The Supporting Independent Immunization and Vaccine Advisory Committees (SIVAC) Initiative: A country-driven, multi-partner program to support evidence-based decision making

Senouci, Kamel; Blau, Julia J. C.; Nyambat, Batmunkh; Faye, P; Gautier, Lara; Silva, Alfred Da; Favorov, Michael O.; Clemens, John D.; Stoeckel, P.; Gessner, Brad

doi:10.1016/j.vaccine.2010.02.028

Cited by 41 publications

(27 citation statements)

References 1 publication

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“…In many LMICs, there are not fully functional immunization technical advisory groups to advise national authorities on decisions to introduce new vaccines or to adjust existing immunization strategies [9]. Where they are in place, these authorities are confronted with difficulties in interpreting or adapting results as part of a context-specific analysis.…”

Section: Discussionmentioning

confidence: 99%

Results from evaluations of models and cost-effectiveness tools to support introduction decisions for new vaccines need critical appraisal

Hutubessy

Henao

Namgyal

et al. 2011

BMC Med

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The World Health Organization (WHO) recommends that the cost-effectiveness (CE) of introducing new vaccines be considered before such a programme is implemented. However, in low- and middle-income countries (LMICs), it is often challenging to perform and interpret the results of model-based economic appraisals of vaccines that benefit from locally relevant data. As a result, WHO embarked on a series of consultations to assess economic analytical tools to support vaccine introduction decisions for pneumococcal, rotavirus and human papillomavirus vaccines. The objectives of these assessments are to provide decision makers with a menu of existing CE tools for vaccines and their characteristics rather than to endorse the use of a single tool. The outcome will provide policy makers in LMICs with information about the feasibility of applying these models to inform their own decision making. We argue that if models and CE analyses are used to inform decisions, they ought to be critically appraised beforehand, including a transparent evaluation of their structure, assumptions and data sources (in isolation or in comparison to similar tools), so that decision makers can use them while being fully aware of their robustness and limitations.

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Section: Discussionmentioning

confidence: 99%

Results from evaluations of models and cost-effectiveness tools to support introduction decisions for new vaccines need critical appraisal

Hutubessy

Henao

Namgyal

et al. 2011

BMC Med

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“…Multi-variate analyses have suggested which interventions are related to faster uptake [27]. Although some authors have described supportive roles played by outside actors [16,20,21], in general the possible mechanisms for PDPs to support country decision making remain largely undocumented.…”

Section: How Pdps Fit Into Country Decision Makingmentioning

confidence: 99%

“…Within the information and evidence categories are many sub-categories to be considered by country stakeholders, including public health priority, disease burden, efficacy, quality, safety, comparison with other available interventions, presentation, supply (procurement and distribution), financial impact, and programmatic strength [22]. The process category includes, critically, the identification and convening of a sufficiently broad group of stakeholders who have the mandate and resources to identify and review evidence; this group can be under the aegis of the government (a specific disease control program, the broader Ministry of Health, the Ministry of Finance, a specific agency for technical assessment, or some combination of these agencies) or independent of but mandated by the government [13,16]. The final result should be a policy conclusion and, if the decision is supportive, implementation.…”

Section: How Pdps Fit Into Country Decision Makingmentioning

confidence: 99%

“…An example of this is the Introducing New Approaches and Tools (INAT) sub-working group of the Stop TB Partnership, which looks at ways to encourage the adoption both of new technologies and of new guidelines and practices [36]. Finally, if necessary, PDPs and other partners should facilitate the formation of a normative decision making process that covers all interventions in an area, not just those sponsored by the PDP [16]. …”

Section: How Pdps Fit Into Country Decision Makingmentioning

confidence: 99%

“…Although the policy change process is ultimately controlled by the country, in low and middle income settings in particular there are many other actors who provide input and can strengthen local decision making [16]. One such set of actors is the product development partnerships (PDPs).…”

Section: Introductionmentioning

confidence: 99%

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Adoption of new health products in low and middle income settings: how product development partnerships can support country decision making

Wells

Brooks

2011

Health Res Policy Sys

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When a new health product becomes available, countries have a choice to adopt the product into their national health systems or to pursue an alternate strategy to address the public health problem. Here, we describe the role for product development partnerships (PDPs) in supporting this decision-making process. PDPs are focused on developing new products to respond to health problems prevalent in low and middle income settings. The impact of these products within public sector health systems can only be realized after a country policy process. PDPs may be the organizations most familiar with the evidence which assists decision making, and this generally translates into involvement in international policy development, but PDPs have limited reach into endemic countries. In a few individual countries, there may be more extensive involvement in tracking adoption activities and generating local evidence. This local PDP involvement begins with geographical prioritization based on disease burden, relationships established during clinical trials, PDP in-country resources, and other factors. Strategies adopted by PDPs to establish a presence in endemic countries vary from the opening of country offices to engagement of part-time consultants or with long-term or ad hoc committees. Once a PDP commits to support country decision making, the approaches vary, but include country consultations, regional meetings, formation of regional, product-specific committees, support of in-country advocates, development of decision-making frameworks, provision of technical assistance to aid therapeutic or diagnostic guideline revision, and conduct of stakeholder and Phase 4 studies. To reach large numbers of countries, the formation of partnerships, particularly with WHO, are essential. At this early stage, impact data are limited. But available evidence suggests PDPs can and do play an important catalytic role in their support of country decision making in a number of target countries.

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Vaccine Marketing

Angelmar¹,

Morgon²

2013

International Series in Quantitative Marketing

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Long perceived as an unattractive segment of the pharmaceutical industry, most of the leading fi rms have stepped up vaccine investments in recent years. Unlike mainstream pharmaceuticals, vaccines generally treat healthy individuals, most are administered only once or very infrequently during a life time, and they engender positive externalities, because vaccinated individuals reduce the risk of transmission to unvaccinated persons, leading authorities to mandate some vaccinations. Resistance to vaccination may lead to immunization failure and disease resurgence.The public and private market each account for about one-half of the global vaccine market in value. Bringing new vaccines to market requires carefully orchestrated programs targeting the multiple types of customers. For example, in parallel with the clinical development program designed to obtain FDA approval for its HPV vaccine Gardasil, Merck developed health-economic evidence to obtain a positive recommendation for vaccination and public fi nancing. Physician educational programs and unbranded DTC campaigns were started many months prior to launch. Following FDA approval and positive vaccination and public fi nancing recommendations, Merck developed market access programs targeted at states and private insurers, and launched branded physician and DTC campaigns.Successful global diffusion of a vaccine generally requires the development of a tiered pricing policy which takes country differences in per capita income into account.A successful launch often creates new problems for vaccine marketers. They must maintain the motivation to engage in and pay for vaccination despite the quasi-disappearance of the disease. And they must combat anti-vaccination information claiming that the vaccine is the cause of serious side effects.

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The Supporting Independent Immunization and Vaccine Advisory Committees (SIVAC) Initiative: A country-driven, multi-partner program to support evidence-based decision making

Cited by 41 publications

References 1 publication

Results from evaluations of models and cost-effectiveness tools to support introduction decisions for new vaccines need critical appraisal

Results from evaluations of models and cost-effectiveness tools to support introduction decisions for new vaccines need critical appraisal

Adoption of new health products in low and middle income settings: how product development partnerships can support country decision making

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