NICE Develops a Medtech Innovation Briefing on Selective Internal Radiation Therapy

SIR-Spheres and TheraSphere for treating inoperable hepatocellular carcinoma

NICE announced in March 2016 that it has developed a medtech innovation briefing (MIB) on SIR Spheres for treating inoperable hepatocellular carcinoma. SIR Spheres are a form of selective internal radiation therapy consisting of resin microspheres containing radioactive yttrium 90. They are designed to be used to treat patients with inoperable hepatocellular carcinoma. SIR Spheres can also be used to downstage tumours for resection or liver transplantation, or as a bridge to transplantation. SIR Spheres deliver radiation directly to tumours through the hepatic artery, which limits damage to normal liver cells.

The evidence from 11 studies summarised in the NICE briefing is of mixed quality and shows no significant difference in adverse events between SIR Spheres and transarterial chemoembolisation (TACE) and between SIR Spheres and sorafenib. Studies showed mixed results on the impact of SIR Spheres on overall survival compared with TACE or with sorafenib. One study showed no significant difference in disease control between SIR Spheres and conventional TACE with lipiodol. One study showed no significant difference in time to progression between SIR Spheres and drug-eluting bead TACE (DEB-TACE) using doxorubicin. However, 1 study found that time to progression was significantly longer with sorafenib than SIR Spheres.

The list price of SIR Spheres is 8,000 GBP, excluding VAT. The total price used to reimburse NHS centres is about 21,550 GBP, which covers the total cost of the SIR Spheres treatment.

NICE has also produced a Medtech innovation briefing on another selective internal radiation therapy technology, TheraSphere.

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.