How can we help?
LIVV helps you navigate the complexities of Belgian healthcare system by aligning the needs of diverse stakeholders. As market access experts, we collaborate with patients, healthcare providers, economists, and authorities to ensure timely access to innovative treatments for those who need them most. We are working with trusted consultants for the Netherlands.
Patient-Centric Approach
At LIVV, we place patients at the heart of our market access services. Our priority is to ensure that innovative treatments reach patients quickly and effectively, addressing their needs while improving their quality of life. By focusing on timely access, we align our strategies to deliver real-world impact where it matters most.
How do we define your Market Access Strategy?
At LIVV, we specialize in developing tailored market access strategies for innovative pharmaceutical products and medical devices. Our approach:
- By engaging in early discussions, we align with the expectations of stakeholders, such as the client, healthcare providers, payers, and regulatory authorities, to establish a clear pathway for market entry.
- An in-depth landscape assessment
- A thorough analysis of the product’s clinical and socio-economic value
How do we engage with Stakeholders?
LIVV is commited to building and managing strong relationships with all stakeholders, which is crucial in developing pricing and reimbursement dossiers and achieving successful market access strategies. Our approach:
- Our team engages with healthcare authorities, payers, and other key players to identify and address their concerns.
- We conduct interviews and surveys. We organize Delphi panels and focus groups.
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 many therapeutic areas
Belgium
- Class 1
- Orphan medicines
- Class 2B
- Modification of reimbursement criteria Art 59
- Class 3
The Netherlands
Extramural medicines
Hospital medicines
- Reimbursement dossiers for medicines placed in the lock
- Requests for financing of ‘add-on’s to diagnosis related combination