A time trade-off study to determine health-state utilities of transplant recipients with refractory cytomegalovirus infection with or without resistance

Abstract

Background Health-state utility values (HSUVs) for post-transplant refractory cytomegalovirus (CMV) infection (with or without resistance [R/R]) were determined using a time trade-off (TTO) survey completed by 1,020 members of the UK general public. Methods Existing literature and qualitative interviews with clinicians experienced in treating R/R CMV were used to develop initial draft vignettes of health states. The vignettes were refined to describe three clinical states of R/R CMV: clinically significant and symptomatic (CS-symptomatic CMV); clinically significant and asymptomatic (CS-asymptomatic CMV); and non-clinically significant (non-CS CMV). Each clinical state was valued independently and combined with three events of interest: graft-versus-host disease; kidney graft loss; and lung graft loss to generate twelve vignettes. The final vignettes were evaluated by a sample of the UK general public using an online TTO survey. Exclusion criteria were applied to the final data to ensure that responses included in the analysis met pre-defined quality control criteria. Results Overall, 738 participants met the inclusion criteria and were included in the analysis. The sample was representative of the UK general population in terms of age and sex. Non-CS CMV had the highest mean HSUV (95% confidence interval) (0.815 [0.791, 0.839]), followed by CS-asymptomatic CMV (0.635 [0.602, 0.669]), and CS-symptomatic CMV (0.443 [0.404, 0.482]). CS-symptomatic CMV with lung graft loss had the lowest mean HSUV (0.289), with none of the health states considered on average worse than dead. Conclusions Post transplant R/R CMV has substantial impact on the health-related quality of life of patients. The utility values obtained in this study may be used to support economic evaluations of therapies for R/R CMV infection.

Cost‐effectiveness of maribavir versus conventional antiviral therapies for post‐transplant refractory cytomegalovirus infection with or without genotypic resistance: A US perspective

“…The QoL values for csCMV and n-csCMV were derived from the SOLSTICE trial 18 and a vignette study. 16 The vignette study was used to quantify QoL differences between csCMV and n-csCMV by eliciting preferences between cssymptomatic, csasymptomatic, csCMV SOT, csCMV HSCT, nonclinically significant, disutility adjustment csCMV (SOT), and disutility adjustment csCMV (HSCT). 16 Utility scores from the vignette study were combined with SOLSTICE data to derive the utility score for the csCMV health state.…”

“…16 The vignette study was used to quantify QoL differences between csCMV and n-csCMV by eliciting preferences between cssymptomatic, csasymptomatic, csCMV SOT, csCMV HSCT, nonclinically significant, disutility adjustment csCMV (SOT), and disutility adjustment csCMV (HSCT). 16 Utility scores from the vignette study were combined with SOLSTICE data to derive the utility score for the csCMV health state. The SOT-and HSCT-specific weighted csCMV utility values from the vignette study were subtracted from the vignette n-csCMV utility score to derive a disutility score for each transplant type, which was then subtracted from the respective SOT and HSCT n-csCMV transplant and health-state-specific utility.…”

“…14,15 Health-state valuations from a vignette study showed that refractory CMV and its conventional anti-CMV treatment place a substantial burden on the health-related quality of life (QoL) of transplant recipients. 16 Furthermore, the IV route of administration for many of the available antiviral options imposes additional costs and burden. 17 Results from the Phase 3 SOLSTICE trial (NCT02931539) demonstrated that maribavir was superior to investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) for viremia clearance at Week 8 in transplant recipients with refractory CMV.…”