Frequently Asked Questions NPP
The difference between these two programs is that an EAP provides access to pre-approval, investigational drugs that are still being studied/tested in clinical trials. A NPP provides access to post-approval drugs that are no longer in clinical trial and are commercially available in one or more country.
Pharmaceutical companies are not required to provide their products through a formal NPP. However, there are several benefits associated with named patient drug supply that may be of interest to companies. See the Sponsors NPP section for more information.
Companies do not have to wait for commercialization to provide their products through a NPP. Following marketing approval (occurs prior to commercialization), companies can use an NPP to continue supplying their drug to clinical trial patients, or any additional patients, before it becomes commercially available to them. This allows companies to begin generating revenue and serves as a cost-effective alternative to an open-label extension study.
Companies can provide drug to patients in any country in which they have not yet received marketing approval. This includes countries in which a company plans to seek marketing approval, as well as those countries in which a company does not plan to seek marketing approval.
To import a drug into a patient’s home country through a NPP, the patient’s physician will have to complete the necessary importation documentation. This documentation will be reviewed by the FDA, or the equivalent regulatory body, when the drug arrives in the patient’s home country. Without this documentation, the drug will not be allowed to pass through customs and will most likely be sent back to the origin country.
WEP Clinical can help provide support in obtaining the right permits and can assist physicians with the completion of the right documentation.
Information can usually be found on manufacturer websites if they have an approved NPP. Additionally, WEP Clinical is always happy to help research potential options on your behalf, and even beginning a dialogue with the manufacturer.
At WEP, we take product visibility, and custody very seriously. Deploying a controlled NPP program can improve a Sponsor’s compliance profile which ensures product integrity, and avoids diversion. Patients benefit because they have access to authentic and correctly handled products at a price approved by the sponsor.
There are two critical factors to executing exceptional compliance for NPPs which minimizes reputational and legal risks with the aim of a positive patient experience:
- The distributor is fully compliant and audited to EU, US and World Health Organization (WHO) guidelines to Good Distribution Practices.
- Supply is in compliance with any local country specific regulations
Through working alongside our distribution partners, we can provide visibility into a product status throughout its journey “end to end”. Your product will not leave our control at any stage, nor will it enter the hands of any unknown supply chains.