Direct-Acting Antiviral (Daa) Regimens
Treatment of chronic hepatitis C virus (HCV) infection. The submission addresses changes to PBS listings and conditions for DAA regimens following a clinical stakeholder meeting.
Access path
- Mar 2019Recommended
- PBS listing · Authority Required
From the public summary
4.1 The PBAC provided specific advice on the changes requested by clinical stakeholders as outlined below.PSD · Mar 2019
4.2 The PBAC recommended the removal of the requirement for mandatory pre- treatment determination of patient genotype. In making this recommendation, the PBAC considered that with the listing of pan-genotypic treatments, the risks associated with not knowing patient genotype prior to initiating therapy were reduced, and acknowledged that awaiting the results of genotyping may delay initiation of therapy or increase the risk of loss to follow-up.PSD · Mar 2019
Cost-effectiveness
This is a stakeholder advice item regarding listing conditions and administrative changes; no economic evaluation or ICER is presented.
Decision context
PopulationPatients with chronic hepatitis C virus infection eligible for treatment with direct-acting antiviral regimens, including those in corrective services and hospital settings.
Risk sharingRisk share arrangements are mentioned as existing arrangements that would need to be considered in any changes to streamlined authority listings for DAA regimens.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Recommended | — | — | Other |
Consumer voice
Stakeholders raised concerns about treatment barriers including delays from genotype testing (particularly in corrective services), the need for streamlined authority listings incorporating cirrhotic status, inability of nurse practitioners to prescribe under Section 100 arrangements, age restrictions, and the terminology used in listings.
Stakeholders highlighted that this was of particular concern in the corrective services setting where any delay to treatment may be a barrier as patients often move between settings at frequent and unexpected intervals. Consumer comments · PSD