Development and Validation of the Medical Affairs Pharmaceutical Physician Value (MAPPval) Instrument

Abstract

Background A pilot study conducted in 2020 suggested that Medical Affairs Pharmaceutical Physicians (MAPPs) may be inherently undervalued within the pharmaceutical industry and vulnerable to replacement by less qualified roles. There are currently no standardized metrics to measure MAPP performance, thus it is necessary to measure the value of MAPPs to employers and clarify the need for their specific skills. Objectives The first aim of this study was to identify a list of indicators to produce an MAPP value measurement tool, and the second aim was to determine its discriminant validity by showing that the 'MAPPval instrument' differentiated the MAPP role from other internal stakeholders (regulatory affairs, market access, commercial, and patient advocacy) in terms of accountability for pharmaceutical company activities and level of engagement with external stakeholders. Methods MAPPs were recruited using convenience sampling via professional networks and completed a qualitative online survey to identify a list of key role indicators using a consensus method known as the Jandhyala method. Responses were coded and scored, and aggregated responses were presented to participants in a Consensus Round. Participants rated their agreement with each item on a 5-point Likert scale, from strongly agree to strongly disagree. Indicators that reached a consensus index of > 50% (CI ≥ 0.51) were retained in the final MAPP performance instrument. Participants' retrospectively self-reported professional activities over a period of 12 months were used to validate the measure. A two-proportion z-test and Mann-Whitney tests were used to determine discriminant validity by showing whether the value of the MAPP role as defined by the instrument was significantly different from that of other internal stakeholders in terms of their accountability for and external stakeholder benefit from each MAPP activity. Results In total, 11 MAPPs participated in the Jandhyala method, which generated 22 unique MAPP value indicators. Payor-targeted activities and journal publications had the two highest awareness indexes (1.00 and 0.98, respectively). The retrospective study confirmed the MAPPval instrument's validity. MAPPs were the only internal stakeholder classified as accountable for at least one activity that benefited all four stakeholders. They were classified as accountable for activities that influenced significantly more external stakeholders than other internal stakeholders, even when activities influenced fewer than four external stakeholders. MAPPs were also accountable for significantly more activities recorded over the 12-month period than regulatory affairs, market access, commercial, and patient advocacy. Conclusions This study generated and validated the first measure of MAPP value to pharmaceutical companies. MAPPs have unique value to pharmaceutical companies compared with other roles in terms of their accountability for activities that influence regulators, payors, prescribers, and patients. Through their accountability for pharma...

Development of a Definition for Medical Affairs Using the Jandhyala Method for Observing Consensus Opinion Among Medical Affairs Pharmaceutical Physicians

“…Items of the medical affairs definition could be categorised into four previously defined MAPP functions ( Table 2 ) ( Jandhyala, 2022 ). Content analysis showed that the consensus-generated definition varied from previous definitions in four key ways: the designation of medical affairs as a medical specialty, the leadership of medical affairs in medicine adoption, the generation of real-world evidence and the specification of distinct stakeholders who benefit from medical affairs ( Table 3 ).…”

“…Therefore, the definition was robustly supported by consensus. All items could be categorised into four previously defined MAPP functions: protecting patients’ interests, medicine adoption and regulation, evidence generation and gatekeeper stakeholder engagement ( Jandhyala, 2022 ), which provided confidence in the reliability and validity of our findings.…”

“…We generated descriptive meanings for each item according to previous findings and categorised items according to previously described MAPP functions( Jandhyala, 2022 ). To demonstrate the utility of the definition, we conducted a comparative content analysis ( Vaismoradi et al, 2013 ) with the most recent existing definition we could find in the literature, which was as follows: “Medical affairs departments aim to fulfil unmet medical needs through the generation of scientific evidence and to deliver scientific value to key stakeholders and patients.…”

“…Previous work has addressed the functions and unique value of MAPPs to pharmaceutical companies ( Jandhyala, 2022 ), but as yet, there has been no empirically generated definition of medical affairs. While definitions have been proposed within empirical studies on related topics ( Jain, 2017 ; Maeda, 2021 ), and growing attention has been given to what changes have occurred in the role of medical affairs post-COVID-19 ( Rajadhyaksha, 2020 ; Ghosh et al, 2021 ), there is no consensus on what constitutes medical affairs and its boundaries of scope.…”

“…Additionally, organisational studies of professional functions have suggested that role scope is determined by the position of the professional and the hierarchical level of the function within an organisation ( Rieg, 2018 ). Preliminary evidence from a pilot study has suggested that medical affairs may not be prioritised within pharmaceutical companies in terms of hierarchy ( Jandhyala, 2020a ), despite the key role of MAPPs in satisfying distinct multiple external stakeholder requirements ( Keene et al, 2020 ; Jandhyala, 2021a ) for the successful adoption of medicines ( Jandhyala, 2021b ; Jandhyala, 2022 ).…”