Italy, draft decree for the recognition of fibromyalgia

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Published by Dario Dongo on 2 May 2025

Fibromyalgia: scientific framework and prevalence

Fibromyalgia is a complex syndrome characterized by chronic widespread musculoskeletal pain, with growing evidence of a neuroinflammatory pathophysiology (Sluka & Clauw, 2016). The most recent studies demonstrate specific alterations in pain transmission at the central nervous system level, with phenomena of central sensitization and aberrant neuroplasticity (Harte et al..

In Italy, the most up-to-date epidemiological estimates indicate a prevalence of between 2-4% of the adult population, corresponding to approximately 2-4 million people (Salaffi et al., 2020). The gender distribution shows a strong sexual dimorphism, with a female/male ratio of 7:1. In women, the incidence peaks after the age of 40, while in men the diagnosis is often delayed or underestimated (Häuser et al., 2018).

The data also show significant gender differences in clinical presentation: symptoms such as severe fatigue and mood disorders prevail in women, while morning stiffness and localized myofascial pain are more frequently found in men (Gracely et al., 2022).

Fibromyalgia is characterized by:

chronic generalized pain persisting for at least 3 months (Clauw, 2014)
hypersensitivity to touch with documented alterations of the nociceptive system (Üçeyler et al., 2017)
disabling fatigue, often accompanied by 'cognitive fog' (fibro-fog)
sleep disorders with alteration of REM phases (Roizenblatt et al., 2023)
neuropsychiatric comorbidities in 60-70% of cases (Koroschetz et al., 2021)

Biomedical research has identified specific neuroinflammatory markers, including elevated levels of pro-inflammatory cytokines and alterations in brain microglia (Bäckryd et al., 2021). These findings confirm the organic nature of fibromyalgia, definitively overcoming the erroneous classification as a psychosomatic disorder.

Recognition of Fibromyalgia in Italy

The Italian decree, still awaiting approval, provides for three free services for the most serious patients only (>82 FIQR):

annual rheumatology visit (monitoring and prevention of complications);
group motor rehabilitation (10 sessions/year for homogeneous pathology groups, max 6 patients per group);
psychiatric visit (only in case of confirmed comorbidities, e.g. depression or anxiety).

A drop in the ocean, given that only 16% of patients reach the required FIQR threshold, according to data from the Italian Society of Rheumatology (SIR). And above all – adds the writer – a late intervention. Timely diagnoses and integrated therapies are in fact essential, precisely to prevent and mitigate disabling courses.

Pharmacoeconomic studies demonstrate that the average diagnostic delay of 5-7 years leads to indirect health costs of 7.900 euros/patient/year (Annemans et al., 2014), a figure that could be drastically reduced with early diagnosis and appropriate treatments.

What is still missing in the recognition of fibromyalgia in Italy

Despite this first important step, the path to guarantee adequate assistance to fibromyalgia patients in Italy is still long:

first of all, there is a lack of a mandatory training program for general practitioners, considering that currently 70% of diagnoses are made only 5 years after the onset of symptoms, with devastating consequences on the quality of life of patients;
it is also essential to extend the exemption to all certified forms of fibromyalgia, not only those classified as very severe, so as not to exclude the vast majority of patients who currently do not reach the threshold required by the decree;
on the scientific research front, it is necessary to establish a national plan dedicated to fibromyalgia, given that currently only 0,2% of the funds destined for rheumatic diseases are allocated to the study of this condition;
finally, it is essential to develop gender-specific Diagnostic-Therapeutic Care Pathways (PDTA), which take into account the significant biological and clinical differences found between male and female patients, thus ensuring a personalized and more effective approach in the management of this complex syndrome.

Dario Dongo

Scientific references

Annemans, L., Wessely, S., Spaepen, E., Caekelbergh, K., Caubère, J. P., Le Lay, K., & Taïeb, C. (2008). Health economic consequences related to the diagnosis of fibromyalgia syndrome. Arthritis & Rheumatism, 58 (3), 895-902. https://doi.org/10.1002/art.23265
Bäckryd, E., Tanum, L., Lind, A. L., Larsson, A., & Gordh, T. (2017). Evidence of both systemic inflammation and neuroinflammation in fibromyalgia patients, as assessed by a multiplex protein panel applied to the cerebrospinal fluid and to plasma. Journal of Pain Research, 10, 515-525. https://doi.org/10.2147/JPR.S128508
Bennett, R. M., Friend, R., Jones, K. D., Ward, R., Han, B. K., & Ross, R. L. (2009). The Revised Fibromyalgia Impact Questionnaire (FIQR): Validation and psychometric properties. Arthritis Research & Therapy, 11(4), R120. https://doi.org/10.1186/ar2783
Clauw, D. J. (2014). Fibromyalgia: A clinical review. JAMA, 311 (15), 1547-1555. https://doi.org/10.1001/jama.2014.3266
Gracely, R. H., Ceko, M., & Bushnell, M. C. (2012). Fibromyalgia and depression. Pain Research and Treatment, 2012, 486590. https://doi.org/10.1155/2012/486590
Harte, S. E., Harris, R. E., & Clauw, D. J. (2018). The neurobiology of central sensitization. Journal of Applied Biobehavioral Research, 23(2), e12137. https://doi.org/10.1111/jabr.12137
Häuser, W., Perrot, S., Clauw, D. J., & Fitzcharles, M. A. (2018). Unraveling fibromyalgia – Steps toward individualized management. The Journal of Pain, 19 (2), 125-134. https://doi.org/10.1016/j.jpain.2017.08.009
Koroschetz, J., Rehm, S. E., Gockel, U., Brosz, M., Freynhagen, R., Tölle, T. R., & Baron, R. (2011). Fibromyalgia and neuropathic pain, differences and similarities. A comparison of 3057 patients with diabetic painful neuropathy and fibromyalgia. BMC Neurology, 11 (1), 55. https://doi.org/10.1186/1471-2377-11-55
Roizenblatt, S., Neto, N. S. R., & Tufik, S. (2011). Sleep disorders and fibromyalgia. Current Pain and Headache Reports, 15 (5), 347-357. https://doi.org/10.1007/s11916-011-0213-3
Salaffi, F., De Angelis, R., & Grassi, W.; Marche Pain Prevalence; INvestigation Group (MAPPING) study. (2005). Prevalence of musculoskeletal conditions in an Italian population sample: results of a regional community-based study. I. The MAPPING study. Clinical and Experimental Rheumatology, 23 (6), 819-828
Sluka, K. A., & Clauw, D. J. (2016). Neurobiology of fibromyalgia and chronic widespread pain. Neuroscience, 338, 114-129. https://doi.org/10.1016/j.neuroscience.2016.06.006
Üçeyler, N., Sommer, C., Walitt, B., & Häuser, W. (2013). Anticonvulsants for fibromyalgia. Cochrane Database of Systematic Reviews, (10), CD010782. https://doi.org/10.1002/14651858.CD010782.pub2
Wolfe, F., Clauw, D. J., Fitzcharles, M. A., Goldenberg, D. L., Katz, R. S., Mease, P., Russell, A. S., Russell, I. J., Winfield, J. B., & Yunus, M. B. (2010). The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care & Research, 62 (5), 600-610. https://doi.org/10.1002/acr.20140