Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA publishes Note 99 for the prescription of medicines against COPD - AIFA publishes Note 99 for the prescription of medicines against COPD

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AIFA publishes Note 99 for the prescription of medicines against COPD

AIFA announces that, as of 1 September 2021, the Note 99 for the prescription of inhalers indicated in the maintenance therapy of chronic obstructive pulmonary disease (COPD) will apply.

According to data from the Italian Institute of Statistics (ISTAT), COPD in Italy affects around 3.5 million adults, a significant proportion of whom is diagnosed only in the advanced stages of the disease. In addition, data from the recently published OSMED 2020 Report indicate that, once maintenance therapy has started, some patients undergo early discontinuation of treatment.

The Note stems from the need to improve the management of this condition in terms of appropriateness of diagnosis and pharmacological therapy.

The medicines included in Note 99 are inhalers with an indication in COPD maintenance therapy, i.e. long-acting beta2-agonists (LABA), long-acting anticholinergics (LAMA) and combinations of LABA + ICS (inhaled corticosteroid), LABA + LAMA and LAMA + LABA + ICS.

Note 99 is also associated with the elimination of the therapeutic plan (TP) for LABA/LAMA combinations, which may be prescribed also by a General Practitioner (GP). The triple LABA/LAMA/ICS combinations will continue to be prescribed by a specialist doctor within a TP.

Finally, Note 99 forms part of a more general approach attributing a primary role to GPs in the management of patients with chronic diseases, as already happened with Note 97 for the prescription of new oral anticoagulants in nonvalvular atrial fibrillation.


Published on: 31 August 2021

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