PNS260 Problems Experienced By Involving Patients at Post-Launch STAGE of Pharmaceutical Product Development

Abstract

Previous studies showed that patients are involved at the post-launch stage of pharmaceutical product development consisting of these phases; positioning of pharmaceutical products (POPP), detailing of pharmaceutical products (DOPP) and reimbursement and formulary submission (R&FS). The involvement of patients at these stages is not without its problems. This study investigated problems experienced by involving patients at the post-launch stage based on the perspectives of professionals from health economics and outcomes research (HEOR) and market access (MA) background. A questionnaire was used for the present study. A questionnaire was administered at the ISPOR Glasgow 2017 to 104 participants. They were asked about the patient-related issues arising from POPP, DOPP and R&FS. Participants responded under 6 domains i.e. communication, cost, effectiveness, external factors, Quality of life (QoL) and safety. Thematic analysis was used for this study. Communication with stakeholders regarding pharmaceutical product development was a major problem experienced by patients at POPP 38%, DOPP 32% and R&FS 26%. Cost was at R&FS 30% and QoL 21%. At DOPP phase, issues faced by patients were external factors 36%. Lastly, at POPP phase external factors were 18%; and QoL 14% were issues experienced by patients. Communication was a major problem experienced by involving patients in the development of pharmaceutical products at post-launch, this problem was experienced at all phases that is, POPP, DOPP and R&FS. Cost was a problem experienced at R&FS phase. Lastly, external factors - which is about partnership and effective working with stakeholder and policymakers was an issue experienced at DOPP phase. Policymakers and stakeholders are to investigate how these issues can be resolved by focusing on the findings from this study.