pricing is the benefit horizon for the product. HTAs and payers will typically reduce the benefit horizon for a newly launched product to the length of treatment seen in the phase 3 trial. Gaining a longer benefit horizon will require the IEP to focus on the continuation of phase 2 trials of the drug product to demonstrate that the clinical benefit seen with the drug persists for a period much longer than what was evaluated in the phase 3 trial. Failure to include this in the IEP can result in perceived values and pricing of a newly launched product that are orders of magnitude lower than what is expected.
In the highly competitive and regulated pharmaceutical industry, achieving consistent commercial success requires more than just innovative products. A well designed and executed IEP can produce long-term product differentiation and optimize a new product launch. Competitive advantage can be gained by engaging market access expertise early in the product development cycle and leveraging it as a scientific function to purposefully address coverage and payer agency needs in the face of ever-changing payment regulations and market opportunities.
Success in market access efforts requires a deep understanding of the diverse and evolving payer landscape, as well as the science of value evidence generation and communication. Furthermore, the scientific approach to Market Access involves continuous learning and adaptation. As healthcare systems, payment and health technology assessment methodologies evolve and new evidence emerges, Market Access teams must stay abreast of the latest developments and adjust their strategies accordingly.
Companies that adopt a strategic, scientific, and early-engagement approach to market access across Business and Product Development and across the product’s life cycle, coupled with integrated evidence planning, are better equipped to achieve consistent commercial success. By prioritizing market access and integrated evidence planning as core components of their business strategy, pharmaceutical manufacturers can enhance their competitive advantage, drive sustainable growth, and ultimately improve patient outcomes.
Please find the original article here.