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Selective internal radiation therapies (SIRTs) for treating hepatocellular carcinoma

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2 Information about QuiremSphere, SIR-Spheres and TheraSphere

QuiremSpheres (Terumo Europe)

CE marking

QuiremSpheres received its CE mark on 1 April 2015. It is classified as an Active Implantable Medical Device (AIMD) by Council Directive 90/385/EEC. It is indicated for treating unresectable liver tumours.

Dosage in the CE mark

The company has stated that the typical number of particles that are given by QuiremSpheres is approximately 20 to 30 million.

Price

The company has stated that the cost of QuiremSpheres is £9,896 for a single treatment.

The company has a commercial arrangement (simple discount patient access scheme), which would have applied if the technology had been recommended.

SIR-Spheres (SIRTEX)

CE marking

SIR-Spheres received its CE mark as a class III active medical device in October 2002. It is indicated for treating advanced inoperable liver tumours.

Dosage in the CE mark

SIR‑Spheres is given through a catheter to the hepatic artery. It is supplied at 3 GBq yttrium‑90 per vial in 5 ml water for injection in a shielded shipping vial. Each vial contains 40 to 80 million microspheres, ranging from 20 to 60 micrometres in diameter (median diameter 32.5 micrometres). The maximum range of beta emission in tissue is 11 mm with a mean of 2.5 mm. The average number of particles implanted is 30×106 to 60×106.

Price

The company has stated that the cost of SIR‑Spheres is £8,000 for a single treatment. Costs may vary in different settings because of negotiated procurement discounts.

TheraSphere (BTG)

CE marking

TheraSphere received its CE mark as a class III active medical device in September 2014. It is indicated for treating hepatic neoplasia.

Dosage in the CE mark

TheraSphere is given through a catheter to the hepatic artery. It is supplied in 6 dose sizes: 3 GBq, 5 GBq, 7 GBq, 10 GBq, 15 GBq or 20 GBq in 0.6 ml pyrogen‑free water supplied in a 1 ml vial, inside an acrylic shield. Custom dose sizes are also available in increments of 0.5 GBq between 3 GBq and 20 GBq. A single treatment with TheraSphere contains 1.2 to 8 million microspheres. The recommended dose to the liver is 80 Gy to 150 Gy.

Price

The company has stated that the cost of Thera‑Spheres is £8,000 for a single treatment. Costs may vary in different settings because of negotiated procurement discounts.