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Currently, reimbursement decisions based on health technology assessments (HTA) in the Netherlands mostly concern outpatient pharmaceuticals. The Dutch government aspires to broaden the systematic application of full HTA towards other types of health care in order to optimise the content of the basic benefit package. This paper identifies important challenges for broadening the scope of full HTA to other types of health care. Based on a description of the Dutch reimbursement decision-making process, five important characteristics of outpatient pharmaceuticals were identified, which are all relevant to the successful application of HTA: (i) closed reimbursement system, (ii) absence of alternative policy measures, (iii) existence of marketing authorisation, (iv) identifiable and accountable counterparty, and (v) product characteristics. For a selection of other types of health care, which may be subject to HTA more frequently in the future, deviations from these characteristics of outpatient pharmaceuticals are discussed. The implications of such deviations for performing HTA and the decision-making process are highlighted. It is concluded that broadening the application of HTA will require policy makers to meet both important policy-related and methodological challenges. These challenges differ per health care domain, which may inform policy makers which expansions of the current use of HTA are most feasible.

IntroductionMost collectively funded healthcare systems set limits to their benefit package. Doing so requires judgements which may involve economic evaluations. Performing such evaluations brings methodological challenges, which may be more pronounced in non-pharmaceutical interventions. For example, for medical devices, the validity of assessment results may be limited by learning effects, incremental innovation of the devices and the context-dependency of their outcomes.ObjectiveTo review the extent to which "learning effects", "incremental innovation" (related to outcomes) and "context-dependency" are included and/or discussed in peer reviewed economic evaluations on medical devices using Transcatheter Aortic Valve Implementation (TAVI) as an example.MethodsA systematic review was performed including full economic evaluations of TAVI for operable patients with aortic stenosis identified using the Pubmed database. Study characteristics, study results and text fragments concerning the aforementioned aspects were extracted. The quality of the studies was assessed using a quality checklist (CHEC-extended).ResultsWithin 207 screened records, 15 studies were identified. Two studies referred to all three aspects, four studies referred to none. "Learning effects" were discussed in five studies, one of which described a method to cope with this challenge. “Incremental innovation” was described in seven studies. Limitations in generalizability of results related to context of care provision were discussed in seven studies.ConclusionThe challenges related to economic evaluations of TAVI and their influence on the validity of reported results, are typically only partly discussed and rarely dealt within peer reviewed studies. It is important for better informed policy decisions that this improves.