AciclovirAciclovir Accord
Treatment of Herpes simplex keratitis (HSK).
Decisions on record
- Meeting Mar 2021 Not recommended Herpes simplex keratitis
- Meeting Jul 2015 Recommended Herpes simplex keratitis
Access path
- TGA registered · Aciclovir Accord
TGA label equal than the PBS population
- Jul 2015Recommended · restricted
vs aciclovir (Zovirax)
- Jul 2015Recommended · restricted
- Mar 2021Not recommended
Inadequate basis for the requested AEMP (higher than the delisted Zovirax and currently listed AciVision); no evidence…
From the public summary
6.1 The PBAC did not recommend the listing of the Xorox brand of aciclovir 3% eye ointment for the treatment of HSK. The PBAC considered there was an inadequate basis for the requested AEMP, which was higher than the delisted Zovirax and the currently listed Section 19A approved product, AciVision.PSD · Mar 2021
6.2 The PBAC reiterated there was a clinical need for aciclovir 3% eye ointment supply to be maintained on the PBS. However, the PBAC noted that under Section 101(3B) of the National Health Act 1953, when the proposed medicine is substantially more costly than an alternative therapy, the Committee cannot make a positive recommendation unless it is satisfied that, for some patients, the proposed medicine provides a significant improvement in efficacy …PSD · Mar 2021
5.3 The PBAC noted and welcomed the input from one individual via the Consumer Comments facility on the PBS website. The comment described the impact of HSK on a patient’s quality of life.PSD · Mar 2021
Cost-effectiveness
This is a minor submission for a generic brand of an existing PBS-listed medicine; no economic evaluation or ICER was modelled.
The listing of ACICLOVIR AciVision 3mg/ml (3%, 4.5 g), as proposed would replace the use of ACICLOVIR Zovirax 3% (4.5 g), resulting in no additional cost to the Commonwealth. PSD · 2015
Decision context
PopulationPatients with Herpes simplex keratitis requiring topical aciclovir 3% eye ointment.
Why it was knocked back
- Inadequate basis for the requested AEMP (higher than the delisted Zovirax and currently listed AciVision); no evidence of significant improvement in efficacy or reduction of toxicity over the alternative therapy (AciVision)
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2021 | Not recommended | AciVision | — | Cost-minimisation · Cost-minimisation |
| Jul 2015 | Recommended · restricted | aciclovir (Zovirax) | — | Cost-minimisation · Cost-minimisation |
| Jul 2015 | Recommended · restricted | aciclovir (Zovirax) | — | Cost-minimisation · Cost-minimisation |
Consumer voice
One individual provided consumer input via the PBS website describing the impact of HSK (Herpes Simplex Keratitis) on a patient's quality of life.
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify treatment of Herpes simplex keratitis with topical aciclovir 3% eye ointment; PBAC adds no additional restrictions beyond the TGA label.