2 Information about QuiremSpheres, SIR-Spheres and TheraSphere

CE mark for QuiremSpheres

2.1

QuiremSpheres (Quirem Medical, manufacturer; Terumo Europe, distributor) received its CE mark in April 2015. It is classified as an Active Implantable Medical Device by Council Directive 90/385/EEC. It is indicated for treating unresectable liver tumours.

Dosage in the CE mark for QuiremSpheres

2.2

QuiremSpheres is given through a catheter to the hepatic artery. The product is supplied as a customised, patient-specific dose. The maximum range of the emitted beta particles in tissue is 8.7 mm with a mean of 2.5 mm. Also, holmium‑166 emits primary gamma photons (81 kilo electronvolt, KeV). The half-life is 26.8 hours, which means more than 90% of the radiation is given in the first 4 days after the procedure. At the moment of treatment, the activity per microsphere is 200 to 400 Becquerel (Bq). The number of particles implanted depends on the targeted liver volume and ranges, on average, from 10 to 30 million.

Price for QuiremSpheres

2.3

The company has stated that the acquisition cost of QuiremSpheres is £9,896 for a single treatment. The company has a commercial arrangement, which would have applied if the technology had been recommended.

CE mark for SIR-Spheres

2.4

SIR-Spheres (Sirtex) received its CE mark as an Active Implantable Medical Device in October 2002. It is indicated for treating advanced inoperable liver tumours.

Dosage in the CE mark for SIR-Spheres

2.5

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 million to 60 million.

Price for SIR-Spheres

2.6

The company has stated that the acquisition cost of SIR‑Spheres is £8,000 for a single treatment. The company has a commercial arrangement. This makes SIR‑Spheres available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

CE mark for TheraSphere

2.7

TheraSphere (BTG) received its CE mark as an Active Implantable Medical Device in September 2014. It is indicated for treating hepatic neoplasia.

Dosage in the CE mark for TheraSphere

2.8

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 million to 8 million microspheres. The recommended dose to the liver is 80 Gy to 150 Gy.

Price for TheraSphere

2.9

The company has stated that the acquisition cost of TheraSphere is £8,000 for a single treatment. The company has a commercial arrangement. This makes TheraSphere available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)