Abstract

To describe when in the life-cycle of a technology the HTA is requested. We analyzed all HTA reports by an independent Argentinian HTA agency (IECS) for a consortium of public, social security and private institutions in Argentina and Uruguay during 2013-2016. We considered health technologies (HTs) in the following stages: experimental stage without approval from regulatory agencies (FDA, EMA, National Agency) or with quality of evidence (GRADE) very low or low (except for orphan diseases); and non-experimental if HT was approved by regulatory agencies and GRADE was moderate or high. Non-experimental HTs were classified in three groups: innovative if recommendation was positive or positive with restrictions and not yet widely adopted by coverage policies; in general use when fulfilling the criterion for innovative HT with at least five policies recommending coverage; or non-effective if recommendation was negative. Finally, an HT could be in obsolescence/replacement. We evaluated 317 HTA reports: 25.55% related to drugs, 20.19% devices, 26.81% medical procedures and 27.44% diagnostic technology. Twenty one were for orphan diseases. We found that 56.15% (178/317) HTs were approved by at least one regulatory agency. GRADE was high in 20.50%, moderate in 39.43%, low in 28.08%, and very low in 11.99%. No HTs were requested at research/development or obsolescence/replacement stages. 62.78% (199/317) of evaluated HTs were in experimental stage; most frequently in medical procedures (36.69%) and diagnostic technologies (33.67%), 19.10% for devices and 10.55% for drugs. The difference was statistically significant (p=0.001). 118 HTs (37.22%) were non-experimental: 83 (26.18%) were at innovative stage and 35 (11.04%) in general use. Considering all HTAs, 56.15% (178/317) had positive or positive with restrictions coverage recommendations. Nearly two-thirds of HTs were evaluated at experimental stage without evidence for routine use. Over half of HTs were finally recommended for wider use.

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