OBJECTIVES: Polish patients have poor access to expensive innovative drugs. In 2017, emergency access to drug technologies (RDTL) was introduced to enable access to last resort therapies to single patients. The aim of this study was to describe the RDTL pathway, financing and current status.

METHODS: A search was conducted in websites of Ministry of Health (MoH), Polish HTA Agency (AHTAPol), and grey literature to identify information about RDTL.

RESULTS: RDTL submissions are made by the service provider (hospital) to the MoH. Submission, supported by opinion of clinical consultant in therapeutic area of concern, should state that all available treatment options were ineffective. MoH has 14 days to issue decision for a maximum 3 months (or 3 cycles) of treatment. Afterwards new application needs to be submitted. If the cost of therapy exceeds the threshold (25% of GDP per capita) or another RDTL application has been previously submitted for another patient in the same indication, the procedure is more complex as MoH is obliged to ask AHTAPol for a recommendation that needs to be prepared within 30 days. In this case, in order to continue reimbursement beyond 3 months manufacturer has to submit a standard reimbursement application within 90 days following positive MoH decision on RDTL.

There is no separate budget for RDTL. The cost is included in lump sum hospitals receive from National Health Fund.

In 2018, 818 RDTL applications were submitted (480 approved). However by mid 2018 only 8,5% of patients really received drug.

CONCLUSIONS: RDTL was meant to provide early access to expensive, last resort medicines. In reality its use is limited due to high administrative and financial burden imposed on hospitals. Patients’ organizations are calling for creation of separate budget and simplification of the procedure to ensure equity in access to last resort drugs in Poland.