MaribavirLivtencity
Acute treatment of post-transplant cytomegalovirus (CMV) infection and disease resistant, refractory or intolerant to one or more prior therapies in adults who have undergone haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).
Decisions on record
- Meeting Nov 2024 Recommended Post-transplant cytomegalovirus infection and disease
- Meeting Nov 2023 Not recommended Post-transplant cytomegalovirus infection resistant/refractory/intolerant to prior therapies
Access path
- TGA registered · Livtencity
TGA label narrower than the PBS population
- Nov 2023Not recommended
vs standard medical management including ganciclovir…
- ↻ resubmittedNov 2024Recommended · restricted
Comparator changed: standard medical management including ganciclovir, valganciclovir…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of maribavir, for the treatment of post-transplant CMV infection and disease that is resistant, refractory or intolerant to one or more prior therapies, on the basis that it should be available only under special arrangements under Section 100 (HSD).PSD · Nov 2024
7.2 The PBAC noted the consumer comments and acknowledged the clinical need for effective treatments for CMV disease, and the clinical utility of an orally active agent to treat CMV infection, with a different side effect profile to currently available therapies. The PBAC considered that there was a clinical need for additional treatment options for patients with disease resistant to available therapies. 29PSD · Nov 2024
6.21 The economic evaluation remained largely unchanged from that presented in November 2023. The resubmission presented a stepped economic evaluation based on evidence from SOLSTICE, and a retrospective study of SOT and HSCT patients (TAK620-5001 and TAK620-5002; referred to as OTUS = Outcomes, Treatment Patterns and Healthcare Resource Utilization Study).PSD · Nov 2024
Type of analysis Cost-utility analysis (cost-effectiveness analysis). Outcomes $/QALY and LYG.PSD · Nov 2024
6.17 The resubmission described maribavir as superior in terms of effectiveness compared to SoC. The commentary considered the therapeutic conclusion presented in the 13PSD · Nov 2024
6.18 The resubmission described maribavir as non-inferior in terms of safety compared to SoC. The resubmission accepted the PBAC’s advice that a claim of superiority in terms of safety over SoC with respect to safety was not supported, and that a claim of non- inferior safety would be more reasonable (para 7.14, maribavir PSD, November 2023 PBAC meeting). The ESC considered the claim of non-inferior safety was reasonable.PSD · Nov 2024
6.4 The PBAC noted and welcomed the input from one health care professional working in rural Australia, via the Consumer Comments facility on the PBS website. The comments described the benefits of treatment with maribavir in terms of having an alternative treatment for patients resistant to current treatment, and access to an oral treatment that can be used at home, avoiding hospital admission.PSD · Nov 2024
6.5 The PBAC also recalled input from health care professionals (2) regarding the previous submission. The comments described the impact of CMV infection for transplant recipients as having high morbidity, graft failure and mortality.PSD · Nov 2024
Cost-effectiveness
ICER values are redacted/commercially sensitive. The document states 'The effective DPMQ of maribavir has been reduced by %' and refers to confidential effective prices of '$' for public and private hospitals, indicating the economic model contains commercial-in-confidence data.
Decision context
PopulationAdults with post-transplant (HSCT and SOT) CMV infection and disease resistant, refractory, or intolerant to one or more prior therapies (ganciclovir, valganciclovir, cidofovir, or foscarnet).
Risk sharingSpecial Pricing Arrangements apply; the maribavir price was reduced compared to the November 2023 submission to reflect uncertainty in clinical data and short duration of efficacy in patients who develop resistance.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | standard of care (oral valganciclovir, intravenous ganciclovir, intravenous foscarnet, and/or intravenous cidofovir) | — | RCT · CMV viremia clearance |
| Nov 2023 | Not recommended | standard medical management including ganciclovir, valganciclovir, foscarnet, and cidofovir | — | RCT · CMV viraemia clearance |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| SOLSTICE (NCT02931539) | Ph 3 | 352 | Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV… | completed |
Consumer voice
One rural healthcare professional highlighted the benefits of maribavir as an alternative treatment for resistant patients and its oral home-based administration, which is particularly valuable in rural settings with limited hospital resources.
The comments described the benefits of treatment with maribavir in terms of having an alternative treatment for patients resistant to current treatment, and access to an oral treatment that can be used at home, avoiding hospital admission. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to HSCT or SOT recipients only, whereas TGA label covers all post-transplant patients without specifying transplant type.