AIFA removes the proteinuria criterion from the Fabhalta registry

The Italian Medicines Agency (AIFA) is removing the blocking proteinuria criterion from the eligibility form of the monitoring registry for Fabhalta, the medicinal product indicated for complement 3 glomerulopathy. The modification is mandated by Determination October 15, 2026, n. 58/2026, published in the Official Gazette of the Italian Republic, General Series n. 250 of October 27, 2026 under reference 26A05604. The act, signed in Rome by the agency’s technical-scientific director, takes effect the day following publication and effectively expands the pool of patients eligible for treatment.

The measure rewrites Art. 1 of the determination and redefines the scope of the registry for the indication “treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients intolerant to RAS inhibitors or for whom a RAS inhibitor is contraindicated.” The point that changes concerns the population with recurrent C3G after kidney transplant, which until now was bound by a proteinuria threshold value.

The determination is based on a chain of acts cited in the preamble:

• AIFA Determination n. PRES/316/2026, published in the Official Gazette, General Series n. 70 of March 25, 2026, regarding the reimbursement regime and price;
• Resolution n. 7 of January 28, 2026, of the board of directors of AIFA;
• the opinion of the Scientific-Economic Committee for Pharmaceuticals (CSE), expressed in the session of September 7-11, 2026;
• Art. 48 of Decree-Law September 30, 2003, n. 269, establishing the agency, and the Decree of the Minister of Health September 20, 2004, n. 245;
• Art. 8, paragraph 10, of Law December 24, 1993, n. 537, on the classification of medicinal products provided at the expense of the National Health Service.

The blocking field being removed

Art. 1, paragraph 2, of the determination is explicit: the modification “aims to eliminate, in the eligibility form, the blocking field for UPCR <1 g/g (and for proteinuria <1 g/24h) for the population of patients with recurrent C3G after kidney transplant.” These are therefore two distinct parameters, expressed respectively as the urine/protein ratio and as 24-hour proteinuria, which until today conditioned access to the registry.

Paragraph 3 refers to the updated conditions and methods of use, “available in the updated monitoring form, which can be consulted on the AIFA institutional portal,” at the address registri-e-piani-terapeutici. The form published online thus becomes the operational reference for clinicians entering patients into the registry.

The decision-making process and entry into force

The preliminary investigation is reconstructed in the premises. The CSE established the modification of the registry during the session of September 7-11, 2026; subsequently, the marketing authorization holder was heard and, as stated in the act, “on October 7, 2026, following the communication of the opinion expressed by the Scientific-Economic Commission for Pharmaceuticals (CSE), together with the proposal for the graphic update of the relevant monitoring registry, they did not intend to raise any objections.”

Art. 2 sets out the final provisions: the determination takes effect from the day following its publication in the Official Gazette and will be notified to the company holding the authorization. The act is signed on behalf of the technical-scientific director by RUSSO, a role held by Pierluigi Russo, appointed by decree of the Minister of Health on February 9, 2024; the references also include the appointment of the chairman of the board of directors Robert Giovanni Nisticò, ordered by decree on April 5, 2024.

Impact on Expenditure and Access

The determination also addresses the economic profile. The text states that “any increase in pharmaceutical expenditure borne by the National Health Service resulting from the opinion expressed by the Scientific-Economic Commission for Pharmaceuticals will be evaluated within the framework of the next renegotiation procedure for the price and reimbursability conditions of the medicinal product.” No expenditure figures or numbers of treated patients are indicated in the measure.

The decision is consistent with the practice of AIFA registries, referred to by Art. 48, paragraph 33-ter, of Decree-Law no. 269 of 2003 regarding medicinal specialties subject to conditional reimbursability: the registries are an integral part of the National Health Service information system and their activation is verified annually, also for the purpose of potential reimbursement by pharmaceutical companies.

For kidney transplant patients with C3G recurrence, the change is concrete: the clinical evaluation no longer depends on exceeding a proteinuria threshold set in the form, and prescribing centers will be able to enroll those with higher values in the registry. Other indication requirements, the obligation to complete the updated form, and the monitoring accompanying conditional reimbursability remain unchanged.

Official source: Official Gazette of the Italian Republic, General Series no. 250 of October 27, 2026 — AIFA Determination October 15, 2026, no. 58/2026 (26A05604), p. 8.