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Worst-case scenarios emerging in the French drug evaluation reform? ITR versus SMR/ASMR
I have got news in relation to the French pricing and reimbursement (P&R) reform, which is meant to see the replacement of the country's SMR/ASMR system with a single drug evaluation index, the ITR. I'll be honest with you, as it stands it seems that our early suspicions that this reform could toughen market access conditions in France are not unfounded.
Decision-making algorithm, ITR score and impact on market access
Based on IHS primary research, the ITR score will influence reimbursement eligibility, reimbursement levels, and price levels. As it stands, we found that this score is calculated based on a four-step decision-making algorithm, which in a nutshell considers dossier admissibility, drug efficacy, clinical-trial endpoints, and modifying factors (e.g., tolerability).
The French regulatory authorities have run test cases and discussed their results. While these show that there are a number of challenges/question marks associated with the proposed ITR decision-making algorithm, let's not dwell on the strengths and weaknesses of the said algorithm. Instead, I'd like to consider how the ITR reform could pose fresh challenges to the drug industry based on one of the test cases.
Pirfenidone would fail to secure reimbursement under proposed ITR scoring system
Pirfenidone (Esbriet) is an orphan drug indicated for the treatment of mild to moderate idiopathic pulmonary fibrosis in adults. In March 2012, the transparency commission granted the drug an actual benefit (SMR) of "low" and an improvement in actual benefit (ASMR) of IV (minor) when used in the target patient population. Under the SMR/AMSR system, pirfenidone secured a reimbursement rate of 15%. While this doesn't seem much, the cost of the medicine to patients with supplementary health insurance (i.e., 96% of the French population in 2010 according to official public figures) is actually limited to that of the prescription fee (i.e., EUR0.5 per box).
When evaluated under the proposed ITR algorithm, according to our primary research, pirfenidone secured a score of -1, which would make the product ineligible for reimbursement. This score is a composite of (i) a positive (although minor) improvement in actual benefit over the appropriate comparator (placebo), (ii) the selection of a poor clinical study endpoint (a surrogate, when a hard endpoint such as mortality could have been assessed), and (iii) an unfavourable tolerability profile.
Needless to say that, in the case of pirfenidone, the outcome of the P&R process is less favourable under the ITR system than under the existing SMR/ASMR system. This is significant for at least two reasons. First, achievable market share for the product in France would be severely restricted as lack of reimbursement under the public healthcare system would also mean that supplementary health insurers are highly unlikely to fund treatment costs. Second, rejecting orphan drugs for reimbursement would constitute a paradigm shift for the country. Indeed, also based on IHS primary research, all approved orphan drugs are currently marketed and reimbursed in France. This is without even considering that lack of reimbursement in France could send alarm bells ringing in other European markets.
ITR reform, next steps
In light of the concerns raised during the test cases, it is likely that the proposed ITR decision-making algorithm will be fine-tuned before the reform is rolled out. Having said that, the decision-making criteria are unlikely to radically change and neither is the backbone of the reform. For the pharmaceutical companies that have yet to fully anticipate the associated market access changes, now is the time to give it some serious thoughts: as demonstrated by the pirfenidone case study, this proposed reform has the potential to reduce market share of some medicines to zero.
Admittedly, there is still no set implementation date for the ITR reform. However, the process is clearly moving along and "Un homme averti en vaut deux" (forewarned is forearmed) as the French say!
Learn more about our research into the French P&R reforms (and download a sample analysis), which also considers the impact of economic evaluation on the market-access process.
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