EU HTA Readiness and Strategy

Navigate the EU HTA Journey With an Integrated, Evidence-Led Strategy

The EU HTA Regulation (EU 2021/2282) fundamentally changes how clinical value translates into access across Europe.

Beginning in January 2025, Joint Clinical Assessments (JCA) introduced:

One EU-level clinical assessment (replacing national duplication)
A binding PICO framework vs. standard of care
Compressed timelines with limited room to address evidence gaps

Evidence gaps are no longer confined to individual markets but now impact all EU Member States simultaneously. Misalignment with PICO requirements can restrict reimbursable populations. Meanwhile, clinical, regulatory, and market access decisions are increasingly interdependent.

HTA readiness cannot be treated as a submission exercise. It must be embedded early and designed as part of a broader, integrated market access strategy.

Alira Health brings first-wave JCA experience and delivers integrated HTA readiness. We partner with your market access, clinical, and executive teams to establish JCA-ready frameworks across governance, processes, and evidence generation. Using a lead asset as a pilot, we build and validate the approach, then scale it across the portfolio.

Our HTA Regulation Offering: From Pilot to Portfolio

We provide end-to-end support aligned with the EU HTA process, from early development through JCA and national access. Explore the sections below to learn more.

Enterprise Readiness Framework

Pre-registration trial

EU HTA landscape and early PICO forecasting HTA bodies consultation support: Joint Scientific consultation (JSC) or EMA-JSC parallel advice, national advice or mock JSC
Clinical package optimization: pivotal clinical trial design and protocol/SAP optimization
Integrated evidence generation plan: clinical and non-clinical data

Registrational trial

Trial read-out

JCA Process

EU Payer and HTA Landscape Mapping

Schedule a 30-minute JCA preparedness consultation

Why Work With Us

Proven JCA experience: Direct involvement in one of the first EU JCAs (oncology, NSCLC), from PICO prediction through dossier submission
Integrated expertise: Seamless alignment of clinical, medical, regulatory, biostatistics, market access, and HEOR strategies to deliver a single, coherent value narrative
Therapeutic depth: Strong track record in oncology and rare diseases, with deep understanding of evolving HTA expectations
Scientific consultation leadership: Differentiated capabilities in JSC and early evidence strategy, enabling effective PICO shaping and pivotal clinical trial alignment
End-to-end market access perspective: HTAR embedded within a broader global access strategy, linking evidence generation to pricing and reimbursement outcomes

EU HTAR Expert Team

Andrea Mantovani

Partner, Global Value, Access, Pricing, and EU HTA Regulation

Isabel de la Paz

Director, Business Development, Patient, Access, and Evidence

Expert Insights

Preparing Rare Disease Manufacturers for JCA: The Role of Early Stakeholder Engagement

Discover how stakeholder engagement helps rare disease manufacturers prepare for JCA and how to apply stakeholder management best practices in the JCA context.

Patient Involvement Under EU HTA: What JSC and JCA Mean for Pharma, Biotech, and Medtech Companies

Learn where patient involvement fits within JSC and JCA under EU HTA Regulation and how to prepare your engagement strategy.