Recombinant Varicella Zoster Virus Glycoprotein E Antigen (As01b Adjuvanted) Vaccine

7.1 The PBAC did not recommend the listing of the varicella zoster virus vaccine (HZ/su) on the National Immunisation Program (NIP) for the prevention of herpes zoster in adults aged 60 years, with a five-year catch-up program.PSD · Nov 2018

7.2 The PBAC noted that the submission did not include an evaluation of NIP-funded HZ/su vaccine at a lower age threshold of at least 50 years, as was recommended in the ATAGI pre-submission advice, for: (i) Indigenous individuals (who have a greater burden of disease); or (ii) people who are immunocompromised as a result of underlying medical conditions or treatment who cannot receive the live-HZ vaccine (unmet need).PSD · Nov 2018

6.42 The submission presented a stepped, modelled economic evaluation based on direct randomised trials. The type of economic evaluation presented was a cost-utility analysis.PSD · Nov 2018

6.43 Although the ESC considered that the HZ/su vaccine would provide direct benefits to the treated individual, it was concerned about the high opportunity costs. The ESC recalled that the threshold of incremental quality-adjusted life years (QALYs) gained previously accepted by the PBAC for treatments with large opportunity costs, such as population preventative interventions including lipid-lowering, anti-hypertensive drugs and vaccines, was at the …PSD · Nov 2018

6.37 The submission described two doses of the HZ/su vaccine as having:  Superior efficacy and a similar safety profile, despite being more reactogenic, compared with the live-HZ vaccine, the current funded standard of care for individuals aged 70 to 79 years; and.  Superior efficacy and slightly inferior safety when compared with no vaccine (placebo) for individuals aged 60 to 69 years and 80 years and over.PSD · Nov 2018

6.38 In terms of efficacy, the ESC considered that the HZ/su vaccine was superior to placebo and the live-HZ vaccine. However, the ESC considered that the magnitude of benefit in both comparisons should be considered with caution as:  The trials excluded individuals who had previously experienced HZ, had previously received a varicella/HZ vaccine, or were immunocompromised or immunosuppressed.PSD · Nov 2018