About the project
The project presents the GAP tool to monitor an innovative medicines and diagnostics access in selected therapeutic areas in the Visegrád (V4) countries.
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Aims
Our aim was to develop a framework of several indicators that can meaningfully capture multiple dimensions of patient access (not restricted to availability alone) for 12 diseases while reflecting the special characteristics of the Central European region based on the Visegrád (V4) countries.
12 indications (therapy areas) that serve as typical examples for describing and evaluating patients' access to innovative therapies were selected. The selection criteria included the availability of new products, i.e., disease areas with no new therapeutic alternatives were excluded from our analysis. The assumption was to identify only these areas where deficiencies in patient access to new medicines are present in the current clinical practice.
The initiative has been carried out with the support of a consortium led by HTA Consulting.
Check the dataWhat are indicators?
Patient access indicators are descriptive measurements that evaluate the level of patient access by defining a set of benchmarks against which to measure.
We selected a total of 12 indications (therapy areas) in 3 categories that serve as typical examples for describing and evaluating patients’ access to innovative therapies in the Visegrád (V4) countries. Evaluated therapy were those for which at least several new innovative treatments have been approved in Europe recently (i.e. between 2010 and 2022), therefore it was possible to assess the extent to which they have become available to patients in real life. Therapy areas selected for gap assessment are the following: breast cancer, non-small-cell lung cancer (NSCLC), ovarian cancer and prostate cancer in oncology; acute myeloid leukemia (AML), lymphoma (multiple types), spinal muscular atrophy (SMA), and cystic fibrosis in rare diseases; and diabetes mellitus, multiple sclerosis (MS), asthma and Parkinson’s disease (PD) in the ‘other’ diseases category.
After conducting a review of existing and publicly available patient access indicators in international measurements, we developed a multi-level, hierarchical indicator framework, in which indicators are aggregated for each therapeutic area and for each country making it possible to compare several layers in a flexible way. All therapeutic areas are evaluated by using the same set of 8 indicators capturing different aspects of patient access, including availability, affordability, and accessibility of innovative pharmaceutical products, treatments recommended by clinical guidelines as well as diagnostics; furthermore, real-life utilization of selected therapies was also considered. All indicators were adapted to the specific therapeutic area in terms of relevant pharmaceutical products and diagnostic tests.
Data on which the indicators are based is published by local authorities in each country, including national reimbursement databases, reimbursement protocols, and prescription databases. Furthermore, we used international guidelines published by professional organizations as a benchmark. In cases when certain necessary data points were not publicly available in all countries, we used estimates based on the available data. For a detailed description of our methodology and development of indicators, check this document. (English only)
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