Varicella Zoster Virus Recombinant Vaccine
Prevention of herpes zoster (shingles) in individuals aged 65 years and older, Aboriginal and Torres Strait Islander people aged 50 years and older, and immunocompromised people aged 18 years and older with specified high-risk medical conditions or therapies.
Decisions on record
- Meeting Nov 2023 Recommended Prevention of herpes zoster and post-herpetic neuralgia (ages 18-64, moderate-high risk immunocompromised)
- Meeting Jul 2023 Recommended Prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN)
- Meeting Mar 2023 Recommended Prevention of herpes zoster (HZ) and post-herpetic neuralgia
Access path
- Mar 2023Recommended · restricted
vs no vaccine
- Jul 2023Recommended
- Nov 2023Recommended · restricted
Evidence: RCT → Registry
- PBS listing · Restricted
From the public summary
The PBAC recommended that varicella zoster virus recombinant vaccine (RZV) be a designated vaccine for the purposes of the National Health Act 1953, for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) for individuals aged 18 years and older at a moderate to high risk of infection, as defined by the Australian Technical Advisory Group on Immunisation (ATAGI) in Table 1.PSD · Nov 2023
The PBAC noted the consumer comments were supportive of expanding access to RZV on the NIP. Many of the comments noted the benefits of vaccinating immunocompromised individuals against HZ infection and described the effectiveness and safety of RZV in this population. The PBAC noted a majority of the populations considered to be at high risk of HZ infection (and referred to in the consumer comments) will be covered by this recommendation.PSD · Nov 2023
4.7 As an early re-entry resubmission, the economic analysis was not independently evaluated.PSD · Jul 2023
4.8 In March 2023, the PBAC considered the extent of uncertainty regarding the cost- effectiveness of RZV for non-Indigenous individuals aged 65 to 69 years and ≥ 71 years to be too high. At the March 2023 meeting, the PBAC maintained its advice from the November 2018 consideration that given the large opportunity cost of including RZV on the NIP for this population, more conservative cost-effectiveness analyses were required.PSD · Jul 2023
4.6 The PBAC reaffirmed its March 2023 advice that the clinical claim that RZV is superior in terms of effectiveness compared with placebo and slightly inferior in terms of safety 4PSD · Jul 2023
MS Australia noted RZV offers an effective, inactivated vaccine suitable for the wider immunocompromised population over the age of 18, including individuals with MS on specific disease modifying therapies. The organisation strongly supported its inclusion on the NIP for the broader immunocompromised population over the age of 18 years.PSD · Nov 2023
CCA supported the inclusion of RZV on the NIP for vaccination of people living with Crohn’s disease and ulcerative colitis. CCA noted that people with inflammatory bowel disease (IBD) are at higher risk of HZ infection than those who do not and people with IBD taking immunosuppressants are at even higher risk of HZ infection.PSD · Nov 2023
Cost-effectiveness
This is a vaccine submission for NIP listing; no cost-effectiveness ICER was calculated. The sponsor provided cost per dose and budget impact modelling rather than a traditional cost-utility analysis.
Decision context
PopulationPeople aged 65 years and older; Aboriginal and Torres Strait Islander people aged 50 years and older; immunocompromised people aged 18 years and older with specified high-risk conditions (haemopoietic stem cell transplant, solid organ transplant, haematological malignancy, advanced or untreated HIV) and immunocompromised individuals with additional conditions and therapies as defined by ATAGI (inborn errors of immunity, end-stage renal disease, B and T-cell targeted monoclonal antibody therapies, conventional immunosuppressive agents, biologic therapies, immunomodulatory drugs, and oral small molecule targeted therapies).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended · restricted | — | — | Registry · Other |
| Jul 2023 | Recommended | no vaccine | — | RCT · Cases of HZ, cases of PHN, and HZ-associated complications |
| Mar 2023 | Recommended · restricted | no vaccine | — | RCT |
Consumer voice
Seven organisations and one healthcare professional submitted comments supporting RZV vaccination for immunocompromised populations. Comments highlighted the vaccine's effectiveness in immunocompromised individuals, disease-specific risks of herpes zoster reactivation, and concerns about high private costs.
RZV is a more effective vaccine than the live varicella zoster vaccine and can be used in immunocompromised individuals which is a significant advantage. Consumer comments · PSD