Alternative access schemes for pharmaceuticals in Europe

Towards an emerging typology

Olga Löblová, Marcell Csanádi, Piotr Ozierański, Zoltán Kaló, Lawrence King, Martin McKee

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

European governments employ sophisticated health technology assessment and regulatory procedures to identify which pharmaceuticals to fund publicly. However, there are persisting demands from patients for those drugs excluded from positive reimbursement lists, leading to the emergence of what are here termed “alternative access schemes”. This paper presents a purposive review of these schemes based on available scholarly and grey literature, illustrated with real-world examples from recent practice. It puts forward an original typology of alternative access schemes based on their marketing authorization (regulation) and reimbursement (redistribution) status. We describe the complex, multidimensional policy trade-offs between the principles of patient freedom of choice, clinical autonomy, encouragement of innovation, evidence-informed decisions on safety and quality, access to treatment, and financial sustainability, involved in marketing authorization and reimbursement decisions. We discuss the ways in which alternative access schemes differ and conclude that our typology can illuminate salient policy dilemmas raised by alternative access schemes in national drug reimbursement systems.

Original languageEnglish
Pages (from-to)630-634
Number of pages5
JournalHealth Policy
Volume123
Issue number7
Early online date20 May 2019
DOIs
Publication statusPublished - 1 Jul 2019

Keywords

  • Early access
  • Off-label
  • Oncology
  • Pharmaceuticals
  • Pricing and reimbursement
  • Rare diseases

ASJC Scopus subject areas

  • Health Policy

Cite this

Alternative access schemes for pharmaceuticals in Europe : Towards an emerging typology. / Löblová, Olga; Csanádi, Marcell; Ozierański, Piotr; Kaló, Zoltán; King, Lawrence; McKee, Martin.

In: Health Policy, Vol. 123, No. 7, 01.07.2019, p. 630-634.

Research output: Contribution to journalArticle

Löblová, Olga ; Csanádi, Marcell ; Ozierański, Piotr ; Kaló, Zoltán ; King, Lawrence ; McKee, Martin. / Alternative access schemes for pharmaceuticals in Europe : Towards an emerging typology. In: Health Policy. 2019 ; Vol. 123, No. 7. pp. 630-634.
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