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Sirtex Medical - Navigating complex regulatory process

Situation

The National Institute for Health and Clinical Excellence (NICE) started assessment of Selective Internal Radiation Therapy (SIRT) - a new technique for treating liver cancer not appropriate for surgery – without notifying the sole approved world manufacturer, Sirtex Medical. Even when Sirtex discovered this, NICE refused to consider their evidence.

Programme

Ruder Finn worked with Sirtex to

  • identify and facilitate contact with key opinion formers in Whitehall and Westminster and
  • coordinated contact with Department of Health ministers.

Ruder Finn also helped present the case highlighting inconsistencies with NICE's own procedures, as well as the unfairness of the situation from the patient's perspective.

Results

NICE was persuaded to delay the process, and to consider fully evidence submitted by Sirtex. The initial provisional recommendation was overturned – and as a result, potentially up to 20,000 patients with cancer will now have the right to treatment in the NHS.

Sirtex Medical

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