Services HTA & Market Access Support

HTA & Market Access Support

DLRC provides strategic HTA & Market Access support that helps pharmaceutical and biotech companies navigate EU complexity, strengthen reimbursement readiness and accelerate patient access. Our integrated support connects regulatory planning, evidence generation, and market access strategy to address payer expectations early and prepare effectively for HTA and reimbursement decisions.

DLRC is a trusted HTA, access and regulatory partner with a global footprint. From pre-clinical to post-launch, our EU, UK and US teams partner with biotech, pharma, advanced therapy and MedTech innovators to support successful access across key markets.

HTA Roadmap DLRC

The measurable impact of strategic HTA & Access support

Maximised evidence ROI

Every research investment should support future reimbursement success. We help you prioritise the evidence generation activities most relevant to HTA bodies and payers, so your development programme delivers stronger pricing, reimbursement and pricing outcomes. This reduces evidence gaps and helps direct investment where it creates the greatest value.

Accelerated time-to-reimbursement

Speed to market launch and reimbursement creates a competitive advantage. Our HTA planning starts early, helping to strengthen evidence generation strategies for pivotal studies. By identifying payer-relevant evidence requirements before pivotal studies begin, we help reduce downstream evidence gaps and support a smoother path for reimbursement.

Data transformed into value stories

Clinical data alone is rarely enough to secure favourable access decisions. We help identify evidence gaps early, shape studies that address HTA and payer requirements, and develop submissions that clearly communicate clinical value. This strengthens your value story and supports more effective decision-making.

HTA & Access services that drive results

We provide end-to-end support across the HTA & market access, pricing & reimbursement journey, including:

HTA Strategy & Planning

We develop comprehensive HTA roadmaps that connect evidence generation, regulatory planning and commercial objectives. By assessing HTA expectations across target markets early, we identify critical evidence gaps and define practical solutions to pave the path for optimal evaluation. Our planning helps ensure that the clinical development programmes generate evidence that is relevant not only for regulatory approval but also for reimbursement.

Evidence Generation Consulting

We design and execute evidence strategies that address HTA body expectations and support robust value propositions. DLRC can advise on health economics, comparator strategy, burden of illness, and payer-relevant evidence needs to help ensure your studies support pricing and reimbursement objectives. We help prioritise the activities that will have the greatest impact for coverage and pricing negotiations.

HTA Submission Preparation

We support preparation for the EU HTA procedure, including Joint Clinical Assessment (JCA) and Joint Scientific Consultations (JSC). Building on this foundation, we help clients translate EU-level evidence requirements into effective national HTA and reimbursement strategies across key markets. Our support ensures submissions and supporting materials are scientifically rigorous, strategically structured, and tailored to the expectations of relevant decision-makers. This helps reduce common pitfalls, strengthen positioning and avoid unnecessary delays across the access pathway.

Pricing & Reimbursement Support

We deliver strategic and tactical market access support to help achieve optimal pricing and reimbursement outcomes, including value-based pricing analyses, pricing landscape assessment, and evidence-based recommendations for payer engagement. Our access to a global pricing database further enables robust international benchmarks and nuanced insights into pricing dynamics across markets.

Stakeholder Engagement & Advisory

We facilitate productive dialogue with HTA bodies, payers, clinical experts, and patient advocacy groups throughout the review process. We coordinate advisory boards, manage scientific consultations, and prepare teams for committee interactions and presentations. Our established relationships help navigate complex stakeholder dynamics and address their concerns in a structured and credible way.

Market Access Intelligence

We provide strategic and tactical market access support to inform pricing and reimbursement decisions. Our team monitors policy developments, tracks competitor activity, and analyses trends to inform access strategies that are realistic, evidence-based, and commercially relevant.

Key Resources

Whitepaper: From Regulatory Approval to Patient Access

FAQ: EU HTA Joint Clinical Assessment (JCA)

Project Spotlight: Aligning Regulatory and HTA Strategy Through a Parallel Joint Scientific Consultation

Article: EU HTA and JCA - Redefining Market Access Strategy in Europe

Ready to align your regulatory strategy with market access success?

Book a no-obligation discovery call to explore how our HTA experts can help connect regulatory planning, evidence generation, and payer expectations across your market access journey.

Book a discovery call

Beyond traditional HTA services

Many HTA consultants focus primarily on either regulatory or commercial access questions. DLRC connects both perspectives, ensuring that evidence and strategy support not only approval, but also successful reimbursement and market access.

The DLRC Difference: Regulatory & Commercial Alignment

Integrated teams

Our regulatory and HTA experts work together on every engagement, helping you make decisions that reflect the full evidence-to-access pathway.

Dual success metrics

We don’t stop at technical HTA advice. We help shape strategies that improve payer relevance, strengthen reimbursement positioning, and support commercially meaningful outcomes.

Cross-functional deliverables

Every recommendation considers regulatory implications, HTA expectations, and commercial impact together. This cross-functional strategic integration helps you, as our strategic partners, make better-informed decisions and creates more consistent strategies across development and product launch.

Find out more about DLRC

Explore regulatory services Meet the team Contact our experts

Testimonials

See what our clients have to say about DLRC

Thank you so much for your support and for guiding us through the entire process! Especially the last couple of weeks were so intense and have shown how important a well aligned team is! Great job everyone … You were our compass all the time… you were always spot on when needed; and all the time, you gave us the confidence to get where we wanted to be at the end.

We wanted to extend our thanks for all of your hard work, expertise and thoughtful partnership … You have been instrumental in operationalizing … capabilities we have been building together across people, process, tech, and content. We know that it hasn’t been easy at times because we are building something totally new and consider you a great partner to navigate this with. We are really looking forward to our continued work … Thank you!”

I take this opportunity to thank you for your initiative and agility in leading regulatory response and strategy in unexpected circumstances … Your support is indispensable and highly appreciated.

I would like to thank DLRC for the great leadership of the filing team and the fantastic preparation and chairing of the pre-submission meeting with the team and rapporteurs. It is great to have your experience and expertise on board for this important filing. The team managed to get all possible information from the rapporteurs in a fruitful and professional atmosphere, fostering great communication amongst the attendees.

We’d like to acknowledge DLRC for their hard work and ‘whatever it takes’ mindset during the recent project activities they completed for us, including key protocol amendment submissions made across multiple countries.

As a small biotech company with no facilities in Europe, we needed a strong partner to represent us and to support our global initiatives. The team assigned to our program has provided a broad range of regulatory expertise and operational support, and has been thorough, organized, responsive, and a pleasure to work with. The onboarding of the DLRC team was seamless, and they made efforts to familiarize themselves with our product and program right away so that they could contribute to both strategic planning and execution. I look forward to continuing our partnership as we progress our program.