Early Access to New Medications

Greek legislation stipulates that people who suffer from a disease that may cause severe disability or is life threatening, can have access to a drug which has not been formally approved yet or has not been priced for the Greek market without charge to patients that have previously used all other approved medications. The compassionate use programs are not clinical trials and they are under the direct jurisdiction of the National Organization for Medicines (EOF).

If a patient is planning to undergo a compassionate use treatment with a non – approved medicine, he/she should be fully informed on the following program details:

• The inclusion and exclusion criteria of the program
• The indications of the drugs that he/she will be using as they emerge from clinical trials or approval in another country
• The duration of the program
• The firm commitment that the sponsor of the program will assume all costs of the drugs
• The contraindications of the drug
• Any risks or possible adverse reactions of the drug
• He/ She must have read and signed the patient consent form
• He/ She is certain that all other therapeutic methods including all approved medication have been exhausted
• The assessment of the National Organization of Medicines (EOF) on the specific program
• The sponsor is not permitted to discontinue the treatment when a patient continues to benefit from a specific treatment, unless there is information about serious danger or prohibitive toxicity from the specific drug

Our team participates in several expanded access or compassionate use programs. The compassionate use programs that are currently available are the following:

• Early access program to alpelisib for patients with PIK3CA mutated HR-positive, HER2-negative advanced breast cancer who developed disease progression during or after treatment with aromatase inhibitor

Finally there are several drugs that have been approved in another country or for another indication that are currently unavailable or have not yet received a price for the Greek market. Patients can have access to such medication with the permission of the National Organization of Medicines, if there is enough literature to support this use and if the patient has already received all approved medications.

The practice also has access to the Novo TTF – 100A device, an FDA approved but still investigational in Europe for the treatment of patients with glioblastoma. Clinical trials of the device show that this method may increase the length of time until disease progression compared to standard therapy although these results are not yet fully validated. Of note, this device is meant for home use.

Unfortunately, the TTF – 100A cannot be sponsored so the patient has to be aware of its costs before the treatment. If a patient or his/her family is interested they should request further information.