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Strategies to Increase Medical Affairs' Role in Health Outcomes Data Generation and Utilization


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With the shift toward evidence-based medicine and value-based pricing, many bio-pharmaceutical companies are transitioning their Health Economics and Outcomes Research (HEOR) function away from the Commercial organization to Medical Affairs. This has some major implications towards the interactions with key stakeholders, the way interactions are documented and the skill sets & activities that may be required. Development of strong health outcomes capabilities within Medical Affairs organizations requires an increase in that function’s involvement with health outcomes groups, development of field-based health outcomes capabilities, customization of health outcomes data by stakeholders and building real world data capabilities to generate and utilize health outcomes information.

Best Practices, LLC undertook this study to identify strategies to increase MA’s role in Health Outcomes data generation and utilization. Specifically, the study highlights the role of Medical Affairs function in HO activities, industry drivers and resource levels for HO groups, challenges of MA’s involvement in HO activities and strategies for effective HO data communication and utilization.

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Strategies to Increase Medical Affairs' Role in Health Outcomes Data Generation and Utilization

  1. 1. Best Practices, LLC Strategic Benchmarking Research Medical Affairs’ Role in Health Economics & Outcomes Research 1
  2. 2. Table of Contents  Executive Summary pp. 3-13  Research Objectives & Methodology pp. 3  Participating Companies pp. 4  Segments & Abbreviations pp. 5-6  Key Findings & Insights pp. 7-13  Longevity of HO Groups pp. 14-16  HO Leadership pp. 17-20  HO Reporting Structure pp. 21-24  HO Group Staffing pp. 25-31  MA’s Role in HO Activities pp.32-38  MA’s Role in Collecting HO Data pp.39-42  Utilization of HO Data pp. 43-50  Impact of HO Data on Decisions pp. 51-56  About Best Practices, LLC pp. 57-58 2
  3. 3. Field Research & Insight Development: Twenty-three survey responses from Medical Affairs leaders at 23 top life-science companies within mature markets Segmentation based on two areas: Company Size, HO Group Maturity Additional deep-dive interviews with 5 selected Medical Affairs executives- 2 VPs, 2 Directors and 1 Manager. Provide Leading Insights on: • Identify involvement level of Medical Affairs groups in HO activities • Define opportunity fronts and strategies to increase Medical Affairs' role in HO data generation and utilization Research Objectives & Methodology Research Objectives:  Illustrate how Medical Affairs (MA) is involved in Health Outcomes (HO) data generation and utilization  Highlight strategies for effective HO data communication and utilization  Understand challenges about Medical Affairs' involvement in HO activities  Identify industry drivers regarding HO groups  Define resource levels for HO groups Business Objective: This research delivers current data, insights and best practices from Medical Affairs leaders at top biopharmaceutical companies. The benchmark data in this study will help companies find better ways to develop successful Health Outcomes (HO) groups. 3
  4. 4. Universe of Learning: Research Participants from 2014-2015 Study This study engaged 23 executives from 23 leading life sciences companies. Segmentation analysis was key to examining trends and effective practices. We created segments based on two criteria: Company Size and HO Group Maturity. Benchmark Class 4 Large Companies Segment
  5. 5. Segments and Abbreviations 5 Abbreviations: • MA: Medical Affairs • HO: Health Outcomes • HEOR: Health Economics Outcomes Research • TA: Therapeutic Areas • TBC: Total Benchmark Class • TL: Thought Leader • TLM: Thought Leader Management • LCS: Large Companies Segment • M&SCS: Medium & Small Companies Segment
  6. 6. We Analyzed Two Main Segments in the Research We created two main segments and four sub-segments through the data we collected from our benchmark survey. N=19-28 Segmentation HO Group Program Maturity Company Size Based Segmentation Mature Groups: ≥ 4 Yrs. Young Groups < 4 Yrs. Large Companies Segment: > $10B Medium & Small Companies Segment: ≤ $10B 6
  7. 7. INCREASE MEDICAL AFFAIRS' ROLE IN HO ACTIVITIES DEVELOP FIELD- BASED HO CAPABILITIES  Medical Affairs and HO groups must customize their data communications according to the needs of different stakeholders  Internal: Product’s efficacy and safety, as well as economic value  Patients: Quality of life and burden of illness  Payers: Economic value and cost analysis  Providers: Product’s efficacy and safety, burden of illness CUSTOMIZE DATA DELIVERY DEVELOP REAL WORLD DATA CAPABILITIES Below are some of the key findings culled from Best Practices’ research into Medical Affairs’ role with Health Outcomes.  Medical Affairs’ increasing involvement in Health Outcomes activities is critical for both Medical Affairs and HO groups  Medical Affairs will expand the use of HO data in strategic decisions  HO groups will benefit from expanding Thought Leader communication through Medical Affairs' field-based teams.  A majority of HO groups have limited field-based activities and FTEs. As a result, collaborating with field-based teams can help HO groups to increase effective interaction with external stakeholders and develop stronger field-based capabilities.  Medical Affairs organizations have opportunities to grow their real world data generation and utilization skills by developing an HO group that reports to Medical Affairs or collaborating with existing HO groups.  Medical Affairs can take a leading role in market access, formulary inclusion and reimbursement discussions by increasing HO activities. High-Level Key Findings for Medical Affairs’ Role in HO Research 7
  8. 8. Majority of Participants Have Had a HO Program for More Than Four Years A majority of the total benchmark class has had a HO program in place for four or more years. Still, one-third of respondents have no formal group or it is less than a year old. N=23 Longevity of Health Outcomes Group(s): How long has the HO program been in place at your company? % Respondents 8 No formal HO group 4% More than 5 years 39% 4-5 years 13% 1-3 years 18% Less than a year 26% Total Benchmark Class +
  9. 9. Younger HO Groups Inclined to Report in Medical Affairs; Older Groups Tend to Report to Either Medical or Clinical Affairs or a Market Access Group While 82% of HO groups less than four years old report to Medical Affairs, only 25% of HO groups that are older have a similar reporting structure. Less mature HO groups mostly report to Medical Affairs. However, older HO groups try different reporting models. For example: Market access, access and policy, global value, etc. N=12 % Respondents 9 Reporting Structure: To whom does the Health Outcomes group(s) report? N=11 Other: Global value, access and policy, managed markets, international marketing and medical, market access. Other, 33% Sales and marketing (Commercial), 8% Clinical development, 33% Medical affairs, 25% HO Program ≥ 4 Years Other, 18% Medical affairs, 82% HO Program < 4 Years
  10. 10. 50% 48% 45% 45% 43% 30% 27% 17% 27% 27% 36% 9% 36% 36% 18% 18% 78% 64% 55% 80% 50% 27% 40% 18% Developing clinical protocols for outcomes research Delivering scientific presentations / speeches Presenting pharmaco- economic data Training commercial teams on outcomes data Training speakers on outcomes data Identifying payers and building relationships Identifying providers and building relationshps Formulary discussions with payers Medical Affairs Led HO Activities – HO Group Maturity TBC HEOR ≥ 4 Yrs. HEOR < 4 Yrs. Medical Affairs Leads HO Training and Clinical Protocol Development in Young Groups Medical Affairs leads a majority of the HO activities in the segment that has young HO groups. Medical Affairs groups where there are young HO groups play a significant role in three activities: Developing clinical protocols for outcomes research, training commercial teams on outcomes data, and training speakers on outcomes data. N=22 % Respondents 10 Health Outcomes Activities: Please indicate the level of your Medical Affairs organization’s involvement in each of the following activities. N=10-11N=11
  11. 11. Best Practices®, LLC is an internationally recognized thought leader in the field of best practice benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by leveraging the best business practices, operating tactics and winning strategies of world-class companies. 6350 Quadrangle Drive, Suite 200 Chapel Hill, NC 27517 (Phone): 919-403-0251 Learn More About Our Company: 11