OBJECTIVES: Cytomegalovirus (CMV) infection represents a serious post-transplantation complication, particularly among transplant recipients with resistant or refractory (R/R) infection. Despite the improvement made in CMV prevention and treatment, remains a need for new therapies that are better tolerated and safer for patients, especially for refractory or resistant (R/R) infections. This analysis investigates the cost-effectiveness of maribavir versus investigator-assigned therapy (IAT) for treatment of post-transplant R/R CMV in the Italian context.METHODS: The analysis was conducted from the National Health Service (NHS) perspective using a Markov model previously developed in Excel® to evaluate the cost-effectiveness of maribavir versus IAT for the treatment of post-transplant R/R CMV. Health event rates and transition probabilities were informed by data from observational studies and from SOLSTICE clinical trial, which compared maribavir to conventional antiviral treatments for transplant patients with R/R CMV infections. Utilities were from SOLSTICE and a utility vignette study. Costs inputs were derived from published literature and Italian national tariffs for outpatient and hospital services. Costs and outcomes were discounted by 3%.RESULTS: Maribavir compared to the IAT used for the treatment of post-transplant R/R CMV achieved an incremental cost of € 11,455 for an incremental quality adjusted life year (QALY) gain of 0.313. This resulted in an incremental cost-effectiveness ratio of € 36,626/QALY, for maribavir compared to IAT, which is below the generally accepted, national willingness-to-pay threshold for orphan drugs (€ 37,000/QALY).CONCLUSIONS: This analysis showed that maribavir, an orphan drug treatment, is cost-effective compared to the current antiviral treatments used for treatment of post-transplant R/R CMV.

[Cost-Effectiveness Analysis of Maribavir in Patients with Post-Transplant Cytomegalovirus Infection or Disease that are Refractory or Resistant to Conventional Therapy]

Additional file1. Table S1. Summary of participants' clinical experience. Table S2. Final vignette: Clinically significant and symptomatic CMV (CS-symptomatic CMV). Table S3. Final vignette: Clinically significant and symptomatic CMV (CS-symptomatic CMV) with GvHD. Table S4. Final vignette: Clinically significant and symptomatic CMV (CS-symptomatic CMV) with kidney graft loss. Table S5. Final vignette: Clinically significant and symptomatic CMV (CS-symptomatic CMV) with lung graft loss. Table S6. Final vignette: Clinically significant and asymptomatic CMV (CS-asymptomatic CMV). Table S7. Final vignette: Clinically significant and asymptomatic CMV (CS-asymptomatic CMV) with GvHD. Table S8. Final vignette: Clinically significant and asymptomatic CMV (CS-asymptomatic CMV) with kidney graft loss. Table S9. Final vignette: Clinically significant and asymptomatic CMV (CS-asymptomatic CMV) with lung graft loss. Table S10. Final vignette: Non-clinically significant CMV (non-CS CMV). Table S11. Final vignette: Non-clinically significant CMV (non-CS CMV) with GvHD. Table S12. Final vignette: Non-clinically significant CMV (non-CS CMV) with kidney graft loss. Table S13. Final vignette: Non-clinically significant CMV (non-CS CMV) with lung graft loss. 

Additional file 1 of A time trade-off study to determine health-state utilities of transplant recipients with refractory cytomegalovirus infection with or without resistance

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.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.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.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. 

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

This study evaluated the cost-effectiveness of maribavir versus investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) for post-transplant refractory cytomegalovirus (CMV) infection with or without resistance. A two-stage Markov model was designed using data from the SOLSTICE trial (NCT02931539), real-world multinational observational studies, and published literature. Stage 1 (0-78 weeks) comprised clinically significant CMV (csCMV), non-clinically significant CMV (n-csCMV), and dead states; stage 2 (78 weeks-lifetime) comprised alive and dead states. Total costs (2022 USD) and quality-adjusted life years (QALYs) were estimated for the maribavir and IAT cohorts. An incremental cost-effectiveness ratio was calculated to determine cost-effectiveness against a willingness-to-pay threshold of $100 000/QALY. Compared with IAT, maribavir had lower costs ($139 751 vs $147 949) and greater QALYs (6.04 vs 5.83), making it cost-saving and more cost-effective. Maribavir had higher acquisition costs compared with IAT ($80 531 vs $65 285), but lower costs associated with administration/monitoring ($16 493 vs $27 563), adverse events (AEs) ($11 055 vs $16 114), hospitalization ($27 157 vs $33 905), and graft loss ($4516 vs $5081), thus making treatment with maribavir cost-saving. Maribavir-treated patients spent more time without CMV compared with IAT-treated patients (0.85 years vs 0.68 years), leading to lower retreatment costs for maribavir (cost savings: -$42 970.80). Compared with IAT, maribavir was more cost-effective for transplant recipients with refractory CMV, owing to better clinical efficacy and avoidance of high costs associated with administration, monitoring, AEs, and hospitalizations. These results can inform healthcare decision-makers on the most effective use of their resources for post-transplant refractory CMV treatment.

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

EE484 Multinational Real-World Data in Transplant Patients with Refractory/Resistant Cytomegalovirus Infection Enhance Cost-Effectiveness Modelling Outcomes

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EE571 Cost-Effectiveness of Maribavir for Post-Transplant Refractory Cytomegalovirus Infection With or Without Resistance: A UK Perspective

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EE484 Multinational Real-World Data in Transplant Patients with Refractory/Resistant Cytomegalovirus Infection Enhance Cost-Effectiveness Modelling Outcomes

EE512 Comparing Costs of Immune Checkpoint Inhibitors for Treatment of 1L NSCLC in Colombia – A Cost Minimisation Analysis

EE383 Cost-Effectiveness Analysis of Nivolumab Plus Relatlimab (NIVO+RELA) Versus Nivolumab Monotherapy (NIVO) for Patients With Advanced Melanoma in the Netherlands

EE571 Cost-Effectiveness of Maribavir for Post-Transplant Refractory Cytomegalovirus Infection With or Without Resistance: A UK Perspective