Authors' objectives: The objective of this report is to assess the cost-effectiveness and budget impact of the hydrogel rectal spacer SpaceOAR™ for the prevention of radiation induced harm in patients with prostate cancer in Norway.

Authors' results and conclusions: Results: The estimated absolute shortfall for patients suffering from the radiation-induced adverse events was 1.85 QALYs, which places it in the least severe of the six classes suggested by the Magnussen group https://www.regjeringen.no/no/dokumenter/paramme-alvor/id2460080/). We find SpaceOAR™ to be more costly (incremental costs: 15,330 NOK) and slightly more effective (incremental effects: 0.008 QALYs) than radiation therapy alone. The resulting incremental cost-effectiveness ratio (ICER) is 2,006,985 NOK/QALY. Note that the high ICER is a result of the very modest health gain achieved by the intervention. The results of sensitivity analysis illustrated that the price 7 Executive summary (English) of the spacer, the quality of life weights and the efficacy of the intervention had the greatest impact on the results. The probabilistic sensitivity analysis indicates that the health benefit of the intervention is very uncertain, with only 59% of simulations resulting in a net health gain as measured in QALYs. There is however 100% certainty that the spacer will increase costs. The budget impact analysis indicated that adoption of hydrogel rectal spacer would increase spending by approximately 15 million NOK per year. Conclusion: This report has assessed to what degree the technology meets the Norwegian priority setting criteria (health benefits, resource use and disease severity). The absolute shortfall is 1.85 QALY, placing the disease in the lowest priority setting group following the approach suggested by the Magnussen group (https://www.regjeringen.no/no/dokumenter/pa-ramme-alvor/id2460080/ ). The health benefit of the intervention is small (0.008 QALYs) and very uncertain.

Authors' methods: In order to evaluate the cost-effectiveness of SpaceOAR™, we developed a health economic model consisting of a decision tree and a state-transition Markov model. We calculated the severity of disease, measured as absolute shortfall, by subtracting the model predicted prognosis of patients receiving current treatment from the age adjusted number of remaining quality adjusted life years, as recommended for priority setting in Norway. The cost-effectiveness analysis compares the incremental costs expressed in 2020 Norwegian kroner (NOK) and health effects as measured in quality adjusted life years (QALYs) of the device in combination with the radiation therapy with radiation therapy alone. The analysis applies a ten-year time horizon and a broad healthcare perspective on costs, as recommended in Norwegian guidelines. Data on the efficacy and safety of SpaceOAR™ were collected from a 2020 EUnetHTA report (1). A Norwegian summary of this EUnetHTA report is included in the appendix 14. We discounted costs and health effects using an annual discount rate of 4%. The results were expressed as incremental cost-effectiveness ratio (ICER), i.e. expected incremental costs (NOK) per unit of health gain (QALY). We performed on-way sensitivity analyses and a probabilistic sensitivity analysis. To estimate the financial consequences of implementing the device in health care practice, we conducted a budget impact analysis.

Project Status: Completed

Year Published: 2021

URL for published report: https://www.fhi.no/en/publ/2021/Hydrogel-rectal-spacer-SpaceOAR-in-prostate-cancer-radiation-therapy/

English language abstract: An English language summary is available

Publication Type: Other

Country: Norway

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo