PNS256 HOW TO RESOLVE PROBLEMS EXPERIENCED WITH REGULATORY APPROVAL, PRICING AND LAUNCH PLAN OF PHARMACEUTICAL PRODUCTS WHEN PATIENTS ARE INVOLVED

Abstract

Patients are to be involved at the peri - launch of pharmaceutical product development (Fatoye et al., 2018). However, this is usually associated with some problems. This study investigated how the problems experienced by patients being involved in the development of pharmaceutical products at Regulatory Approval of Pharmaceutical Products (RAOPP), Pricing of Pharmaceutical Products (PPP), and Launch Plan of Pharmaceutical Products (LPPP) stages can be resolved. A questionnaire was administered to 104 participants at the ISPOR Glasgow (2017) to Market Access (MA) and Health Economics and Outcomes Research (HEOR) professionals. They were asked how issues experienced by patients could be resolved. Participants responded under six domains; communication, cost, effectiveness, external factors, quality of life (QoL) and safety. Thematic analysis was used to identify strategies to resolve problems experienced by patients in the development of RAOPP, PPP, and LPPP from professionals’ perspective. Communication was suggested as a strategy for resolving the problems experienced at all stages i.e RAOPP 14 (35%), PPP 13 (30%) and LPPP 17 (55%). External factors, such as the relationship with stakeholders, were also identified as one of the strategies to resolve problems experienced at RAOPP 12 (30%). Cost was identified both under the PPP 13 (30%) and RAOPP 4 (10%) stages. QoL was another factor identified across the two stages of pharmaceutical development with 6 (15%) responses for both RAOPP and PPP. Communication was the main strategy suggested for resolving problems at all stages of pharmaceutical development. Other strategies identified related to external factors. Reducing cost was another strategy identified to resolve the problems experienced at the three stages but more dominant at PPP stage. The last issue identified was QoL. Policy makers should focus on these strategies in order to increase the involvement of patients at peri launch development of pharmaceutical products.