Cracking the Puzzle: Research for Drug Approval and Access

Can you visualize the main steps that a drug follows from clinical trials to market approval and a successful launch? Don’t forget the twists, turns, and roadblocks—it’s a long road. And if it includes international destinations, bumps and stops are unavoidable.

At Bazis Americas, we support companies throughout the product lifecycle by conducting patient journey mapping, unmet needs assessments, payer research, and many more research steps that lead up to a drug approval, and market access.

One consistent finding from our research: a successful market entry relies on strong pre-launch activities. In this article, we wanted to guide you through how market research helps across different drug approval scenarios.

But first, let’s examine the four key research aspects of a successful drug launch:

1. Understanding the current experience of a patient navigating health systems and treatments today. In research terms, this is referred to a patient journey.
2. What if potential challenges reside with the payers, entities such as private insurers, HMOs, pharmacy benefit managers? Getting first-hand input from this group about current practices and treatment costs can help pharma players predict and address potential challenges.
3. Even if the new therapy has clear efficacy benefits and low risk profile, future stakeholders (doctors, patients, payers) need to hear about the unique value proposition in a clear, persuasive way. Research around stakeholder communication is a step that no new launch can afford to skip
4. Behavioral economics talks about authority bias: people tend to place greater trust in the opinions of recognized experts or authoritative figures, such as KOLs. In turn, KOLs influence peer behavior (social proof concept). Engaging influential medical experts in research early on can significantly shape perceptions within the medical community.

With these stepping stones in mind, let’s explore three distinctapproval strategies through some realistic scenarios that draw on our experience in healthcare research. We will show how targeted market research can support and enhance each approach.

Scenario 1: The US-First

Imagine a promising new oncology drug called OncoAdvance. The developing company, a mid-sized biotech firm, opts for a US-first approval strategy. This approach is often chosen because of the enormous potential of the US market and the FDA’s globally respected review process.

The company focuses its initial regulatory efforts on the FDA, conducting clinical trials primarily in the US. Once approved by the FDA, international regulatory bodies may have a favorable attitude.

In this scenario, Bazis Americas would implement a comprehensive research plan:

1. Conduct in-depth oncologist interviews to uncover adoption barriers and refine positioning
2. Perform patient research to identify unmet needs and optimize support programs
3. Engage with payers to reflect on the value perceptions and explore potential formulary placement

This focused approach not only establishes a strong US market presence. It will serve a basis for entering markets outside of North America. The insights gained help identify key oncologists, understand treatment patterns, and develop targeted initiatives that resonate with both healthcare providers and patients.

Scenario 2: The Emerging Markets First

Now consider TropiCure, a new treatment for a tropical disease. Given the disease’s prevalence in developing countries, the company chooses an “emerging markets first” strategy. They target initial approvals in Brazil, India, and Indonesia, where the disease burden is high and regulatory cycle may be faster.

For TropiCure, Bazis Americas would tailor its approach to the unique challenges of each market:

1. Map out treatment patterns and unmet needs in each market, with an emphasis on differences between public and private hospitals and regional disparities in infrastructure.
2. Put together advisory boards with Brazilian, Indian, and Indonesian KOLs from both public and private hospitals. Involve experts (infectious disease specialists, pediatricians, immunologists, epidemiologists) to refine the product’s value proposition.
3. Conduct pricing research to balance affordability and sustainability. Develop tiered pricing for rural public and urban private hospitals.
4. Summarize policies and conduct expert interviews with Brazil’s ANVISA, India’s CDSCO, and Indonesia’s BPOM to get advice on how to streamline approvals. Sometimes, there are accelerated pathways available to fast-track the approval for unmet medical needs.
   
   Note. Research with government bodies and PBMs is notoriously hard to conduct, but we have a number of successful projects under the belt to come up with feasible recruitment strategies.

This strategy allows the company to address urgent health needs while simultaneously gathering valuable real-world data. These insights not only support future applications in other markets but also help navigate the complexities of diverse healthcare systems, enabling the development of tailored market access strategies.

Scenario 3: The Simultaneous Submission

In our final (and favorite!) scenario, a large pharmaceutical company has developed GeneThera, a breakthrough therapy for a rare genetic disorder. Given the global nature of the condition and the company’s resources, they choose simultaneous submission strategy. The goal is roll out simultaneously, or in close time proximity, across regions.

This ambitious strategy requires a coordinated global effort which Bazis Americas supports through:

1. Conducting parallel patient journey studies across multiple regions. We involve project managers from each country at the research design stage – this provides invaluable, quick regional view!
2. The above step may be done in parallel with multi-country payer research to inform nuanced market access strategies. Here, small samples per country with high project management costs could be a challenge.
3. Supporting communication research around core messages on the value proposition, that can be customized for each market while maintaining a consistent core voice.

For GeneThera, success comes from one core value proposition that connects with healthcare systems around the world. Our research helps uncover the universal themes that shape a strong global strategy, while also relentlessly looking for local nuances that bring a personalized touch.

What a journey! These scenarios show just how adaptable you need to be in today’s fast-paced pharmaceutical world. At Bazis Americas, we understand that market research goes beyond just methodologies and numbers — it’s about truly grasping the cultural and healthcare dynamics at play. Our team brings expertise from North America, Eastern Europe, China, India, and beyond, with multiple languages spoken by our moderators and project managers. Yes, it’s possible in a small research team, and we’re proud of the unique blend of backgrounds and perspectives we bring. Whether your approach is US-first, focused on emerging markets, or aiming for a global rollout, we’ve got the know-how and passion to support you.