Dtpa-Hepb-Ipv-Hib Vaccine

7.1 The PBAC recommended the listing of Hexaxim on the National Immunisation Program (NIP) for the primary vaccination series against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b at 2, 4 and 6 months of age, on a cost-minimisation basis that 3 x 0.5mL doses of Hexaxim is equi-effective 3 x to 0.5mL doses of Infanrix Hexa, when an 18-month DTPa-containing booster is available on …PSD · Mar 2015

7.2 The PBAC noted the pre-submission and post-submission advice from the Australian Technical Advisory Group on Immunisation (ATAGI).PSD · Mar 2015

6.18 The submission presented a cost-minimisation analysis comparing Hexaxim with Infanrix Hexa when used as a three-dose primary vaccination series in infants. The equi-effective doses were based on the recommended dosing regimens outlined in the relevant product information documents which are the same as the doses used in the included clinical trials: 6PSD · Mar 2015

6.19 The requested cost minimised price of Hexaxim is exactly equal to the assumed NIP list price of Infanrix Hexa ($''''''''''''', based on the last known historical price).PSD · Mar 2015

6.15 The submission described Hexaxim as non-inferior in terms of comparative efficacy and safety compared to Infanrix Hexa.PSD · Mar 2015

6.16 In the pre-submission advice, the Australian Technical Advisory Group on Immunisation (ATAGI) advised that there is currently insufficient information to determine whether there are relevant clinical differences between this vaccine and the comparator (particularly in regards to pertussis which has no accepted thresholds for antibody response that can be used as a surrogate for protection).PSD · Mar 2015

6.25 The submission did not propose a risk sharing arrangement.PSD · Mar 2015