Abstract
Since 2015, innovative ATMPs (Alofisel, Kymriah, Holoclar, Imlygic, Spherox, Strimvelis, Yescarta, Zalmoxis, Luxturna and Zynteglo) have been reached market authorization through the EMA. The aim is to compare pathways in market access for such therapies. A targeted literature research on official reimbursement / health technology assessment agencies websites complemented with local market access expert interviews were executed in spring 2019. France: Six of these innovative therapies were assessed by the transparency committee: five obtained a positive reimbursement decision (Yescarta, Kymriah, Luxturna, Holoclar, Alofisel); their price is under negotiations. Kymriah, Yescarta and Luxturna are available through ATU/post-ATU process and Holoclar which can be funded by hospitals. Germany: 5/10 therapies were assessed within the AMNOG process. Core reason for a non-assessment was the decision to treat such therapies as a procedure for the inpatient usage. Kymriah was the first ever therapy in Germany on which a pay-for-performance deal was agreed. Italy: 2/10 drugs are reimbursed to date (both with a payment-by-results), others are still under negotiation. Spain: Two therapies are reimbursed (Kymriah and Yescarta; both with a payment by results agreement), one is commercialised but not reimbursed (Holoclar); and the others are not commercialised. UK: 6/10 drugs are reimbursed to date. Only one of these, Strimvelis, was reimbursed at its full list price. Spherox was reimbursed via NICE’s STA with some restrictions. The two CAR-Ts were reimbursed via NHS England’s Cancer Drugs Fund. Meanwhile, two technologies (Holoclar & Imlygic) were recommended using a simple discount Patient Access Scheme. Zalmoxis, Luxturna and Zynteglo have not yet been appraised by NICE. Alofisel was not recommended by NICE. There is no difference in market access processes for ATMP therapies in comparison to standard pathways in Europe. Innovative and sustainable pricing schemes are under discussions within all payers in Europe.
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