Dolutegravir/RilpivirineJuluca

7.1 The PBAC recommended the listing of the combination drug dolutegravir with rilpivirine (Juluca®) on the basis that it should be available only under special arrangements under section 100 (Highly Specialised Drugs Program – Community Access) and only in the circumstances: Authority Required (STREAMLINED) for treatment of virologically suppressed human immune deficiency virus (HIV) infected patients.PSD · Jul 2018

7.2 For reason’s explained further below, the PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost‐effectiveness of Juluca would be acceptable if it were cost‐minimised against a mixed comparator of Eviplera® (TDF/FTC/RPV)/Stribild® (TDF/FTC/EVG/c) and Odefsey® (TAF/FTC/RPV)/Genvoya® (TAF/FTC/EVG/c), the latter accounting for the small patient population (6% of the total population) ineligible to receive a TDF …PSD · Jul 2018

6.23 The submission conducted a cost‐minimisation analysis against the primary comparator of dolutegravir 50mg + rilpivirine 25mg taken concomitantly, and the secondary comparator of a basket of antiretrovirals.PSD · Jul 2018

6.24 For the primary comparator, the submission estimated that one FDC tablet of dolutegravir 50mg/rilpivirine 25mg was equivalent to one tablet each of dolutegravir 50mg (Tivicay®) + rilpivirine 25mg (Edurant®).PSD · Jul 2018

6.18 The submission described Juluca as bioequivalent to DTG+RPV. The TGA has accepted this claim.PSD · Jul 2018

6.19 The submission also described Juluca as non‐inferior compared to a basket of comparators representative of the current treatment switch landscape in Australian HIV patients. The evaluation considered this claim (assumed to be in regards to comparative effectiveness and comparative safety) was reasonable; however, noted that the SWORD 1&2 trials indicated non‐inferiority to current‐antiretroviral therapy, including multiple comparators that the …PSD · Jul 2018