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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 />

Page 7

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