WEP Clinical – Expanded Access to Medications Not Yet Approved for General Prescription
October 2019 Addendum
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- Access to Unapproved Medicine: Is This an Option for Me? (USA)
- Access to Unapproved Medicine: Is This an Option for Me? (Canada)
Do you and your healthcare provider feel you might benefit from access to a medication that is not yet available/approved in your country or that is still in clinical trials? WEP Clinical* might be able to help you with this access. The Hypersomnia Foundation is working with WEP Clinical, which has the stamp of approval from the European equivalent of the FDA, to provide our constituents with helpful information about WEP Clinical’s programs. Although WEP Clinical will work with patients directly, patients will need to work with their healthcare providers to provide appropriate prescriptions for the requested medications. If you have exhausted available treatment options, you may want to schedule an appointment with your healthcare provider to discuss WEP Clinical.
What Is WEP Clinical?
WEP Clinical is a clinical services company which sets up and manages Expanded Access Programs (EAPs) on behalf of pharmaceutical companies. EAPs (also known as Compassionate Use or Named Patient Programs) allow pharma companies to make their pre-approval drugs available to patients who cannot access them through an established clinical trial. EAPs also allow pharma companies to make their post-approval drugs available to patients living in countries where the drug is not yet, or may never be, approved.
Because WEP Clinical has knowledge and expertise in the expanded access space, they have recently set up a non-commercial (charitable) side of their business, through which they work with advocacy groups like the Hypersomnia Foundation to support patients who are trying to access much needed medication. WEP Clinical works with pharma day in day out, so they have company contacts that they can use to make the process of getting in touch with the right people in the right company much easier than it would be for patients working on their own.
Importing a Medication
In most circumstances, WEP Clinical will reach out to the pharma companies and lobby for expanded access. However, they can also help patients import medications that are not commercially available in the patient’s home country but which are available elsewhere in the world. For example, patients in the US can import a drug (on a ‘personal use’ basis) that is not commercially available in the US. WEP Clinical will help the patient and healthcare provider to complete all the documentation necessary to import a drug for personal use and will source the drug, deliver the drug, and clear it through customs. The only caveat is that patients will have to pay however much it costs for WEP Clinical to buy the drug and ship it to the US.
It is important to note that WEP Clinical unfortunately cannot help with insurance coverage or access to “off-label” medications that are already approved for use for any reason in a patient’s home country.
WEP Clinical may be able to help patients in the following situations:
- A drug is approved but is not approved in their home country.
- A drug is in clinical trial, but the patient is not eligible for the trial or does not live where a trial site is set up.
- A drug is approved/in clinical trial but for a different condition (narcolepsy for example). Note that it is easier to help in this scenario if the drug is still in clinical trial because EAP patients can help the pharma company gain additional safety and efficacy data to support their approval request with the FDA. This benefit to companies does not exist if the drug is already approved.
If you would like more information on the kinds of drugs that might be applicable, please contact the Hypersomnia Foundation at . If you know of a drug you would like to access, and you would like WEP Clinical’s help, please contact .
For further information, both doctors and patients can contact Yasmin Khera at or visit www.wepclinical.com.
The Hypersomnia Foundation is working with WEP Clinical to provide our constituents with information about WEP Clinical’s programs, which we hope will be helpful. HF is not, however, a healthcare provider and cannot work directly with or on behalf of particular patients. HF cannot provide medical advice, confirm diagnoses, or advise as to the use or dosage of medications. Please consult your healthcare provider if you have questions about any of these matters.
* Please note similar companies, like IDIS Managed Access, may also be of help, though the HF has not yet worked with them.