Objectives: Within Europe, contrasting approaches have emerged for rewarding the value added by new drugs. In Ireland, The Netherlands, Sweden and the UK, the price of, and access to, a new drug has to be justified by the health gain it delivers compared with current therapy, typically expressed in quality-adjusted life-years (QALYs) gained. By contrast, in France and Germany, the assessment of added benefit is expressed on an ordinal scale, based on an assessment of the clinical outcomes as compared with existing care. This assessment then influences price negotiations. The objective of this paper is to assess the pros and cons of each approach, both in terms of the assessments they produce and the efficiency and practical feasibility of the process.
Methods: We reviewed the technology appraisals performed by the National Institute for Health and Care Excellence (NICE) relating to 49 anticancer drug decisions in the UK from September 2003 to January 2012. Estimates of the QALYs gained and incremental cost per QALY gained were then compared with the assessments of the Amélioration du Service Médical Rendu (ASMR) made by the Haute Autorité de Santé (HAS) in France for the same drugs in the same clinical indications. We also undertook a qualitative assessment of the two approaches, considering the resources required, timeliness, transparency, stakeholder engagement, and political acceptability.
Results: In the UK, the estimates of QALYs gained ranged from 0.003 to 1.46 and estimates of incremental cost per QALY from £3,320 to £458,000. The estimate of cost per QALY gained was a good predictor of the level of restriction imposed on the use of the drug concerned. Patient access schemes, which normally imply price reductions, were proposed in 45 % of cases. In France, the distribution of ASMRs was I, 12 %; II, 18 %; III, 24 %; IV, 18 %; V, 22 %; and uncategorized/non-reimbursed, 4 %. Since ASMRs of IV and above signify minor or no improvement over existing therapy, these ratings imply that, in around 40 % of cases, the drugs concerned would face price controls. Overall, the assessments of value added in the two jurisdictions were very similar. A superior ASMR rating was associated with higher QALYs gained. However, a superior ASMR was not associated with a lower incremental cost per QALY. There are substantial differences in respect of the other attributes considered, but these mainly reflect the result of institutional choices in the jurisdictions concerned and it is not possible to conclude that one approach is universally superior to the other.
Conclusions: The two approaches produce very similar assessments of added value, but have different attributes in terms of cost, timeliness, transparency and political acceptability. How these considerations impact market access and prices is difficult to assess, because of the lack of transparency concerning prices in both countries and the fact that market access also depends on a broader range of factors. There is some evidence of convergence in the approaches, with the movement in France towards producing cost-effectiveness estimates and the movement in the UK towards negotiated prices.