As the regulatory and market access landscape continues to evolve across Europe, timely and strategic engagement with health technology assessment (HTA) bodies is becoming increasingly critical. Nearly one in four HTA submissions have faced at least one prior rejection, highlighting the importance of meeting HTA body expectations around evidence quality and clinical benefit demonstration.1 To navigate HTA submissions effectively, it is essential to have a clear understanding of the assessment processes employed by different HTA bodies. Early HTA advice offers an opportunity to align internal evidence generation with payer and HTA expectations before pivotal trials begin.
The landscape is set to become significantly more complex with the introduction of the EU HTA Regulation (EU Regulation 2021/2282), which includes mandatory Joint Clinical Assessments (JCAs). While the JCA aims to harmonise the clinical evaluation of health technologies across all member states, there have been concerns that this will compress timelines and multiple evidence demands, stretching the resources of cross-functional teams.2 Success will depend on strong internal alignment among global, regional and local regulatory and market access teams to plan resource requirements and integrate evidence effectively.
Early HTA advice processes are designed to address key considerations such as defining reimbursable patient populations, selecting appropriate comparators, identifying relevant clinical endpoints, and mitigating clinical and economic uncertainties. Various options exist for seeking advice, including national scientific advice and informal HTA input through advisory boards. Additionally, Joint Scientific Consultations (JSCs), introduced as an integral part of the EU HTA Regulation, are resource-intensive but valuable for early HTA advice, particularly when defining PICOs (Populations, Interventions, Comparators, Outcomes). Proactive engagement with HTA bodies is vital to align internal strategies and meet evolving external expectations.
This article explores how early engagement with HTA bodies drives better internal alignment, streamlines development and ultimately leads to more robust pricing and market access outcomes.
The Strategic Value of Early HTA Advice
Early HTA advice provides manufacturers with critical insights that influence both development and commercial strategies, helping reduce appraisal timelines by 3 months.3 As a result, market access strategy is moving towards involvement in clinical trial planning, helping to ensure that key stakeholder perspectives are integrated from the outset. By engaging with HTA bodies during the early phases of clinical development, manufacturers can design pivotal trials that not only meet regulatory standards but address the expectations of payers and HTA bodies.
With the introduction of the EU HTA Regulation, it is becoming more vital that scientific advice is sought prior to Phase III protocol development, enabling manufacturers to incorporate regulatory guidance into the clinical trial design. Aligning the goals of the clinical development teams with the priorities of HTA bodies can:
- Identify and address evidence gaps at a stage when changes are still feasible
- Ensure that clinical endpoints are relevant and meaningful to HTA bodies and payers
- Understand the evolving requirements across different jurisdictions, thereby future-proofing submissions
Breaking Down Silos: Aligning Clinical, Regulatory and Commercial Functions
Early HTA advice unites clinical, regulatory and commercial teams through shared objectives and evidence expectations. This coordinated effort naturally eliminates departmental isolation and fosters a collaborative environment, ensuring all departments internalise the payer perspective. Furthermore, seeking HTA advice can provide early external validation for clinical and economic evidence plans, strengthening their robustness and enhancing the credibility and relevance of data. It also improves internal efficiency, increasing the agility needed to navigate an evolving HTA landscape. By embedding HTA considerations early, manufacturers build a ‘one story’ approach, where a consistent, compelling narrative underpins every submission and stakeholder interaction.
Practical Steps to Operationalise Early HTA Advice
Successful implementation of early HTA advice into development planning requires a structured and inclusive approach. This begins with early initiation of cross-functional discussions during Phase II planning or even earlier, to proactively identify the needs of early HTA advice. Establishing a working group of cross-functional internal stakeholders from the onset, including clinical, regulatory, medical affairs, HEOR, market access, commercial and legal, guarantees an integrated approach that can maximise the strategic value of early payer feedback.
It is also important for manufacturers to clearly define their non-negotiables and areas where flexibility exists before engaging with HTA bodies. This clarity ensures that cross-functional teams are aligned on critical positions and can confidently negotiate or adapt where appropriate. Such preparation helps shape internal alignment on key priorities and reduces internal conflict, while preventing the receipt of redundant advice that is impractical to implement due to internal constraints.
Conclusion
Seeking early HTA advice is no longer a discretionary activity but a strategic imperative. By seeking scientific guidance early in the development process, manufacturers can align clinical, commercial, regulatory and market access objectives, ensuring a unified and compelling value story. Through early engagement with HTA bodies, manufacturers can streamline internal decision-making and validate their external value proposition.
The evolving landscape, marked by initiatives such as the JCA, further reinforces the need to adopt early HTA advice as a standard practice. Those who act early and collaboratively will be best positioned to navigate payer expectations and secure optimal outcomes for their therapies.
Remap Consulting offers strategic guidance and practical support to manufacturers seeking early HTA advice, supporting them through tailored strategic input and planning guidance.
Join our upcoming webinar, Navigating Early Scientific Advice for Pricing and Market Access Success, to learn how we can help you operationalise early HTA advice and position your assets for long-term success: Register here.
References:
- Kanavos P. How HTA processes are used to shape access to medicines? NR.
- IQVIA. The future of EU HTA: How pharmaceutical companies can prepare for the new process. 2022.
- NICE. NICE Advice service. NR.