DolutegravirTivicay
Recommended Infectious diseaseAuthority RequiredFirst-line line
Treatment of HIV infection in combination with other antiretroviral agents in patients with CD4 count less than 500 cells/mm³ or symptomatic HIV disease, and continuing treatment in patients who have previously received PBS-subsidised therapy for HIV infection.
1
Submissions
2013–13
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2020 Recommended Human immunodeficiency virus (HIV) infection
- Meeting Nov 2014 Recommended dolutegravir 50 mg + abacavir 600 mg + lamivudine 300 mg tablet, 30 Triumeq® ViiV Healthcare Pty Ltd New listing (Major submission) HIV Infection Section 100 Authority Required listing for the treatment of HIV infection in patients meeting certain criteria.
- Meeting Nov 2013 Recommended Tivicay® ViiV Healthcare Pty Ltd Major submission Human immunodeficiency virus (HIV) infection Section 100 (Highly Specialised Drugs Program) Authority Required (+/-STREAMLINED) listing for the treatment of HIV infection in combination with other anti-retrovirals, in a patient with a CD4 count of le
Access path
- TGA registered · Tivicay
TGA label narrower than the PBS population
- Nov 2013Recommended
vs raltegravir
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC noted that the VIKING-3 study used a dose of 50 mg dolutegravir twice daily in patients with documented INI resistance mutations. The PBAC considered that this difference in dose would affect the cost-minimisation analysis and should be accounted for in the determination of the appropriate cost-minimised price for dolutegravir. PBAC · 2013
Cost-effectiveness accepted
Decision context
PopulationTreatment-naïve and treatment-experienced HIV-infected adults with CD4 count less than 500 cells/mm³ or symptomatic HIV disease, to be used in combination with other antiretroviral agents.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2013 | Recommended | raltegravir | — | RCT · HIV RNA <50 |
Clinical evidence
Similar precedents
Dolutegravir With Lamivudine77%Dolutegravir + Abacavir + Lamivudine77%Raltegravir75%Dolutegravir/Rilpivirine74%Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride73%Emtricitabine + Tenofovir Alafenamide72%Tenofovir Alafenamide, Emtricitabine, And Rilpivirine72%Tenofovir Disoproxil Fumarate With Emtricitabine71%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to CD4 <500 cells/mm³ or symptomatic disease; TGA label has no CD4 or symptom threshold.