Implications of the new HTA in France
Since October 2013, the Transparency Committee (CT) can request medico-economic assessments of drugs. The purpose of these assessments is to ensure proportional incremental costs and effectiveness, as well as an aid to managing budgets. The good news is that these medico-economic assessments will only cover:
- Drugs or medical devices
- ASMR I to III (claimed by company)
- With significant impact on healthcare expenses (>€20 miliion/year)
This is expected to apply to less than 20% of products (in 2012, only 15 products out of 80 achieve ASMR I – III).
The assessment will be done by the Economic and public health evaluation committee (CEESP) and in parallel to the CT assessment. It will utilise data provided by the company to compare the expected or observed efficiency in comparison to existing new drugs or technologies. It will consider cost and comparative effectiveness and incremental cost effectiveness ratio (ICER) €/QALY at different price levels. However, there is no predefined ICER threshold. The assessment will be provided to the pricing committee (CEPS) to help inform their decision making.
The outputs from the CEESP are expected to be either:
If the cost-effective analysis does not comply with the HAS guidelines
- Efficiency of the technology is not demonstrated
- Major limitations of the analysis are highlighted
- No ICER will be provided
If the cost-effective analysis does comply with the HAS guidelines
- Efficiency of the technology is demonstrated
- ICERs will be presented at different price thresholds (but without a reference threshold)
- Methodological limitations of the analysis are discussed, as well as uncertainties over the quantitative results and parameters
Products currently being considered for medico-economic assessments include Defibrotide, Panitumumab, Trastuzumab emtansine and Sofosbuvir.
The implications are that for the most innovative drugs, the HAS is now expecting them to prove their value on numerous economic endpoints against current products, in addition to the clinical endpoints currently required by the CT. The aim is to only pay for innovation that delivers significant clinical and economic benefit to patients above the current therapies. Future changes still being discussed include changing the P&R system into an ITR (relative therapeutic interest) system, but no timelines have yet been set.