Key economic and value considerations for plasma-derived medicinal products (PDMPs) in Europe

PDMPs constitute several classes of biologic therapies, i.e. clotting factors, immunoglobulins (IgGs, including hyperimmune globulins), alpha-1 proteinase inhibitors, albumin and C1-esterase inhibitors. PDMPs share a unique nature: they are derived from human biologic material (plasma) and have a highly complex and regulated manufacturing process.

This paper aims to analyse and demonstrate the unique nature and value of PDMPs (Plasma-derived Medicinal Products) across clinical, economic, and societal dimensions, and focuses on improving Patient Access. Patient Access is viewed from two angles: formal access based on reimbursement coverage, and therapeutic access based on the availability of an optimal treatment paradigm. It also analyses key challenges that affect the full realisation of the value of PDMPs. Finally, it offers a comprehensive view of possible solutions to the identified challenges.

PDMPs are unique biological therapies derived from human plasma and are used to treat patients with rare, often genetic conditions with a high disease burden. Despite decades of effective therapeutic use in Europe, and demonstrable clinical and societal value, these treatments still face numerous Patient Access challenges pertaining to the plasma donation landscape, regulatory and reimbursement frameworks, and treatment paradigms.

There is a growing clinical need of European patients for PDMPs, and considerably more plasma must be collected in Europe. As new indications arise more patients are diagnosed with diseases requiring PDMP treatment. Even when diagnosed and if therapy is available, patients often are denied adequate PDMP treatment because of therapeutic and formal Patient Access challenges. To overcome these challenges, it is necessary to form close and trust-based partnerships between industry and all healthcare stakeholders.

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