Table 3 ATMPs status across EU5
Country | Italy | UK | France | Germany | Spain | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ATMP | Status | MEAs | Price, discounts | Status | MEAs | Price, discounts | Status | ASMR/SMR | Price, discounts | Status | NUB, MEAs | Price | Status | MEAs | Price |
Holoclar | ✓ | Payment by result | 95,000 € | ✓ STA, restricted target population | PAS | 88,993 €/eye (hidden discount excluded) | ✓ | ASMR IV | Reimbursed as DRG | ✓ Medical procedure | NUB 4 | DRG price | ✗ | – | – |
Imlygic | ✗ Request not submitted | – | – | ✓ STA | PAS | 1.858 €/vial (hidden discount excluded) | NA | – | – | ✓ No additional benefit | NUB 1 | Lauertaxe at launching: 2,398.50 €. After negotiation: 1,220.52€ | ✗ Request not submitted | – | – |
Strimvelis | ✓ Innovative status (expired) | Payment by result | 594,000 € | ✓ HST | 594,000 € (+ hospital costs coverage in Italy) | NA | – | – | ✗ | – | – | ✗ | – | – | |
Zalmoxis* | ✓ | Flat price/patient | 149,000 € | NA | – | – | ✗ | SMR insufficient | – | ✓ Not quantifiable benefit | NUB 1 | Lauertaxe at launching: 163,900€. After negotiation: 130,000€ | ✗ | – | – |
Spherox | ✗ Request not submitted | – | – | ✓ STA, Restricted target population | – | 11,124 € (hidden procurement discount excluded) | NA | – | Reimbursed as DRG | ✓ Medical procedure | – | – | ✗ | – | – |
Alofisel | ✗ | – | – | ✗ | – | Submitted price: 60,083 € | ✓ | ASMR IV | 54,000 € | ✓ Not quantifiable benefit | NUB 1 | 60,000 € | ✓ | – | 60,000 €/ treatment |
Kymriah | ✓ Innovative status for both indications | Payment "at" result for both indications | 320,000 €, discount for DLBC | ✓ STA | CDF (MAA, CAA) | 313,766 € (hidden discount excluded) | ✓ | ASMR IV for DLBCL; ASMR III for ALL | 297,666 €  + 15,000 € on top of DRG | ✓ Not quantifiable benefit (re-assessment after 1 year) | NUB 1; Outcome-based MEA with few insurance | 320,000 € | ✓ | Payment "at" result for both indications | 320,000 € |
Yescarta | ✓ Innovative status for both indications | Payment "at" result for both indications | 327,000 €, discount | ✓ STA | CDF (MAA, CAA) | Confidential price + discount | ✓ | ASMR III | 327,000 € + 15,000 € on top of DRG | ✓ Not quantifiable benefit (re-assessment after 3 year) | NUB 1; Outcome-based MEA with few insurance | 327,000 € | ✓ | Payment "at" result for both indications | 327,000 € |
Luxturna | Ongoing CPR | – | – | ✓ HST | – | 682,673 € (hidden discount excluded) | Ongoing | ASMR II | – | ✓ Considerable added benefit | NUB 1 | 345,000 € | Ongoing | – | – |
Zynteglo | Ongoing CTS | – | – | Ongoing STA | – | – | Ongoing | ASMR III | – | ✓ Not quantifiable added benefit | 315,000 € up front and 4 additional annual payments (at result) | 1.58 million € (full price) | Ongoing | – | – |
Zolgensma | Ongoing CTS | – | – | Ongoing HSTP | – | – | ✓ ATU | – | NA | Ongoing | – | – | Ongoing | – | – |