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Tenofovir Disoproxil Fumarate With Emtricitabine / Tenofovir Disoproxil Maleate With Emtricitabine / Tenofovir Disoproxil Phosphate With EmtricitabineAdrenaline Viatris

Recommended · restricted Infectious diseaseRestrictedFirst-line line

Pre-exposure prophylaxis (PrEP) against HIV infection in individuals at risk of acquiring HIV.

1
Submissions
1 resub
2020–20
On the record
ICER range
Cost-min
Cost basis

Access path

1 submission · public record
  1. TGA registered · Adrenaline Viatris
  2. Sep 2020
    Recommended · restricted

    vs Not applicable

  3. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
6.1 The PBAC recommended the continued PBS listing of tenofovir disoproxil with emtricitabine (TD/FTC) for pre-exposure prophylaxis (PrEP) against HIV infection and further recommended the restriction level be reduced to a Restricted Benefit to support broad access for patients who are at risk of HIV infection.PSD · Sep 2020
6.2 In making this recommendation, the PBAC considered the guidelines and additional training provided by the ASHM, as a peak clinical organisation in this field, provide an adequate framework for PrEP prescribing that is likely to result in the cost-effective use of PrEP in the context of:  the level of price reduction since listing and current price of TD/FTC on the PBS (and possible future price reductions due to price disclosure);  the PBS …PSD · Sep 2020

Cost-effectiveness

No ICER calculated in this submission. This is a consideration of changed PBS prescribing criteria for an already-listed drug. PBAC noted the Kirby Institute model from December 2017 showed cost-effectiveness below $30,000 per QALY in all scenarios at current price ($1,355 annual cost).

ICER uncertainEconomic model disputedCost-effectiveness accepted

Decision context

PopulationIndividuals at risk of HIV infection, including men who have sex with men (MSM), Indigenous populations, overseas-born MSM, and heterosexuals; no specific risk classification required under revised criteria.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Sep 2020 Recommended · restricted Not applicable Cost-minimisation · Cost-minimisation

Similar precedents

By decision profile

Regulatory · TGA