PATIENTS RELATED ISSUES ARISING FROM REGULATORY APPROVAL, PRICING AND LAUNCH PLAN OF PHARMACEUTICAL PRODUCTS.

Author(s)

Fatoye C1, Betts A2, Odeyemi A3, Fatoye F4, Odeyemi I2
1HEMAC, Manchester, LAN, UK, 2Manchester Metropolitan University, Manchester, UK, 3Cureativ-Ceutical Limited, London, UK, 4Manchester Metropolitan University, Manchester, LIN, UK

OBJECTIVES: Involving patients in the process of certification of pharmaceutical products for global marketing approval at peri launch stage might help to reduce impact of side effects and complications associated with such products if patients gives feedback on the use of such products. Peri - launch stages are Regulatory Approval of Pharmaceutical Products (RAOPP), Pricing of Pharmaceutical Products (PPP), and the Launch Plan of Pharmaceutical Products (LPPP). However, this process can be time consuming and problematic. The study investigated patient related issues arising from involving them in RAOPP, PPP, and LPPP.

METHODS: A questionnaire survey was used for the present study. The questionnaire was administered at the ISPOR Glasgow (2017) to 104 participants. Participants responded under six domains i.e. communication, cost, effectiveness, external factors, quality of life (QoL) and safety. Thematic analysis was used to examine patient related issues arising from the development of RAOPP, PPP and LPPP. Analysis was on the six domains by examining the professionals’ responses under each domain.

RESULTS:At PPP stage, 37 (60%) participants stated cost was a major problem experienced. Ten (16%) participants at PPP stated that communication was another issue experienced. Also at RAOPP and LPPP 15 (24%), and 15 (31%) participants, respectively stated that communication was an issue. Other factors raised at the three stages were QoL of patients and external factors, which is about relationship with stakeholders.

CONCLUSIONS:The findings of this study suggest that cost is a major issue for pricing of pharmaceutical products by patients as perceived by participants. Communication, external factors and QoL were identified at the three stages suggesting that they are problems experienced by involving patients at peri launch (RAOPP, PPP, and LPPP). Stakeholders and policy makers are to consider these factors in the development and effective uptake of pharmaceutical products by patients.

Conference/Value in Health Info

2019-05, ISPOR 2019, New Orleans, LA, USA

Value in Health, Volume 22, Issue S1 (2019 May)

Code

PNS255

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

No Specific Disease

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