Table 2.

Time of clinical development, regulatory assessment and patient access for ATMPs in Italy (data shown in days)

N	Brand name	AIFA decision	Clinical development timea	EMA assessment timea	Lag time between EC and AIFAa.d	AIFA assessment timeb	Regulatory timeb	Average time to first patient accessc
1	Holoclar	Reimbursed	6474	692	367	361	1430	430
2	Strimvelis	Reimbursed	8447	364	−51	116	431	–
3	Spherox	Not reimbursed	5650	1656	886	682	3256	–
4	Kymriah	Reimbursed	2787	273	−51	397	627	387
5	Yescarta	Reimbursed	3084	371	−48	481	816	611
6	Luxturna	Reimbursed	3605	462	31	709	1241	305
7	Alofisel	Not reimbursed	2452	729	−93	271	928	–
8	Zolgensma	Reimbursed	1608	564	8	283	863	148
9	Tecartus	Reimbursed	1522	321	−45	483	773	155
10	Libmeldy	Reimbursed	3500	385	−13	450	861	–
11	Abecma	Not reimbursed	1591	454	−41	768	1185	–
12	Upstaza	Reimbursed	1908	902	122	348	1406	–
13	Carvykti	Under ev.	2036	370	33	–	–	–
14	Breyanzi	Under ev.	1636	627	58	–	–	–
15	Roctavian	Under ev.	2141	405	83	–	–	–
16	Hemgenix	Under ev.	2827	333	−10	–	–	–
17	Ebvallo	Under ev.	9732	386	109	–	–	–
		Mean	3588	547	79	446	1151	340.6
		Median	2787	405	8	424	896	216.0
		Std. Dev.	2500	333	234	195	729	328.5
		IQR	1697	257	128	201	477	425.0

AIFA, Italian Medicines Agency; ATMPs, advanced therapy medicinal products; EC, European Commission; under ev, under evaluation; Std. Dev., standard deviation; IQR, inter-quartile range

^aStatistics calculated on n = 17 ATMPs

^bStatistics calculated on n = 12 ATMPs

^cStatistics calculated on n = 6 ATMPs

^dFor eight ATMPs the dossier was submitted to AIFA before the EC decision.