NICE has developed a medtech innovation briefing (MIB) on the Prolaris gene expression assay for assessing long-term risk of prostate cancer progression.
The Prolaris test is a multi-gene assay designed to predict the aggressiveness (growth and spread) of prostate cancer. Most of the relevant evidence is on clinical validity, and evidence for the prognostic value of Prolaris is based only on the retrospective analyses of archived material. No studies examined the prospective use of Prolaris on patient outcomes. Two studies examined whether Prolaris results affected clinicians’ treatment decisions. In 1 study, 65% of clinicians changed their treatment recommendation based on Prolaris results. In the second study results caused a change in treatment in 47.8% of patients. Limited economic evidence was identified. The list price for Prolaris is £1,800, excluding VAT. MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.
Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.
MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.