Early Advice, Long-Term Value: How HTA Engagement Drives Pricing Success 

The key to pricing success for any pharmaceutical product is effectively exhibiting the asset’s value to payers, often through the Health Technology Assessment (HTA) process. However, navigating the HTA process is complicated. Manufacturers often face challenges in meeting the diverse expectations of payers from different markets while developing a comprehensive global clinical trial programme. Many manufacturers question how to appropriately showcase their asset value in pivotal clinical trial designs to secure optimal pricing outcomes for the asset.¹  

Many HTA bodies offer early scientific advice (ESA) to accommodate and help manufacturers fulfil payer HTA requirements.^2,3,4 During ESA, manufacturers can proactively collaborate with relevant HTA bodies to align clinical development with payer expectations. Participation in ESA can enhance evidence generation during the clinical development programme, accurately reflecting asset value and improving pricing negotiations. This article will discuss how engaging with HTA bodies during the ESA process can boost an asset’s long-term value and pricing success. 

Understanding Early Scientific Advice in the EU/UK Context

ESA is a process during which manufacturers can interact with relevant HTA bodies to receive guidance on relevant aspects of the clinical trial design and evidence generation plan. During the ESA process, manufacturers submit a briefing book to the relevant HTA body, which can include the asset value proposition, current clinical trial plan and questions and company positions from the manufacturers to the HTA body. Following the submission of the briefing book, manufacturers will usually attend a meeting with the HTA body, which may also include relevant clinicians and patients’ representatives. Based on the submitted documents and discussions during the ESA meeting, the HTA body will generate answers to questions submitted by manufacturers in the form of a report.^2-4 

Currently, most European HTA bodies offer an ESA service, with the most popular being NICE, G-BA and HAS.^2,3,4 In January 2025, the EU regulation on HTA (Regulation (EU) 2021/2282) (EU HTA Regulation) was implemented, which includes two key elements: a mandatory Joint Clinical Assessment (JCA) and an optional Joint Scientific Consultation (JSC).⁵ Manufacturers can submit a request for JSC to help prepare for and navigate the mandatory JCA.⁵ Although the required documents and the format of the ESA process may vary, all procedures provide manufacturers with the opportunity to align their clinical trial designs and evidence generation plans with information relevant to the market of interest. 

Timing and Strategic Planning

Strategically positioning ESA within the clinical development timelines is key to utilising the full potential of the ESA process in value and pricing optimisation. For a range of reasons, the optimal stage of seeking ESA is pre- or during the Phase II stage, or during Phase III development. This is because:  

• There is a clear value communication strategy – the asset’s value proposition is likely established at this stage. Therefore, ESA presents an excellent opportunity for manufacturers to validate their initial hypotheses regarding their assets’ strengths. 

• Phase III development programme has an initial design, or the planning is ongoing – At this stage of clinical development, manufacturers should have developed an initial design for the Phase III development programme. This enables manufacturers to fully benefit from the ESA process, with questions targeted at expected trial caveats and shortcomings, as well as any possible trial additions and inclusions that manufacturers may be unsure about.  

• There is time to adapt the Phase III development programme. The Manufacturer should aim to receive ESA feedback before the programme is expected to start so that advice can be implemented into the trial design and evidence generation strategy. 

Carefully positioning ESA within the asset’s development plan enables manufacturers to incorporate HTA feedback into the clinical and economic evidence generation plan. This should ultimately enable manufacturers to achieve better pricing outcomes for the asset at the HTA submission stage. Moreover, the ESA process presents an opportunity for manufacturers to enhance cross-functional collaboration among clinical, regulatory and market access teams to develop a consistent value proposition and strategy for the asset. 

Aligning Clinical Development with Payer Expectations 

The main goal of ESA is to align the Phase III development programme and evidence generation plans with payer expectations, which is crucial during pricing negotiations. Payers can be characterised by which elements of the asset value package they consider when deciding on the asset price. For example, German and French payers value the relative clinical effectiveness of the drug against comparators used in the clinical setting.^3-4 In contrast, English payers value the asset’s cost-effectiveness against its comparators.² A pivotal clinical trial should generate sufficient evidence to present these aspects during the HTA process in order to allow manufacturers to achieve the optimal price for their assets. 

To align with payer expectations, manufacturers must choose the relevant trial population, intervention, comparators and outcomes. For example, for most assets launching in Germany³, achieving an additional benefit status, which enhances the asset price potential, is conditional on choosing an appropriate trial comparator and patient subgroups. Similar conclusions can be extended to other markets, such as France⁴ or the UK.² ESA opens an opportunity for manufacturers to, for example, confirm whether the trial comparator or trial population aligns with payer expectations, which will ultimately create a better position for the pricing potential of the asset.  

For markets which utilise cost-effectiveness in their HTA process (like the UK), transferring the asset’s value into an economic model is the key to optimising the asset’s price potential. An appropriate choice of utility measures and methods for generating QALYs can enable manufacturers to reflect the asset’s actual value in the submitted economic model.² For example, assessing the impact of the asset on patient QoL with disease-specific tools can be challenging to incorporate into HTA-standardised cost-effectiveness models. During the ESA process, manufacturers can gain insights into which utility values are important for payers and how and which disease-specific QoL tools can be mapped to measures such as EQ-5D and optimally included in the economic model. This approach will reduce the model’s uncertainty, incorporate relevant utilities into the model, and potentially result in a more favourable incremental cost-effectiveness ratio. 

Impact on Pricing and Reimbursement Success 

ESA offers manufacturers with an opportunity to gain strategic insights and understand payer expectations for the asset. These insights can be incorporated into the pivotal clinical trial design to increase the chance of achieving a favourable price for the asset through: 

• Enhancing Negotiation Leverage – The improved clinical trial data is more likely to align with payer expectations. Thus, during the relevant pricing negotiations, the asset’s value is more effectively presented to payers, further enhancing the manufacturer’s negotiation leverage.¹ 

• Reducing Market Access Risks – Clarifying expected trial shortcomings and caveats creates less space for risk associated with future HTA submissions. Unknowns such as comparator or outcomes choice can be clarified during ESA to achieve a more favourable HTA outcome and strengthen the manufacturer’s position during price negotiations. 

• Building Payer Trust – Participating in ESA allows manufacturers to demonstrate transparency and commitment to an open dialogue with HTA bodies. Hence, the benefits of ESA can go beyond the process itself, as ESA participation strengthens the relationship between payers and the manufacturers.¹ 

Navigating the Evolving HTA Landscape

Participating in ESA allows manufacturers to stay on top of the ever-changing HTA landscape. Not only does ESA allow manufacturers to confirm whether new regulations would apply to their assets, but it also enables manufacturers to ask HTA bodies how new regulations would affect their development plans. A great example of this is the introduction of the EU HTA regulation, which includes mandatory JCAs that will apply to all new pharmaceutical products from 2030.⁵ JSCs enable manufacturers to obtain scientific consultation during the planning of the clinical studies and clinical investigations of a health technology, on the information and evidence needed for subsequent JCAs, ultimately informing their pricing success. 

Conclusion 

In summary, ESA allows manufacturers to optimise their pricing strategy and boost pricing success by: 

• Aligning pivotal clinical trial package with payer expectations 

• Identifying potential risks and uncertainties in the initial trial design 

• Strengthening manufacturers’ relationships with relevant HTA bodies 

These points combined enhance manufacturers’ positions when negotiating or setting the asset price during the HTA submission process.  

To fully take advantage of the ESA process, manufacturers should: 

• Plan the ESA participation early, with the optimal time of ESA being pre- or during the Phase II clinical trial. 

• Review recommendations from HTA bodies and implement relevant changes to the Phase III development programme.  

• Develop internal team alignment on the asset development strategy and its value proposition. 

• Be confident when submitting the ESA package to HTA bodies – do not be afraid to pinpoint any relevant shortcomings at this stage, as ESA is not binding. 

• In the case of JSC, manufacturers must explain why their development plan submitted to the JCA deviates from the JSC advice 

Remap Consulting has extensive experience in guiding pharmaceutical and biotechnology companies through the ESA process. With a proven track record during the ESA in markets such as the UK (NICE), Germany (G-BA), and the EU (JSC), Remap has helped multiple manufacturers to optimise their clinical trial development and enhance the pricing potential of their assets. If you are planning to incorporate ESA during the development of your asset, contact us.

References

1. Wu F, Rusher K, Hunt M. Early Health Technology Assessment Advice: Opportunities to Achieve Collaborative and Efficient Dialogue. Value & Outcomes Spotlight. 2023. 
2. National Institute for Health and Care Excellence (NICE). NICE Advice Service – Scientific Advice (webpage). Accessed 2 June 2025. 
3. Federal Joint Committee (G-BA). Benefit Assessment of Medicinal Products – Parallel EMA/HTA Scientific Advice (webpage). Accessed 2 June 2025. 
4. Haute Autorité de Santé (HAS). Guidance for National Early Dialogues on Medicinal Products. 2015. 
5. Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on Health Technology Assessment. Official Journal of the European Union L 458/1.