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Real World Evidence & Medical Affairs

Key points from the ​APPA/MA webinar “Real World Evidence & Medical Affairs” include:

Real world evidence (RWE) is an opportunity to improve patient outcomes and knowing the value of medicines in real life clinical settings is crucial to realising the true potential of innovative medicine.

The integration of RWE activities from the planning perspective involves: setting the local evidence generation strategy; involving medical affairs leadership in the generation of RWE; and gathering insights from external partners about the healthcare ecosystem.

When setting the local RWE strategy it’s important to consider both global and regional plans; to undertake a gap assessment on local needs; to prioritise projects, taking into account budget planning; and to ensure that the projects are endorsed globally and locally.

Medical Affairs is uniquely positioned to help realise opportunities represented by RWD and RWE. Medical Affairs leaders are in the position to facilitate external engagement to shape and validate approaches; to enable internal alignment; to oversee process navigation; and to ensure that there is a robust publication process, taking into account external stakeholder needs.

The Australian environment provides scope of innovative and fit for purpose approaches to evidence generation. One example discussed was the National Blood Cancer Registry as a real-world data registry that doubles as a master screening platform for all acute leukaemia research. Further, in areas of high unmet needs (eg blood cancers) RWD provides critical insights into care pathways and outcomes.

There are lots of new methodologies being developed and validated for RWE analyses and these are being assessed by HTA bodies.

International initiatives include:

  • 1. HTAi Global Policy Forum;

  • 2. IMI GetReal and GetReal Institute;

  • and 3. Real World Data in Asia for HTA in Reimbursement (REALISE) working group.

Thanks to Matthew Britland, Jan Lewis, Franz Pichler, Delaine Smith, Pinky Dharmshaktu and APPA Australia