86P - Making the precision oncology landscape of Europe and the Republic of Ireland programmatically accessible

Background

Precision oncology knowledge bases such as OncoKB, CIViC, and the Molecular Oncology Almanac are crucial to the clinical interpretation of cancer variants. Although globally used, they primarily focus on approvals from the FDA. Curating EMA precision oncology indications and making them openly accessible alleviates this bias, supports EU precision oncology, and enables comparative studies. In Europe, access to new medicines post-EMA approval varies due to national or regional pricing and reimbursement decisions. For example, the Republic of Ireland has private and public systems funded by insurance and the state, respectively. While private insurers cover EMA-approved cancer treatments, the Health Service Executive (HSE) first performs additional review before offering reimbursement to ensure that constrained resources are used in a cost-effective way that provides value-for-money for patients and taxpayers. Characterizing this landscape would empower biomarker-driven analysis of potential treatment disparity and value-based care.

Methods

Approvals and derived relationships were curated in a JSON format following the Molecular Oncology Almanac’s standard operating procedure. Product information labels for medications approved for use by the EMA and cancer drugs approved for reimbursement through the HSE are both available online. Evidence was considered up to April 1st, 2024.

Results

The EMA’s 334 authorized human cancer medicines were manually reviewed and 189 therapeutic indications involving at least one biomarker were identified. From these, 349 precision oncology relationships were derived spanning 80 biomarkers, 29 genes, 103 therapies, and 39 cancer types. Similarly, 178 relationships from 94 indications across 73 treatment regimens from the HSE were derived. We observed that the HSE has currently agreed to reimburse 76/189 (40.2%) of EMA authorized precision oncology indications.

Conclusions

Private and public patients in Ireland face inequity regarding access to precision oncology treatments. Data will be made publicly available at moalmanac.org and, to our knowledge, this is the first curation of these indications into open-source knowledge bases.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

B. Reardon: Non-Financial Interests, Institutional, Other, pending institutional patents for methods in clinical interpretation: Dana-Farber Cancer Institute. E.M. Van Allen: Financial Interests, Personal, Advisory Role: Enara Bio, Manifold Bio, Monte Rosa, Novartis Institute for Biomedical Research, Serinus Bio; Financial Interests, Personal, Research Funding: Novartis, Bristol Myers Squibb, Sanofi, NextPoint; Financial Interests, Personal, Stocks/Shares: Tango Therapeutics, Genome Medical, Genomic Life, Enara Bio, Manifold Bio, Microsoft, Monte Rosa, Riva Therapeutics, Serinus Bio, Syapse; Other, Personal and Institutional, Other, Institutional patents filed on chromatin mutations and immunotherapy response, and methods for clinical interpretation: Dana-Farber Cancer Institute; Other, Personal, Other, Editorial Boards: Science Advances: Science Advances; Other, Personal, Other, intermittent legal consulting on patents for Foaley & Hoag: Foaley & Hoag. All other authors have declared no conflicts of interest.