What is an Early Access, Compassionate Use or Medical Need Program?
Early access programs (also named Compassionate Use, Expanded Access, Named Patient, Medical Need Programs) provide a way for patients with life-threatening diseases to access drugs before they are approved for market use.
These programs are designed for patients who have no other treatment options, including those who do not qualify for clinical trials, or have completed a trial and still need the drug before it is officially authorized.
The process is ethical, controlled, and compliant with regulations, ensuring that patients can benefit from these treatments in a safe manner.
Early Access programs in Belgium
In Belgium two types of early access programs exist:
- Compassionate Use program (CUP): for non-authorized products
- Medical Need Program (MNP): for products that are authorized in different indications in Belgium
How do we ensure the regulatory and operational success of Early Access Programs in Belgium?
Regulatory compliance and smooth program operations are critical to the success of Early Access Programs. LIVV takes a comprehensive approach to manage all necessary aspects of these programs in Belgium:
- We provide strategic guidance on feasibility and country-specific regulatory frameworks to ensure the program is viable in Belgium.
- Our team works closely with regulatory bodies to ensure a successful submission of applications, including detailed dossier writing that aligns with Belgian health authority requirements.
- Once approved, we focus on operationalizing the program by ensuring proper patient and healthcare provider flows, and setting up the necessary processes for safety reporting and drug stock monitoring.
By combining regulatory expertise with operational efficiency, our team ensures that the program is not only compliant but also practical, timely, and patient-centric.
What sets LIVV apart in supporting pharmaceutical companies with Early Access Programs?
At LIVV, our dedicated in-house experts provide a unique combination of strategic and operational support to pharmaceutical companies. What distinguishes us is our ability to approach Early Access Programs from multiple critical angles:
- Patient-Centric Approach: At the heart of LIVV’s mission is our unwavering commitment to patients. We design and execute Early Access Programs that prioritize patient safety, timely access to potentially life-saving therapies, and clear communication. By deeply understanding patient needs, we ensure that our services also deliver tangible, meaningful benefits to patients and their families.
- Our team offers protocol authoring that integrates market access considerations, ensuring the program is designed with both patient needs and commercial goals in mind.
- We facilitate early dialogue with Health Technology Assessment (HTA) bodies, helping to align your program with market access pathways and future reimbursement strategies.
- Comprehensive regulatory guidance, including guiding you through the submission of applications to health authorities, preparing detailed dossiers, and liaising with regulators to ensure all requirements are met for approval.
- LIVV’s operational support extends to every detail, from budget management to vendor selection and ensuring smooth distribution of medicinal products.
With extensive experience in managing Early Access Programs, LIVV is uniquely positioned to navigate the complex landscape of EAPs with a dual focus on regulatory compliance and market success, while keeping the patients needs at the center.
Our experience
Set-up and management of Early Access Program for Johnson & Johnson
Our team has been 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
Want to Learn More? Contact Us Today!
If you are interested in learning more about how we can support your Early Access, Compassionate Use or Medical Need Program, our team is here to help. Whether you need expert guidance on program design, regulatory submissions, or operational execution, we offer tailored solutions to meet your specific needs.
Reach out to us for more information, and let’s explore how we can work together to bring life-saving treatments to patients in need.
