Strengthening national decision-making on immunization by building capacity for economic evaluation: Implementing ProVac in Europe.

BACKGROUND: For many years, low- and middle-income countries have made efforts to strengthen national decision-making on immunization. The Pan American Health Organization (PAHO) ProVac Initiative was established to help expedite the use of evidence-based decision-making around new vaccine introduction. This initiative provides training in user-friendly cost-effectiveness models and supports the development of country-led economic evaluations. Due to the success of the ProVac Initiative in the Americas, and following requests from countries from outside the Americas, the Bill & Melinda Gates Foundation funded a two-year pilot effort to expand the initiative to other world regions. Called the ProVac International Working Group (IWG), this endeavor took place in 2012 and 2013. It was coordinated by PAHO and carried out in collaboration with several international partners, including the Agence de Médecine Préventive (AMP), London School of Hygiene & Tropical Medicine (LSHTM), Program for Appropriate Technology in Health, Sabin Vaccine Institute, United States Centers for Disease Control and Prevention, and the World Health Organization (WHO). In the WHO European Region, technical support was provided by AMP, in close collaboration with the WHO Regional Office for Europe and other ProVac IWG partners. METHODS: In 2012, AMP, the WHO Regional Office for Europe, and other partners held a training workshop in Dubrovnik, Croatia, for 31 participants from four countries of the WHO European Region. The aim was to train health professionals in standard methods of economic evaluation and to assess regional demand for economic studies to support decision-making on immunization. AMP and the other organizations also supported four national cost-effectiveness studies in the WHO European Region. The assistance included country visits and support over a period of six months, the establishment of multidisciplinary teams of experts, ongoing training on the TRIVAC decision-support model for new-vaccine economic analysis, review of local evidence, recommending key data inputs, and support in presenting results to national decision makers. RESULTS: National cost-effectiveness studies were conducted in four countries: Albania (rotavirus vaccine [RV]), Azerbaijan (pneumococcal conjugate vaccine [PCV]), Croatia (PCV), and Georgia (PCV). All four countries improved their estimates of the burden of disease preventable by the new vaccines. National advisory bodies and ministries of health obtained economic evidence that helped Albania and Croatia to make decisions on introducing the new vaccines. Azerbaijan and Georgia used economic evidence to confirm previously made preliminary decisions to introduce PCV and make corresponding financial commitments. The study helped Albania to obtain access to affordable prices for rotavirus vaccines through participation in the UNICEF procurement mechanism for middle-income countries. Croatia was able to define the PCV price that would make its introduction cost-effective, and can use this figure as a basis for price negotiations. DISCUSSION: Despite some challenges due to competing national priorities, tight budgets for immunization, and lack of available national data, the ProVac IWG helped to build capacity of national health professionals, support decision-making for the introduction of new vaccines, and promote utilization of economic evidence for making decisions on immunization. This type of strong collaboration among international partners and countries should be scaled up, given that many other countries in the WHO European Region have expressed interest in receiving assistance from the ProVac IWG.

Progress in the establishment and strengthening of national immunization technical advisory groups: analysis from the 2013 WHO/UNICEF joint reporting form, data for 2012.

The majority of industrialized and some developing countries have established National Immunization Technical Advisory Groups (NITAGs). To enable systematic global monitoring of the existence and functionality of NITAGs, in 2011, WHO and UNICEF included related questions in the WHO/UNICEF Joint Reporting Form (JRF) that provides an official means to globally collect indicators of immunization program performance. These questions relate to six basic process indicators. According to the analysis of the 2013 JRF, data for 2012, notable progress was achieved between 2010 and 2012 and by the end of 2012, 99 countries (52%) reported the existence of a NITAG with a formal legislative or administrative basis (with a high of 86% in the Eastern Mediterranean Region - EMR), among the countries that reported data in the NITAG section of the JRF. There were 63 (33%) countries with a NITAG that met six process indicators (47% increase over the 43 reported in 2010) including a total of 38 developing countries. 11% of low income countries reported a NITAG that meets all six process criteria, versus 29% of middle income countries and 57% of the high income ones. Countries with smaller populations reported the existence of a NITAG that meets all six process criteria less frequently than more populated countries (23% for less populated countries versus 43% for more populated ones). However, progress needs to be accelerated to reach the Global Vaccine Action Plan (GVAP) target of ensuring all countries have support from a NITAG. The GVAP represents a major opportunity to boost the institutionalization of NITAGs. A special approach needs to be explored to allow small countries to benefit from sub-regional or other countries advisory groups.

Indicators to assess National Immunization Technical Advisory Groups (NITAGs).

A National Immunization Technical Advisory Group (NITAG) is an expert advisory committee that provides evidence-based recommendations to the Ministry of Health (MoH) to guide immunization programs and policies. The World Health Organization (WHO), the Initiative for Supporting National Independent Immunization and Vaccine Advisory Committees (SIVAC) at Agence de Médecine Préventive (AMP) and the US Centers for Disease Control and Prevention (US CDC) engaged NITAG stakeholders and technical partners in the development of indicators to assess the effectiveness of NITAGs. A list of 17 process, output and outcome indicators was developed and tested in 14 countries to determine whether they were understandable, feasible to collect, and useful for the countries. Based on the findings, a revised version of the indicators is proposed for self-assessment in the countries, as well as for global monitoring of the NITAGs.

Monitoring of progress in the establishment and strengthening of national immunization technical advisory groups.

The majority of industrialized and some developing countries have established technical advisory bodies to guide and formulate national immunization policies and strategies. These are referred to as National Immunization Technical Advisory Groups (NITAGs), WHO and its partners have placed a high priority on assisting in the establishment or strengthening of functional, sustainable, and independent NITAGs. To enable systematic global monitoring of the existence and functionality of NITAGs, in 2010, WHO and UNICEF included related questions in the WHO-UNICEF Joint Reporting Form (JRF) that provides an official means for WHO and UNICEF to collect indicators of immunization programme performance. This paper presents the status of NITAGs based on the analysis of the 2010 JRF. Although 115 countries (64% of responders) reported having a NITAG in 2010, only 50% of countries reported the existence of a NITAG with a formal administrative or legislative basis. Despite limitations in the ability to compare 2010 JRF data with that from a 2008 global survey, it appears that substantial progress has been achieved globally over with 43 committees reporting affirmatively about six NITAG process indicators, compared with 23 in the 2008 survey. Impressive progress has been observed in the proportion of countries reporting NITAGs with formal terms of reference (24% increase), a legislative or administrative basis (10% increase), and a requirement for members to disclose their interests (14% increase). Some of the poorest developing countries now enjoy support from a NITAG which meet all six process indicators. These may serve as examples for other countries.

The cost-effectiveness of rotavirus vaccination in Armenia.

The cost-effectiveness of introducing infant rotavirus vaccination in Armenia in 2012 using Rotarix(R) was evaluated using a multiple birth cohort model. The model considered the cost and health implications of hospitalisations, primary health care consultations and episodes not leading to medical care in children under five years old. Rotavirus vaccination is expected to cost the Ministry of Health $220,000 in 2012, rising to $830,000 in 2016 following termination of GAVI co-financing, then declining to $260,000 in 2025 due to vaccine price maturity. It may reduce health care costs by $34,000 in the first year, rising to $180,000 by 2019. By 2025, vaccination may be close to cost saving to the Ministry of Health if the vaccine purchase price declines as expected. Once coverage has reached high levels, vaccination may prevent 25,000 cases, 3000 primary care consultations, 1000 hospitalisations and 8 deaths per birth cohort vaccinated. The cost per disability-adjusted life year (DALY) saved is estimated to be about $650 from the perspective of the Ministry of Health, $850 including costs accrued to both the Ministry and to GAVI, $820 from a societal perspective excluding indirect costs and $44 from a societal perspective including indirect costs. Since the gross domestic product per capita of Armenia in 2008 was $3800, rotavirus vaccination is likely to be regarded as "very cost-effective" from a WHO standpoint. Vaccination may still be "very cost-effective" if less favourable assumptions are used regarding vaccine price and disease incidence, as long as DALYs are not age-weighted.

Comparative economic evaluation of Haemophilus influenzae type b vaccination in Belarus and Uzbekistan.

BACKGROUND: Hib vaccine has gradually been introduced into more and more countries during the past two decades, partly due to GAVI Alliance support to low-income countries. However, since Hib disease burden is difficult to establish in settings with limited diagnostic capacities and since the vaccine continues to be relatively expensive, some Governments remain doubtful about its value leading to concerns about financial sustainability. Similarly, several middle-income countries have not introduced the vaccine. The aim of this study is to estimate and compare the cost-effectiveness of Hib vaccination in a country relying on self-financing (Belarus) and a country eligible for GAVI Alliance support (Uzbekistan). METHODS AND FINDINGS: A decision analytic model was used to estimate morbidity and mortality from Hib meningitis, Hib pneumonia and other types of Hib disease with and without the vaccine. Treatment costs were attached to each disease event. Data on disease incidence, case fatality ratios and costs were primarily determined from national sources. For the Belarus 2009 birth cohort, Hib vaccine is estimated to prevent 467 invasive disease cases, 4 cases of meningitis sequelae, and 3 deaths, while in Uzbekistan 3,069 invasive cases, 34 sequelae cases and 341 deaths are prevented. Estimated costs per discounted DALY averted are US$ 9,323 in Belarus and US$ 267 in Uzbekistan. CONCLUSION: The primary reason why the cost-effectiveness values are more favourable in Uzbekistan than in Belarus is that relatively more deaths are averted in Uzbekistan due to higher baseline mortality burden. Two other explanations are that the vaccine price is lower in Uzbekistan and that Uzbekistan uses a three dose schedule compared to four doses in Belarus. However, when seen in the context of the relative ability to pay for public health, the vaccine can be considered cost-effective in both countries.

Rotavirus burden among children in the newly independent states of the former union of soviet socialist republics: literature review and first-year results from the rotavirus surveillance network.

BACKGROUND: Data on rotavirus burden among children in the 15 newly independent states of the former Union of Soviet Socialist Republics, particularly contemporary data from poorer countries, are not widely available. These data are desired by policy makers to assess the value of rotavirus vaccination, especially since the GAVI Alliance approved financial support for the region's eligible countries. The Rotavirus Surveillance Network was established to provide these data. METHODS: We reviewed the region's literature on rotavirus burden. We established an active surveillance network for rotavirus and analyzed data from 2007 from 4 sentinel hospitals in 3 countries (Georgia, Tajikistan, and Ukraine) that were collected using standardized enrollment and stool sample testing methods. RESULTS: Specimens for rotavirus testing were collected before 1997 in most studies, and the majority of studies were from 1 country, the Russian Federation. Overall, the studies indicated that approximately 33% of hospitalizations for gastroenteritis among children were attributable to rotavirus. The Rotavirus Surveillance Network documented that 1425 (42%) of 3374 hospitalizations for acute gastroenteritis among children aged <5 years were attributable to rotavirus (site median, 40%). Seasonal peaks (autumn through spring) were observed. Genotype data on 323 samples showed that G1P[8] was the most common type (32%), followed by G9P[8] (20%), G2P[4] (18%), and G4P[8] (18%). Infections due to G10 and G12 and mixed infections were also detected. CONCLUSIONS: The burden of rotavirus disease in the newly independent states is substantial. Vaccines should be considered for disease prevention.