Zoster Virus Vaccine Live
Recommended VaccinesRestrictedNot applicable line 💬 consumer voice
Prevention of herpes zoster and post-herpetic neuralgia in immunocompetent people aged 70 years (ongoing cohort) and 71-79 years (catch-up cohort).
2
Submissions
2 resub
2014–14
On the record
$15k–45k
ICER range
1 sourced ICER · 2014
Not modelled
Cost basis
Decisions on record
- Meeting Nov 2014 Recommended 0.65 mL injection, prefilled syringe Zostavax® bioCSL (Australia) Pty Ltd New listing (Major submission) Immunisation against herpes zoster (shingles) National Immunisation Program (NIP) listing for an ongoing cohort of 70 year old individuals and a catch-up cohort for individuals aged 71-79 years.
- Meeting Mar 2014 Deferred Zostavax® bioCSL (Australia) Pty Ltd Herpes zoster (shingles) Resubmission to reinstate the PBAC recommendation for the listing of zoster virus vaccine live (Zostavax) on the National Immunisation Program (NIP) for the vaccination of an ongoing cohort of 60 year olds and a catch-up cohort of 61 to 7
- Meeting Mar 2008 Recommended Vaccine for shingles
Access path
- Mar 2014Deferred
vs standard medical management of patients with herpes zoster…
- Nov 2014Recommended
Comparator changed: standard medical management of patients with herpes zoster /…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of zoster virus vaccine live on the National Immunisation Program (NIP) for the vaccination of immunocompetent persons aged 70 years, and a catch-up cohort of immunocompetent persons aged 71 to 79 years.PSD · Nov 2014
7.2 The PBAC was satisfied that zoster virus vaccine live provides, for some patients, a significant improvement in efficacy over standard medical management of patients with zoster/PHN. The PBAC noted the consumer comments on this item.PSD · Nov 2014
Economic analysis
6.16 The submission presented a cost-utility analysis. The model structure, time horizon, outcomes measured and methods used to generate the results (table below) remained unchanged from the model in the submission considered at the March 2014 PBAC meeting.PSD · Nov 2014
Outcomes QALYs Methods used to Markov model cohort expected value analysis generate results Cycle length 1 year Transition Comparator arm: probabilities Zoster - age specific annual incidence rate of zoster (BEACH data); Age specific annual incidence rate of PHN given zoster (SPS data); Age specific all-cause mortality (ABS data).PSD · Nov 2014
Clinical claim
6.14 A clinical claim was not stated in the re-submission. The presented evidence supported a claim that zoster vaccine is superior to placebo in terms of reducing the incidence of zoster and PHN and inferior to placebo in terms of comparative safety for the target cohort of people aged 70 years and a catch up cohort aged 71-79 years.PSD · Nov 2014
6.15 In the post-submission advice, ATAGI maintained that “it is reasonable to assume that the initial vaccine efficacy of Zostavax would decrease with increased age.PSD · Nov 2014
Consumer comments
6.2 The PBAC noted and welcomed the input from individuals (4), a health care professional (1) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of zoster virus vaccine, 3PSD · Nov 2014
Financial management – risk sharing
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Cost-effectiveness
Economic model presented but ICER values not stated in public text; likely commercially sensitive.
At the March 2014 meeting the PBAC deferred its decision on Zoster Vaccine and considered that a major submission to the PBAC was required to determine cost-effectiveness of zoster vaccine in the 70 year old cohort. PBAC · 2014
ICER uncertain
Decision context
PopulationImmunocompetent people aged 70 years (ongoing cohort) and 71-79 years (catch-up cohort).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2014 | Recommended | standard medical management of patients with zoster / PHN | — | RCT · Other |
| Mar 2014 | Deferred | standard medical management of patients with herpes zoster / post-herpetic neuralgia (PHN) | $15k–45k | RCT · Reduction in zoster incidence and PHN incidence |
Consumer voice
Seven respondents (4 individuals, 1 healthcare professional, 2 organisations) submitted comments describing benefits of zoster virus vaccine, including potential prevention of pain, reduced quality of life impact, reduced burden to patients and families, and the need for affordability.
the potential prevention of pain and reduced quality of life Consumer comments · PSD
quality of lifepain preventiontreatment burden on familyaccess barriersunmet need
Similar precedents
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Regulatory · TGA
Label narrower than PBS population — PBAC restricted to ages 70–79 years and immunocompetent patients; TGA label includes ages 50+ without immunocompetence restriction.