Implementing a systematic access planning policy for R&D projects

Bayer introduced a new systematic access planning policy in 2021. It now commits to develop access plans for all its pipeline candidates (both in-house and collaborative) and aims to register new products in LMICs within 12 months of first global launch. Bayer’s structured access planning process begins during Phase I of clinical trials, and specific access plans are created during Phase II. The new policy also aims to address barriers to access and opportunities for inclusion of LMICs in access planning during the R&D stage.

The 2022 Index has identified six companies that now have access plans in place for all late-stage R&D projects. However, Bayer leads in its geographic scope, applying its process to a wide number of countries in scope of the Index and seeking to register candidates in a large number of LMICs, rather than focus on a small cohort of emerging markets. For the late-stage candidates analysed, Bayer had eight access plans that included, on average, 26 countries in scope of the Index (compared to the industry average of six countries). Of these, 63% include at least one low-income country (far above the industry average of 15%).

Bayer performs well in access planning for both communicable and non-communicable diseases (NCDs), providing evidence of a tailored approach for each R&D project. In general, for all companies, access plans for R&D projects targeting communicable diseases are more comprehensive than those for NCDs. This is because R&D projects for communicable diseases are often donor-funded and created in partnership with access-oriented organisations to facilitate widespread access.

Bayer leads in access planning for late-stage R&D pipeline products for NCDs, demonstrating best practice not just in the quality of plans overall, but for the breadth of countries in which it plans to register products – a necessary first step for access.

For example, for finerenone (Kerendia®), developed for patients with chronic kidney disease associated with type 2 diabetes, it has a comprehensive plan across 29 countries in scope (including low-income countries) and a strategy to gain regulatory approval in a wide range of countries. It has multiple innovative measures and a clear objective to increase access by considering affordability for patients.

For vericiguat (Verquvo®), developed with MSD to treat patients with heart failure, Bayer has an access plan covering 24 countries in scope including several low-income countries. This also considers innovative pricing strategies to ensure affordability.

Next steps

As the industry shifts toward systematic access planning during R&D, more companies are mainstreaming and integrating access planning in their pipelines. Bayer demonstrates best practice through planning for accelerated access in a large number of countries in scope and leading in access planning for NCDs.