Rethinking JCA Readiness: Why BioPharma Needs Smarter Tools, Not Just More Consulting Projects

The European pharmaceutical landscape is evolving rapidly. With the EU Health Technology Assessment Regulation (HTAR 2021/2282) now in effect, market access strategic planning has entering a new era. Central to this shift is the Joint Clinical Assessment (JCA) framework, which requires biopharma companies to coordinate evidence generation, regulatory planning, and submission execution across multiple EU member states. This centralized approach requires new operating models.

For many companies, especially those preparing their first JCA submission, the challenge is daunting. Traditional approaches often rely heavily on external consulting support, repeatable manual tasks, and disjointed cross-functional coordination. Not only is this costly, but it also increases the risk of delays, rework, and misalignment that can impact revenues and thereby risking access.This is where HTA Compass™ comes into play.

What is HTA Compass™?

HTA Compass™ is a SaaS platform designed specifically to help biopharma teams navigate the complexities of JCA readiness. Instead of relying solely on expensive consulting projects, HTA Compass provides a centralised, structured, and AI-enabled solution for planning, executing, and tracking JCA submissions.

The platform empowers teams to:

• Access pre-specified templates for JCA readiness submission planning.

• Align regulatory and clinical development plans through centralised scenario planning.

• Track budgets and submission statuses across cross, functional teams.

• Leverage AI enabled Smart Assist, giving instant access to dossier templates and methodological guidance.

• Benefit from tech and advisory support for strategy and execution from experienced professionals who have lived experiences in access, pricing and HTA roles in pharma and biotechs

Why HTA Compass™ Matters: The ROI Case

Beyond compliance and alignment, HTA Compass™ delivers real, measurable value for companies in five key areas:

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1. Consulting Cost Savings
A typical JCA readiness project can cost anywhere from €100k to €300k per product. Many of the tasks involved, gap scans, checklist reviews, and dossier formatting, are repeatable and operational. HTA Compass™ automates roughly 30- 50% of these tasks, significantly reducing reliance on external consultants. For example, a company preparing three submissions per year could save €250k annually by using a hybrid of the platform and advisory support.

Costs of not being compliant
An incomplete 1,000,000 in lost sales, costing millions in sales efficient reviews3. Efficiency and Productivity Gains
Manual JCA readiness often requires 4–6 6 full, time to 6 full-time employees working for weeks 12–18 per product submission. HTA Compass™ reduces this effort by 40% to 60%, thanks to AI-enabled checkpointing and standardised workflows. The time saved can be redeployed to higher-value work, such as payer strategy, evidence planning, or other strategic initiatives.

4. Governance and Alignment Savings
Cross, functional misalignment leads to duplicated efforts, delayed reviews, and miscommunication. HTA Compass™ structures workflows, aligns teams, and centralizes reporting, typically saving 10% to 20% of cycle time. While harder to quantify, the impact on efficiency and team coordination is significant.

5. Procurement Advantages
Consulting projects create unpredictable spikes in operating expenses, complicating budgeting and approval processes. SaaS subscriptions, on the other hand, offer predictable, budget, friendly costs, which finance teams love. By switching from variable consulting fees to a structured platform subscription, organizations can plan more effectively.

The Bigger Picture

HTA Compass™ is more than just a tool, it’s a capability enabler. It transforms JCA readiness from a reactive, costly process into a proactive, repeatable, and measurable capability. For pharmaceutical companies operating in an era of compressed timelines, rising regulatory demands, and increasingly complex evidence requirements, smarter tools like HTA Compass™ are no longer optional; they’re essential.

By combining AI, structured workflows, and expert guidance, HTA Compass™ ensures that teams can focus on high, value strategy rather than low-value manual work. The result is faster market access, fewer delays, lower costs, and ultimately, a stronger competitive edge in the EU market.

Conclusion

The JCA framework represents a significant shift in European market access strategy. Companies that adapt early, plan proactively, and leverage smart tools like HTA Compass™ will gain a clear advantage. HTA Compass empowers organizations to explore, learn, and prepare effectively, turning JCA readiness from a risk-heavy manual work into a scalable, strategic capability.