Cost-utility analysis of selective internal radiation therapy with Y-90 resin microspheres in hepatocellular carcinoma.

Background: The study assessed the cost-utility of selective internal radiation therapy (SIRT) with Y-90 resin microspheres versus sorafenib in UK patients with unresectable hepatocellular carcinoma ineligible for transarterial chemoembolization. Materials & methods: A lifetime partitioned survival model was developed for patients with low tumor burden (≤25%) and good liver function (albumin-bilirubin grade 1). Efficacy, safety and quality of life data were from a European Phase III randomized controlled trial and published studies. Resource use was from registries and clinical surveys. Results: Discounted quality-adjusted life-years were 1.982 and 1.381, and discounted total costs were £29,143 and 30,927, for SIRT and sorafenib, respectively. Conclusion: SIRT has the potential to be a dominant (more efficacious/less costly) or cost-effective alternative to sorafenib in patients with unresectable hepatocellular carcinoma.

Yttrium-90 Radioembolization Is Cost Effective in Intrahepatic Cholangiocarcinoma: A SEER Medicare Population Study.

PURPOSE: To analyze the cost-effectiveness of radioembolization in the treatment of intrahepatic cholangiocarcinoma (ICC) using the Surveillance, Epidemiology, and End Results (SEER) Medicare cancer database. MATERIALS AND METHODS: Cost as measured by total treatment-related reimbursement in patients diagnosed with ICC who received chemotherapy alone or chemotherapy and yttrium-90 radioembolization was assessed in the SEER Medicare cancer database (1999-2012). Survival analysis was performed, and incremental cost-effectiveness ratios were generated. RESULTS: The study included 585 patients. Average age at diagnosis was 71 years (standard deviation: 9.9), and 52% of patients were male. Twelve percent of patients received chemotherapy with radioembolization (n = 72), and 88% of patients (n = 513) received only chemotherapy. Median survival was 1043 days (95% confidence interval [CI]: 894-1244) for chemotherapy plus radioembolization and 811 days (95% CI: 705-925) for chemotherapy alone (P = .02). Patients who received combination therapy were slightly younger (71 vs 69 years, P = .03). No significant differences were observed between treatment groups in age at treatment, sex, race, or city size. Multivariable analysis showed a hazard ratio for progression for combination therapy versus chemotherapy alone of 0.76 (95% CI: 0.59-0.97, P = .029). The incremental cost-effectiveness ratio, a measure of cost of each added year of life, was $50,058.65 per year (quartiles: $11,454.63, $52,763.28). CONCLUSIONS: Combination therapy of ICC with chemotherapy and radioembolization is associated with higher median survival and can be a cost-effective treatment, with a median cost of $50,058.65 per additional year of survival.

Treatment of hepatocellular carcinoma: a cost analysis of yttrium-90 transarterial radioembolization versus sorafenib.

AIM: The aim was to evaluate cost-effectiveness of yttrium-90 transarterial radioembolization (TARE) in comparison to sorafenib treatment. PATIENTS & METHODS: A single-center, retrospective, observational study was performed, 166 patients with intermediate-/advanced-stage hepatocellular carcinoma were treated with sorafenib and 19 with TARE. The patients out of the sorafenib group matching the inclusion criteria for TARE, were reassigned to a subgroup SOR3. RESULTS: Mean costs for SOR3 patients amounted to €27,992 per patient, instead for TARE treatment, mean expense per patient was €17,761 (p = 0.028). Overall survival was similar between the two groups, while midterm survival rates (p = 0.012) were significantly higher with TARE treatment. CONCLUSION: TARE causes significantly lower treatment costs than sorafenib with better outcome in midterm survival.

Cost-effectiveness of selective internal radiation therapy using yttrium-90 resin microspheres in treating patients with inoperable colorectal liver metastases in the UK.

OBJECTIVE: Selective internal radiation therapy (SIRT) using SIR-Spheres(®) (90)Y-labeled resin microspheres has been shown to be a well-tolerated, effective treatment in patients with inoperable liver-dominant chemotherapy-refractory metastatic colorectal cancer (mCRC). This study estimated the cost-effectiveness of (90)Y-resin microspheres compared to best supportive care (BSC) from a UK perspective. METHODS: Survival data from a comparative retrospective cohort study was analyzed and used in a state-transition cost-effectiveness model, using quality-adjusted life years (QALYs) gained as the measure of effectiveness. The model incorporated costs for the SIRT procedure, monitoring, further treatment, adverse events, and death. Utility values, reflecting patient quality-of-life, were taken from a published source. RESULTS: SIRT using (90)Y-resin microspheres compared to BSC improved overall survival by a mean of 1.12 life years and resulted in a cost per QALY gained of £28,216. In sensitivity analysis, this varied between £25,015-£28,817. CONCLUSION: In an area of large unmet need, treatment with (90)Y-resin microspheres offers a clinically effective and cost-effective treatment option.

Radioembolisation with yttrium‒90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma (SARAH): study protocol for a randomised controlled trial.

BACKGROUND: Untreated advanced hepatocellular carcinoma (HCC) is linked to poor prognosis. While sorafenib is the current recommended treatment for advanced HCC, radioembolisation (RE; also called selective internal radiation therapy or SIRT) with yttrium-90 microspheres has shown efficacy in cohort studies. However, there are no head-to-head trials comparing radiation therapy with yttrium-90 microspheres and sorafenib in advanced HCC. The SARAH trial has been designed to compare the efficacy and safety of sorafenib therapy and RE using yttrium-90 resin microspheres (SIR-Spheres™; Sirtex Medical Limited, North Sydney, Australia) in patients with advanced HCC. Quality of life (QoL) and cost-effectiveness will also be compared between therapies. METHODS/DESIGN: SARAH is a prospective, randomised, controlled, open-label, multicentre trial comparing the efficacy of RE with sorafenib in the treatment of patients with advanced HCC. The trial aims to recruit adults with a life expectancy of >3 months, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1, and: advanced HCC according to the Barcelona criteria (stage C) or recurrent HCC after surgical or thermoablative treatment who are not eligible for surgical resection, liver transplantation or thermal ablation; or two rounds of failed chemoembolisation. Patients will be randomised 1:1 to receive either RE or sorafenib 400 mg twice daily. All patients will be monitored for between 12 and 48 months following start of treatment. The primary endpoint of the SARAH trial is overall survival (OS). Secondary endpoints include: adverse events, progression-free survival at 6 months; tumour response rate; general or liver disease-specific QoL scores; and cost of each treatment strategy. Assuming an increase in median OS of 4 months with RE versus sorafenib therapy, randomising at least 400 patients (200 in each treatment arm) will be sufficient for 80% power and a bilateral alpha risk of 5%; therefore, 440 patients will be enrolled to allow for 10% loss of patients due to ineligibility. DISCUSSION: The SARAH trial is the first randomised head-to-head study to compare RE with sorafenib in advanced HCC, and will establish the potential role of RE in HCC treatment guidelines. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01482442, first received 28 November 2011.

90Y radioembolization versus chemoembolization in the treatment of hepatocellular carcinoma: an analysis of comparative effectiveness.

Locoregional catheter-based therapies for unresectable hepatocellular carcinoma (HCC) include conventional transarterial chemoembolization (cTACE), drug-eluting bead chemoembolization and yttrium-90 ((90)Y) radioembolization. Although current guidelines recommend cTACE for inoperable HCC, comparative effectiveness of drug-eluting bead chemoembolization and (90)Y radioembolization in the management of HCC remains undefined due to the lack of data evaluating safety and effectiveness among these therapies. A comprehensive search of the literature was carried out for studies examining comparative effectiveness of cTACE and (90)Y based on objective tumor response and overall patient survival. Further data on efficacy, safety, toxicity and cost-effectiveness was also examined. The National Cancer Institute Levels of Evidence for Cancer Treatment Studies provided a useful framework for the critical understanding and stratification of current evidence on locoregional therapy for unresectable HCC. Based on current retrospective cohort studies, evidence for similar efficacy and safety between cTACE and (90)Y radioembolization was demonstrated. Further prospective, randomized studies are required to validate these observations and to analyze cost-effectiveness of these interventions in unresectable HCC patients for definitive recommendations to be made.

Transarterial chemoembolization and selective internal radiation for the treatment of patients with metastatic neuroendocrine tumors: a comparison of efficacy and cost.

BACKGROUND: Hepatic arterial therapy (HAT) has been proven to be effective at palliation of hormonal symptoms of metastatic neuroendocrine tumors (NETs), as well as a means of cytoreduction. Recently, the newer modalities of yttrium-90 and drug-eluting beads with doxorubicin (DEBDOX) have been reported to be effective in the treatment of metastatic NETs. The aim of this study was to compare the safety, efficacy, and cost of selective internal radiation with DEB therapy. METHODS: An institutional review board-approved, multicenter, multinational prospective treatment registry to investigate the safety and efficacy of yttrium-90 and doxorubicin microspheres was reviewed. RESULTS: In all, 43 patients underwent a combined 69 HAT treatments, with 15 patients receiving 23 yttrium-90 treatments and 28 patients receiving 46 DEBDOX treatments. The extent of disease-based on the number of lesions, bilobar distribution, patient performance status, and size of largest lesion-was similar in both the yttrium-90 and DEBDOX groups. After a median follow-up of 12 months, response rates were similar with the two treatments, but then there was a significantly lower response rate in the yttrium-90 group at 12 months than in the DEBDOX group. In an evaluation of cost for the two treatments, the median cost for yttrium-90 was $25,243 and the median cost for DEBDOX was $13,400. CONCLUSION: HAT is a safe and effective therapy in patients with unresectable NETs to the liver. The size of the lesions, total lesion volume, and expense of therapy need to be considered when choosing which HAT method is optimal.