A Compassionate Drug is a new drug.
So, first of all one needs to know that a Compassionate Drug is a new drug. The newest there is. This is a drug that is at the forefront of medicine. Not chemotherapy from two hundred years ago but a drug that aims to promote cancer medicine, in our case. It is called Compassionate but has no relation to the physical state of the patient and the medical condition.
Now, there are three types of Compassionate Drugs –
Type one –
Is a compassionate drug provided by the pharmaceutical company for free to patients under a framework called a “Compassion Program” or an “Early Access Program”. A compassionate program can only be for a drug that has just been approved, say, by the FDA but has not yet reimbursed and covered by the local health authorities. Here, the interest of the pharmaceutical company is clear because it wants to get the oncologists’ support in its efforts to reimburse the drug and also that they will gain experience in providing treatment with the new drug so that if it is reimbursed, oncologists will prescribe it right away and sales will be high from the beginning.
For the patients and families, it is not interesting because what is interesting is to get the most advanced medicine and for free.
It’s a WIN-WIN for everyone.
By the way, since in this case the drug is approved, it can be bought privately and for those who have health insurance, the insurance can cover the costs. Not every drug company will offer a compassion plan but will prefer to sell the drug. Usually what they do in these cases is offer the drug as compassion to those who do not have health insurance and to those who do have, they buy it through the insurance. In this way, the pharmaceutical company increases the exposure to the drug; more patients enjoy treatment with a new and advanced drug without having to pay for it. If there is no compassionate plan, some patients will purchase the drug privately at their own expense.
Type Two –
There is another compassionate drug and it is a new drug that is still in the stages of the drug company’s application for approval by the FDA and which has completed all clinical trials (clinical = in humans) with it. The drug is no longer being investigated. There are no studies that patients can join and receive the drug through the study.
In this case, we reach out the drug company – wherever it is in the world – and ask it to show compassion for the patient who cannot receive the drug as part of a study because there is no ongoing clinical trial, and to send the drug to the country for the patient specifically and for free. If the pharmaceutical company agrees, we call it also “Compassionate Drug” because the pharmaceutical company has shown compassion for the patient.
Type Three –
And there is a compassionate drug that is a new drug that is still in clinical trials. Even in such cases we reach out the drug company and ask to receive the study drug as a compassionate drug, outside the scope of the clinical trial, especially when interim results on efficacy and safety have been published and they seem to be groundbreaking results compared to any other treatment. Here too, if the drug company agrees, it will ship the drug to the patient’s country for free.
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