CUP 101 Since there seems to be some confusion, here are some basics regarding Compassionate Use Programs:
1) The initiative is by the pharma companies - they decide to offer it & deliver it & pick up the tab (no cost to the physician or hospital).
2) The pharma companies decide to which country they will offer the CUP for their product (drug or in this case Pg). This specific protocol agreement is in compliance with & pre-approved by the country's regulatory body (this minimizes time lost due to red tape when a physician makes an order). So the regulatory body (US-FDA or Health Canada) are fully aware of the program - no brilliant hack). In addition, due to possible legal risks, the pharma co. will not decide to offer the CUP to a country that does not offer certain 'legal protection'.
So CUP is generally available worldwide but several countries are often omitted by the pharma co.
3) Physicians make a request to the pharma co. for an individual patient case & it is rapidly processed only if certain criteria are met (no other treatment available, inability to enroll in the clinical trial, etc.). For each request initiated, the regulatory body is notified so once again the regulatory body is aware of each request. This helps them keep track & in case there is an Adverse event, etc.
4) The CUP info can be used as supplemental data but they cannot use the data as part of the respective ongoing clinical trials (different conditions, different protocol & as mentioned above, the patient was not able to participate either because of location or other unmet criteria)
Other tidbits:
- Awareness of CUP is generally word of mouth by doctors.
- European countries/physicians seem to be much more open-minded & quicker to make CUP requests (compared to more conservative Canadian or North American doctors).
Summary:
Great news but data cannot be used to directly support ongoing clinical trials. Hopefully now more physicians become aware of the CUP for Pg & more confident to use it.
Hope this is helpful! :)
GLTA longs!