Dolutegravir + Abacavir + LamivudineTriumeq
Treatment of HIV infection in antiretroviral treatment naïve patients aged 12 years or older weighing 40 kg or more, as well as in patients who have previously received PBS-subsidised therapy for HIV infection.
Access path
- TGA registered · Triumeq
TGA label narrower than the PBS population
- Nov 2014Recommended · restricted
vs dolutegravir + Kivexa (abacavir + lamivudine FDC)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended Section 100 (Highly Specialised Drugs Program) listing of dolutegravir+lamivudine+abacavir (Triumeq FDC). The PBAC recommended the special arrangements under the Highly Specialised Drugs Program, Private Hospital Authority Required and Public Hospital Authority Required (STREAMLINED).PSD · Nov 2014
7.2 The PBAC recommended the listing of Triumeq on a cost-minimisation basis with emtricitabine+tenofovir+efavirenz (Atripla FDC) for the treatment of patients with HIV.PSD · Nov 2014
6.18 The submission presents a cost-minimisation analysis based on 1 Triumeq tablet = 1 dolutegravir 50mg tablet + 1 Kivexa tablet, presented below.PSD · Nov 2014
Cost-minimisation analysis of Triumeq to dolutegravir plus Kivexa Cost per daily dose (1 tab Max Pack Product PBS Code Strength DPMQ dolutegravir + 1 tab Kivexa Qty size OR 1 tab Triumeq) S100 (Public) Dolutegravir 10065R 50mg 60 30 '''''''''''''''''''''' '''''''''''''''''' Abacavir 300mg Kivexa 5603x 60 30 ''''''''''''''''''''' ''''''''''''''' Lamivudine 300mg Dolutegravir 50mg Triumeq NA Abacavir 300mg 60 30 '''''''''''''''''''''''' '''''''''''''''' …PSD · Nov 2014
6.17 The submission describes the Triumeq FDC as bioequivalent to dolutegravir 50mg + Kivexa. The ESC agreed this may be reasonable, subject to advice from the TGA. For detail on PBAC’s view, see section 7 “PBAC outcome”PSD · Nov 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design. Costs in the economic model table are redacted (shown as asterisks).
Decision context
PopulationHIV-infected antiretroviral treatment naïve patients aged 12 years or older weighing 40 kg or more, or patients who have previously received PBS-subsidised HIV therapy, excluding those with integrase inhibitor resistance.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2014 | Recommended · restricted | dolutegravir + Kivexa (abacavir + lamivudine FDC) | — | RCT · Bioequivalence |
Clinical evidence
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to treatment-naïve patients aged ≥12 years weighing ≥40 kg, or prior PBS-subsidised patients, excluding integrase inhibitor resistance.