Prescription restrictions on many drugs in Italy could be relaxed significantly. The Italian Medicines Agency (AIFA) has convened a technical table to review therapeutic plans and AIFA notes. It will start work on 19th July 2024.
Prescription restrictions in Italy may see a significant relaxation as the Italian Medicines Agency (AIFA) initiates a comprehensive review of therapeutic plans and AIFA notes starting on 19th July 2024. The current framework includes 39 AIFA notes that specify reimbursement conditions for certain medications and 144 national therapeutic plans prepared by specialists. These plans govern long-term treatment, including prescribing by general practitioners (GPs), and cover more than 350 active substances, representing 25% of the active substances reimbursed by the National Health Service.
Prescription Access and Renewal Challenges in Italy’s Therapeutic Plans
Access to drugs subject to therapeutic plans can be arduous and time-consuming. Typically, a GP refers the patient to a specialist, who then prescribes the medication and draws up the therapeutic plan for the GP to follow. These plans generally require renewal every 6-12 months, ideally at the same facility that initiated the treatment. Patients face further complications if they are treated outside their region, but their home region does not deem the treatment necessary.
During the COVID-19 pandemic, the government temporarily allowed for the automatic renewal of treatment plans, enabling GPs to prescribe drugs without a referral to specialists unless there were complications or a change in therapy. However, not all regions implemented this concession, leading to inconsistencies and continued barriers for patients.
Pierluigi Russo, the Technical-Scientific Director of AIFA and a member of the new Scientific-Economic Commission, emphasized the need for a balanced approach: “While respecting the need for sustainability of pharmaceutical expenditure, a balanced use of these regulatory tools is necessary, avoiding excessive recourse that could complicate patients’ care pathways.
It is not enough just to streamline and simplify the use of these instruments: what is needed is a collaborative approach with doctors and scientific societies that enables AIFA to develop prescriptive guidelines capable of integrating the governance requirements of drug reimbursability with those of clinical and care appropriateness for patients.”
Prescription Reform: FNOMCEO Advocates for Broader Doctor Prescribing Powers
Filippo Anelli, President of the National Federation of Orders of Surgeons and Dentists (FNOMCEO), advocates for a more radical change. He believes in going beyond therapeutic plans, allowing all doctors to prescribe, without bureaucratic burdens, those drugs that have proven effective and safe. FNOMCEO proposes that specialists initially prescribe certain drugs and monitor the patient for a year, but then allow any physician to continue the use of these products.
Such a change would cut bureaucracy, reduce costs and waiting lists, and streamline treatment pathways for patients. Anelli points out that “citizens are frequently forced to incur non-negligible costs and long journeys to reach authorised specialist facilities, for the sole purpose of renewing treatment plans. Often, in the face of such difficulties, one is forced to fall back on less effective drugs, or even to interrupt treatment.”
The review by AIFA aims to address these inefficiencies and challenges faced by patients under the current system. By relaxing the restrictions, the goal is to facilitate easier access to necessary medications, thereby improving patient outcomes and reducing the administrative burden on healthcare providers. The involvement of a wide range of stakeholders, including doctors and scientific societies, is crucial in developing new guidelines that ensure both the clinical appropriateness of treatments and the sustainability of pharmaceutical expenditure.
As AIFA prepares to implement these changes, the focus will be on creating a more patient-centric approach that aligns with the evolving healthcare needs and the capabilities of modern medical practice. The anticipated reforms have the potential to significantly improve the efficiency of the healthcare system, making it more responsive to the needs of patients while maintaining rigorous standards of care and cost-effectiveness.
In conclusion, the planned relaxation of prescribing restrictions by AIFA marks a significant step towards optimizing healthcare delivery in Italy. The collaborative efforts of regulatory bodies, healthcare professionals, and scientific communities will be pivotal in ensuring that these changes lead to better healthcare outcomes, reduced burdens on patients, and a more sustainable healthcare system.
This new was inspired by Neil Grubert.
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