EU HTA Regulation Strategic Support

Navigating HTA Compliance for Faster Market Access

Home » EU HTA Regulation Strategic Support

Regulation (EU) 2021/2282 on health technology assessment (HTAR) is reshaping market access for pharmaceuticals. Companies now face stricter evidence requirements, accelerated timelines, value-based pricing demands, and increased engagement with HTA bodies. These changes add significant workload, requiring seamless cross-functional coordination and integrated data strategies.

To succeed, pharma companies must prioritize patient-centric development, ensuring that new therapies address real-world needs while meeting evolving regulatory standards and sustainability goals. Aligning global, regional, and local teams for Joint Clinical Assessments (JCA), optimizing biometrics, and streamlining regulatory submissions are critical. We help our clients navigate this complex landscape, ensuring organizational readiness and execution excellence—so they can bring innovative therapies to patients faster, gain broad acceptance, and secure sustainable reimbursement.

Our Approach to HTAR Readiness

We propose a six-module approach to help monitor and understand the impact of the HTAR. This approach aims to proactively address challenges posed by these changes, enhancing market access and commercial success of new therapies in the evolving European healthcare landscape.

Step 1

New regulations current status and monitoring: increase the knowledge on the new EU regulations through regulatory training and continuous update service

Step 2

EU HTAR process tracking: identify the critical JCA to local P&R steps, milestones, deadlines, action items to implement and task owners

Step 3

Pipeline impact assessment: analyze the level of readiness the pipeline towards the new EU regulations

Step 4

Organizational assessment and cross-functional readiness: evaluate the level of readiness of your corporate characteristics, policies, and pipeline to approach the requirements of the HTAR

Step 5

Integrated implementation roadmap: translate the outcomes of the diagnostic process in areas of intervention and into a tactical roadmap to guide your next steps

Step 6

Role of AI and BI tools: review AI and BI tools that could enhance internal processes towards the internal application of the HTAR

A Range of Access Activities for Your Commercial Success

Market Acces and Pricing

Regulatory

Patient Engagement

Market Acces and Pricing

Regulatory

Patient Engagement

One of the most significant changes is the need for early engagement with European HTA bodies. Companies now need to collaborate with HTA stakeholders much earlier in the development cycle to ensure their clinical trial designs, endpoints, comparators, and patient populations align with JCA expectations.

Andrea Mantovani
Partner, Market Access and Pricing

Why Partner With Us?

An integrated, patient-centric approach, offering end-to-end consulting driven by real-world evidence to align regulatory, clinical, and commercial strategies for maximum impact.
A proven track record of delivering results, partnering with leading pharma, biotech, and medtech companies to provide tailored strategies, innovative tools, and actionable recommendations.
A deep expertise in market access and HTA, which allows us to provide strategic insights to navigate complex HTA regulations, ensuring faster and more sustainable market access.

How to Navigate the JCA Era:
Market Access Strategy Optimization in the EU

With the JCA now in effect, we spoke with Andrea Mantovani, Alira Health Partner, Market Access and Pricing, about its impact on pharmaceutical companies hoping to bring new therapies to market.