what changes for patients

The Italian Medicines Agency (AIFA) approved the refundability of Rinvoq, drug based on upadacitinib for the care of Crohn's disease, a serious chronic inflammation of the gastrointestinal part. This was announced by the company that produces the drug, the Abbvie. Patients who take this medicine will no longer have to pay the full price but only a small part.

One of the most important roles ofAifa for sick people is to approve the drugs circulating in Italy for reimbursement by the National Health System. This is not a rapid process, which can take more than a year, and sometimes, as in the case of birth control pillthe implementation of these decisions is subject to further scrutiny by governments.

The main drug for Crohn's disease will be reimbursable

The Italian Medicines Agency has made the drug reimbursable by the National Health Service upadacitinib (trade name Rinvoq), also for the treatment of Crohn's disease. The company that produces it announced it, Abbvie, who commented on the result:

“The European Commission had approved upadacitinib in April 2023 thanks to the results of two induction clinical studies, U-Exceed and U-Excel, and one maintenance study, U-Endure.1 The clinical studies showed positive results in endoscopic response, in achieving clinical remission and in the healing of the intestinal mucosa” we read in a company press release

“Sixth indication reimbursed by the National Health Service in Italy for upadacitinib. In addition to Crohn's disease, in Italy upadacitinib is reimbursed for the treatment of adult patients with ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis” specified Abbvie, recalling that reimbursement by the National Health System also depends on the use made of the medicine itself.

As recalled by the company itself, the disease of Crohn's And: “A chronic systemic disease which manifests itself with inflammation of the gastrointestinal wall, causing persistent diarrhea and abdominal pain. It is a progressive disease, meaning it worsens over time in a significant percentage of patients and can lead to complications that require urgent medical attention, including surgery. Because the signs and symptoms of Crohn's disease are unpredictable, this has a significant impact on the people who live with it, not only physically but also emotionally and economically.”

The AIFA drug approval system

The approval for reimbursement of a drug is one of the most important measures that the'Aifa can take, in addition to approval for the use of the drugs themselves. The cost of a treatment not reimbursed by the National Health System can make it unaffordable to large segments of the population, particularly if it concerns chronic diseases such as Crohn's which therefore force patients to remain in treatment for a long time.

According to the statistics of AIFA itself, which analyzed the data on the timing of reimbursements between 2018 and 2021. The entire procedure, through various international bodies first and then AIFA itself, can last up to 8 or 9 months in total. A good result, below the European average, despite the analysis being carried out in a period of crisis for the Agency, in the midst of the Coronavirus pandemic.