Optune is based on the tumour-treating fields (TTFields) technology. TTFields are electrical fields that inhibit cell division (mitosis) of proliferating cells. Optune is intended for patients diagnosed with histologically-confirmed glioblastoma.
Glioblastoma is the most common type of malignant brain tumor among adults. TLV assesses this condition as extremely severe. Median progression-free survival from the randomization was 6.7 months for the Optune and Temozolomide group, as compared with four months for the Temozolomide alone group. Median overall survival from randomization was 20.9 months for the Optune and Temozolomide group as compared to 16 months for the Temozolomide alone group. Impairment of important quality of life parameters, such as pain and leg weakness, were statistically significantly delayed for patients using Optune. Even though the follow-up period in the clinical study is extensive, there are uncertainties regarding to how much longer patients live if they have been treated with Optune with Temozolomide versus Temozolomide alone, as well as uncertainty concerning the assessment of quality of life in the clinical study.
In the economic evaluation of Optune, the company's economic model is based on clinical study data that has been extrapolated for the patients’ lifetime horizon using published epidemiological data. Both TLV and the company use a product cost of SEK 189 000 per month. According to the company's calculations, the cost per quality-adjusted life years (QALY) is SEK 1.8 million if Optune has a monthly cost of SEK 189 000. TLV calculates that SEK 2.1 million is a better estimate.