Developing innovative pharmaceutical products is a lengthy process with no guarantee of success at the end. Manufacturers struggle with coordinating strategy internally and incorporating multiple payer requirements in clinical development programs.
In the fourth of her five-part series on digital transformation in market access, Dr. Patti Peeples, CEO of HealthEconomics.com, sits down with Dr. William Aaron Grandy, Product Owner of Digital Applications at PRMA Consulting, to discuss how a digitally enabled assessment process reduces the risk of developing medicines that fail to meet payer and patient needs.
Dr. Peeples: What challenges do you see companies facing when developing market access strategies?
Dr. Grandy: Without a regulatory license, market access is all but impossible, so historically clinical development programs were driven by the needs of regulators.
However, a regulatory label alone does not mean that patients are automatically granted access to a new treatment, and being fast to market no longer correlates with being quickly reimbursed. If companies are to succeed in ensuring patients have access to new treatments and securing reimbursement, they need evidence packages that meet specific payer needs. Therefore, clinical development programs need to be aligned with those needs and ensure trials are being designed in ways that demonstrate payer-relevant value.
Another key challenge we see companies facing is how to keep track of constantly changing treatment landscapes and evolving approaches to patient management, which of course can vary significantly per market. Making sure your market access plans are robust yet flexible enough to respond to changing environments is important.
Dr. Peeples: What is your top tip to companies when they are developing a market access strategy?
Dr. Grandy: Make sure that local knowledge is incorporated into the global market access strategy early on in your product’s life cycle. This can be challenging; resources are often constrained at the local level, usually by the need to focus on immediate product launches, but it is vital.
This is where a digital application can really help.
At PRMA Consulting, we have designed our own digital application, the PRMA Healthcheck®, which was developed to bring specific local payer needs and global strategy together. A structured assessment of the risks and opportunities in multiple markets is generated to identify potential evidence gaps. To reach this point the application follows a consistent process and prompts you to answer the following questions:
- What is the context for the assessment in terms of evidence and payer thinking?
- What are the potential gaps in the evidence base in each market?
- What are the key challenges to optimize the HTA/reimbursement submissions?
- What evidence is needed to mitigate these key challenges?
This gives companies a single shared vision across markets while retaining local market specificity, ensuring everyone is working with the same understanding of the issues and evidence.
Dr. Peeples: In your experience, are there any barriers to coordinating market access information from global and local teams?
Dr. Grandy: Those working in market access are no strangers to the need to consult many internal stakeholders. However, this can be difficult to do efficiently and reliably. It is all too easy for global, regional, and local teams to develop their own way of doing things, which can lead to duplication of effort, strategic misalignment, and evidence packages not matching local payer requirements.
The PRMA Healthcheck® helps our clients to consider the clinical development program and supporting evidence generation activities through the lens of multiple payers. It provides a single, robust, systematic framework for all teams to use, which results in information that is more consistent and easier to navigate. This makes it much easier for everyone to unpick the key issues and identify and prioritize additional data requirements. Distilling this wealth of information into something everyone can understand quickly is another key feature of the PRMA Healthcheck®. A red-amber-green heatmap is used to highlight evidence gaps for individual markets, so it can be seen at a glance across markets where the key issues and opportunities are.
Dr. Peeples: So how can digital technologies make the market access process more efficient?
Dr. Grandy: PRMA Consulting first began working on the Healthcheck approach over 8 years ago. Our clients were requesting a way to ensure their market access approach was optimized to be consistent, robust, and reliable. Efficiency is a natural by-product of these demands.
Using a digital application makes it much easier for companies to ensure that all previous thinking has been captured, and it is a living resource; everything can be quickly updated as new evidence surfaces.
In real life, it is unlikely that any company has the resource or the time to do all the evidence generation activities it identifies; the PRMA Healthcheck® supports companies to ensure they are prioritizing the work that has the highest value. Where similar risks are identified across markets, there is a shared vision for mitigating these. The process drives a team approach – accommodating diversity and embracing commonality. So, in answer to your question – this technology is most certainly driving efficiency, bringing consistency and collaboration with it.
Dr. Peeples: At what stage in a product’s life cycle would you use a PRMA Healthcheck®?
The PRMA Healthcheck® can be used at any time in your product’s life cycle. Earlier on, there is an advantage in shaping the clinical development program more broadly towards payer needs, while keeping an eye on how the market may look in the future. In late Phase 2 or early Phase 3, the process becomes more concordant with current payer requirements. Guided by the application, the common approach can be consistently applied throughout the product life cycle, bringing together a range of perspectives at different points in time. The focus is always on the product and meeting the needs of payers.
The PRMA Healthcheck® has its basis in HTA-based markets where meeting payer evidence requirements is the clear goal; with experience and time, it has been adapted to accommodate rapidly evolving regions, such as in the Asia-Pacific markets. In the near future, it will also facilitate responding to a wide variety of US payer archetypes. Our clients tell us that this approach is working. Wherever teams work, they need to work together; the PRMA Healthcheck® brings information together and ensures that medicines are developed with robust evidence packages that ultimately meet payer needs.
