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New HTA Decisions in England
November 2018
Drug name
TOOKAD® (padeliporfin)
Company
Steba Biotech
Decision date
21/11/2018
Therapeutic area
Cancer
Therapeutic sub area
Prostate cancer
Decision
Not recommended
Indication
For untreated, unilateral, low-risk prostate cancer in adults
Decision Detail
Summary
It was stated by the committee that there was no clinical evidence demonstrating how effective padeliporfin is at slowing rate of disease progression compared to radical therapies. Despite trial evidence showing that padeliporfin, at two years, is more effective at slowing prostate cancer compared to active surveillance, it is unclear whether this leads to people then living longer after the two year time point. Uncertainties were also raised regarding the trial population; NHS England would not support using padeliporfin for low-risk prostate cancer due to long term side effects. The company compared padeliporfin with radical therapies in its cost-effectiveness analyses however, the committee could not consider these as clinical effectiveness evidence did not consider this comparison. Padeliporfin therefore cannot be recommended for untreated, unilateral, low-risk prostate cancer.