A wave of new medications is poised to become reimbursable in 2026, offering potential benefits to patients across a range of conditions. Beyond the highly anticipated Kaftrio (ivacaftor/tezacaftor/elexacaftor) – recently approved by the Italian Medicines Agency (AIFA) for expanded use in cystic fibrosis – several other therapies are on the horizon.
Among these is Mounjaro (tirzepatide), already recognized for its weight-loss capabilities, but indicated for the treatment of type 2 diabetes. A monoclonal antibody designed to address cognitive decline in the early stages of Alzheimer’s disease is progressing toward availability. A significant number of new anti-cancer drugs are also anticipated, including Anktiva (nogapendekin alfa inbakicept) for early-stage bladder cancer and a new generation of CAR T-cell therapy aimed at treating acute lymphoblastic leukemia with reduced toxicity and improved efficacy.
These potential additions represent a portion of the 104 medications that received a positive opinion from the European Medicines Agency (EMA) in 2025, and are expected to become available to physicians and patients in Italy following authorization from the European Commission. Of these, 38 are based on new active substances, 16 are orphan drugs for rare diseases, and a substantial 41 – approximately 40% of the total – are biosimilars, the generic equivalent of original biologic drugs.
To expedite access to these medications following European approval, AIFA has placed nearly all of them in Class Cnn (Class C not negotiated) – a category for drugs not yet evaluated for reimbursement – and has defined their supply arrangements. Negotiations for national health service (SSN) reimbursement have been initiated for some medications, with companies submitting applications. To date, reimbursement has been achieved for 80% of the drugs authorized by the EMA, a rate among the highest in Europe.
Robert Nisticò, President of AIFA, emphasized that the agency’s strategy includes ensuring responsible spending by authorizing reimbursement for drugs that demonstrate a genuine therapeutic advantage over existing options. “Fermo restando che la strategia di Aifa – specifica il Presidente dell’Agenzia, Robert Nisticò – è quella di garantire anche il governo della spesa autorizzando la rimborsabilità di quei farmaci che dimostrino di apportate un reale vantaggio terapeutico rispetto a quelli già disponibili gratuitamente per i pazienti.”
Many of these new drugs, according to AIFA, offer novel solutions for patients who have exhausted existing treatment options or for whom current therapies are insufficient or highly toxic. Others represent the first available treatment for conditions that previously lacked any therapeutic interventions.
Nisticò highlighted the challenges and opportunities ahead, stating, “Even this year, the Agency has a challenging and stimulating mission to accomplish: to make available in a short time the wave of new drugs arriving, many of which are highly innovative and expensive.” He specifically noted advancements in cancer therapies, with research yielding increasingly targeted, effective, and less toxic gene and cell therapies for specific patient subgroups who do not respond to current treatments.
AIFA is working to streamline evaluation and negotiation procedures through close collaboration between technical offices and the Scientific and Economic Commission. The agency acknowledges the financial sustainability concerns surrounding some of these medications, prompting a broader reflection on pharmaceutical expenditure management and a call for updated regulations and governance. Nisticò stated the agency is providing support to lawmakers in defining a more modern pharmaceutical framework.
The clinical use of these new drugs will be carefully monitored to assess both efficacy and safety, as initial expectations may not always be confirmed in real-world practice. AIFA has a responsibility to ensure that medications reimbursed by the National Health Service are justified by their demonstrated therapeutic value.
The anticipated approvals reflect ongoing progress in medical research, particularly in areas like oncology, where innovative therapies are emerging. These advancements offer hope for improved outcomes and quality of life for patients facing serious illnesses. The focus on both new active substances and biosimilars aims to balance innovation with affordability and access to essential medications.
As of , the process of evaluating and negotiating reimbursement for these new drugs is ongoing, with AIFA committed to ensuring that patients in Italy have access to the most effective and appropriate treatments available.
