Welcome to the first newsletter from Remap Consulting. In this quarterly newsletter, we will be sharing our perspectives on the latest news, developments and thinking within the pricing and market access field.
This issue focuses on the recent introduction of cost effectiveness data in France, interesting pricing and reimbursement articles that caught our eye and the current situation in the UK. Follow us on Twitter @remapconsulting for the latest info.
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Paul Craddy & Virginie Lavaud
Managing Directors & Founders – Remap Consulting
Cost effectiveness data requirements and implications for 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 effectiveness and costs of new therapies, as well as an aid to managing budgets. The good news is that these medico-economic assessments will only cover:
- Drugs or medical devices
- with an ASMR I to III (claimed by company)
- With significant impact on healthcare expenses (>€20 million/year)
These criteria means that the assessments will 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 of the new intervention in comparison to existing 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 data presented by the CEESP in their final report is expected to contain either:
If negative (i.e. 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 positive (i.e. 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 the drugs 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.