Cabotegravir And RilpivirineCabenuva
Treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine.
Decisions on record
- Meeting Nov 2021 Recommended Human Immunodeficiency Virus (HIV) infection
- Meeting Mar 2021 Not recommended HIV infection in virologically suppressed adults
Access path
- TGA registered · Cabenuva
TGA label equal than the PBS population
- Mar 2021Not recommended
vs Dolutegravir/rilpivirine (DTG/RPV, Juluca)
- ↻ resubmittedNov 2021Recommended · restricted
Comparator changed: Dolutegravir/rilpivirine (DTG/RPV, Juluca) → weighted basket of…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the listing of cabotegravir oral tablets and cabotegravir and rilpivirine long-acting injectable (CAB LA + RPV LA), on the basis that it should be available only under special arrangements under Section 100 (Highly Specialised Drugs Program – Community Access).PSD · Nov 2021
The PBAC reiterated that it was satisfied CAB LA + RPV LA is of noninferior comparative effectiveness (in terms of virologic suppression outcomes) and safety to daily oral anti- retroviral therapy (ART) alternatives on the PBS.PSD · Nov 2021
The type of economic evaluation presented in the resubmission was a stepped cost- utility analysis (CUA) that was conducted to determine the incremental cost per QALY gained for patients who were stabilised on ART and chose to switch their treatment to CAB LA + RPV LA versus continuing oral ART. The steps of the stepped economic evaluation are described in Table 14.PSD · Nov 2021
Table 11 provides a summary of the model structure and key inputs.PSD · Nov 2021
The resubmission described CAB LA + RPV LA Q8W as noninferior in terms of effectiveness in comparison to oral ART for the treatment of HIV infection in treatment-experienced patients. The PBAC had previously considered that CAB LA + RPV LA either given once every four weeks or once every eight weeks, was of 18PSD · Nov 2021
Given the similarity of the evidence base in the resubmission (continuing to rely on ITC involving FLAIR, ATLAS and ATLAS-2M), the evaluation considered that the same conclusion was likely reasonable.PSD · Nov 2021
The PBAC noted and welcomed the input from an individual (1) and health care professionals (17) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with a LAI option for the management of HIV in terms of quality of life and improved adherence, especially for people in complex living circumstances where the risk of disclosure of HIV status and stigma negatively impact mental health and sometimes …PSD · Nov 2021
6.72 No special pricing arrangement was requested for CAB tablets. However, the sponsor requested a special pricing arrangement for CAB LA + RPV LA injections with an effective price of $''''''''''''''''' per two monthly injection compared to a published price of $2,827.74. 34PSD · Mar 2021
Cost-effectiveness
ICER value redacted (commercially sensitive pricing information denoted by asterisks in the document)
Decision context
PopulationAdults with HIV-1 infection who are virologically suppressed (HIV-1 RNA <50 copies/mL) and switching therapy, with no known or suspected resistance to cabotegravir or rilpivirine
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended · restricted | weighted basket of fixed-dose combination antiretroviral therapies (BIC/FTC/TAF, DTG/ABC/3TC, ELV/c/FTC/TAF, RPV/FTC/TAF | — | RCT · Proportion of subjects with HIV-1 RNA ≥50 copies/mL at Week 48 |
| Mar 2021 | Not recommended | Dolutegravir/rilpivirine (DTG/RPV, Juluca) | — | RCT · Proportion of subjects with HIV-1 RNA ≥50 copies/mL at week 48 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ATLAS-2M | Ph 3 | 1,049 | Percentage of Participants With Plasma Human Immunodeficiency Virus-ribonucleic Acid (HIV-… | active not recruiting |
Consumer voice
Three consumer organizations (NAPWHA, NACCHO, and Thorne Harbour Health) highlighted that anxiety, stigma, and fear of unintentional disclosure of HIV status significantly impact mental health and quality of life for people living with HIV, with particular concerns for Aboriginal and Torres Strait Islander communities. Consumer input emphasized issues around treatment fatigue, adherence anxiety, a
anxiety, stigma and fear of unintentional disclosure of HIV status were a real concern for many PLHIV and has direct impact on mental health and QoL Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify virologically suppressed adults with no resistance to cabotegravir or rilpivirine; PBAC's 'switching therapy' is clinical context, not a population restriction.