| Summary: | Cabotegravir oral tablets (CAB; Vocabria), in combination with rilpivirine (RPV) oral tablets and cabotegravir plus rilpivirine (CAB + RPV; Cabenuva) extended release injections constitute a complete two-drug treatment regimen and are indicated for the treatment of HIV type 1 (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 ribonucleic acid [RNA] < 50 copies/mL). The CAB + RPV regimen consists of separate once-monthly injections with CAB and RPV preceded by an oral lead-in phase during which oral CAB tablets (30 mg) are taken in combination with RPV tablets (25 mg) once daily for at least 28 days. The final oral doses of CAB and RPV should be taken on the same day that the initiation intramuscular (IM) injections are started. Initiation of the IM injections consists of CAB (600 mg) and RPV (900 mg) in the first month followed by continuation of monthly IM injections of CAB (400 mg) and RPV (600 mg) during scheduled visits. At the sponsorsubmitted prices of $26.52 per CAB tablet (RPV is $15.50 per tablet according to the Ontario Drug Benefit Formulary), $2,418.75 per initiation injection (600 mg/400 mg), and $1,209.38 per continuation injection (600 mg/900 mg), the first-year cost of CAB + RPV is $15,742 per patient; thereafter, the annual maintenance cost is $14,513 per patient. The sponsor's reimbursement request was in accordance with its Health Canada indication. The sponsor submitted a cost-utility analysis based on a hybrid model of a decision tree, integrating a Markov cohort state transition model to capture disease progression, to evaluate the costs and quality-adjusted life-years (QALYs) of CAB + RPV relative to a pooled comparator of combination oral antiretroviral therapies (ARTs)
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