PowerPoint - Imperial College Faculty of Medicine
PowerPoint - Imperial College Faculty of Medicine
PowerPoint - Imperial College Faculty of Medicine
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P&R landscape: France<br />
Products will be awarded an ASMR and an SMR rating; ASMR 4 (parity) or ASMR 5<br />
(EU reference pricing for product) would mean no price premium vs existing<br />
products.<br />
Decision-making process<br />
ASMR decision criteria<br />
Key trends<br />
• SMR rating is based on<br />
severity <strong>of</strong> the disease:<br />
• major<br />
• important<br />
• moderate<br />
• minor<br />
• insufficient to justify<br />
reimbursement<br />
• ASMR (incremental benefit<br />
vs SOC) is rated between 1<br />
and 5:<br />
• major (1)<br />
• important (2)<br />
• moderate (3)<br />
• minor (4)<br />
• none (5)<br />
1. Innovative product <strong>of</strong><br />
significant therapeutic benefit<br />
2. Product <strong>of</strong> therapeutic benefit<br />
in terms <strong>of</strong> efficacy and/or<br />
reduction in side-effect pr<strong>of</strong>ile<br />
3. Existing product where<br />
equivalent pharmaceuticals<br />
exist; moderate improvement<br />
in terms <strong>of</strong> efficacy and/or<br />
reduction in side-effect pr<strong>of</strong>ile<br />
4. Minor improvement in terms <strong>of</strong><br />
efficacy and/or utility<br />
5. No improvement but still<br />
granted recommendations to<br />
be listed<br />
• ASMR ratings are getting lower<br />
• SMR ratings are increasingly<br />
being used to deny or restrict<br />
reimbursement<br />
• Importance <strong>of</strong> incremental<br />
clinical benefit (better efficacy<br />
or better safety pr<strong>of</strong>ile, as<br />
evidenced in relevant clinical<br />
trials) will increase<br />
• Innovative technologies will<br />
require pharmacoeconomic<br />
studies showing that they<br />
provide cost-savings and<br />
improve disease management<br />
• Patient stratification is<br />
becoming increasingly<br />
important to limit budget<br />
impact<br />
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