Why is it important for a biopharma company that is launching a new product to understand these market archetypes?

Chelsey Campbell: 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. A thorough understanding of the three common archetypes — cost-effectiveness — comparing value for improved outcomes; clinical effectiveness — comparing evidence between similar products; and regional — markets where reimbursement or access decisions are not happening on a national level — could influence launch strategy.

The overall strategic approach will be different for each key archetype. For example, Spain (regional/decentralized) would look for cost-effectiveness data at the national (and sometimes province/state) level, but they're probably looking for budget impact at the hospital level. It's partially about generating the right data, but also about the strategic approach and understanding how access is gained in key markets and depending on how your product is going to be administered and reach patients.

Remember, archetypes help simplify and streamline how we think about evidence generation needs. Think of archetypes as loose groupings, not as monoliths or official designations that conform to the exact same process. Essentially, they "categorize" markets based on similarities in their approach to an HTA assessment.

Understanding the archetypes helps you to plan ahead. And you can't make decisions on what comparator or what data you need too far down the road. There are nuances to every country's approach, and it's wise and prudent to clearly understand the requirements for each individual market that you're looking to enter. Biopharma companies may not stop and assess how these approaches can help them generate their strategy for HEOR and market access.

How is clinical trial design impacted by the archetypes and what other processes should biopharma companies consider?

Chelsey Campbell: It is a difficult process, if not theoretically impossible, to please every single authority. Prioritize what markets you're entering and align that with your trial design and evidence generation plan leading up to market access. Demonstrating that the endpoints in your trial align with the needs of these individual markets is a key step.

Keeping markets in mind is important when developing an evidence generation strategy and also for thinking about your trial design. If you have the right endpoints in your clinical trial, you're able to show the types of evidence that they need to make it an accurate assessment of your drug's value. This leaves less room for questions about the product's validity.

With early scientific advice, reach out to the authorities before you start your trial to get feedback on the endpoints, comparators, and other key elements that will have an impact on your HTA submission and evaluation down the road.

Plan ahead to ensure your models are adaptable to all applicable markets and prepare adequately where local data are required. The types of evidence-generation activities, meta-analyses, modeling, and so forth are all impacted by these HTA archetypes.

What is the correlation between market access and patient access?

Chelsey Campbell: Market access is essential for patient access. Outside of compassionate use programs or early access programs in very special patient cases, there is limited patient access without having reimbursement. It's not a correlation so much as a necessary step to make patient access even a reality. There's so much more to patient access than just reimbursement. It's awareness, it's advocacy, it's education. But without that essential step, it turns off the water to everything below to get to patient access.

Another important consideration is how differences in route of administration and disease area, etc., could influence the reimbursement process within these markets. For example, in certain markets, an oncology product might only be available in a center of excellence, so the reimbursement process could look different.

What tools and services should a commercialization partner offer to help biopharma companies approach market access strategy efficiently?

Chelsey Campbell: There's a lot of pieces to the puzzle, and a commercialization partner should be able to assist you every step of the way and not drop off the radar after you reach a certain point of the process. The partner must understand how the archetypes will inform your go-to-market strategy.

Thinking strategically early on and putting together a proper plan for what evidence you need is critical. If you have a clinical trial protocol developed, a partner can put together an advisory board featuring experts in each market to provide feedback. Commercialization partners also collect and share expert advice on models, meta-analyses, and indirect treatment comparison networks.

Local affiliates are going to need assistance from a global team. And that global team should be supported by a commercial data partner that helps them execute with finesse and knowledge of the usefulness of tools across multiple markets.

Once the strategy is complete, an end-to-end commercialization partner should help with the submission itself, getting it to each HTA market's authority and defending it and responding to questions.

Being proactive and getting on board with a partner who knows the process and knows the global needs and knows how to build from the information repository to edit local submissions, that's powerful.