LIVV supports pharmaceutical and biotechnology companies with market access, pricing and reimbursement in Belgium. We combine strategic advice with hands-on execution, supporting clients from early reimbursement strategy and evidence assessment through dossier development, submission and follow-up.
Our approach brings together clinical and economic evidence, Belgian healthcare system expertise, stakeholder insights and the patient perspective to build a clear and evidence-based pathway towards reimbursement and patient access.
Our support can include:
- Belgian market access and reimbursement landscape assessment
- Pricing and reimbursement strategy
- Treatment pathway and comparator assessment
- Clinical evidence review and evidence gap analysis
- Systematic literature reviews
- Stakeholder mapping and engagement
- KOL interviews, advisory boards, Delphi panels, focus groups and surveys
- Patient research and patient insights
- Health economic modelling
- Budget impact analysis
- Value proposition and strategic positioning
- Pricing and reimbursement dossier development and medical writing
- Submission preparation and coordination
- Responses to questions during the assessment procedure
- Post-submission strategic support
Integrating the patient perspective
Patient perspectives can provide important insights into disease burden, unmet needs, treatment experience and outcomes that matter to patients. LIVV integrates the patient voice into market access projects through qualitative and quantitative patient research, including interviews, surveys, focus groups and patient advisory activities.
These insights can inform the value proposition, evidence strategy, reimbursement dossier and broader stakeholder engagement strategy, helping ensure that market access decisions reflect not only clinical and economic evidence but also the realities of patients living with the condition.
3-step approach
How do we manage Price & Reimbursement (P&R) activities?
LIVV writes and submits pricing and reimbursement dossiers to support the product’s market entry. Each dossier is tailored to meet the requirements of healthcare authorities and payers, showcasing the product’s value and benefits. After submission, we engage with stakeholders to address any questions, aiming to secure favorable pricing and reimbursement outcomes that ensure broad access to the product.
- We assess the specific local requirements and regulations.
- We facilitate interactions with all stakeholders, including patients, health authorities and decision-makers.
- We collect insights from stakeholders through interviews, focus groups, and surveys.
- We prepare submission ready P&R dossiers that include all necessary reports, aligned with local legislation and healthcare guidelines.
- We assess the unique value of your product for your company, as well as for patients, healthcare systems, and society as a whole, by creating health economic models.
- We guide you through every step of the P&R dossier assessment process.
- We offer continuous support after submission as regulations and market conditions evolve.
Experience
Set-up and management of Early Access Programs
Early access programs (also named Compassionate Use or Medical Need Programs) provide a way for patients with life-threatening diseases to access investigational medicinal products before they are approved for market use.
Our team was involved in a Global Early Access Program from Johnson & Johnson in the hematology field. Our expertise encompassed:
- Defining market access strategies for EU countries
- Provide guidance for program design in collaboration with key stakeholders
- Writing of application dossier for submission to Health Authorities
- Set-up of the patient and HCP flow to ensure a smooth and efficient program process
- Vendor selection and management for medicinal product distribution
- Set-up and management of global program budget
Strategic dossier development & submission for change in nomenclature
A pharma company reached out to LIVV to request support in preparation and submission of a dossier to request a change in nomenclature in Belgium.
Our approach:
- Phase 1: strategic analysis including stakeholder engagement.
- Phase 2: execution phase with delivery of an application dossier including Budget Impact Analysis.
- Phase 3: support after submission.
P&R dossiers in Belgium and the Netherlands in several therapeutic areas
Belgium
- Class 1
- Orphan medicines
- Class 2B
- Modification of reimbursement criteria Art 59
- Class 3
Discuss your pharmaceutical market access strategy
Whether you are preparing for a Belgian pricing and reimbursement application, assessing the reimbursement potential of a new medicine or looking for support with a specific part of your dossier, we would be happy to discuss your project.
Tell us briefly about your product, development stage or market access question, and we can explore how our expertise may support you.
Contact LIVV
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