In 2013, a client with a Named Patient Programme (NPP) designed to treat patients with an unmet ‘special’ clinical need following the end of a Phase I/II trial of their oncology product approached us to manage the programme. We have successfully managed the NPP with significant improvements and substantially refined procedures implemented.
- A UK based NPP for an early phase unlicensed IMP.
- NPP legislation is not well defined and despite having a similar macroscopic appearance to a clinical trial, is not governed by GCP.
- NPPs are most often conducted for products with well documented safety profiles at the latter stages of development, such as Phase IV drugs, products awaiting the outcome of a marketing authorisation (MA) application or marketed products used differently to their MA. In comparison, the safety profile of our client’s young product was less well understood.
- Due to the early stage of development, a clear and well defined indication for the drugs prescription could not be established.
- Knowledgeable – Our experienced pharmacovigilance and regulatory teams provide expertise across a depth of specialities.
- Connected – We contact regulatory authorities, including the MHRA, to discuss specifically identified issues, such as reporting requirements for NPP adverse drug reactions (ADR’s).
- Experienced – We review and update the literature provided to physicians in order to ensure that accurate, concise and useful information was provided regarding the client product.
- Proactive – We actively review and update project documents facilitating continual process improvement and compliance within current legislature.
- Expertise – Our medical team review named patient physician’s declaration forms as part of a well-orchestrated IMP ordering process.
- Relationships – We maintain a close relationship with our clients, seeking to discuss complex or ambiguous cases.
- Successfully managed the NPP for 3 years, continuing to this day.
- 84 new patients have joined the programme.
- Strong relationships with the treating hospital, requesting physicians, product courier and manufacturer.
- Attended on-site meetings to discuss the on-going coordination of the programme with primary contacts at the treating hospital.
- Collaboration with hospital management to monitor the volume of patients being treated on the programme.