To 2022 and beyond: what the latest budget law in Italy means for its pharmaceutical market

By Andrea Bernardini, Senior Analyst

Email: [email protected]

The latest approved Budget Law for the three-year period 2022-2024 is quite extensive and covers the whole planned spending for the Italian state. What are the expected changes for healthcare and pharma? Below we have summarised the most salient changes on planned healthcare expenditure and access to innovative therapies.

  • General NHS budget: Overall, the national NHS budget is set to increase by €2 billion Euros every year for the next three years. This means the budget will be ~€124 billion in 2022 and will reach ~€128 billion by 2024
  • Innovative drugs fund: The fund for innovative drugs will incrementally increase with an additional €100 million in 2022, up to an additional €300 million in 2024 versus the previous year. This means the budget for the reimbursement of innovative drugs will increase by €600 million over the next three years
  • Hospital drugs budget cap: The cap for the direct purchases, which comprise of drugs used by hospital and local sanitary agencies, will increase to 8% (from a previous 7.65%) of the total NHS budget for the year 2022. In 2023 it will be 8.15% and 8.3% in 2024. This means an estimated additional €430 million available for hospital expenditure. However, these percentages can be subject to yearly changes based on potential proposals by the ministry of health, together with AIFA and the ministry of economy. It is also important to notice that this increase in funds will not apply for manufacturers that did not pay the outstanding 2019-2020 paybacks. Going ahead, AIFA can also stop the current reimbursement of an authorised product if its payback is not cleared and its substitution with a therapeutically equivalent drug is verified
  • Hereditary Retinal Dystrophies network fund: A new network for the clinical governance of hereditary retinal dystrophies has been set up. Each year, between 2022 and 2023, a new fund of €500k will be established for the optimisation of care for patients suffering from rare eye diseases
  • Tumoural Genomic profiling fund: A yearly fund of €5 million for the years 2022-2023 has been established for the Next-Generation Sequencing (NGS) tests for the enhancement of the tumoural genomic profiling aimed at improving precision oncology
  • Neonatal Screening: The addition of new pathologies to screen during neonatal screenings will no longer require HTA studies by the National Agency for Regional Sanitary Services (AGENAS). This was the main cause for delays in the addition of new pathologies to be included in the neonatal screening, in particular for lysosomal and immunodeficiencies pathologies. Spinal muscular atrophy (SMA), mucopolysaccharidosis (MPS), Fabry disease, Gaucher disease, Pompe disease, ADA-SCID and Adrenoleukodystrophy (ALD) are all likely to be added to the neonatal screening panel in January 2022

Overall, the trend in Italy is clear: the government is increasing pharma expenditure with special attention being given to rare diseases. Therefore, there is an increased opportunity for orphan drugs manufacturers to drive successful reimbursement as well as a broader and faster patient access thanks to this renewed attention on rare disease.

This is to be looked within the bigger picture of the National Resilience Plan (NPPR), with which Italy aims to transform its healthcare system with increased funding and various reforms for more efficient healthcare delivery processes. However, we are just looking at the beginning of this process, of which the foundations have just been laid out. P4A will provide constant updates on how to navigate and seize opportunities in the Italian market in what appears to be an eventful 2022.


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