Early access programmes facilitate the access to new medicines for patients with chronical or severely disabling diseases. Early access programmes include compassionate use programmes, ˝Named-patient basis˝ treatments and donations of medical products.
This study evaluated the availability and characteristics of early access programmes in Slovenia. The study reviewed 458 indications of innovative medicines that were granted a marketing authorization by the European Medicines Agency through the centralised procedure between the years 2010 in 2019. Data on the early access programmes was provided by the Agency for Medical Products and Medical Devices of the Republic of Slovenia and pharmaceutical companies, while data on drug reimbursement was acquired from The Health Insurance Institute of Slovenia.
In Slovenia, between 2010 and 2019, a total of 58 indications of medicines were available through early access programmes, 32 within compassionate use programmes, 23 donations of medical products, and 3 both programmes. 60 % of medicines available through early access programs were for oncology indications. The final beneficiaries of early access medicines were tertiary health care institutions in 70 % of cases. Through compassionate use programmes medicines were available in median 19 months prior to national reimbursement. This time could be expanded for 6 months if compassionate use programmes were initiated as soon as the application for a marketing authorization was submitted. Through donations medicines were available 8 months prior to national reimbursement. This time could be prolonged for a median of 8 months if donations were available right after the marketing authorization was granted.
In Slovenia, a number of medicines were available through compassionate use programmes and donations of medical products, allowing patients access to medicines ahead of their national reimbursement. The described situation leaves room for improvement, both in the extent and duration of early access programmes.
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