Tuesday, July 16, 2024

Hepatocellular Carcinoma Treatment Recommended by NICE with QuiremSpheres for Advanced Cases

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The National Institute for Health and Care Excellence (NICE) has recommended QuiremSpheres selective internal radiation therapy (SIRT) as a treatment option for adults with unresectable advanced hepatocellular carcinoma (HCC) under specific conditions. This treatment is recommended for individuals with Child-Pugh grade A liver impairment when conventional transarterial therapies are unsuitable, and the company provides it according to the commercial arrangement.

This recommendation ensures that patients currently receiving QuiremSpheres treatment before the publication of this guidance can continue their therapy without any changes to the funding arrangements. The decision to stop the treatment will be made by patients and their National Health Service (NHS) healthcare professionals.

This evaluation is a partial review of NICE’s technology appraisal guidance on selective internal radiation therapies for treating hepatocellular carcinoma (TA688) and includes new evidence submitted by the company regarding QuiremSpheres. Treatment options for hepatocellular carcinoma depend on the disease stage and liver function, including surgery, transarterial therapies (such as SIRT with SIR-Spheres and TheraSphere), chemotherapy, and best supportive care. For most patients, these treatments do not cure hepatocellular carcinoma. QuiremSpheres offers an additional treatment option that can be used instead of SIR-Spheres and TheraSphere.

QuiremSpheres Recommended by NICE as a Cost-Effective Option for Treating Unresectable Liver Tumors

Although clinical trial evidence for QuiremSpheres is limited and has not been directly compared with SIR-Spheres and TheraSphere, an indirect comparison suggests that it is as effective as these alternatives. A cost comparison also indicates that QuiremSpheres has similar costs to SIR-Spheres and TheraSphere, making it a recommended option.

QuiremSpheres (Terumo) received its CE mark in April 2015 and is classified as an Active Implantable Medical Device by Council Regulation (EU2017/745). It is indicated for treating unresectable liver tumors. QuiremSpheres is administered through a catheter to the hepatic artery and is supplied as a customized, patient-specific dose. The emitted beta particles have a maximum range of 8.7 mm in tissue, with a mean of 2.5 mm. Additionally, holmium-166 emits primary gamma photons. The radiation half-life is 26.8 hours, meaning over 90% of the radiation is delivered within the first four days post-procedure. The number of particles implanted depends on the targeted liver volume and ranges from 10 to 30 million.

The acquisition cost of QuiremSpheres is stated to be £12,000 for a single treatment, with a commercial arrangement providing a discount to the NHS. The size of the discount is confidential. Integrated care boards, NHS England, and local authorities must comply with these recommendations within three months of publication, with funding agreed to be provided 30 days after publication.

Hepatocellular Carcinoma

NHS Wales to Fund NICE-Recommended QuiremSpheres for Advanced Hepatocellular Carcinoma Treatment

In Wales, the NHS must usually provide funding and resources for NICE-recommended treatments within two months of the publication of the final guidance. When NICE recommends a treatment “as an option,” the NHS must ensure its availability within the specified period. This means that if a patient has hepatocellular carcinoma and their healthcare professional considers QuiremSpheres appropriate, it should be available in line with NICE’s recommendations.

The four technology appraisal committees are standing advisory committees of NICE. This topic was considered by the chair and the vice-chair of Committee C. Committee members are required to declare any interests in the technology being evaluated. If a conflict of interest is identified, the member is excluded from participating further in that evaluation.

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The comprehensive evaluation and subsequent recommendation of QuiremSpheres for treating advanced hepatocellular carcinoma provide an additional therapeutic option for patients with specific liver impairments. This aligns with NICE’s goal of ensuring that innovative and effective treatments are accessible within the NHS framework. The structured approach ensures that the recommendations are based on a thorough review of clinical and cost-effectiveness, thereby promoting optimal patient outcomes and resource utilization within the healthcare system.

 

Resource: National Institute for Health and Care Excellence, July 03, 2024

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