Key Statistics
9
CAR-T therapies assessed
All approved EU/UK CAR-T products
38%
Positive reimbursement rate
Across EU5 + UK at 24 months post-approval
6
HTA agencies covered
NICE · G-BA · HAS · AIFA · AEMPS · SMC
24mo
Median access gap
EU approval to first reimbursement
$400K+
Median list price per course
One-time therapy pricing dominant
100%
With managed access / outcomes deals
All reimbursed products have PBA / MEA
Target Profile
| Products in Scope | Kymriah (tisagenlecleucel) · Yescarta (axicabtagene) · Tecartus · Breyanzi · Abecma · Carvykti · Aucatzyl · Omisirge · Carvykti (EU approval 2024) |
|---|---|
| HTA Agencies | NICE (England) · G-BA (Germany) · HAS (France) · AIFA (Italy) · AEMPS/GENESIS (Spain) · SMC (Scotland) |
| Evidence Challenges | Single-arm trials (no RCT)Short follow-up data at submissionSmall patient populationsUncertain long-term durabilityComparator definition disputes |
| Reimbursement Models Used | Performance-based agreements (PBA)Managed entry agreements (MEA)Registry-based outcomes trackingInstallment payment modelsAnnuity / subscription pricing |
| Key Finding | Germany (G-BA) provides immediate post-approval access under AMNOG with later benefit assessment — fastest route to reimbursement. UK NICE requires commercial agreement with NHS — slowest median access (30+ months). |
3Positive (full)
6Positive (conditional)
4Under assessment
2Negative
1Withdrawn
3Not yet submitted
Drug Landscape
| Drug Name | Company | Modality | Indication | Stage | Mechanism |
| Kymriah (tisagenlecleucel) | Novartis | CAR-T | DLBCL / ALL | Reimbursed (4/6) | CD19 CAR-T · Conditional positive in DE, FR, IT, ES |
| Yescarta (axicabtagene) | Gilead / Kite | CAR-T | DLBCL / FL | Reimbursed (5/6) | CD19 CAR-T · Positive NICE + DE + FR + IT + ES |
| Carvykti (ciltacabtagene) | J&J / Legend | CAR-T | Multiple Myeloma | Under assessment | BCMA CAR-T · NICE + G-BA assessments ongoing |
| Breyanzi (lisocabtagene) | BMS | CAR-T | DLBCL 2L/3L | Partial (2/6) | CD19 CAR-T · UK negative; DE reimbursed |
| 🔒 Full Outcomes Data | All 9 products | — | Full HTA decisions | Locked | All 6-market outcomes in paid report |
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