Salutequity

Review of the pharmaceutical formulary: no to cost increases for citizens

Political control and direction by Parliament and the Ministry of Health, transparency of the process and participation of all stakeholders are necessary

by Tonino Aceti*

20 May 2026

Closeup view of pharmacist hand taking medicine box from the shelf in drug store. Pharmacy and health care. littlewolf1989 - stock.adobe.com

4' min read

Translated by AI

Versione italiana

4' min read

Translated by AI

Versione italiana

Article 1, paragraphs 376 - 379 of Law no. 199 of 30 December 2025 provides that the Italian Medicines Agency (AIFA) shall 'annually, and in any case by 30 November of the year preceding the reference year, revise and update the national pharmaceutical handbook (PFN) of medicines that can be supplied at the charge of the National Health Service, in order to pursue the objectives of rationalisation of pharmaceutical expenditure. The revision is carried out on the basis of the criteria of clinical efficacy, safety, appropriateness of use, ease of access to the drug for the patient, cost-benefit and overall cost-effectiveness for the National Health Service... For medicinal products excluded from the NFP, AIFA may provide for transitional measures aimed at guaranteeing therapeutic continuity for patients already under treatment, establishing the modalities and duration thereof."

We are facing a real revision of the Essential Levels of Public Pharmaceutical Care, i.e. the perimeter of the rights demanded by patients.

Increased drop-out

This is a useful and eagerly awaited operation, but at the same time also a very delicate one, because its success, from the users' point of view, will be anchored to the ability to guarantee an increase in the level of public coverage of pharmaceutical assistance, the sustainability of the NHS, and at the same time a reduction in the level of private spending by citizens.

The difference will therefore be 'how' the revision of the handbook will be carried out and how the therapeutic continuity of patients already on treatment will be managed.

In a context characterised by treatment renunciation galloping, reaching, according to ISTAT, 9.9% of the population in 2024, and private healthcare expenditure now standing at around EUR 43 billion and private spending on pharmaceuticals at over EUR 10 billion, an increase of about 1.5 billion compared to 2020 (due to regional co-payments and the difference between the price of an expired patent medicine and the corresponding reference price, class A medicines purchased privately and class C medicines (Osmed Report 2024), to fail to revise the National Pharmaceutical Catalogue would mean undermining the principles of universality, equity and solidarity of our National Healthcare System.

Adressing inefficiencies

This is why it is important to attack criticalities, inefficiencies and redundancies starting from a shared and certified knowledge base of the available evidence, starting with that produced by AIFA itself through the latest 'Monitoring of pharmaceutical expenditure January-October 2025':

1. Breach of the planned ceiling for direct pharmaceutical expenditure.

There is a deficit compared to planned expenditure of +4.24 billion eur (net of medicinal gases and expenditure for innovative medicines), equivalent to a 12.06% share of the National Social Security Fund instead of 8.30% as required by the regulations.

2. Conventional pharmaceutical expenditure under control.

Conventional pharmaceutical expenditure net of paybacks in force is EUR 7.21 billion, with a share of 6.39% of the National Social Security Fund instead of 6.80%, generating a surplus of EUR 461.3 million.

3. Expenditure ceiling for medical gases under control.

The verification of the planned expenditure ceiling shows a surplus over planned expenditure of EUR 13.0 million.

4. Pharmaceutical expenditure for innovative medicines under control.

The expenditure amounts to EUR 579.3 million.

The revision process, according to an official communiqué from Egualia (the official representative body of the generic equivalent medicines, biosimilars industry), seems to have been set in motion, starting with the sector that is already under control (because it has a significant surplus), namely that of contract pharmaceuticals.

In particular, again according to Egualia, it would start with 'proton pump inhibitors (PPIs), whose public spending is reported to be shrinking by 7.7 %, while private spending is growing by 8 %'

Pantoprazole represents the second active ingredient by expenditure (256.3 million) after atorvastatin, according to the report 'The use of medicines in Italia. National report year 2024, Agenzia Italiana del Farmaco"

Increasing public discussion and debate

Perhaps, given the implications and the delicacy of the operation of revising the handbook, it would be opportune to increase the level of comparison and public debate on this operation, through, for example, the publication on Aifa's website of the 'project for revising the NFP' that it intends to put in place, together with a multidimensional impact assessment on citizens, on the NHS, on employment, on the production system, etc.. This operation would make it possible to launch a true public consultation on the revision of the NFP, guaranteeing the involvement and the point of view of all the actors, starting with the Patients' and Citizens' Associations.

After all, we are talking about a review of the pharmaceutical LEAs and it is not clear why in this area of care, according to the rule, the only subject to deal with it by procedure is AIFA, unlike what happens in the canonical LEA updates with Prime Ministerial Decree on the other areas of care, where responsibilities and precise steps are also provided for with the Ministry of Health, Parliament (which proceeds with hearings of all the actors), Regions,...

Reducing the revision of the National Pharmaceutical Guidebook to a merely technical-administrative operation between 'insiders' and not accompanying it by a strong control and political activity of the other institutions and all the actors of the NHS could lead us astray, and this the NHS cannot really afford.

*President Salutequità

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