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New HTA Decisions in England
March 2021
Drug name
QUIREMSPHERES™; SIR-SPHERES®; THERASPHERE™ ()
Company
Quirem Medical, manufacturer, Terumo Europe, distributor; Sirtex; BTG
Decision date
26/02/2021
Therapeutic area
Cancer
Therapeutic sub area
Liver cancers
Decision
Recommended with restrictions
Indication
The selective internal radiation therapy (SIRT) SIR‑Spheres is recommended as an option for treating unresectable advanced hepatocellular carcinoma (HCC) in adults. The SIRT TheraSphere is recommended as an option for treating unresectable advanced HCC in adults. The SIRT QuiremSpheres is NOT recommended for treating unresectable advanced HCC in adults.
Decision Detail
The selective internal radiation therapy (SIRT) SIR‑Spheres is recommended as an option for treating unresectable advanced hepatocellular carcinoma (HCC) in adults, only if: • used for people with Child–Pugh grade A liver impairment when conventional transarterial therapies are inappropriate, and; • the company provides SIR‑Spheres according to the commercial arrangement (there is a simple discount patient access scheme for SIR‑Spheres). The SIRT TheraSphere is recommended as an option for treating unresectable advanced HCC in adults, only if: • used for people with Child–Pugh grade A liver impairment when conventional transarterial therapies are inappropriate, and; • the company provides TheraSphere according to the commercial arrangement (there is a simple discount patient access scheme for TheraSphere). The SIRT QuiremSpheres is not recommended for treating unresectable advanced HCC in adults.
Summary
SIRTs are small radioactive beads that are injected into the liver's blood supply to treat liver cancer. QuiremSpheres, SIR-Spheres and TheraSphere are the 3 SIRTs considered in this appraisal. The assessment group (AG) did a systematic review of the clinical evidence on SIRTs and comparators. Randomised controlled trials (RCTs) were eligible for inclusion in the review. The AG had identified all the RCTs that were also identified by the companies in their submissions. The committee was aware of non-RCT evidence and noted that typically the risk of bias in non-RCT evidence is higher than in RCT evidence. It agreed with the AG's approach to only include non-RCT evidence in the review when there was not enough RCT evidence. The clinical trial data for these SIRTs compared with other treatment options are limited. But, compared with sorafenib, SIRTs may have fewer and more manageable adverse effects, which can improve quality of life. There is not enough evidence to consider SIRTs a cost-effective use of NHS resources for people with early and intermediate HCC. For people with advanced HCC, QuiremSpheres is less clinically effective than sorafenib and costs more, so it is not recommended. SIR-Spheres and TheraSphere are slightly less clinically effective than sorafenib but cost less. The cost savings mean that SIR Spheres and TheraSphere can be recommended as options for people with Child–Pugh grade A liver impairment when conventional transarterial therapies are inappropriate.