Italy is looking to pilot a new early access programme akin to the French model. The Health Minister, Orazio Schillaci, discussed the limitations of current provisions in Italy and the need for a new initiative in response to a parliamentary question (tinyurl.com/4avs97ea).
Italy already has three early access pathways:
● Compassionate use is an option for off-label prescribing, medicines authorised in other countries but not in Italy, and drugs that are undergoing clinical trials but could be used for other indications where treatment options are lacking.
● The AIFA National Fund (5% Fund) provides access on a named-patient basis prior to commercialisation of orphan drugs and off-label treatments for certain serious diseases. The money comes from 50% of the annual contribution that pharmaceutical companies make to AIFA, equivalent to 5% of expenditure on promotional activities to physicians.
● Law 648/96 allows the prescribing of unauthorised medicines subject to strict controls. AIFA negotiates the purchase price of the drug with the manufacturer.
Schillaci noted that “the current regulatory framework does not allow, beyond the instruments mentioned, a more general possibility of early access to medicines, i.e., access following EMA approval but prior to national pricing and reimbursement negotiation, which is the responsibility of AIFA. This lack of regulation may not always adequately meet patients' treatment needs in the case of rapidly progressive diseases.”
The Minister disclosed that the government is considering regulatory proposals that, “in addition to the existing instruments, would allow a new early access mechanism to be tested, which can be activated by the pharmaceutical company, and also inspired by the French early access model, for those medicines that actually represent a hope of cure for serious pathologies in the absence of therapeutic alternatives, for which the marketing authorisation application or the request for extension of the therapeutic indications at European level has been submitted, provided that they comply with the innovativeness requirements set out in the 2017 AIFA determination, with specific reference to added therapeutic value and unmet therapeutic need.”
He added that the proposals will have to be coordinated with the revision of the EU general pharmaceutical legislation, which seeks “to make access to medicines fairer, more uniform and faster” in all Member States.
It will be interesting to see how the government defines “those medicines that actually represent a hope of cure for serious pathologies in the absence of therapeutic alternatives.” How will the innovativeness requirements related to added therapeutic value and unmet therapeutic need be determined prior to AIFA evaluation?
It is also noteworthy that the French system faces a review of what the National Health Authority has described as the “gamble” of early access (tinyurl.com/mv68hebb).
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