Managing a named patient programme

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.

The project

  • A UK based NPP for an early phase unlicensed IMP.

Challenges

  • 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.

Our approach

  • 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.

Outcomes

  • 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.

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