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The cost per dose of Pentaxim® plus hepatitis B vs. Hexaxim® for the baseline scheme was Malaysian ringgit (RM) 31.90 (7.7 United States dollar [USD]) vs. 17.10 (4.1 USD) for direct medical cost, RM 54.40 (13.1 USD) vs. RM 27.20 (6.6 USD) for direct non-medical cost, RM 221.33 (53.3 USD) vs. RM 110.66 (26.7 USD) for indirect cost, and RM 307.63 (74.2 USD) vs. RM 155.00 (37.4 USD) for societal (total) cost. A similar trend was observed for the alternative scheme. Compared with Pentaxim® plus hepatitis B, total cost savings per dose of Hexaxim® were RM 137.20 (33.1 USD) and RM 104.70 (25.2 USD) in the baseline and alternative scheme, respectively. Eighty-four percent of physicians and 95% of nurses supported the use of Hexaxim® in the NIP. The majority of parents/caregivers had a positive perception regarding Hexaxim® vaccine in various aspects.
The costing questionnaire had two versions: one directed to the PHCs (Supplementary Table 1) and the other to the district health office (Supplementary Table 2). The costing questionnaire was developed upon reviewing previous related studies [20, 23, 24] and modified after several field visits to the PHCs to evaluate all the supplies and expenses included in the vaccination process. One part of the costing questionnaire was directed to the matron or head nurse of maternal and child department, and the other part was directed to the related staff in the district health office. The costing questionnaire was designed to extract raw data, transformed to direct medical cost of vaccines borne by the healthcare provider. This cost included cost of consumables (swabs, syringes, needles, and safety box), hazardous waste disposal, vaccine wastage, and cold chain storage (refrigerator and cold box).
The time and motion chart (Supplementary Table 3) was designed to record the time spent by 46 nurses to accomplish tasks associated with vaccination process; this recorded time was used to calculate the cost of vaccine administration time, which is a component of direct medical cost borne by the health care provider. Time and motion chart was prepared after reviewing previous related studies [20, 25]. It was modified after several field visits to the PHCs to entail all the steps included in the vaccination visits and undertaken all the detailed steps in the injection process. This chart was reviewed and validated by the head nurse of each PHCs visited to ensure they follow the same ordered steps in the vaccination process.
The costing method employed in the economic evaluation study was based upon the societal perspective, that is, the sum of costs paid by providers and parents/caregivers. The vaccine societal cost was calculated as cost per dose, per fully immunized child (FIC), and per birth cohort, and then the net cost savings were calculated for each. There are 11 components of the cost analysis. Table 1 below summarizes the cost components and the formula. The specific formula and inputs for each cost component are summarized in Supplementary Table 7.
Sensitivity analyses were conducted to investigate how sensitive the findings of an economic evaluation are to changes in the assumptions used in the study and to examine variations in the parameter estimates. Sensitivity analyses were calculated based on vaccine wastage rate (2.5 and 10%) and administration time (minimum and maximum) as both are the key variables that affect the cost saving.
A summary of cost borne by providers (direct medical), parents (direct non-medical and indirect cost), and societal (total) vaccine cost by immunization schemes is shown in Tables 2, 3, and 4, respectively. In the baseline scheme, the cost per dose of partially combined vaccine vs. Hexaxim® was Malaysian ringgit (RM) 31.90 vs. 17.10 (direct medical cost), RM 54.40 vs. RM 27.20 (direct non-medical cost), RM 221.33 vs. RM 110.66 (indirect cost), and RM 307.63 vs. RM 155.00 (societal cost). Cost savings with Hexaxim® were as follows: RM 137.20 per dose, RM 458.00 per FIC, and RM 267,977,435 per birth cohort. In the alternative scheme, cost per dose for both partially and fully vaccines was the same as in the baseline scheme since the additional vaccine effect was added to the cost per FIC. The cost per FIC of partially combined vaccine vs. Hexaxim® was RM 112.91 vs. 83.10 (direct medical cost), RM 190.40 vs. RM 136.00 (direct non-medical cost), and RM 774.64 vs. RM 553.31 (indirect cost). Cost savings with Hexaxim® were as follows: RM 104.70 per dose, RM 305.50 per FIC, and RM 204,540,947 per birth cohort.
Figure 1 demonstrates the percentages of cost components contribution in the direct medical vaccine cost per dose for the baseline scheme. The major contributor to direct medical cost per dose was the cost of administration time (86.9% for the partially combined vaccine vs. 80.9% for fully combined vaccine), followed by the cost of vaccine wastage per dose (8.85 vs. 15.2% for partially and fully combined vaccines respectively).
The economic evaluation results demonstrated that Hexaxim® had a lower cost per dose, per FIC, and per birth cohort (2019) and significant cost savings with regards to direct medical cost borne by HCP and direct non-medical cost (transportation) and indirect cost (loss of productivity) borne by parents/caregivers, compared with Pentaxim® plus Hep B. These results are supported by the results of a similar cost minimization study (from the public sector perspective only) conducted in South Africa in 2014 that also analyzed replacing Pentaxim® and Hep B vaccine with Hexaxim® vaccine . The direct medical cost saving per dose of Hexaxim® for the present study was RM 11.10 (in baseline scheme) compared with RM 7.4 (29.4 African rand) in the South African study . Moreover, based upon the costing profile generated in this study, it appeared that administration time was the cost component that contributed the most to the total direct cost per dose of Pentaxim® plus Hep B (86.9%) and Hexaxim® (80.9%). In contrast, Mogale et al. showed that cold chain storage was the major cost component for both partially and fully combined vaccines . This inconsistency arose due to the different methods used to calculate the administration cost. To assess the cost of cold chain storage, Mogale et al. have used the capital costs, which means the researchers calculated how much space each vaccine would occupy compared with the refrigerator cost or cost of appliance. This method yielded a higher cost because of the expensive purchase price of vaccine appliances. In the current study, cold chain storage cost calculation was based upon the recurrent cost of energy for each dose of the vaccine, which resulted in a relatively minor contribution to the cost per dose compared with the other cost components for partially (0.009%) and fully combined (0.0009%) vaccines.
At the clinic, the patient receives a discount for the cost of a pre-vaccination consultation with a doctor. This price (with a discount) is combined with the price of the vaccine preparation and makes up the final cost of the service.
There are no additional restrictions on the use of other features of the service. Saving the history of vaccination, information about vaccines, recommendations for pregnant women and alerts are provided free of charge.
News that pharmaceutical manufacturer Changchun Changsheng Biotechnology had fabricated records and was ordered to cease production of rabies vaccines has revived deep consumer unease over product safety in the country, fuelled by recurring scandals over the years.
The National Advisory Committee on Immunization (NACI) provides the Public Health Agency of Canada (PHAC) with ongoing and timely medical, scientific, and public health advice related to immunization. PHAC acknowledges that the advice and recommendations set out in this statement are based upon the best available current scientific knowledge, and is disseminating this document for information purposes. Persons administering or using the vaccines or drugs discussed in this statement should also be aware of the contents of the relevant product monograph(s). Recommendations for use and other information set out here may differ from that set out in the product monograph(s) of the Canadian licensed manufacturer(s) of the vaccine(s). Manufacturer(s) have sought approval of the vaccine(s) and provided evidence as to its / their safety and efficacy only when used in accordance with the product monographs. NACI members and liaison members conduct themselves within the context of PHAC Policy on Conflict of Interest, including yearly declaration of potential conflicts of interest.
In Canada, there are two manufacturers that supply three combination vaccines against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib), for use in infancy through early childhood. While these products offer equivalent protection against these diseases, they differ slightly in composition. The recommendations within this statement focus on the interchangeability of the presently approved products based on current scientific data, experiences of other countries and expert opinion.
As the number of combination vaccine products being developed and marketed in Canada increases, it is important to consider the issue of vaccine interchangeability. While combination products reduce the number of injections given to each child, their introduction necessitates switching from single antigen vaccinations. Where combination products are already the standard of care, several factors may necessitate giving different products to the same child over time. If the previously administered product is not known, or is not available, a switch may be required. Even when faced with vaccine product shortages, deferring vaccination is not desirable as one study demonstrated that 25% of deferred children never return for the indicated vaccinationFootnote 1.
When examining candidate vaccines for potential interchangeability, there are several factors that should be taken into account. The vaccines should be approved with the same indications and should be equally acceptable in terms of safety, reactogenicity, immunogenicity and efficacy. Even when approved for the same indications, different manufacturers use different production methods, antigen concentrations, stabilizers and preservatives. Each of these could potentially impact on the immunogenicity, safety or efficacy profile of the product. In addition, if an immunization regimen is to be changed to use different vaccine products interchangeably, the new regimen should be equally acceptable from the perspective of safety and efficacy, as well as scheduling. 781b155fdc