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Shingrix to replace Zostavax on the National Immunisation Program
The news has been welcomed by the Immunisation Coalition, but there are also concerns about eligibility restrictions.
The Federal Government has allocated $446.5 million for the varicella virus recombinant vaccine (RZV, sold as Shingrix) to replace the less effective live-attenuated varicella zoster virus vaccine (Zostavax) on the National Immunisation Program (NIP).
The new funding follows a Pharmaceutical Benefits Advisory Committee (PBAC) recommendation from its most recent meeting.
The vaccine was last year identified by the Australian Technical Advisory Group on Immunisation (ATAGI) as being more effective than the live-attenuated varicella zoster virus vaccine (Zostavax) currently available on the NIP, but is currently only available in Australia via private prescription.
However, while the vaccine’s sponsor GlaxoSmithKline Australia requested that it be listed for adults 65 years or older and Aboriginal and Torres Strait Islander people over 50 to protect against herpes zoster (HZ) infection, the PBAC has recommended it only be made available for a more limited cohort.
‘The range of incremental cost effectiveness ratios … were acceptable at the price requested … for non-Indigenous individuals aged 70 years, Aboriginal and Torres Strait Islander individuals aged 50 years [or older] and immunocompromised individuals aged 18 years [or older] with conditions at “high risk” of HZ infection,’ the recommendation stated.
‘The PBAC did not recommend RZV for non-Indigenous individuals aged 65–69 years and individuals aged 71 years [or older] … [as] these populations were of lower clinical priority and represented a high volume of doses.
‘In the context of the total cost, the PBAC considered the extent of uncertainty regarding the cost-effectiveness of RZV in these populations to be too high.’
GP Dr Rod Pearce, who is also Chair of the Immunisation Coalition, is pleased that the more effective vaccine has been slated for inclusion on the NIP, but told newsGP he has concerns about the suggested restrictions.
‘I’m a little bit disappointed that a vaccine that has shown it’s got a good result in older people and seems to be effective 10 years after given will only be recommended for 70-year-olds rather than people greater than 71,’ he said.
‘It’s lost in the jargon a little bit … [but] if I’m 75, it’s a bit of a worry that PBAC thinks I’m a “lower clinical priority”.
‘I’m not sure what that means … there are some issues around the 70-plus cut off that need to be thought through.
‘When we’ve got what appears to be clinically effective vaccines for 80-year-olds, then they should be considered.’
Dr Pearce also suggests that more work is needed to better identify people deemed to be at ‘high risk’ of HZ infection.
‘The high-risk group is a complicated area and there are so many different categories,’ he said.
‘Australia’s got a real challenge to work out what it means by at-risk groups because so many vaccines need to go to people whose treatment or illness causes a compromise in their immune system, and it’s a mixed bag of how that’s described.
‘It results in such clinical complexity that … Australia fails in its adult population to achieve high coverage in these groups.’
The PBAC also raised similar concerns and deferred its decision on the broader population of immunocompromised adults to seek further ATAGI advice on the appropriate definition of this cohort.
‘The PBAC considered there was likely to be a broader population of immunocompromised individuals aged 18 years [or older] at increased risk of HZ for whom RZV was cost effective, but this population had not yet been clearly defined,’ the committee stated.
A date for RZV’s inclusion on the NIP has not yet been announced, but the Zostavax catch-up program for people aged 70–79 is due to expire on 31 October.
RZV is not the only new vaccine set to be included on the NIP.
A recommendation from the same PBAC meeting also indicates that 15-valent pneumococcal conjugate vaccine (15vPCV, sold as Vaxneuvance) will be made available for the prevention of pneumococcal disease in the following paediatric populations:
- Non-Indigenous infants and Aboriginal and Torres Strait Islander infants living in ACT, NSW, VIC and TAS
- Infants with specified medical risk conditions and Aboriginal and Torres Strait Islander infants living in WA, NT, SA and Qld
- Children and adolescents between 12 months and 18 years newly diagnosed with a specified medical risk condition
- Haematopoietic stem cell transplant recipients aged 12 months to under 18 years
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