LenacapavirSunlenca
Treatment of adults with highly multidrug-resistant HIV-1 infection in combination with optimised background regimen, for patients who have no more than 2 fully active antiretrovirals remaining from the 4 main classes that can be effectively combined to form a viable regimen.
Decisions on record
- Meeting Nov 2023 Recommended Highly multi-drug resistant HIV infection
- Meeting Nov 2022 Not recommended Highly multi-drug resistant human immunodeficiency virus type 1 infection
Access path
- TGA registered · Sunlenca
TGA label narrower than the PBS population
- Nov 2022Not recommended
vs optimised background regimen (OBR)
- ↻ resubmittedNov 2023Recommended · restricted
Comparator changed: optimised background regimen (OBR) → OBR (optimised background…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Section 100, Highly Specialised Drugs Program (Community Access), Authority Required (STREAMLINED) listing of lenacapavir (LEN), in combination with optimised background regimen (OBR), for the treatment of patients with highly multi-drug resistant (hMDR) human immunodeficiency virus (HIV) infection.PSD · Nov 2023
Noting there is likely to be a reluctance to alter treatment regimens for patients with hMRD HIV infection where an acceptable therapeutic outcome is being achieved through currently available combinations of anti-retrovirals (ARVs), the PBAC considered the uptake of LEN in the resubmission was overestimated. The PBAC considered there was a risk of leakage to people who do not meet the strict definition 42PSD · Nov 2023
The randomised period was of uncertain Not addressed. applicability to the proposed population because the comparator during that time was a known failing regimen, rather than OBR (paragraph 7.5, LEN PSD, Nov 2022).PSD · Nov 2023
Transitivity issues including the small Partially addressed. The resubmission attempted to patient numbers in CAPELLA, the lack of balance ARVs used in OBR. However, the ITC remains a common comparator, and differences in unanchored with no common comparator and patient the trial populations regimen or agents numbers (n=72) from the CAPELLA trial remain low. used (paragraph 7.6, LEN PSD, Nov 2022). 2PSD · Nov 2023
Lenacapavir in addition to OBR demonstrates a non-inferior safety profile with OBR alone (placebo + OBR) in PLWH who are hMDR. Source: Table 1-2, pp3-4 of the resubmission.PSD · Nov 2023
The resubmission claimed that, for PLWH who are hMDR, LEN + OBR is superior in terms of effectiveness compared with OBR (± placebo) or OBR alone. Additionally, LEN + OBR is non-inferior in terms of safety compared with OBR. 26PSD · Nov 2023
The PBAC recalled it had previously received input from 1 individual highlighting the need for additional treatment options for people living with highly multi-drug resistant HIV infection (paragraph 6.2, lenacapavir PSD, November 2022 PBAC meeting). The PBAC noted and welcomed the input from health care professionals (1) and from the National Association of People with HIV Australia (NAPWHA) via the Consumer Comments facility on the PBS website.PSD · Nov 2023
The resubmission did not propose a risk sharing arrangement.PSD · Nov 2023
Cost-effectiveness
ICER range redacted as commercial-in-confidence. Document states base case ICER range is $75,000 to <$95,000 per QALY; alternative base case ICER is $115,000 to <$135,000 per QALY.
Decision context
PopulationAdults with highly multidrug-resistant HIV-1 infection who have no more than 2 fully active antiretrovirals remaining from the 4 main antiretroviral classes (NRTIs, NNRTIs, INSTIs, PIs) that can be effectively combined to form a viable treatment regimen.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended · restricted | OBR (optimised background regimen) alone | $75k–95k | RCT · Surrogate |
| Nov 2022 | Not recommended | optimised background regimen (OBR) | — | RCT · Reduction in HIV-1 RNA of ≥0.5 log10 copies/mL at 14 days |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CAPELLA | Ph 2, PHASE3 | 72 | Percentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in H… | active not recruiting |
Consumer voice
A healthcare professional and the National Association of People with HIV Australia (NAPWHA) expressed support for additional treatment options for highly treatment-experienced people with multi-drug resistant HIV, with NAPWHA concerned that the proposed listing was too narrow and advocating for the benefits of a new mechanism of action with favorable safety and drug interaction profiles.
The comment from the health professional highlighted the need for additional treatment options in this highly treatment-experienced group and noted the evidence indicated good activity against drug-resistant HIV. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to highly multidrug-resistant patients with ≤2 fully active antiretrovirals remaining across 4 main classes; TGA label only requires multidrug resistance without this specific quantified limitation.