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New HTA Decisions in England
November 2019
Drug name
PREVYMIS® (letermovir)
Company
Merck, Sharpe & Dohme
Decision date
30/05/2019
Therapeutic area
Infections
Therapeutic sub area
Infections: general and other
Decision
Recommended
Indication
Within its marketing authorisation, as an option for preventing cytomegalovirus (CMV) reactivation and disease after an allogeneic haematopoietic stem cell transplant (HSCT) in adults who are seropositive for CMV.
Decision Detail
It is recommended only if the company provides it according to the commercial arrangement.
Summary
The clinical trial evidence for letermovir was presented from a phase III randomised placebo-controlled trial, PN001. The committee concluded that compared with placebo, letermovir is effective in reducing the incidence of clinically significant CMV infection after allogeneic HSCT and in reducing the need for pre-emptive therapy. The company also did an exploratory analysis using week 48 data, which included people who withdrew early from the trial but were confirmed to be alive after the trial had ended. The clinical experts stated that a mortality benefit with letermovir is plausible although it has not been proven. The committee agreed that the 48‑week post hoc analysis provided a more complete data set because it included mortality events in PN001 that occurred after week 24. It concluded that it would consider the 48‑week analysis for decision making, but acknowledged that the size of letermovir's mortality benefit is uncertain because of the limited trial follow up. The committee noted that when taking into account its preferred assumptions and other considerations, the ICER would be below £24,269 per QALY gained and could be lower than £20,000 per QALY gained. But it recognised that there was uncertainty about the size of the all-cause mortality benefit associated with letermovir, the structure of the economic model and the health-related quality-of-life benefit of letermovir. The committee agreed that the most plausible ICER for letermovir compared with placebo is within the range normally considered to be an acceptable use of NHS resources.