title: Priority setting for the implementation of artemisinin-based combination therapy policy in Tanzania: evaluation against the accountability for reasonableness framework.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmaceutics and Pharmacy Practice, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania. pax_amani@yahoo.com
authors.forename: Amani Thomas
authors.initials: AT
authors.lastname: Mori
authors.forename: Eliangiringa Amos
authors.initials: EA
authors.lastname: Kaale
mesh_terms: D000962:Antimalarials / Q000191:economics / Q000600:supply & distribution / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000191:economics / Q000600:supply & distribution / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D003625:Data Collection; D004338:Drug Combinations; D004345:Drug Industry; D018432:Drug Resistance, Multiple; D004983:Ethanolamines / Q000191:economics / Q000600:supply & distribution / Q000627:therapeutic use; D005449:Fluorenes / Q000191:economics / Q000600:supply & distribution / Q000627:therapeutic use; D006292:Health Priorities; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000191:economics; D018401:Sample Size; D012941:Social Responsibility; D013636:Tanzania; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; C031327:artemisinin