Market access abroad: Three reasons why early planning is critical for HTA countries

Regulatory approval may represent a giant leap forward in a product's path to commercialization, but in Europe and several other regions, it is far from the last step. In these markets, health technology assessments (HTAs) add complexity and nuance to global launch plans. HTAs mandate formal documentation, robust evidentiary requirements, and other activities that convey a therapy's value. If every obligation is not met, it can delay market entry.

"The HTA hurdle links directly to market access and reimbursement, and it is an extremely important barrier to overcome, just as much as regulatory approval," said Dr. Thomas Mittendorf, Vice President, Real-World Evidence & HTA Support. "In essence, the HTA basically determines whether or not your product can be reimbursed and accessible in the market. And that can have a significant impact on a manufacturer's global planning and commercial success."

Moreover, HTA processes across countries vary from one to another, representing a diversity of specific and rigorous market access requirements. It can all make a biopharma company wonder how to expand its international footprint to places like Germany, the UK, France, or others. It is particularly challenging for organizations that lack a formal market access department.

So what do small and midsize biopharma companies need to do?

Think ahead — far ahead: Biopharma companies should assess their HTA roadmaps in the early phases of clinical trials. After all, HTA requirements can take more time and preparation than you might think.

1. Lining up the right local expertise can take time

HTA or not, market access is an undertaking that is strongly influenced by the local environment. You have to know the language and be versed in local politics, economics, culture, and other unwritten rules to better understand access, pricing, and reimbursement decisions.

Given the current diversity of approaches, local insights are particularly important in markets that require HTAs. Some countries, like Germany and France, approach their requirements on a more clinically oriented basis. Others, like the UK and Sweden, focus more on cost-effectiveness. And still others, like Spain and Italy, add an extra layer of regional and local requirements, especially on budget impact.

Rooting out these regional nuances presents a challenge, however. Biopharma companies usually cannot engage HTA agencies' members as advisors because they are often government employees. Instead, you might need a non-government advisory group, and that takes time to assemble.

Xcenda, for example, engages a broad network of partners who are local, trusted experts. With this network, biopharma companies can access local experience, insight, and relationships, and they will generally get the most out of them when they start those efforts well in advance.

2. HTA plans call for comprehensive, long-term market access strategies

Depending on the specific product and market, biopharma companies may have several market access strategies worth considering. The earlier you approach planning, the more long-term levers you may have available to you.

For example, Mittendorf typically recommends that companies engage directly with the HTA body. He says doing so can establish positive relationships for a smoother submission process. But there is a window of opportunity for that coordination, Mittendorf adds. If you miss it, you might be too late.

Building and executing a plan for both global and local market access and developing evidence around the clinical trial program is essential — and where qualified consultants are ready to step in and assist. Even before any of that, there is an opportunity to refine the clinical trial protocols to ensure the program generates the necessary data for each HTA agency.

After the initial regulatory hurdle, comes the HTA hurdle, which links to market access and reimbursement. If a product is not reimbursed, it is unlikely that patients will be able to access it. It is critical to start planning for reimbursement and access as early as possible, ideally before or around the time when the product is in phase 2.

Ultimately, the plan is just as important as its execution: preparing for global and local market access and developing evidence around the clinical trial program can create more opportunities down the line.

"There are several tactics manufacturers can employ," Mittendorf said. "It is dependent on the product and where the manufacturer is on their development journey. The earlier you think about these things, though, the more strategies you can execute."

3. Integrated partners can do more with more time

Small and midsize biopharma companies benefit from working with a consulting partner when planning to break into a new market, especially when approaching a country with HTA requirements.

Integrated partners typically provide the best value for these needs because they can combine multiple service offerings that complement and inform each other — not just market access but also development and distribution support. But to optimize and parallel-path those services, programs will need more time to plan and execute strategic goals.

A trusted partner will assess biopharma companies in the very early phases of clinical trial programs, determining some of the endpoints and inputs that they may require to position a new product for reimbursement.

"It is a good idea to look for a single partner that can support you with many of the activities you need within the magic triangle of clinical development, distribution as well as 3PL and market access," Mittendorf said. "There is a distinct advantage you get when you engage early with those organizations to carry forward insights throughout development and post-launch."

Optimize your international approach with the right plan

HTA markets are often complex and locally nuanced for asset launches, but with a long enough runway and sufficient preparation, anything is possible. By planning ahead and working with a market access partner early on — during or before clinical trials — small and midsize biopharma companies can optimize their international approach and ultimately bring their products to more people worldwide.