OBJECTIVES: Innovative pricing arrangements are frequently based on drug utilization data [DUD] to be able to differentiate drug prices by indications, by drugs used in combination or by achieved outcomes. Besides other information such DUD may potentially contain identifiable personal data. This research assesses the impact of data privacy on innovative pricing models.

METHODS: Required data fields for DUD were identified incl. examples of patient level DUD reports. An appropriate framework for data transfer was developed with stakeholders from pharma, data providers and regulating bodies.

RESULTS: Identified personal data (e.g. name, birthdate) is not required to execute innovative pricing arrangements but identifiable personal data (e.g. pseudonymised patient IDs) is potentially required for claim reconciliation, payback management and report traceability. The need to include identifiable personal information varies by type of innovative pricing arrangements.

CONCLUSIONS: Adherence to data privacy regulations is fundamental for successful implementation and execution of innovative pricing arrangements. Sharing of identifiable personal data should be avoided where possible. In case identifiable personal data is shared as part of an agreement operational and contractual mechanisms as well as appropriate risk mitigation mechanisms need to be put in place involving all parties, to ensure the key for re-identification of the data subject is not shared. Respecting Data privacy is an imperative consideration for the design of any DUD report.