Recent health policy choices made by the Regions, linked to financial sustainability objectives, limit the therapeutic options available for drugs used in the treatment of maculopathies, raising relevant issues in terms of therapeutic appropriateness, prescribing freedom and informed consent of patients. This was reported in a note on Macula Committee, the first and only Italian association to give a voice to patients with maculopathies or retinopathiesexpressing its concern at the reports received from many patients, from all over Italy, relating to the replacement of pharmacological treatments to which they have been subjected for years, with less expensive drugs for health systems, whose real efficacy and possible complications in the indications of retinal pathologies.
“It is recent the fact reported in the press, which saw 8 patients in the Ophthalmology department of a Tuscan hospital, undergoing treatment against maculopathy, report problems that referred to a probable infection following the intravitreal injection received – says Massimo Ligustro, president of Macula Committee – From what appears, it was an intravitreal biosimilar drug of an ‘off label’ drug that needs to be ‘set up’ in a hospital pharmacy before being injected “.
Age-related macular degeneration (DMLE) is the leading cause of blindness in industrialized countries, in people over the age of 65. It has a progressive course and can lead to complete and irreversible loss of central vision. “Although it is a disease of serious social and health importance – observes Ligustro – fortunately today we are in possession of all the tools and methods to stem this pathology. Patients can, in fact, be treated with intravitreal injections of anti-angiogenic drugs, the so-called anti-Vegf, which not only prevent vision loss but, in some cases, also recover lost visual acuity “. several drugs currently used in clinical practice, some in an ‘on-label’ regimen – that is, drugs that are used in full compliance with the indications contained in the product data sheet, as approved by the competent authorities – and others in the regimen ‘off-label’, for which, the absence of registration studies that certify efficacy and safety, leaves the responsibility of the clinical practice to the full responsibility of the treating specialist.
In the case of drugs for the treatment of maculopathiessome health policy choices made by the Regions have recently been made, linked to financial sustainability objectives, which limit the therapeutic options available, raising relevant issues in terms of therapeutic appropriateness, prescribing freedom and informed consent of patients, highlights the Committee.
Emblematic – continues the note – is the case of the Lombardy Region, where in July 2019 a resolution on pharmacological services for the treatment of age-related macular degeneration was published, in which a “fixed quantum of reimbursement” was defined, thus limiting the prescriptive freedom on the part of the specialist. In August 2020, a ruling by the TAR on the appeal of the manufacturers of anti Vegf drugs canceled the part of the resolution that reduced the reimbursement of the therapies themselves, establishing that each doctor will be able to prescribe the therapy that he deems most appropriate for the individual.
In 2021, the Sentence of the Council of State, called upon to rule on the appeal of the Lombardy Region, confirmed the right to choose the most appropriate drugs, confirming with extreme clarity the exclusive competence of the Medicines Agency (Aifa) and the Ministry of Medicines health. “In fact, to date, this sentence is ignored and we are witnessing a very dangerous drift – Ligustro complains – where the method of imposing a cost containment policy on the Regions favors any type of other sentence”.
For this reason, the Macula Committee, representing patients with age-related macular degeneration, wishes to underline the importance of the patient’s involvement in their own therapeutic path for the success of the therapy itself which – according to what is also reported in the recent ‘Manifesto of rights of the maculopathic patient ‘- must be’ adequate, personalized and innovative ‘. The patient therefore has the right to the continuity of a treatment that is providing the desired results and, on the other hand, the prescribing freedom of the doctor must be safeguarded, which cannot be conditioned by economic and administrative aspects.
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