Maprium and Vitaccess partner on managed access programs and real-world evidence

Maprium and Vitaccess have announced a collaboration combining global managed access program management with patient-centered real-world evidence generation.

The Baseline

• Maprium and Vitaccess have teamed up to integrate real-world evidence generation into managed access programs.
• Maprium will provide program management technology, while Vitaccess will provide research and evidence-generation services.
• The collaboration aims to incorporate evidence planning and data collection into program design to support regulatory, reimbursement, and market access decision-making.

Maprium has announced a collaboration with real-world research consultancy Vitaccess to incorporate real-world evidence (RWE) generation into managed access programs (MAPs). Maprium will provide its platform for the management and oversight of MAPs, while Vitaccess will provide research and evidence-generation services.

MAPs can provide patients with access to medicines outside established commercial access routes and may also provide opportunities to collect information on treatment use and patient outcomes in clinical practice. For pharmaceutical companies, this creates the potential for MAPs to contribute evidence that informs regulatory, health technology assessment (HTA), reimbursement and broader market access decisions.

However, program delivery and evidence generation may be managed through separate vendors, systems and processes, potentially making it more difficult to coordinate data collection with wider evidence needs. The collaboration between Maprium and Vitaccess is intended to bring these activities together, allowing evidence generation to be considered as part of MAP design and delivery.

The collaboration combines Maprium's program management technology with Vitaccess' research capabilities. Maprium's platform will support the planning, governance, and oversight of MAPs, while Vitaccess will provide services including RWE strategy, protocol development, patient-reported outcomes, digital data collection, and data analysis.

Under the collaboration, evidence-generation plans can be incorporated during MAP design rather than developed separately from program delivery. This may include defining relevant outcomes and data collection methods during planning and collecting patient-reported outcomes and other clinical information during the program.

Potential regulatory, HTA and reimbursement evidence requirements can also be considered during program planning. This may enable data collected through MAPs to contribute to subsequent evidence needs, although the suitability of such evidence will depend on factors including the program design, data quality and requirements of individual decision-makers.

"MAPs represent a valuable opportunity to understand how treatments perform in real-world clinical practice. By combining our expertise in patient-centered research with Maprium's operating system, pharmaceutical companies can design evidence generation into programs from the start, ensuring the data collected is scientifically robust and supports future decision-making," said Mark Larkin, CEO and Founder of Vitaccess.

According to the companies, integrating program management and evidence generation is intended to provide greater visibility across MAP operations and data collection while reducing reliance on separate systems and vendors.

Dr Romina Oxborough, CEO of Maprium, highlighted the potential for MAPs to serve a broader role alongside facilitating access:

“MAPs should deliver value far beyond patient access alone. Through this collaboration, pharmaceutical companies can manage programs through a single platform while integrating high-quality evidence generation into routine operations.”