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Objective The objective of this study was to assess the feasibility and acceptability of institutionalizing Health Technology Assessment (HTA) in Malawi. Methods This study employed a document review and qualitative research methods, to understand the status of HTA in Malawi. This was complemented by a review of the status and nature of HTA institutionalization in selected countries.Qualitative research employed a Focus Group Discussion (FGD ) with 7 participants, and Key Informant Interviews (KIIs) with12 informants selected based on their knowledge and expertise in policy processes related to HTA in Malawi.Data extracted from the literature was organized in Microsoft Excel, categorized according to thematic areas and analyzed using a literature review framework. Qualitative data from KIIs and the FGD was analyzed using a thematic content analysis approach. Results Some HTA processes exist and are executed through three structures namely: Ministry of Health Senior Management Team, Technical Working Groups, and Pharmacy and Medicines Regulatory Authority (PMRA) with varyingdegrees of effectiveness.The main limitations of current HTA mechanisms include limited evidence use, lack of a standardized framework for technology adoption, donor pressure, lack of resources for the HTA process and technology acquisition, laws and practices that undermine cost-effectiveness considerations. KII and FGD results showed overwhelming demand for strengthening HTA in Malawi, with a stronger preference for strengthening coordination and capacity of existing entities and structures. Conclusion The study has shown that HTA institutionalization is acceptable and feasible in Malawi. However, the current committee based processes are suboptimal to improve efficiency due to lack of a structured framework. A structured HTA framework has the potential to improve processes in pharmaceuticals and medical technologies decision-making.In the short to medium term, HTA capacity building should focus on generating demand and increasing capacity in cost-effectiveness assessments. Country-specific assessments should precede HTA institutionalization as well as recommendations for new technology adoptions.

BackgroundThe objective of this study was to assess the feasibility and acceptability of institutionalizing Health Technology Assessment (HTA) in Malawi focusing on the form, scope, capacity and financing requirements for a limited resource setting such as Malawi.MethodsThis study employed a desk review and qualitative research methods. An extensive literature review was conducted on relevant key policy documents, reports and publications to understand the status of HTA in Malawi. The study included one focus group discussion with 7 participants and 12 key informant interviews with key stakeholders selected purposely based on their knowledge and expertise in HTA. ResultsThe study found that partial or informal HTA processes exist and that HTA is practiced without a standardized framework. The partial HTA processes are executed through three structures; Ministry of Health Senior Management Team, Technical Working Groups and Pharmacy and Medicines Regulatory Authority (PMRA) with varying levels of effectiveness. The results revealed that lack of an institutional HTA creates severe shortfalls. This includes partial HTA mechanisms, limited evidence use, especially concerning cost-effectiveness, lack of a standardized framework for technology adoption, donor pressure, lack of resources for the HTA process and technology acquisition, laws and practices that undermine cost-effectiveness considerations. ConclusionInstitutionalizing HTA in Malawi is acceptable and feasible. The results suggest that any HTA institutionalization in the short to medium term could involve strengthening the capacity of PMRA to appraise Cost-effectiveness Analysis (CEAs) within academia and MOH health financing division. Furthermore, rather than creating new HTA institutions, country-specific assessments should precede any specific recommendations for new technology adoptions. A technical capacity in Academic institutions such as Health Economics and Policy Unit (HEPU) at Kamuzu University of Health Sciences (KuHes) can be developed either as “offshore” HTA capacity fully aligned to MOH and executing HTA evidence and knowledge management function in a sub-contractor capacity.Running HeadHealth technology assessment in Malawi