WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR LIVTENCITY?: CADTH recommends that Livtencity should be reimbursed by public drug plans for the treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are refractory (with or without genotypic resistance) to 1 or more prior antiviral therapies if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Livtencity should only be covered to treat adult patients with CMV infections that are refractory (with or without resistance) to 1 or more of the following antiviral drugs: valganciclovir, ganciclovir, foscarnet, or cidofovir. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Livtencity should only be reimbursed if prescribed by clinicians with experience and expertise in transplant medicine, transplant infectious disease, or infectious diseases, and if the cost of Livtencity is reduced. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial demonstrated that in patients with refractory CMV infection, with or without resistance to antiviral drugs, treatment with Livtencity cleared the virus from the bloodstream in more patients than other antivirals. Treatment with Livtencity also resulted in maintaining virus clearance and symptom control. Livtencity meets some of the needs identified by patients, namely a more effective treatment option for controlling the infection and symptoms. Based on CADTH’s assessment of the health economic evidence, Livtencity does not represent good value to the health care system at the public list price; thus, a price reduction is required. Based on public list prices, Livtencity is estimated to cost the public drug plans approximately $30 million over the next 3 years.
WHAT IS CMV INFECTION? CMV infection is a common infection caused by a type of herpes virus. Most people do not experience symptoms; however, it can cause serious complications in patients with weakened immune systems, such as transplant recipients. Serious complications include disease of the infected organ (e.g., liver, lung, digestive tract) or rejection of the transplanted organ. The prevalence of post-transplant CMV infection in Canada is unknown. Estimates of refractory CMV infection in Europe and the US are between 19% and 21% for recipients of solid organ transplant (SOC) and 9% and 47% for recipients of hematopoietic stem cell transplant (HSCT). UNMET NEEDS IN CMV INFECTION: Currently available antiviral treatments are often associated with severe side effects, and there are limited options when treatments are ineffective (i.e., refractory infection) or the infection becomes resistant to available antiviral drugs. HOW MUCH DOES LIVTENCITY COST? Treatment with Livtencity is expected to cost approximately $58,128 per patient per 7.5-week course of treatment.
