PIN63 The Fixed-Dose Combination of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Treatment-Naive HIV-1 Infected Adults: Budget IMPACT Analysis

Doravirine is a new non-nucleoside reverse transcriptase inhibitor (NNRTI) in the Russian pharmaceutical market indicated as a third agent for treatment-nai¨ve adult HIV-infected patients initiating antiretroviral treatment (ART). Doravirine with 2NRTIs and in the once-daily fixed dose combination (FDC) with lamivudine and tenofovir disoproxil fumarate (DOR/3TC/TDF) are recommended as preferred initial ART regimen in certain clinical situations. A budget impact analysis is required to include new drugs into the vital and essential drug list (VEDL) and state reimbursement programs. To assess the financial consequence to a Russian healthcare budget when DOR/3TC/TDF is added to the VEDL for the initial ART in certain clinical situations for special patient groups. The target model population included special groups of patients with unique individual circumstances and needs according to the national clinical guidelines and the standard of primary medical care for treatment-naive HIV-infected adults. Current practice is represented by rilpivirine/ emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) the only FDC recommended by guidelines and included in VEDL for target population. Calculations were based on the statistics, registered prices of antiretrovirals, doravirine FDC project price and tax rates. The cumulative ART budget for target population was estimated at €17.64 million; €20.10 million; €20.62 million in the first, second and third year, respectively without DOR/3TC/TDF (current scenario) and €15.15 million; €15.37 million; €14.48 million after adding DOR/3TC/TDF to the formulary (expected scenario), a reduction of 14.1%, 23.5% and 29.8% respectively. With a gradual increase of DOR/3TC/TDF share from 45% to 95%, the budget expenditures due to introduction of doravirine FDC are reduced by €13,355,931 (22.9%) from €58,355,413 to €44,999,483 over 3 years. DOR/3TC/TDF is an economically feasible option for ART and its use can lead to substantial cost savings compared with currently used RPV/FTC/TDF in certain clinical situations. These budget savings should lead to inclusion in the VEDL.