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To avoid HTAR bottlenecks, NICE and MHRA offer a strategic alternative

With limited JSC slots, arranging a meeting with NICE & MHRA is a strategic alternative for clinical developers seeking early feedback.

 

Regulation (EU) 2021/2282 came into force in January 2022 and applies from January 2025. The new rules introduced a new era of collaboration between regulators and Health Technology Assessment (HTA) bodies across Europe. The objective is to give patients in the EU faster, wider access to innovative and effective health technologies. The joint scientific consultation process is central to the new regulation. The JSC process is designed to provide developers with early, coordinated feedback from both the European Medicines Agency (EMA) and HTA bodies in EU member states. However, it is becoming increasingly clear that JSC slots will be limited for the foreseeable future. Not all drug and medical device developers who wish to avail of them will have the opportunity to do so. 

In our previous UK-focused blog we discussed the value of interacting with the Medicines and Healthcare products Regulatory Agency (MHRA) during drug development. In this blog we dive further into the opportunity for interactions with both the MHRA and the National Institute for Health and Care Excellence (NICE). These meetings offer drug and medical device developers a strategic alternative when they are unable to access a JSC.  

The JSC bottleneck

The JSC process offers a valuable opportunity for developers to align their evidence-generation plans to both regulatory and reimbursement requirements. The meetings are managed by the Member State Coordination Group on HTA (HTACG). Demand for these consultations is high, and the number of available slots is constrained by the capacity of the HTACG and participating agencies. As few as five slots are available for JSCs in 2025 and with 28 marketing authorisation applications for oncology products in 2024, competition for these slots will be fierce.

NICE and MHRA: A strategic alternative

As outlined in our previous blog, seeking advice from the UK’s MHRA and NICE can help sponsors to overcome regulatory obstacles. Joint scientific advice (JSA) from the UK’s MHRA and NICE offers a compelling alternative to developers unsuccessful in obtaining a JSC slot, or those who expect JCA to be a feature of their future marketing authorisation application (MAA).

These joint advice meetings provide a platform to discuss clinical development plans that meet both regulatory and HTA expectations. Rather than separate dialogues, both organisations will be in the same room, increasing collaboration and the likelihood of a clear direction forward. Developers receive tailored feedback on study design, evidence requirements and even health economic modelling. Optional input from the Clinical Practice Research Datalink (CPRD) further enhances the relevance of real-world evidence strategies.

The meeting format is flexible and agreed upon in advance. It will typically be face-to-face and last up to three hours, allowing for detailed conversations. By contrast, the JSC is capped at two hours. Following the meeting, both MHRA and NICE issue separate advice documents, similar to those of the JSC. These documents offer clear, actionable insights to inform development and market access strategies.

 JSCMHRA/NICE JSA
Procedure duration Follows EMA D70 SA timelines but with limited starting slotsFollows MHRA SA timelines with meeting date set based on availability of MHRA/NICE
Available slotsUp to 7 in 2025 for drugsNo cap on the number of MHRA/NICE JSA, however, if demand is high resource constraints may lead to limits 
Meeting duration Up to 2 hoursUp to 3 hours
Cost

EMA SA fees are covered by the relevant regulation and are up to €98,400

HTA fees are not discussed in the guidance

MHRA fees are up to GB£17,516

NICE charges fees and can estimate the fees based on scope
Value of advice to European JCAClear value given involved HTAs will be those assessing the dossier. However, HTAs may come from any participating member state and may not always be a state that will be a priority market.

Direct value is open to discussion 

Prior to Brexit, NICE were a leading payer and a reference payer across Europe and their expertise is well established. Models used by NICE are similar to those of Sweden and the Netherlands with an emphasis on cost effectiveness which is complementary to clinical evidence standards expected by Germany and France and which should be achieved through regulatory scientific advice.

The value of a payer perspective

Engaging with NICE early in the development process is particularly beneficial for companies aiming to optimise their market access strategy. NICE’s scientific advice service provides detailed, confidential feedback on a wide range of topics, including:

  • Evidence generation strategies
  • Health economic modelling
  • Use of real-world evidence
  • Gap analysis of existing data
  • Peer review of economic models

This advice is grounded in NICE’s deep understanding of NHS priorities and HTA requirements, helping developers build a robust value proposition that resonates with payers.

Recent research underscores the impact of NICE’s advice service. A study presented at the ISPOR Europe conference found that products receiving NICE scientific advice reached guidance publication nearly three months faster than those that did not. This acceleration can be critical in competitive markets, where time-to-access influences both commercial success and patient outcomes.

Getting ahead of the curve

Some developers’ products may not meet the JSC selection due to limited novelty, lack of unmet need, or targeting of common conditions. The NICE and MHRA joint advice pathway offers these developers an alternative strategic advantage. It allows companies to refine their development plans with both regulatory and HTA perspectives, increasing the likelihood of a successful marketing authorisation and reimbursement outcome.

While each situation is unique, we recommend early engagement with MHRA and NICE. In a typical development scenario ICON Regulatory Consulting Solutions would suggest arranging the JSA meeting during Phase II development when the pivotal study protocol(s) are being designed. This allows ample opportunity to incorporate the feedback to into the protocols before discussions with the FDA and EMA.

How ICON supports parallel agency and payer interactions

ICON’s approach of seeking parallel advice between payers and regulator helps ensure that pivotal drug development programs are designed to meet the needs of both parties. We offer bespoke support to customers interested in parallel NICE/MHRA advice or a JSC, including:

  • Determining the most appropriate regulatory strategy
  • Authoring briefing packs
  • Developing questions and company positions
  • Leading submission activities and preparing your team using our in-house tools and senior leader lead rehearsals

As a global CRO we collaborate with our colleagues across a range of disciplines to provide additional supports to customers’ as required. These include, but are not limited to, real world evidence, therapeutic area expertise, and clinical and scientific operations.  

Conclusion

As the HTAR framework continues to evolve, the limited availability of JSC slots presents a challenge for many developers. However, this also opens the door to alternative pathways that can be equally, or more, strategic. By engaging with NICE and MHRA through their JSA services, developers gain critical insights, strengthen their evidence base and position their products for success in both regulatory and reimbursement arenas.

In a competitive landscape where early alignment and payer engagement are increasingly vital, these services offer an opportunity to get ahead of the curve - especially for those who may not qualify for JSC but still aim to bring impactful innovations to patients across Europe and the UK.

Contact ICON Regulatory Consulting Solutions for advice on maximising the value of early engagement for your drugs future reimbursement strategy.

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