OBJECTIVES: One of the principles underlying cost-utility analysis is horizontal equity, well illustrated by the controversial “a QALY is a QALY is a QALY”. Today the concept of a single cost-effectiveness threshold irrespective of other considerations seems to be open for reconsideration. Our objective was to review the factors affecting the cost-effectiveness threshold for NICE (England), Scottish Medicine Consortium (Scotland), Haute Autorité de Santé (France), Zorginstituut Nederland (ZIN, Netherlands), Tandvårds-Läkemedelförmånsverket (TLV, Sweden), Norwegian Medical Agency (NoMA, Norway).

METHODS: Review of HTA websites complemented by targeted literature review.

RESULTS: In the UK, NICE has multiple exceptions, which can justify approval of treatment with a higher cost per QALY: end of life criteria, ultra-orphan drugs, product generating a high QALY gain, and oncology products channeled to oncology drug fund when not cost effective. SMC has defined a series of 6 modifiers related to outstanding benefit, severity of the condition and the nature of available treatment alternatives, as well as an exception for orphan drugs. ZIN has different discounting rates for vaccines, public health interactions and non-vaccine drugs leading indirectly to differential cost per QALY, and different thresholds according to severity of the condition and to population vulnerability, based on age (newborns and infants, and elderly). Norway recently developed a modifier based on relative and absolute shortfall considering Quality-adjusted life expectancy. TLV and HAS have a variable threshold that is not described officially but widely stated. The severity of the condition and the rarity of the disease are the main factors affecting the ICER threshold for both countries.

CONCLUSIONS: The pressure on payers to adopt new innovative therapies, the imbalance negotiation power, led to abandon horizontal equity and neglect the opportunity cost concept. Payers are increasingly looking at ways to escape the ICER threshold constraint.