TABLE 1.
MEA classification implemented in AIFA appropriateness' registries (2005–2019).
| Managed Entry Agreement | Definition | Medicinal product (non-OMP) | OMP |
|---|---|---|---|
| Appropriateness’ verification only (A) | Verification of use according to authorised indication, including AIFA restrictions. It is applied to all the registries. | ALECENSA, ALIMTA, AVASTIN, BAVENCIO, BENLYSTA, CABOMETYX, CIMZIA, DUPIXENT, EMPLICITI, ENBREL, ENTYVIO, EPCLUSA, EXVIERA, EYLEA, GAMTEN, GILENYA, HARVONI, HEMLIBRA, HUMIRA, IBRANCE, IGVENA, ILARIS, IMFINZI, INFLECTRA, JAKAVI, JETREA, JEVTANA, JINARC, KEYTRUDA, KINERET, KISQALI, LEMTRADA, LENVIMA, LUCENTIS, LYNPARZA, MABTHERA, MEPACT, NPLATE, OCTAGAM, ODOMZO, OPDIVO, ORKAMBI, PERJETA, PIXUVRI, PRALUENT, PRIVIGEN, REMICADE, REMOVAB, REPATHA, ROACTEMRA, RUBRACA, SAMSCA, SIMPONI, SOVALDI, STIVARGA, TAFINLAR, TECENTRIQ, TYSABRI, VELCADE, VENCLYXTO, VERZENIOS, VOSEVI, XALKORI, XOFIGO, XOLAIR, XTANDI, YERVOY, ZEVALIN, ZINBRYTA, ZYDELIG, ZYKADIA, ZYTIGA | ADCETRIS, ADEMPAS, ATRIANCE, BESPONSA, COMETRIQ, DARZALEX, DELTYBA, ELAPRASE, ESBRIET, FARYDAK, GAZYVARO, IMBRUVICA, IMNOVID, KALYDECO, KANUMA, KUVAN, MYLOTARG, NINLARO, OFEV, ORFADIN, OXERVATE, PREVYMIS, QARZIBA, RAXONE, REVLIMID, REVOLADE, RYDAPT, SOLIRIS, SPINRAZA, THALIDOMIDE CELGENE, TRISENOX, VYNDAQEL, VYXEOS, ZALMOXIS, ZEJULA |
| Financial-based [Cost-sharing (CS) & Capping (capp)] | Capp agreed total budget cap, eligible patients treated for free after cap reached. CS is the application of a discount (fixed or variable, from MAH to NHS) on the cost of the treatment cycles/months for all eligible patients. |
ALECENSA, ARZERRA, AVASTIN, CAPRELSA, CYRAMZA, DAKLINZA, ERIVEDGE, ILARIS, MAVIRET, OLYSIO, OPDIVO, SPRYCEL, SUTENT, TAGRISSO, TARCEVA, TORISEL, VELCADE, VIDAZA, VIEKIRAX, VOTRIENT, ZALTRAP, ZEPATIER | CRYSVITA, DACOGEN, KYPROLIS, LARTRUVO, NEXAVAR, SIRTURO, TASIGNA |
| Risk-sharing (RS) | Discount (fixed, usually 50% from MAH to NHS) for non-responders (according to pre-defined criterion) | VECTIBIX, ERBITUX | |
| Payment BY result (PbR) | Extends the modalities of the RS by providing for 100% reimbursement by the MAH to NHS for non-responders. It consists of a months-based payback model. | ABRAXANE, AFINITOR, ALIMTA, AVASTIN, BOSULIF, COTELLIC, ERBITUX, GIOTRIF, HALAVEN, HERCEPTIN, INLYTA, IRESSA, JAVLOR, KADCYLA, MACUGEN, SUTENT, TORISEL, TYVERB, VARGATEF, VECTIBIX, VOTRIENT, XALKORI, XIAPEX, YERVOY, ZELBORAF | ADCETRIS, BLINCYTO, HOLOCLAR, ICLUSIG, MOZOBIL, NEXAVAR, SIGNIFOR, STRIMVELIS, TASIGNA, YONDELIS |
| Combo PbR and CS | SATIVEX | ||
| Success fee (SF) | It is based on the definition of the responder: the hospital/ pharmacy pays the MAH only if the treatment is successful after starting it with free supply. | NA | NA |
| Payment AT result (PaR) | Exploits the SF paradigm: the hospital pays the MAH only if the treatment is successful (outcome-based) after starting with free supply or an up-front payment. It involves an annual payment model. | KYMRIAH, YESCARTA |
Given a medicinal product can have different MEA due to multiple therapeutic indications and also given the MEA dynamism, we limit our representation to only capture the forms of MEA for a MP/OMP without entering into the details for each therapeutic indication/line of treatments and current status of MEA/registry.
MAH, marketing authorisation holder; OMP, orphan medicinal product.