The aim of this project, which has been commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, is to review the submission of the pharmaceutical company (Steba Biotech) on the evidence for the clinical and cost-effectiveness of padeliporfin vascular photodynamic therapy (TOOKAD®) for adults with unilateral, low-risk, localised prostate cancer. The company also included analyses for padeliporfin in adults with unilateral, low-risk prostate cancer, excluding very low risk disease, which was consistent with the current approved indication.

The company’s clinical effectiveness evidence consists mainly of one phase III RCT, the CLIN1001 PCM301 trial, which compared padeliporfin VTP with active surveillance. The co-primary endpoints were absence of definitive cancer at 24 months and treatment failure (defined as progression of cancer from low to moderate risk or higher over 24-month follow-up).

The Aberdeen HTA Group acts as the Evidence Review Group (ERG) for the project and provides an independent critique of the clinical and cost-effectiveness evidence submitted by the company. Based on the findings of the company submission and of the ERG’s critique, NICE will release appropriate clinical guidance. NICE guidance is expected in October 2018.

For more information see:


Miriam Brazzelli;