Reference is made to notice dated 15 October 2020 “Simplified price and reimbursement procedure for generic/biosimilar medicines” published on the AIFA website. Specifically, regarding the paragraph that reads as: “In order to comply with the principle of simplification, generic/biosimilar medicinal products, whose reference product has been included in class C, will also be included in class C as early as the authorisation stage, without carrying out any negotiations with the HTA Department and with AIFA’s Technical-Scientific (CTS) and Price and Reimbursement (CPR) Committees, and without any prior classification in class C(nn)”, AIFA deems it necessary to provide interested companies with useful information on the criteria and rules for the application of the new procedure for classifying medicinal products for reimbursement purposes. This follows further checks carried out. 

Scope

The simplified procedure referred to above applies to medicinal products whose marketing authorisation (MA) or line extension applications have been submitted in accordance with Article 10(1) (‘generic application’), 10(3) (‘hybrid application’) and 10(4) (‘biosimilar application’) of Directive 2001/83/EC (transposed in Italy by Article 10, paragraphs 1, 6 and 7, of Legislative Decree 219/2006 as amended). 

It should be noted that this simplified procedure does not apply to generic/hybrid/biosimilar medicines featuring additional therapeutic indications compared with the reference medicinal product.

This procedure also applies to new packages of medicines whose MA has been issued in accordance with the abovementioned Articles and resulting from type II and type I variations. 

By analogy, it also applies to parallel importation applications.

Rules of application - Cases

Based on the simplification procedure in question, in the cases described below, medicines referred to in the preceding paragraph are included in class C for reimbursement purposes as early as the authorisation stage, without placing them in class “C Non-Negotiated” (C(nn)) beforehand. Consequently, there is no need for further negotiations with the HTA and Pharmaceutical Economics Department or with the CTS and CPR committees.   

Given that, in this context, package interchangeability means that packages have the same quantity of active ingredient, pharmaceutical form, route of administration, methods of release and dosage units, the automatic inclusion in class C for reimbursement purposes within an authorisation procedure is provided for MA applications/line extensions of:

• generic/hybrid/biosimilar medicines whose packages are interchangeable with those of the reference medicinal product, where the reference medicinal product is included in class C;
• generic/hybrid/biosimilar medicines whose packages are not interchangeable with those of the reference medicinal product, where the reference medicinal product is wholly included in class C;
• generic/hybrid/biosimilar medicines whose packages are interchangeable only with those of the reference medicinal product that are included in class C, where the reference medicinal product also features different packages reimbursed by the NHS (Class A/H).

This is without prejudice to the procedure already in place for MA/line extension applications of generic/hybrid/biosimilar medicines with one or more packages that are interchangeable with those of the reference medicinal product that are reimbursed by the NHS (Class A/H).

On the other hand, class C(nn) will include generic/hybrid/biosimilar medicines featuring only packages differing in strength, pharmaceutical form, number of dosage units and methods of release, from those of the reference medicinal product that are reimbursed by the NHS (Class A/H).  This is due the fact that similar packages have never been assessed for classification purposes, and therefore an automatic inclusion cannot be done.

If the reference medicinal product is a European Reference Product (ERP), the generic/hybrid/biosimilar medicine will be included in class C(nn).

The table below summarises the cases described above.

Reference medicinal product whose packages are included only in class C	MA /package additions applications for generic/hybrid/biosimilar medicines relating to packages that are interchangeable (same strength/pharmaceutical form/dosage units) with those of the reference medicinal product	C
	MA /package additions applications for generic/hybrid/biosimilar medicines relating to packages that are different (in terms of strength and/or pharmaceutical form and/or dosage units) from those of the reference medicinal product	C
Reference medicinal product whose packages are included in class A/H/C	MA /package additions applications for generic/hybrid/biosimilar medicines relating to packages that are interchangeable (same strength/pharmaceutical form/dosage units) with those of the reference medicinal product included in class A/H	Negotiations with the HTA and Pharmaceutical Economics Department
	MA /package additions applications for generic/hybrid/biosimilar medicines relating to packages that are different (in terms of strength and/or pharmaceutical form and/or dosage units) from those of the reference medicinal product included in class A/H	C(nn)
	MA /package additions applications for generic/hybrid/biosimilar medicines relating to only packages that are interchangeable (same strength/pharmaceutical form/dosage units) with those of the reference medicinal product included in class C	C
European Reference Product (ERP)	MA /package additions applications for generic/hybrid/biosimilar medicines	C(nn)

 

The above rules will equally apply to new package applications resulting from type II or type I variations of generic/hybrid/biosimilar medicines. 

In case of parallel importation applications (PIA), the packages of the medicines in question are interchangeable with those that have already been authorised for the ‘reference medicinal product’. Therefore, if the reference medicinal product is included in class C, PIA packages will be automatically included in the same class, without any prior inclusion in class C(nn).

Starting date of the new procedure

The new classification rules described above have been introduced as of the February 2021 meeting of the Technical-Scientific Committee. Conversely, for medicinal products under parallel importation, such rules will apply as of the meeting scheduled next month.

It follows that marketing authorisation and variation applications already discussed during previous meetings of the Technical-Scientific Committee will not be affected by the new procedure. 

Lastly, for already authorised medicinal products, any requests for change from class C(nn) to class C must be submitted in accordance with the procedures already in place, since no automatic mechanism for retroactive application is provided for.

Published on: 26 February 2021