L’male hypogonadism it is a condition characterized by a lowering of testosterone levels in the blood, which in its most severe form affects about 6-8% of the male population and, if not adequately treated, causes: impotence, osteoporosis, anemia, obesity, worsening of diabetes mellitus , increased cardiovascular risk and mood disorders. A condition on which the most representative societies for the treatment of male hypogonadism recognized by the Ministry of Health turn the spotlight: Endocrinologists Association (Ame), Italian Society of Andrology and Sexuality Medicine (Siams) and Italian Society of Endocrinology (Sie) . In a document, they denounce critical issues for some patients in accessing substitution therapy and for this reason they ask the Italian Medicines Agency to “undertake useful actions to allow continuity of care for patients suffering from hypogonadism”.
Il right of access “to substitution therapy for these patients – reports a note signed by the presidents Renato Cozzi (Ame), Andrea Isidori (Siams) and Annamaria Colao (Sie) – it must become a priority for Aifa “, they argue. Numerous studies – explain the scientific societies – show that hypogonadism, when left untreated, is associated with an increase in mortality. Testosterone replacement therapy improves the metabolic health of the hypogonadal patient and reduces the progression of pre-diabetes into full-blown diabetes by 50%, with clear savings in health care costs. All national and international scientific societies recommend early treatment of testosterone deficiency to preserve the quality of life of the hypogonadal patient. This pathology is often diagnosed late, probably because the more specific symptoms, including those affecting the sexual sphere, are not reported spontaneously by the patient, due to shame or ignorance. For this reason, male hypogonadism is often underdiagnosed and, even when identified, suffers from a “social stigma” which makes it difficult to identify.
“The note 36 in Aifa – write the presidents of the three scientific societies- recognizes the reimbursement by the National Health Service and the Regional Health Service of testosterone in people with male hypogonadism. The note well identifies patients with true hypogonadism, to prevent testosterone treatment from being misused. The limited prescribability on specialist prescriptions has further prevented improper use, and in fact, in Italy, the number of prescriptions is much lower than that expected based on epidemiological studies”. According to endocrinologists, the recognition of the reimbursement of testosterone is an important milestone for the protection of patients suffering from this condition, which is often irreversible. “However, – they point out – a series of critical issues remain in the implementation of the treatment linked to specific contingencies attributable to the intermittence in the availability of reimbursable preparations and the fact that only a few preparations are reimbursable, moreover in a non-homogeneous way at the regional level”. A mix that, according to the experts, “determines a difference in treatment that mainly affects the weakest subjects, the less well-off classes, and residents in some regions, rather than others, violating the principle of universality of treatments”.
The testosterone formulations “for which distribution in Italy has been authorized – Ame, Siams and Sie remark – are not all recognized in class A reimbursement and therefore usable with the NHS through note 36. Currently they are recognized in class A only two formulations for transdermal administration and one for intramuscular administration (the latter only in some Regions). The other 4 formulations for intramuscular administration are not included in the list of class A drugs. For more than five years there have been repeated shortages of available formulations of testosterone, both in class A and in class C. This shortage has led to discontinuations of treatment, even prolonged, with relevant implications for the quality of life and the patient’s state of health”. For these reasons, “the patients, not finding the prescribed formulation, were forced to resort to new specialist visits to replace the therapeutic plan, dosage adjustment, the necessary information for the transition to a different route of administration, education of the caregiver (many patients who need this treatment are affected by rare or disabling diseases)”.
And again: “If there were a sudden difficulty in finding other hormones in pharmacies, such as levothyroxine or insulin – underline Cozzi, Isidori and Colao – there would be a rapid uprising on the part of the authorities and institutions responsible for guaranteeing the supply . Conversely, if testosterone is missing, no authority seems to care. Nothing is moved, based on the preconception, very wrong, that “no one has ever died of hypogonadism”. In this way, a right enshrined in the constitution is denied to these patients and there is a risk that even that small percentage of hypogonadics who manage to receive a diagnosis and start substitution therapy, end up sinking into the limbo of those who do not get treatment”.
For this reason, the three Societies urge Aifa, within the scope of its competences, and the other political decision-makers, to undertake useful actions to allow continuity of care for patients suffering from male hypogonadism. “Specifically – concludes the note – we ask for the formal commitment to implement all the necessary initiatives to guarantee a constant and adequate availability of testosterone-based specialties, homogeneous throughout the national territory; authorize, in case of lack of preparations reimbursed in band A, the extension of reimbursement to all other preparations in band C; the establishment of an inter-company technical table with Aifa in order to deal with the current emergency, estimate national needs and agree on initiatives aimed at to guarantee the right to health of patients with male hypogonadism”.