Advice

Summary

Summary

  • The technology described in this briefing is clonoSEQ. It is used for assessing minimal residual disease in people with multiple myeloma, acute lymphoblastic leukaemia (ALL) and chronic lymphocytic leukaemia (CLL).

  • The innovative aspects are that clonoSEQ shows improved standardisation, sensitivity and specificity compared with current techniques. clonoSEQ also uses proprietary bioinformatics and analytics to generate quantitative results from complex datasets.

  • The intended place in therapy would be during treatment or after remission in people with multiple myeloma, ALL and CLL.

  • The main points from the evidence summarised in this briefing are from 5 studies: 3 retrospective analyses, 1 prospective cohort study and 1 analytical evaluation of the technology, including 503 people with multiple myeloma, ALL and CLL. They show that the clonoSEQ assay assesses minimal residual disease as an alternative to current clinical practice.

  • Key uncertainties around the evidence or technology are that none of the studies have been done in an NHS context. The exact cost of the clonoSEQ assay in the UK are not yet available for comparison. There is also a lack of randomised studies in the evidence base. Minimal residual disease assessment is currently standard care in the NHS for people with ALL, but only done for some people with multiple myeloma and CLL.

  • Experts advised that clonoSEQ is a novel technology and could overcome issues with current methods such as poor sensitivity and analytical difficulties. Two experts highlighted that the value of minimal residual disease assessment to inform clinical decision making is still unclear.

  • Safety issues identified are potential false positive results or false negative results, which is consistent with all diagnostics.

  • The cost of clonoSEQ is expected to be in the range of £1,100 to £1,400 per unit (excluding VAT). The resource impact would be greater than flow cytometry, which is £300 to £400.