← The record

Grazoprevir With Elbasvir

Deferred HepatologyAuthority Required 💬 consumer voice

Chronic Hepatitis C Virus infection – Genotype 1 or 4 in adults.

1
Submissions
1 resub
2018–18
On the record
ICER range
Cost-min
Cost basis

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
5.1 The PBAC deferred making a recommendation on amending the listing of grazoprevir with elbasvir from Authority Required (In Writing or Telephone) to Authority 7PSD · Mar 2018
5.2 The PBAC noted that this submission is not eligible for an Independent Review as it was deferred. Outcome: DeferredPSD · Mar 2018
Consumer comments
4.2 The PBAC noted and welcomed the input from organisations (1) via the Consumer Comments facility on the PBS website. The submission from Hepatitis Australia described a range of benefits of having an Authority Required (STREAMLINED) listing, including enhancing the roll-out of DAAs; maintaining support for the role of primary care and consistency in prescribing processes to ensure treatment options are available for all patients with CHC.PSD · Mar 2018

Cost-effectiveness

Minor submission; no economic evaluation conducted. Previously listed on a cost-minimisation basis (July 2016).

Decision context

PopulationAdults with chronic Hepatitis C Virus infection – Genotype 1 or 4.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2018 Deferred Cost-minimisation · Cost-minimisation

Consumer voice

Mar 2018

Hepatitis Australia supported an Authority Required (STREAMLINED) listing for hepatitis C treatment, emphasizing benefits including enhanced rollout of direct-acting antivirals, support for primary care involvement, and consistent prescribing to ensure treatment access for all patients with chronic hepatitis C.

The submission from Hepatitis Australia described a range of benefits of having an Authority Required (STREAMLINED) listing, including enhancing the roll-out of DAAs; maintaining support for the role of primary care and consistency in prescribing processes to ensure treatment options are available for all patients with CHC. Consumer comments · PSD
access barrierstreatment consistencyprimary care supportunmet need

Similar precedents

By decision profile

Regulatory · TGA

Label equal than PBS population — Both texts specify chronic hepatitis C genotype 1 or 4 in adults with no additional restrictions.