| Literature DB >> 34994965 |
Ravi Jandhyala1,2.
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.Entities:
Mesh:
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Year: 2022 PMID: 34994965 PMCID: PMC8818008 DOI: 10.1007/s40290-021-00413-9
Source DB: PubMed Journal: Pharmaceut Med ISSN: 1178-2595
Medical affairs pharmaceutical physicians activity types extracted from the ‘MAPPval instrument’
| Activity type | Description |
|---|---|
| Plan | A documented course of action for conducting a series of value-adding activities for a set period of time |
| Submissions | A piece of work, which leaves the company, conducted for the purpose of influencing an external stakeholder with a documented argument supported with evidence |
| Protocol (IIS/CSS) | Participating in the development, review, or progression of a protocol for a clinical study irrespective of sponsorship |
| Clinical study (report) | Participating in the progression of a clinical study to the point of completion |
| Journal publication | Participation in the design, development, and progression of an academic manuscript that culminates in its publication in a peer-reviewed, indexed journal |
| Congress poster | Participation in the design, development, progression of an academic poster culminating in its acceptance in an academic congress |
| Material certification or examination | Certification or medical examination of materials |
| Meetings: One-to-one | A personal meeting with a single external stakeholder (face-to-face, online, or teleconference) |
| Meetings: One-to-many | A personal meeting with a group of members of a stakeholder (face-to-face, online, teleconference) |
| Meetings: Insight-generating advisory board | Participation in an ‘advisory board meeting’ |
| Meetings: Congress | Participation in a meeting at an academic congress |
| Meetings: Training | Participation in training internal or external stakeholders to a required level of competency or knowledge |
CSS company-sponsored study, IIS investigator-initiated study
‘MAPPval instrument’
Italicized text denotes options available for selection under each category
CSS company-sponsored study, IIS investigator-initiated study, MAPP Medical Affairs Pharmaceutical Physicians
Twenty-two unique MAPP value indicators generated through the Jandhyala method
| Codes | Statement | A | C |
|---|---|---|---|
| 1 | Regulator-targeted activities (via regulatory affairs function) | 2 | 2 |
| 2 | Payor-targeted activities (via market access function) | 1 | 2 |
| 3 | Prescriber-targeted activities (via commercial and/or sales function) | 2 | 2 |
| 4 | Patient-targeted activities (via patient advocacy function if available) | 2 | 2 |
| 5 | Multiple-stakeholder-targeted (RWE) medical plan | 2 | 1 |
| 6 | Submissions to external stakeholders | 2 | 2 |
| 7 | Protocols (investigator-initiated study or company-sponsored study) | 2 | 1 |
| 8 | Clinical study milestones | 2 | 2 |
| 9 | Journal publications | 2 | 2 |
| 10 | Congress posters | 2 | 2 |
| 11 | Promotional approvals | 2 | 2 |
| 12 | One-to-one meetings | 2 | 2 |
| 13 | One-to-many meetings | 2 | 2 |
| 14 | Advisory board (insight-generating) | 2 | 2 |
| 15 | Congress presentations | 2 | 1 |
| 16 | Training | 2 | 2 |
| 17 | Responsible for activity | 2 | 2 |
| 18 | Accountable for activity | 2 | 1 |
| 19 | Consulted on activity | 2 | 2 |
| 20 | Informed about activity | 2 | 2 |
| 21 | Objective met | 2 | 2 |
| 22 | Objective not met | 2 | 2 |
A awareness index, C consensus index, RWE real-world evidence, MAPP Medical Affairs Pharmaceutical Physicians
Number of internal stakeholders classified as accountable for at least one activity that benefited all four external stakeholders and fewer than four external stakeholders
| Internal stakeholder | All four external stakeholders (%) | Fewer than four external stakeholders (%) | |
|---|---|---|---|
| MAPP | 5 (50) | 5 (50) | – |
| Regulatory affairs | 0 (0) | 10 (100) | 0.039a |
| Market access | 0 (0) | 10 (100) | 0.039a |
| Commercial | 0 (0) | 10 (100) | 0.039a |
| Patient advocacy | 0 (0) | 10 (100) | 0.039a |
MAPP Medical Affairs Pharmaceutical Physician
aA p-value <0.05 was considered statistically significant using the two-proportion z-test
Number of internal stakeholders classified as accountable for at least one activity that benefited 0, 1, 2, or 3 external stakeholders
| 3 (%) | 2 (%) | 1 (%) | 0 (%) | Median | Mean | ||
|---|---|---|---|---|---|---|---|
| MAPP | 4 (80) | 1 (20) | 0 (0) | 0 (0) | 3 | 2.8 | – |
| Regulatory affairs | 0 (0) | 0 (0) | 6 (60) | 4 (40) | 1 | 0.6 | < 0.001a |
| Market access | 0 (0) | 1 (10) | 5 (50) | 4 (40) | 1 | 0.7 | < 0.001a |
| Commercial | 0 (0) | 2 (20) | 2 (20) | 6 (60) | 0 | 0.6 | < 0.001a |
| Patient advocacy | 0 (0) | 0 (0) | 1 (10) | 9 (90) | 0 | 0.1 | < 0.001a |
MAPP Medical Affairs Pharmaceutical Physician
aA p-value < 0.05 was considered statistically significant using the Mann–Whitney test
Fig. 1a Number of internal stakeholders accountable for activities involving different numbers of external stakeholders. b Number of external stakeholders (fewer than four) influenced by activities for which internal stakeholders have been classified as accountable. c Number of consulted/responsible/informed classifications for each internal stakeholder. MAPP Medical Affairs Pharmaceutical Physician, RAff regulatory affairs, MAcc market access, Comm commercial, PatAdv patient advocacy
Internal stakeholder value for activities recorded in the retrospective study
| Number (%) of activities | ||||||
|---|---|---|---|---|---|---|
| Accountable | Consulted | Responsible | Informed | Not involved | Total | |
| MAPP | 187 (82) | 22 (10) | 15 (7) | 5 (2) | 0 (0) | 229 |
| Regulatory affairs | 10 (4) | 73 (32) | 8 (3) | 20 (9) | 118 (52) | |
| Market access | 12 (5) | 70 (31) | 8 (3) | 46 (20) | 93 (41) | |
| Commercial | 9 (4) | 69 (30) | 26 (11) | 85 (37) | 40 (17) | |
| Patient advocacy | 1 (0.4) | 32 (14) | 5 (2) | 38 (17) | 153 (67) | |
Using the Mann–Whitney (two-tailed) test
MAPP Medical Affairs Pharmaceutical Physician
Fig. 2Accountability of internal stakeholders for all 229 MAPP activities identified. MAPP Medical Affairs Pharmaceutical Physician
| This study developed the first-ever unique Medical Affairs Pharmaceutical Physicians (MAPP) value measurement tool, the ‘MAPPval instrument’. |
| MAPPs were the only internal stakeholder accountable for activities that benefited all four external stakeholders involved in medicine adoption. |
| The MAPPval instrument was validated by successfully discriminating between the value of MAPPs and other internal stakeholders to pharmaceutical companies. |