Case Study: NPP Launch Eases Burden on Sponsor

Named Patient Programme (NPP)

Case Study: NPP Launch Eases Burden on Sponsor

As regulatory review timelines grow, more patients are requesting access to medications in the window between a Phase III trial and marketing approval. Compassionate Use Programmes (CUPs) must balance urgency with eligibility and regulatory guidelines in order to provide essential support to patients. Often sponsors launch a Named Patient Programme (NPP) and can quickly become overwhelmed navigating the hurdles to provide access to pre-approval medication. UBC recently launched a global NPP for a sponsor developing a product for a rare disease.

Challenge: A biotech company launched a Named Patient Programme (NPP) that required complex and dedicated operational support. The NPP demanded expedited patient eligibility review and urgent drug shipment to an extremely sick patient population.  High patient demand from a global population encouraged them to seek a pharma services provider to manage the programme.

Solution: UBC designed and implemented a comprehensive NPP operating infrastructure that was adaptable as the programme expanded, while allowing for robust quality control management. The success of the programme rested on:

  • Automation: Leveraging UBC’s proprietary Electronica Data Capture (EDC), we automated the patient eligibility review, approval and tracking process.
  • Specialized global teams: We assigned a multi-disciplinary global programme team in all the key disciplines required to successfully execute this programme: site operations, medical, regulatory, data management, pharmacovigilance, and programme management. The team supporting the programme was hand-picked and specially trained for this particular NPP
  • Dedicated 24/7 call centre: Trained UBC call centre staff were assigned as the initial physician interface and made available at every hour of the day to support physician requests and answer questions.
  • Safety reporting: Due to the specifics of the NPP process the Pharmacovigilance team created a bespoke process for SAE reporting from treating physicians ensuring events were processed, reviewed and reported within required timelines.

Results: A robust and automated review process coupled with clear training for the dedicated team has allowed us to provide most eligibility decisions within 24 hours of receipt of the request and expedited shipment of drug. The programme has approved more than 400 patients, more than expected in the initial programme launch. Because of the success, the sponsor partnered with UBC to launch an Expanded Access Programme (EAP) in the United States and extended the length of the NPP.

Outsourcing the NPP to UBC allowed the sponsor to focus on marketing approval while continuing to provide life-saving medication to patients with no other options. UBC is uniquely positioned to support early access programmes of all types and sizes and provide seamless transition from investigational product to commercial drug following approval. Contact us to leverage our expertise for your programme.