Poly-L-Lactic Acid
Recommended Infectious diseaseAuthority RequiredNot applicable line 💬 consumer voice
Treatment of severe facial lipoatrophy caused by antiretroviral therapy in HIV-positive patients.
3
Submissions
2 resub
2008–09
On the record
$15k–75k
ICER range
3 sourced ICERs · 2008–2009
ICER stated
Cost basis
Decisions on record
- Meeting Mar 2009 Recommended Injectable polymer to restore lost facial volume
- Meeting Nov 2008 Not recommended Injectable polymer to restore lost facial volume
Access path
- Nov 2008Recommended
vs placebo
- Mar 2009Recommended · restricted
ICER rose $45,000 → $75,000 (+67%)
- Mar 2009Recommended · restricted
ICER rose $45,000 → $75,000 (+67%)
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Base case range; multivariate sensitivity analyses indicated the ICER could be in the $45,000–$75,000 range per QALY
Multivariate sensitivity analyses conducted during the evaluation indicated that the incremental cost effectiveness ratio could be in the $45,000 - $75,000 range per extra Quality Adjusted Life Year (QALY) gained from a base case of between $15,000 - $45,000/QALY. PBAC · 2009
ICER uncertainEconomic model disputed
Decision context
PopulationHIV-positive patients with severe facial lipoatrophy caused by antiretroviral therapy requiring facial administration.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2009 | Recommended · restricted | placebo | $15k–75k | RCT · QoL, Social Functioning, Mental Health Component, Anxiety, Depression |
| Mar 2009 | Recommended · restricted | placebo | $15k–45k | RCT |
| Nov 2008 | Recommended | placebo | $15k–45k | RCT · QoL |
Consumer voice
Consumer comments highlighted the social and psychological impact of facial lipoatrophy resulting from HIV treatment, and the significant effect on quality of life for people with this condition.
The PBAC noted the social and psychological impact that results from facial lipoatrophy which was highlighted in the submission and in the consumer comments and also the impact that facial lipoatrophy has on the quality of life of people with this condition as a result of their treatment for HIV. Consumer comments · PSD
quality of lifepsychological impactsocial impacttreatment burden
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