Fostemsavir (Rukobia)

Key Messages

• CADTH recommends that Rukobia be reimbursed by public drug plans for the treatment of HIV type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen due to resistance, intolerance, or safety considerations if certain conditions are met.
• Rukobia should be covered for patients living with HIV-1 whose disease does not respond to the majority of antiretroviral therapies (ARVs) available (ARVs in at least 3 classes) because the available ARVs no longer work, for those who cannot tolerate side effects, or for those who have other safety concerns. In addition, patients should have 1 fully active available drug left in no more than 2 ARV classes based on current and/or documented historical resistant testing. Lastly, Rukobia should be covered for patients who have a viral load that suggests poor control of their infection (≥ 400 copies/mL of HIV-1 ribonucleic acid [RNA]).
• Rukobia should only be reimbursed if it is initially prescribed by, or in conjunction with, a physician who specializes in the management of HIV-1 infection and if the cost of Rukobia is reduced. Reimbursement of Rukobia should be discontinued if the patient’s viral load is not improving, as this suggests that treatment is not working.