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FamciclovirAPO-FAMCICLOVIR

Recommended Infectious diseaseAuthority RequiredNot applicable line

Episodic and suppressive treatment of moderate to severe recurrent orolabial herpes in patients with HIV infection and CD4 cell counts less than 500 per microlitre (episodic) or less than 150 per microlitre (suppressive) or with other opportunistic infections or AIDS-defining tumours.

2
Submissions
2006–06
On the record
ICER range
Cost-min
Cost basis

Decisions on record

2 decisions
  • Meeting Nov 2007 Recommended Genital herpes no PSD
  • Meeting Nov 2006 Recommended Antiviral

Access path

2 submissions · public record
  1. TGA registered · APO-FAMCICLOVIR
  2. Nov 2006
    Recommended · restricted

    Comparator changed: aciclovir (advanced disease); placebo (less advanced disease) →…

  3. Nov 2006
    Recommended · restricted

    Comparator changed: aciclovir (advanced disease); placebo (less advanced disease) →…

  4. PBS listing · Authority Required
RecommendedDeferredNot recommended

Cost-effectiveness

Cost-minimisation analysis for suppressive therapy against aciclovir; cost-effectiveness analysis for episodic treatment with incremental cost per additional patient avoiding new HSV lesions <$1,000 and per patient avoiding HSV shedding or lesions/symptoms <$15,000. No modelled economic evaluation presented.

The PBAC recommended the listing of famciclovir for suppressive therapy of moderate to severe recurrent oral or labial herpes in patients with HIV infection with CD4 cell counts of less than 150 per microliter or other opportunistic infections or AIDS defining tumours, on a cost-minimisation basis against aciclovir at the price proposed in the submission. PBAC · 2006
ICER uncertainEconomic model disputedSurrogate endpoint

Decision context

PopulationPatients with HIV infection and CD4 cell counts less than 500 per microlitre (episodic treatment) or less than 150 per microlitre or with other opportunistic infections or AIDS-defining tumours (suppressive therapy) with moderate to severe recurrent orolabial herpes.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Nov 2006 Recommended · restricted aciclovir (advanced disease); placebo (less advanced disease) RCT | Cost-minimisation
Nov 2006 Recommended · restricted Aciclovir (for advanced HIV disease); placebo (for less advanced HIV disease) RCT

Similar precedents

By decision profile

Regulatory · TGA