Priority setting for the implementation of artemisinin-based combination therapy policy in Tanzania: evaluation against the accountability for reasonableness framework

Abstract

BackgroundPriority setting for artemisinin-based antimalarial drugs has become an integral part of malaria treatment policy change in malaria-endemic countries. Although these drugs are more efficacious, they are also more costly than the failing drugs. When Tanzania changed its National Malaria Treatment Policy in 2006, priority setting was an inevitable challenge. Artemether-lumefantrine was prioritised as the first-line drug for the management of uncomplicated malaria to be available at a subsidized price at public and faith-based healthcare facilities.MethodsThis paper describes the priority-setting process, which involved the selection of a new first-line antimalarial drug in the implementation of artemisinin-based combination therapy policy. These descriptions were further evaluated against the four conditions of the accountability for reasonableness framework. According to this framework, fair decisions must satisfy a set of publicity, relevance, appeals, and revision and enforcement conditions.In-depth interviews were held with key informants using pretested interview guides, supplemented with a review of the treatment guideline. Purposeful sampling was used in order to explore the perceptions of people with different backgrounds and perspectives. The analysis followed an editing organising style.ResultsPublicity: The selection decision of artemether-lumefantrine but not the rationale behind it was publicised through radio, television, and newspaper channels in the national language, Swahili. Relevance: The decision was grounded on evidences of clinical efficacy, safety, affordability, and formulation profile. Stakeholders were not adequately involved. There was neither an appeals mechanism to challenge the decision nor enforcement mechanisms to guarantee fairness of the decision outcomes.ConclusionsThe priority-setting decision to use artemether-lumefantrine as the first-line antimalarial drug failed to satisfy the four conditions of the accountability for reasonableness framework. In our understanding, this is the first study to evaluate priority-setting decisions for new drugs in Tanzania against the accountability for reasonableness framework. In addition to the demand for enhanced stakeholder involvement, publicity, and transparency, the study also calls for the institution of formal appeals, revision, and regulatory mechanisms in the future change of malaria treatment policies.

The Role of Evidence in the Decision-Making Process of Selecting Essential Medicines in Developing Countries: The Case of Tanzania

“…This finding is not surprising, considering the limited role of pharmacoeconomics in developing countries [49] . Several studies have cited the low availability of pharmacoeconomic studies in Tanzania [33] , [42] , [50] as the main barrier, but this study found that a lack of training could also be an important limitation. Studies have shown that, without training, decision-makers cannot understand, translate or apply economic evidence even when it is made available to them [47] , [48] .…”

“…In addition, medical sales representatives were also considered to be influential in medicine selection as they are viewed as the main source of drug information for prescribers. Experience from East Africa shows that medicine promotion is widespread and poorly regulated and several studies have reported concerns about the influence of these sales representatives in medicine selection [40] , [41] , [42] , [43] .…”

Determinants of bed net policy implementation: A case study of Southern Benin

“…For example, in Tanzania, communities were not adequately involved in decision‐making processes in malaria programs. There was neither an appeal mechanism to challenge the enforcement nor mechanisms to guarantee fairness of the decision outcomes of the government . In a similar vein, Mubyazi et al document that dialog in malaria programs between policy‐makers, drug manufacturers, media, practitioners, and communities was not effective in Tanzania.…”

“…There was neither an appeal mechanism to challenge the enforcement nor mechanisms to guarantee fairness of the decision outcomes of the government. 44 In a similar vein, Mubyazi et al 45 document that dialog in malaria programs between policy-makers, drug manufacturers, media, practitioners, and communities was not effective in Tanzania. In Ghana, Owusu 46 reveals that the level of community participation was only symbolic.…”

Reforms: a quest for efficiency or an opportunity for vested interests’? a case study of pharmaceutical policy reforms in Tanzania

“…The Pharmacy Council claimed to have invited representatives from various institutions and groups to convey ideas at the policy table; however, as was reported in another study, the said representation was neither adequate nor sufficient [21]. Prior to the submission of the proposed bill to Parliament, there was supposed to be extensive and comprehensive stakeholder discussion to build consensus.…”