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Table 3 ATMPs status across EU5

From: Price and reimbursement of advanced therapeutic medicinal products in Europe: are assessment and appraisal diverging from expert recommendations?

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
  1. ALL acute lymphoblastic leukaemia; ASMR Amélioration du Service Médical Rendu (additional clinical value); ATU Autorisations Temporaires d'Utilisation (temporary authorization for use); CAA Commercial Access Agreement; CPR Price and Reimbursement Committee; CTS Scientific Technical Committee; DLBCL diffuse large B-Cell lymphoma; HST Highly Specialized Technologies; MAA Market Access Agreement; MEA Managed Entry Agreement; NA not available; NUB Neue Untersuchungs und Behandlungsmethode (new examination and treatment method); PAS Patient Access Scheme (mainly discounts); P&R Price and Reimbursement; SMR Service Médical Rendu (absolute clinical value); UK United Kingdom
  2. *Withdrawn. = reimbursed; ✗ = not reimbursed