Abstract:
BACKGROUND: Priority 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.
METHODS: This 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.
RESULTS: Publicity: 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.
CONCLUSIONS: The 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.
