NICE Medtech briefing acknowledges consideration of SIR Y-90 resin microspheres as alternative to standard therapy


The UK National Institute for Health and Care Excellence (NICE) has issued a new Medtech Innovation Briefing (MIB) stating that National Health Service (NHS) doctors and commissioners may consider SIR-Spheres Yttrium-90 (Y-90) resin microspheres as an alternative to standard therapy with transarterial chemoembolization (TACE) or sorafenib in the treatment of patients with inoperable primary liver cancer (hepatocellular carcinoma or HCC).

The new NICE MIB states that patients with inoperable HCC have a poor prognosis and limited effective treatment options, and that existing clinical research evidence suggests that SIR-Spheres Y-90 resin microspheres are as effective as both TACE and sorafenib.

One of the MIB specialist commentators noted that SIR-Spheres Y-90 resin microspheres are also better tolerated than TACE, with fewer incidences of post-embolization syndrome and shorter in-patient hospital stays.

The new MIB also explains that unlike TACE, which requires multiple procedures, or sorafenib, a medication that must be taken daily, most patients treated with SIR-Spheres Y-90 resin microspheres usually require only a single treatment. SIR-Spheres Y-90 resin microspheres are an innovative form of local radiotherapy typically delivering 30–40 million tiny radioactive beads directly to liver tumours via the bloodstream, which permits a uniform distribution of radioactivity around the tumour sites whilst sparing normal liver cells. In a few patients with inoperable HCC, treatment with SIR-Spheres Y-90 resin microspheres has sufficiently reduced the size of liver tumours to allow potentially curative surgery with liver resection, ablation or transplantation.

Daniel Palmer of the University of Liverpool and Clatterbridge Cancer Centre says that, “This NICE MIB is welcomed, as it opens the door for UK HCC patients to have access to SIR-Spheres Y-90 resin microspheres as a well-tolerated alternative to other standard therapies. Whilst exciting further research with this technology is already well along the way to completion, the new NICE MIB advice may be particularly important now for our patients who cannot tolerate TACE or sorafenib, or are ineligible for these treatments.”

Patient advocate Andrew Langford, chief executive of the British Liver Trust, states that “For many years, patients with inoperable HCC have had access to only two effective therapy options. Now, with the publication of the NICE MIB, NHS patients will have a further option in the form of SIR-Spheres Y-90 resin microspheres. This form of local radiotherapy is well-tolerated and convenient for the patient.”

Nigel Lange, chief executive of Sirtex Europe, said that, “We are pleased to have received the NICE MIB for the treatment of [Inoperable primary liver cancer] is a difficult cancer to control and better therapies are needed to treat patients safely and effectively, with special attention to the quality of their daily life, which is of utmost importance. We are also working to provide further strong evidence of our technology’s effectiveness and safety in treating unresectable HCC. Results of the large SARAH study are expected to be available later this year. Another large HCC study, SORAMIC, has completed recruitment in the palliative group with results expected in 2018. A third large HCC study, SIRveNIB, is expected to complete recruitment this year, as well.”