LetermovirPrevymis
Prophylaxis of cytomegalovirus (CMV) infection or disease in CMV seropositive patients who have received an allogeneic haematopoietic stem cell transplant (HSCT).
Decisions on record
- Meeting Mar 2019 Not recommended LETERMOVIR is indicated for the prophylaxis of cytomegalovirus (CMV) infection or disease in adult CMV- seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Meeting Mar 2019 Not recommended Indication not stated
- Meeting Jul 2018 Not recommended Prophylaxis of cytomegalovirus (CMV) infection or disease
Access path
- TGA registered · Prevymis
TGA label narrower than the PBS population
- Jul 2018Not recommended
vs placebo
- ↻ resubmittedMar 2019Recommended · restricted
- PBS listing · Authority Required
From the public summary
7.1 The PBAC did not recommend the Section 100 (Highly Specialised Drugs Program) Authority Required listing for letermovir for prophylaxis of CMV infection or disease in CMV sero-positive patients who have received an allogeneic HSCT.PSD · Mar 2019
7.2 The PBAC noted the consumer comments and reiterated its acceptance of the clinical utility of letermovir as an orally active agent to prevent CMV infection in the post HSCT setting.PSD · Mar 2019
6.46 The economic model presented in the resubmission was revised from that presented in the July 2018 submission as outlined in the table below. This table also includes the PBAC and ESC comments on the July 2018 model.PSD · Mar 2019
Table 13: July 2018 economic evaluation, PBAC and ESC comments and changes to the current model July 2018 model PBAC/ESC comments (July 2018 PSD) Resubmission model Paragraph 7.8: The PBAC noted the issues raised by The revised model removed GVHD the ESC, including that the outcomes driving the health states but reduction in use of economic model (the occurrence of GVHD and all- PET was not directly considered as part Overall cause mortality) were not …PSD · Mar 2019
infection or disease compared to placebo. Source: Table 1-2, p5 of the resubmission.PSD · Mar 2019
6.37 The resubmission described letermovir as superior in terms of effectiveness compared with placebo and non-inferior in terms of safety compared to placebo. This was the same as the clinical claim made by the July 2018 submission.PSD · Mar 2019
6.2 The PBAC noted and welcomed the input from health care professionals (3) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described the burden of CMV and highlighted that it remains a serious 6PSD · Mar 2019
6.71 The resubmission stated that the sponsor is willing to enter a risk sharing arrangement with a cap/rebate structure that takes into account uncertainty associated with proportion of seropositive patients, rate of cyclosporin use and treatment duration.PSD · Mar 2019
Cost-effectiveness
ICER values are redacted in the PSD (indicated by '***' and '''''''' placeholders in financial sections); economic model was modified but specific ICER figures not published.
Decision context
PopulationAdult CMV-seropositive recipients of an allogeneic HSCT, aged 18 years or older, who commence treatment within 28 days of transplant.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Recommended · restricted | placebo | — | RCT · CMV infection |
| Jul 2018 | Not recommended | placebo | — | RCT · Prevention of clinically significant CMV infection |
Consumer voice
Healthcare professionals and organisations highlighted the serious burden of CMV in allogeneic HSCT patients and expressed concern about the toxicity of existing treatment options like ganciclovir, valganciclovir, and foscarnet.
it remains a serious cause of morbidity and mortality for people undergoing allogeneic HSCT Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients aged ≥18 years commencing treatment within 28 days of transplant; TGA label lacks these temporal and age specifications.