Historically, the key role of Medical Affairs was supporting the initial regulatory approval. Today, that’s only the first hurdle. Due to increasing healthcare costs and the need to make difficult value-based decisions, the data package is extensive. Pharmaceutical companies must demonstrate the value of products through safety and efficacy trials, health economics trials and comparative efficacy trials, and medical affairs is taking on the bulk of the responsibility in providing that additional data package.
As the Medical Affairs role evolves, more questions arise. And with each company defining the role differently, it is creating confusion.
Reshaping Medical Affairs: delivering value to KOLs and payers provides answers to pressing questions the industry is facing. This report includes primary research from within the pharmaceutical industry and related consulting.
Key Questions Answered
What are the key functions of Medical Affairs teams? How is Medical Affairs positioned in a variety of pharmaceutical companies? How are Medical Affairs teams interacting with internal stakeholders? How are Medical Affairs teams currently interacting with payers and KOLs? What effect are the transparency regulations having on these relationships? How has Medical Affairs evolved in recent years?
Identify potential opportunities for improving performance of your Medical Affairs team Determine ways to improve stakeholder relationships and show value Find out how medical affairs can support the payer relationship Understand what physicians are looking for from Medical Affairs professionals Tap into ways to listen to the voice of the patient Find examples of ways to evaluate quality and value to measure success
Table Of Contents
Reshaping Medical Affairs: delivering value to KOLs and payers 1.Executive summary 2.Research methodology and objectives 2.1.Terminology 3.The evolution of medical affairs 3.1.Defining the key functions of medical affairs 3.1.1.Data generation and research 3.1.2.Communication 3.1.3.Intelligence 3.1.4.Medical governance 3.2.The evolving role of medical affairs 3.2.1.The major changes in medical affairs in recent years 3.2.2.The relationship between medical affairs, market access and commercial 18.104.22.168.Strategic interaction between departments 22.214.171.124.The need for medical affairs approval of commercial information 3.3.1.Becoming more proactive 3.3.2.Training and education 3.3.3.Investigator initiated trials 3.3.4.Pharma sponsored phase IV studies 4.Building valued relationships with stakeholders 4.1.Demonstrating value to stakeholders 4.1.1.Adapting as healthcare provision changes 4.2.The role of medical affairs in the payer relationship 4.2.1.Collaboration between medical affairs and market access 4.2.2.Demonstrating value to payers 4.2.3.Answering payer questions 4.2.4.Accountable Care Organisations (ACOs) 4.2.5.Health economics outcomes research 4.3.Engaging with patient advocacy groups 4.3.1.Regulation on the promotion of medicinal products to patients 4.4.Engaging with physicians 4.4.1.The MSL role in KOL relationships 4.4.2.At what stage of development does KOL engagement begin? 4.4.3.Interacting with physicians when they have questions 4.4.4.Transparency regulation - what has changed since the Sunshine Act? 126.96.36.199.Could interpretation of the Sunshine Act stifle future innovation in the US? 4.4.5.Compliance 4.5.Cross-boundary regulatory compliance 4.6.Transparency, training and compliance tracking 4.7.Communicating via appropriate channels 4.8.Measuring success 4.8.1.Evaluating quality and value 4.8.2.Have we changed patients' lives?