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MaravirocCelsentri

Deferred Infectious diseaseAuthority RequiredFirst-line line

First-line treatment of adult patients with CCR5-tropic HIV-1 infection in combination with other antiretroviral agents; also continuing treatment of HIV-1 infection in patients who have previously received PBS-subsidised therapy.

4
Submissions
2 resub
2008–12
On the record
$15k–75k
ICER range
4 sourced ICERs · 2008–2012
ICER stated
Cost basis
risk sharing

Decisions on record

3 decisions
  • Meeting Nov 2012 Deferred HIV infection
  • Meeting Nov 2009 Recommended Anti-HIV drug
  • Meeting Nov 2008 Not recommended Human Immunodeficiency Virus (HIV) infection

Access path

4 submissions · public record
  1. TGA registered · Celsentri

    TGA label narrower than the PBS population

  2. Nov 2008
    Recommended

    vs optimised background therapy (OBT)

  3. Nov 2009
    Recommended · restricted

    ICER rose $45,000 → $75,000 (+67%)

  4. Nov 2012
    Deferred

    ICER dropped $75,000 → $45,000 (-40%)

  5. Nov 2012
    Deferred

    ICER dropped $75,000 → $45,000 (-40%)

RecommendedDeferredNot recommended

Cost-effectiveness

4 sourced ICERs · 2008–2012
The submission estimated an ICER in the range of $15,000-$45,000/QALY based on the proportion of patients achieving virologic success. PSD · 2012
ICER uncertainEconomic model disputed

Decision context

PopulationAdult patients with CCR5-tropic HIV-1 infection (treatment-naïve and treatment-experienced) identified by tropism testing, with CD4 count less than 500 per cubic millimetre or symptomatic HIV-1 disease for initial treatment.

Risk sharingGenotypic tropism testing was funded for treatment experienced patients in Australia by the sponsor under a risk-share agreement at time of submission.

Submission history

4 entries
DecidedOutcomeComparatorICEREvidence
Nov 2012 Deferred efavirenz $15k–45k RCT, Registry · OS, PFS, DFS, ORR
Nov 2012 Deferred efavirenz (for maraviroc); Enhanced Sensitivity Trofile Assay ESTA (for genotypic tropism testing) $15k–45k RCT · viral load
Nov 2009 Recommended · restricted optimised background therapy (OBT) $45k–75k RCT
Nov 2008 Recommended optimised background therapy (OBT) $15k–45k RCT · Surrogate

Codependent tests

MSAC
ServiceBiomarkerMSAC outcomeYear
Genotypic HIV tropism testing HIV tropism (CCR5 vs CXCR4 tropic virus) not supported 2012

Similar precedents

By decision profile
Raltegravir72%Etravirine69%Dolutegravir67%Cobicistat + Elvitegravir + Emtricitabine + Tenofovir67%Cabotegravir And Rilpivirine66%Bictegravir + Emtricitabine + Tenofovir Alafenamide66%Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride66%Atazanavir/Cobicistat66%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to patients with specific prior treatment failures (3 regimens including NNRTI, NRTI, PIs); TGA label has no such requirement.

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