First strategic field of the EMA’s network strategy

Availability and accessibility of medicines

Tue, 2021 / 01 / 26
In this part of our new blog series about the network strategy of the EMA (European Medicines Agency), we are going to present the first of six strategic areas identified by the EMA and the HMA (Heads of Medicines Agencies). Here, the focus lies on the market access implications which arise from the EMA's strategy document.

The first topic addresses the availability and accessibility of medicines, for which the network has identified two main goals that should be achieved until 2025.

For starters, the availability of medicines for the health of European citizens and animals should be improved. Next, further enhancements in the process of development to evaluation to market access should be driven forward. In this context, the network sees possibilities for improvement regarding the cooperation between regulatory authorities and other stakeholders in the following fields:

  • Evidence generation (including post-market access),
  • Evidence assessment and related methodology, and,
  • Collaboration in market screening, related to new medicinal products.

As a positive example for an enhanced market screening, the IHSI (International Horizon Scanning Initiative) is mentioned in the strategy paper. Based on the EunetHTA efforts, the cooperation between different HTA authorities in Europe should also be improved. These efforts will focus on better documentation and communication of national drug assessments, especially regarding the robustness and quality of the evidence.

Overall, this approach is intended to accelerate market access for medicines that address unmet therapeutic needs and to provide broader coverage.

The targets in this area are primarily:
  • Better evidence to provide an improved basis for decision-making for the various decision-makers (regulators, HTA bodies, payers). This also includes evidence generation after market approval and should enable the entire life cycle of a product to be mapped by evidence and the possibility of adjusting decisions retrospectively.
  • Clear and improved communication with patients, healthcare professionals and downstream decision-makers on the regulatory assessment of individual medicines. This particularly concerns medicines authorised with informational and evidence gaps (e.g. orphans, veterinary medicines with limited markets).
  • New metrics for accessibility of medicines, representing the actual patient access to newly authorised medicines in different markets.
  • Aligning national implementation of compassionate use programmes to ensure equitable access for patients during late-stage development and to generate better use of data from such programmes for later evaluation.

Some of these points may remind one of the recently introduced legal possibility of a registry requirement imposed by the G-BA for the generation of application accompanying evidence. This new strategy at European level reinforces the demand for more real-world evidence and is accompanied by an additional long-term component that could also result in an adjustment of the drug evaluation decisions already taken.

At SKC, we have experienced with various AMNOG-level projects, that a registry requirement and thus the generation of real-world evidence can be successfully anticipated and prepared in the interest of the client. We look forward to supporting you with this dynamic and challenging topic, and to identifying and addressing the opportunities together.

Source: European medicines agencies network strategy to 2025: Protecting public health at a time of rapid change

Author:  Sebastian Marben, M.Sc.

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