OBJECTIVES: Emergency access to drug technologies (RDTL) was introduced in Poland in 2017 in order to improve patient access to expensive, rescue therapies. The procedure is initiated by hospitals and pertains to single patients. In reality, by mid 2018, few patients (8,5% of total applications) received drugs within this procedure. The aim of this study was to discuss the reasons for it.

METHODS: A search was conducted in grey literature to identify the most important limitations of RDTL.

RESULTS: Several limitations of RDTL were identified. The first is administrative burden. It is required that the procedure is initiated by a physician who is obliged to document precisely all previous treatment history. Hospitals do not have additional resources to cover this task, therefore some hospitals are not willing to engage in it.

In addition, there is no extra budget for RDTL and hospitals are expected to finance RDTL within the lump sum they receive from National Health Fund. This may endanger hospitals’ financial stability and makes hospitals reluctant to submit RDTL applications.

For drugs exceeding the cost threshold, MoH is required to ask for opinion of AHTAPol. This threshold is low (25% of GDP per capita) therefore many applications have to follow this path. AHTAPol has 30 days for issuing opinion that prolongs all procedure, which was supposed to be fast (14 days for basic procedure).

If positive opinion is granted by AHTAPol, MoH is obliged to call the manufacturer to submit regular reimbursement application within 90 days, if this is not fulfilled, reimbursement is stopped.

CONCLUSIONS: Low RDTL utilization is caused by several hurdles that exist to its implementation. These include high administrative and more importantly budget burden to hospitals, low drug cost threshold that implies AHTAPol evaluation and discontinuation of financing if no reimbursement application is received from manufacturer.