Early HTA dialogue is a structured consultation process in which drug developers engage with Health Technology Assessment bodies before submitting a formal HTA dossier, allowing them to align their clinical development plans with the evidence requirements that payers and HTA agencies will later use to judge a product’s added therapeutic value. It directly affects market access by reducing the risk of evidence gaps at the time of submission, which can otherwise lead to restricted reimbursement, price negotiations anchored to weak comparator data, or outright rejection.
Under the EU HTA Regulation, which entered into force in 2025 and expanded its scope in 2026, joint scientific consultations at the European level have made early dialogue more structured and consequential than ever for companies seeking access across multiple EU member states simultaneously. The sections below unpack how the process works, who qualifies, and what developers should consider at each stage of their pipeline.
How does early HTA dialogue actually work in practice?
Early HTA dialogue works through a formal or informal consultation process in which a developer submits a briefing document outlining their development program, proposed comparators, and intended endpoints. HTA bodies then review the document and provide written or face-to-face feedback on whether the planned evidence package is likely to meet their assessment criteria. The output is typically a set of recommendations, not binding decisions, but they carry significant weight in shaping development choices.
At the EU level, joint scientific consultations are coordinated by the Health Technology Assessment Coordination Group. A developer submits a scoping request, the coordination group assembles a multistakeholder assessment team, and a structured dialogue follows. The process can include input from patient representatives and clinical experts, making it more comprehensive than a standard regulatory interaction.
Nationally, processes vary considerably. Some agencies, such as NICE in the UK or HAS in France, have well-established scientific advice programs with defined timelines and formats. Others operate more informally. Companies operating across multiple markets often need to run parallel national dialogues alongside EU-level consultations, which requires careful coordination to avoid conflicting guidance. To understand how we support clients through this complexity, visit our services overview.
Which products are eligible for early HTA dialogue?
Under the EU HTA Regulation, early HTA dialogue through joint scientific consultation is available to medicinal products expected to undergo central marketing authorization, particularly those in therapeutic areas covered by joint clinical assessments. This includes oncology products, advanced therapy medicinal products, and products designated as orphan medicines. Medical devices classified as class IIb or class III, and certain in vitro diagnostics, are also within scope.
Eligibility at the national level is broader. Most national HTA bodies will engage in some form of early dialogue with any product that is expected to be submitted for reimbursement, provided the development program is sufficiently advanced to allow meaningful discussion. Products in early phase II are generally the earliest point at which dialogue becomes productive, since the evidence base needs to be concrete enough to discuss comparators and endpoints meaningfully.
Developers of combination products, biosimilars with intended label extensions, and repurposed medicines should also consider early HTA engagement, as these categories often face non-standard assessment frameworks that benefit from early clarification.
What evidence gaps does early HTA dialogue help identify?
Early HTA dialogue helps identify gaps between what a clinical development program is designed to demonstrate and what HTA bodies actually need to make a reimbursement recommendation. The most common gaps involve the choice of comparator, the selection of endpoints, the relevance of the patient population studied, and the duration of follow-up data available at the time of submission.
HTA bodies frequently prioritize outcomes that differ from those required by regulators. A regulatory agency may accept surrogate endpoints such as progression-free survival to grant marketing authorization, while an HTA body may require overall survival or quality-of-life data before recommending reimbursement. Identifying this divergence early allows developers to design trials that satisfy both requirements, or at minimum, to plan supplementary studies that can support the HTA dossier.
Other gaps that early dialogue commonly surfaces include:
- Absence of head-to-head comparator data against the established standard of care in specific markets
- Subgroup analyses that are not pre-specified or adequately powered for the populations most relevant to payers
- Indirect treatment comparison methodologies that HTA bodies may not accept
- Patient-reported outcome measures that were not collected or validated for the target population
- Real-world evidence plans that lack the rigor or timeframe HTA bodies require for post-launch assessments
How does early HTA dialogue differ from regulatory scientific advice?
Early HTA dialogue and regulatory scientific advice are distinct processes with different objectives, even though both involve pre-submission consultation. Regulatory scientific advice, provided by agencies such as the EMA, focuses on whether a product’s development program will meet the standards required for marketing authorization, including safety, efficacy, and quality. Early HTA dialogue focuses on whether the evidence generated will support a positive reimbursement decision and demonstrate added value over existing treatments.
The two processes use different frameworks. Regulators assess absolute benefit-risk profiles against placebo or existing treatments in a controlled setting. HTA bodies assess relative effectiveness in routine clinical practice, often with a much narrower view of which comparators are relevant in their specific national context.
Importantly, the two types of advice can sometimes conflict. A development program designed to optimize regulatory approval may not generate the comparative effectiveness data that HTA bodies need. Running both processes in parallel and reconciling any divergent recommendations is one of the core challenges of modern regulatory and market access strategy. Parallel EMA-HTA scientific advice, which the EU HTA framework now supports, was designed specifically to help developers navigate this tension.
When in the development timeline should companies seek HTA dialogue?
Companies should seek early HTA dialogue no later than the end of phase II, and ideally before finalizing the design of their pivotal phase III trial. This timing ensures that feedback on comparators, endpoints, and patient populations can still be incorporated into the trial protocol rather than requiring costly amendments or supplementary studies after the fact.
For products in complex or fast-moving therapeutic areas, even earlier engagement during phase I or at the proof-of-concept stage can be valuable. This is particularly true for advanced therapy medicinal products, where the evidence generation pathway is less standardized and HTA bodies may have limited prior experience with the product class.
A practical timeline for most products looks like this:
- Phase I to early phase II: Landscape assessment of HTA requirements in target markets, identification of relevant comparators and endpoints
- End of phase II: Formal early HTA dialogue or scientific advice request, covering trial design for the pivotal study
- Phase III initiation: Incorporation of HTA feedback into the protocol, including patient-reported outcomes and subgroup pre-specifications
- Phase III interim or end of study: Follow-up dialogue to address any evolving HTA requirements or changes in the treatment landscape
- Pre-submission: Dossier gap analysis against current HTA guidelines and feedback received
How does early HTA dialogue influence reimbursement and pricing outcomes?
Early HTA dialogue improves reimbursement and pricing outcomes by reducing the uncertainty that payers face when assessing a new product. When a developer has engaged with HTA bodies early and designed their evidence package to address known assessment criteria, the resulting dossier is more likely to receive a positive added-value rating, which directly supports stronger pricing and broader reimbursement conditions.
Products that enter HTA assessment with evidence gaps, particularly around comparator data or long-term outcomes, are frequently rated as having uncertain or minor added value. This results in pricing anchored to the cheapest available alternative, restricted indications, or managed entry agreements with onerous post-launch data collection requirements. Early dialogue reduces the probability of these outcomes by aligning the evidence base with what payers need before the data is collected.
There is also a strategic dimension to pricing. In markets where price negotiations follow the HTA rating, a higher added-value rating gives developers more leverage. Companies that have engaged early and can demonstrate that their clinical program was designed in consultation with HTA bodies are often better positioned to defend their pricing assumptions during negotiations. Learn more about our approach and background to understand the expertise we bring to these strategic discussions.
How Starodub supports your early HTA and market access strategy
Navigating early HTA dialogue requires a clear understanding of both the regulatory pathway and the market access landscape, and aligning the two before pivotal trials begin is where the biggest impact is made. We work with biopharmaceutical companies at every stage of development to ensure that regulatory and HTA strategies reinforce rather than undermine each other.
Our support in this area includes:
- Mapping HTA requirements across EU member states and identifying divergences that need to be addressed in trial design
- Preparing briefing documents and dossiers for early HTA consultations and joint scientific consultations under the EU HTA Regulation
- Coordinating parallel EMA and HTA scientific advice to reconcile regulatory and payer evidence requirements
- Conducting evidence gap analyses to identify what data is missing and how to generate it efficiently within the development program
- Supporting combination product developers, ATMP sponsors, and companies with complex product classifications where HTA frameworks are less established
Whether you are entering phase II or preparing a pre-submission dossier review, we can help you build an evidence strategy that holds up under HTA scrutiny. Get in touch with our team to discuss your product’s development stage and market access goals.
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This content was generated with the help of AI — it may contain mistakes
