Fimea has published an assessment of the effects of ciltacabtagene autoleucel (Carvykti) in the treatment of advanced multiple myeloma

Fimea has published an assessment of the therapeutic and economic effects of ciltacabtagene autoleucel (Carvykti) in adult patients with multiple myeloma who have received at least three prior myeloma treatments. In Europe, Carvykti was granted a marketing authorisation in May 2022.

Clinical effectiveness

Research evidence of Carvykti’s effects on the therapeutic indication subject to assessment is based on the phase 1b/2 open, single-arm, multicentre study (CARTITUDE-1). A total of 113 patient were included in the study and 97 of them received a Carvykti infusion. The primary outcome, the overall response rate, was 98% in the final analysis. No median was achieved for response duration, overall survival (OS) or progression-free survival (PFS). The survival rate at 27 months was 70% and the PFS rate was 55%.

Ninety-four per cent of the patients in the CARTITUDE-1 study experienced at least one ≥ grade 3 adverse event. The most common adverse events of any grade were neutropenia, cytokine syndrome, anaemia, thrombocytopenia, leukopenia and lymphopenia.

Comparison with other myeloma medicines

Because no control group was used in the CARTITUDE-1 study, the marketing authorisation holder provided Fimea with an indirect comparison compared with the usual myeloma medicines. According to Fimea's assessment, Carvykti’s effect on outcomes seems to be better than the effect of the myeloma medicines included in the comparison. As the comparators included in the indirect comparison do not necessarily correspond to the treatments used in Finland, the results of the indirect comparison should be treated with caution.

Cost effectiveness and budget impact

In the analysis provided by the marketing authorisation holder, the incremental cost-effectiveness ratio was EUR 82,000/QALY. Because of the uncertainty related to the comparators, Fimea did not present its main analysis. According Fimea's assessment team, the base case analysis of the marketing authorisation holder may overestimate the long-term effects of Carvykti, which is why Fimea carried out scenario analyses of its own. According to the results of Fimea's scenario analyses, Carvykti's cost-effectiveness ratio compared with the current treatment is between EUR 108,000 and EUR 135,000/QALY.

Fimea estimates the costs of Carvykti to be approximately EUR 446,000 per patient. According to Fimea's estimate, Carvykti's budget impact for 10–15 patients will be EUR 3.4–5.1 million when assuming that Carvykti will fully replace the myeloma therapies used in the line of treatment in question in Finland.

Comments

The assessment report may be commented until 18 October 2022. The comments should be sent to the registry office of the Finnish Medicines Agency Fimea at kirjaamo@fimea.fi. All comments are public and may be published on the Fimea website.

Read more

Siltakabtageeniautoleuseeli (Carvykti) edenneen multippelin myelooman hoidossa (in Finnish)