OBJECTIVES:

To analyse the technologies approved under the Innovative Licensing and Access Pathway (ILAP) and identify any trends or advantages of the programme.

METHODS:

120 applications have been made since the ILAP programme was launched, with 71 passports awarded¹. Only 46% (n=33) of the awarded passports have had information about them made public; as a result, these technologies were further examined via a review of the literature and primary and secondary data.

RESULTS:

Of passports reviewed, 21% were advanced therapy medicinal products and 30% had been positively certified as orphan drugs by the European Medicines Agency (EMA). 33% were oncology products. The majority (67%) of companies applied for the passport prior to Stage 3 clinical trials, with 18% of medicines in pre-clinical development, 12% at Phase 1, and 36% at Phase 2 at the time of the passport being awarded. Ten technologies have been submitted to the National Institute of Health and Care Excellence (NICE): 4 are awaiting development or in progress, 1 was discontinued, and 5 were recommended. Five technologies have been presented to the Scottish Medicines Consortium (SMC), with all but one of them being recommended. All recommended products were for oncology; the time from marketing authorisation (MA) to recommendation ranged from 40 to 1,834 days. Excluding atezolizumab (which had unique difficulties gaining MA), the average time to recommendation in England was 65 days fewer than the average for oncology products submitted through other methods, with same figure for Scotland being 347 days.

CONCLUSIONS:

Innovation passports cover a range of indications, and most are awarded during the early stages of product development. There has been a total of nine positive submissions in England and Scotland to date. The time taken from MA to a recommendation varies, but it is typically less than the average time for oncology drugs submitted through other methods.