For manufacturers, early access pathways can offer significant strategic and product-specific advantages. However, only if manufacturers fully understand their complexity. The specific design of each pathway shapes market-by-market and product-by-product opportunities and risks. In our recent blog, Sama Seyedmousavi, Senior Associate at Inbeeo, outlined the global early access landscape, highlighting the difference between early and alternative access pathways (both referred to as ‘early access pathways’ in this blog series), example pathways, their features, and strategic implications for manufacturers. Now, in this second post in the series, she takes a closer look at the 10 core building blocks that shape how these pathways function, their key features, and their broader impact on manufacturer strategies.
The 10 core building blocks of early access pathways
Early access pathways aren’t one-size-fits-all: each market has its own pathway configuration. Therefore, to navigate them effectively, manufacturers must understand the key structural components and their defining attributes (see Figure 1). These influence everything from the scope of access and revenue potential to pricing risks and evidence obligations, ultimately shaping a pathway’s specific access opportunities and risks.
Figure 1: 10 building blocks with their distinct attributes
Each building block includes key attributes that shape a pathway’s relevance for both the healthcare system and manufacturers. More importantly, it highlights the potential opportunities and risks that manufacturers should weigh when considering these pathways.
1. Pathway initiation
Determines when the pathway can begin: pre-marketing authorisation (MA), post-MA filing, or after a negative (pricing and reimbursement) P&R decision. It also defines who initiates the pathway — whether the manufacturer, healthcare providers, or authorities.
2. Pathway coverage
Defines the breadth of coverage and associated timelines: which patients qualify (individually named patients or cohorts of patients), how fast access decisions happen, and the duration of granted access.
3. Therapy characteristics
Outlines eligible therapies, the data manufacturers must provide, which conditions qualify (e.g., ultra-rare or severe conditions), and included indications (first, follow-on, or any indication).
4. Pathway funding
Describes who pays (public, private, manufacturer, or mixed) and whether funding is guaranteed or assessed on a case-by-case basis.
5. Product pricing
Explains the pricing mechanism (negotiated upfront with later re-negotiation, negotiated once and maintained, or freely set for future negotiations) and how frequently authorities review the price. Also covers whether authorities publish the list or net price, whether payback or clawback rules apply, and to what extent early pricing affects routine P&R.
6. Data opportunities
Specifies whether evidence standards for accessing the pathway differ from those for routine P&R. It also assesses the quality of any real-world data generated through the pathway, and whether manufacturers can use it to support local P&R.
7. Data obligations
Outlines the dossier requirements for starting and sustaining access (high, medium, low burden), what data needs to be reported regarding pharmacovigilance, usage and risk-benefit (re-)evaluation, and who is responsible for reporting (the manufacturer or the Health Care Providers).
8. Continuity obligations
Covers pathway obligations related to supply readiness and commitment to file for local MA. It also defines who can terminate the program and under what conditions, and specifies who funds treatment continuity and for which patient population once the pathway ends.
9. Chance of success
Reflects pathway utilisation frequency and the likelihood of approval based on historical acceptance rates.
10. Pathway governance
Covers pathway transparency, appeal mechanisms, performance monitoring, and whether key performance indicators are published.
From Early Access insights into strategy: What does this mean for manufacturers?
Understanding the underlying attributes of access pathways is more than a technical exercise. In fact, it’s a strategic advantage for manufacturers looking to maximise early access without compromising future success.
- Know where to play: Certain pathways offer more predictability, faster timelines, and clearer funding opportunities. In contrast, others are complex, underused, or pose greater risks to pricing or operational feasibility. Therefore, consider your product’s profile and market objectives ahead of pursuing early access pathways.
- Balance speed and sustainability: Gaining early access is valuable, but not if it undermines long-term pricing. Be intentional with the pricing, data obligations, and evidence generation.
- Align internally: Use a shared framework to coordinate across medical, regulatory, HEOR, commercial, and market access functions, so everyone moves with one strategy and one voice.
- Shape the rules: Engage with national stakeholders to help shape how access pathways are designed and implemented for maximum impact on patient access.
Want to unlock early access globally?
At Inbeeo, we help companies decode the complexity of early access pathways, breaking down each route and its key attributes. With our proprietary access database and deep local expertise, we tailor strategies that fit your product’s profile and your market goals.
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