WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR RUKOBIA?: 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. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? 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]). WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? 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. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from 1 clinical trial demonstrated that Rukobia reduces viral load better than placebo in patients who have received several anti–HIV-1 regimens in the past, and have an HIV-1 virus that is resistant to many ARV medicines. The clinical trial also suggests that a reduction in viral load was maintained over time and an increase in CD4+ counts was also observed. Based on CADTH’s assessment of the health economic evidence, Rukobia does not represent good value to the health care system at the public list price. A price reduction is therefore required. Patients who have received several anti–HIV-1 regimens in the past and have an HIV-1 virus that is resistant to many ARV medicines have few ARV treatment options available. There is a high unmet need for effective treatments for these patients, and Rukobia provides an additional ARV treatment option. Based on public list prices, Rukobia is estimated to cost the public drug plans approximately $19.6 million over the next 3 years.
WHAT IS HIV-1 INFECTION? HIV-1 is a virus that attacks the body’s immune system. As a result, the patient becomes immunocompromised and more likely to get sick from other infections and some cancers. Without adequate treatment, HIV-1 infection can progress to AIDS, which is an advanced and life-threatening stage of the disease. Approximately 62,790 people were living with HIV-1 in Canada in 2020. UNMET NEEDS IN HIV-1 INFECTION: There is no cure for HIV, but patients can live with HIV by controlling their infection with treatment. A subset of patients living with HIV-1 have had experience with several treatments for HIV-1 but have a virus that is resistant to multiple treatments. The HIV-1 infection in these patients cannot be controlled and is at risk of progressing to AIDS. As such, there is a high unmet need for additional treatment options for this group of patients. HOW MUCH DOES RUKOBIA COST? Treatment with Rukobia is expected to cost approximately $45,854 per patient per year.
