The role of RWE across the product lifecycle

Before launch, the questions are about the market, not the product

In the development phase, the evidence requirement climbs steadily. It begins with understanding the standard of care, and feeds directly into target product profile design and trial design, where real-world data on treatment patterns shows what the comparator should be. It continues into patient recruitment, where claims and registry data show where eligible patients are actually treated. Towards the end of development it turns commercial: payer and provider cost offsets, and the size of the unmet need.

This evidence describes the space your product will enter, rather than the product itself. That is why the work has to begin years before anyone asks the question, and why the data sources you set up in this phase determine what you are able to answer later.
 

Launch is where the effort has traditionally concentrated

The graphic marks a band around launch as the traditional focus, and the curve peaks there. Budget impact for the payer submission. Post-marketing commitments on safety. Risk-sharing arrangements such as pay for performance. Then, once the product is in use, utilisation and prescribing patterns, and adherence.
 

Four more peaks, four different triggers

The requirement falls back after launch, then rises again at every event that reopens the discussion about value.
 

1. Conditional pricing review. 

   Payers who granted access on the strength of trial data now want long-term clinical outcomes from routine practice.
    

2. New competition. 

   The question moves to head-to-head comparative effectiveness, and to differentiation in the subpopulations where your product performs better than it does on average.
    

3. New formulation or new indication. 

   Target populations have to be defined again, and the usage differences between formulations become the evidence base.
    

4. Competitor goes generic. 

   The discussion turns to the effects of switching on outcomes, and to differentiating with or against protected galenics.
    

Each of these is a separate question with its own deadline, and none of them can be answered quickly if the data source was not prepared in advance. A retrospective database study takes months to design, obtain access for, and analyse. The trigger events, by contrast, arrive on someone else's schedule.
 

The same evidence, different audiences

Across the whole lifecycle, two needs recur.

The first is to understand epidemiology, treatment patterns and unmet needs, to identify target populations, and to assess healthcare resource use and cost. Regulatory bodies, HTA bodies, payers and clinicians all draw on this.

The second is comparative effectiveness and safety, both before and after approval. Here the audience is wider by one group: patients. That single addition changes how a study has to be designed and which endpoints carry weight, because a payer and a patient do not judge a difference in outcome the same way.
 

What is in the infographic

• The full evidence curve across development, growth and mature phase, with 18 evidence needs plotted against the milestone that triggers them

• The five trigger points marked on the timeline, from launch to competitor goes generic

• A table pairing RWE needs with their stakeholders and with the study design that address them, given as a first and a second option

• One page, formatted for printing or for sharing with your team
   

Download the infographic