Navigate Approvals and Secure Optimal Reimbursement

Securing favorable pricing and reimbursement outcomes requires more than strong clinical data, it demands deep understanding of HTA frameworks, payer priorities, and local healthcare dynamics.

Our HTA and Pricing & Reimbursement services combine technical expertise with proven stakeholder relationships to guide you through complex approval pathways, from Joint Clinical Assessments to national negotiations, ensuring your innovation achieves optimal access conditions. 

Definitions of healthcare pricing and reimbursement strategies

EU and Multi-Country Strategies

EU Health Technology Assessment Regulation (HTAR) Readiness 

Prepare for Joint Clinical Assessments under the new EU HTA framework. We conduct PICO assessments, gap analyses, and JCA readiness evaluations to align your evidence with centralized requirements and de-risk the approval process across member states. 

 

Global Value Dossier Creation 

Develop core evidence platforms that establish consistent value messaging across markets. Global value dossiers provide the foundation for country-specific adaptations while ensuring scientific rigor and strategic alignment with your broader market access objectives. 

 

Stakeholder Engagement and Advisory Services 

Build and maintain strategic relationships with HTA bodies, payers, regulators, and key opinion leaders. Our teams facilitate early scientific advice, parallel consultations, and ongoing dialogue to align evidence generation with decision-maker expectations. 

 

Innovative Pricing Model Development and Testing 

Design and validate outcomes-based agreements, risk-sharing schemes, and performance-based contracts. We model financial implications, test scenarios with payers, and provide implementation support to ensure innovative pricing approaches deliver value while managing risk. 

Expert consulting for healthcare pricing and reimbursement solutions

National and Regional Submissions 

HTA Dossier Development 

Build comprehensive, evidence-based submissions tailored to national and regional HTA bodies. Our dossiers address clinical benefit, comparative effectiveness, and economic value in formats that meet specific assessor expectations and maximize approval likelihood. 

 

Pricing and Reimbursement Dossier Preparation 

Prepare country-specific P&R submissions that address local requirements, reference pricing frameworks, and payer concerns. Our dossiers integrate clinical, economic, and budget impact evidence to support reimbursement applications and pricing justifications. 

 

Subnational and Regional Formulary Positioning 

Accelerate access in decentralized healthcare systems through targeted regional and local strategies. We map formulary pathways, develop regional payer materials, and support submissions to reduce time from national approval to patient access. 

Negotiation and Implementation 

Pricing and Reimbursement Negotiation Support Navigate complex negotiations with payers and national authorities to pursue favorable terms. We provide analytical modeling, scenario planning, budget impact simulations, and strategic counsel throughout the negotiation process to optimize pricing outcomes. 

Why It Matters

The gap between regulatory approval and reimbursement can delay patient access by months or years. Success requires: 

Critical Success Factors: 

  • Deep local expertise – Understanding country-specific HTA processes, payer priorities, and negotiation dynamics 
  • Strong stakeholder relationships – Proven connections with national and regional authorities that facilitate smoother approvals 
  • Technical excellence – Rigorous evidence development that addresses clinical, economic, and budget impact concerns 
  • Strategic agility – Ability to adapt to evolving frameworks like JCA and navigate complex multi-stakeholder environments 

 

Without Strong HTA Capabilities: 

  • Reimbursement delayed by 6-18 months post-approval 
  • Suboptimal pricing or restrictive access conditions 
  • Weak negotiating position with national payers 
  • Inconsistent access across regions and markets 

 

Effective HTA Strategy Delivers: 

  • Faster access  
  • Better pricing outcomes and favorable reimbursement terms 
  • Sustainable reimbursement supporting long-term commercial success 
  • Consistent market access across target geographies 

Our Approach

We combine global capabilities with broad local presence in a variety of markets. 

Our teams bring: 

  • In-depth knowledge of local healthcare systems, regulatory frameworks, payer dynamics, and HTA processes 
  • Strong relationships with national and regional authorities built through years of successful collaboration, including direct experience with over 150 national HTA submissions 
  • Proven track record navigating intricate approval processes and negotiating favorable pricing and reimbursement terms 
  • Integration with health economics, regulatory affairs, and market access strategy to ensure evidence alignment across the product lifecycle 
  • Real-world experience with innovative therapies including cell and gene therapies, digital therapeutics, and precision medicines 

 

Whether preparing for centralized EU assessments or navigating country-specific negotiations, we ensure your evidence meets requirements, your strategy reflects local realities, and your innovation achieves the access it deserves. 

 

Ready to secure optimal reimbursement for your innovation?

Contact us to explore your HTA and pricing strategy.

PLG's extensive expertise, combined with its flexibility and adaptability, ensured not only the correct definition of the product’s value but above all its recognition by the regulatory authorities and the best possible patient access.

Head of Value and Access