Published by Signum, July, 2023

New, innovative medicine requires us to rethink our traditional launch processes. We need to enter the playing field much earlier, and the dialogue with the authorities must be strengthened to make the work with data as relevant as possible.

It’s no secret that it takes longer and longer for medicines to be authorized for use. Fortunately, there is political focus on the challenge, and in parallel with the authorities working to reduce the processing time, we at Pfizer are scrutinizing our own processes. How can we contribute to faster uptake of new medicines?

Preparation is where we can really make a difference. New medicine development is moving towards targeted treatment and treatments for rare diseases, which are often authorized by EMA based on sparse data. This is due to the simple fact that patient populations are smaller, making it time-consuming and difficult, if not impossible, to conduct large-scale phase III trials in the same way that can be done for cardiovascular disease and diabetes, for example.  Therefore, we need to bring new types of data into play that can supplement clinical studies – and this is where real world evidence (abbreviated RWE) comes into play.

Start dialogue and data collection earlier

A prerequisite for more and more relevant data is early dialogue with the authorities. The earlier we begin the dialogue, the sooner we know how we can best support the process. What data is needed? How do we strengthen the authorities’ decision-making basis in a relevant way? For example, if we look at a treatment for a small patient group, we can explore whether we can generate data that track the effect in real time. Such data can for instance be used to support new payment models where patients can get access faster because the company and the authorities share the risk.

Greater investment in the launch process

When Pfizer recognizes the need to start the process earlier, we also bring other resources into play than usual. For example, we need more specialized employees for the task, and we work more globally and share experiences across countries. All of this is happening before clinical trials are finalized, which of course entails a risk that the work may turn out to be wasted. It’s a major investment, but also a necessary one, we believe.

Calculation of dynamic effects

RWE can also play a role when it comes to calculating the so-called “dynamic effects” of investments in health, such as new medicines and treatments. Dynamic effects are the derived effects of an investment, such as fewer sick days, shorter hospitalizations or a reduced need for care or rehabilitation. In other areas of society, these effects are already being recognized, and in 2022 Lif launched a model called BIS (or the Health Investment Calculator), which makes it possible to calculate the effects of healthcare investments. Dynamic effects are important because they provide a holistic assessment, and we can help by ensuring that the right data is available.

We need a lot of data

As businesses, we need access to large, robust amounts of data, and we need experts who can systematize and decode data. No matter what therapy area we’re talking about, the need for data will increase and we will continuously challenge and evolve the way we work with data.

Innovation in the use of data

In the future, access to innovation in the pharmaceutical area will depend, among other things, on how good we in the industry are at obtaining and working with data. A strong and relevant data foundation early in the process can contribute to faster regulatory approval, which is a prerequisite for patients benefitting from new therapies.