The Italian Medicines Agency (Aifa) has approved the reimbursement of Viatris Creonipe 35,000 *, in the high-dose formulation of 420 mg of pancrelipase, as replacement therapy with pancreatic enzymes for the treatment of exocrine pancreatic insufficiency (Ipe). Patients now have a new reimbursed therapeutic opportunity available – the company comments in a note – which joins Creon 10,000, so far the only therapy reimbursed in Italy for the treatment of all patients suffering from IPE, a condition that occurs when, due to insufficient activity of pancreatic digestive enzymes, normal digestion cannot be maintained. And which is often related to damage to the pancreas, caused by several factors: certain diseases such as advanced chronic pancreatitis, cystic fibrosis, pancreatic cancer, diabetes mellitus, but also by consequences of some types of surgical resection of the gastrointestinal tract such as pancreatectomy or gastrectomy. (Video) A scenario, therefore, in which an early and accurate diagnosis, together with the administration of an appropriate enzyme replacement therapy (Pancreatic Enzyme Replacement Therapy, Pert) – continues the note – can significantly contribute to the improvement of nutritional status and of patient health. “If not treated properly, IPE can lead to malnutrition, with a major impact on quality of life due to persistent gastrointestinal symptoms. In cancer patients, then, a state of malnutrition influences the treatment schedules, with an impact on survival “, explains Massimo Falconi, director of the Pancreas Surgery Unit and of the Pancreas Translational & Clinical Research Center of the Irccs San Raffaele hospital in Milan and president of the Italian Pancreas Study Association (Aisp). The approval of the reimbursement of Creonipe 35,000 by Aifa – continues the note – provides a new treatment opportunity for patients, allowing a significant improvement in terms of appropriateness and maximization of the efficacy of the treatment, with the achievement of an adequate target dose, difficult to reach with lower dosages. This important milestone testifies to the value of the collaboration between scientific societies and companies, for a synergistic commitment in the area of pancreatic diseases and chronic pancreatitis “. A turning point – continues the note – which will allow to optimize the implementation of the Pert also in cancer patients with pancreatic cancer, for which the results of clinical studies showed a significantly improved overall survival rate in patients undergoing pancreaticoduodenectomy and treated with pancreatic enzymes, with a median survival of 33.1 vs 26.7 months. This figure is also confirmed in patients with unresectable pancreatic cancer for whom significantly prolonged survival has been reported compared to standard chemotherapy alone4 (189 vs 95 days, respectively). “This decision by Aifa marks an important step forward, long overdue, in an area characterized by high unmet needs on the part of patients “, declares Francesco de Lorenzo, president of the Federation of voluntary associations in oncology (Favo).” The reimbursement of the high-dose formulation Creonipe 35.000 allows to expand access to therapy by all patients with exocrine pancreatic insufficiency, promoting therapeutic adherence through the daily intake of fewer capsules of medicine, with a positive impact on the quality of life and on the state of health of patients “.” With the ‘approval of the reimbursement of Creonipe 35,000 Italian patients will also be able to have this available option for the treatment of IPE, like patients living in other European countries, who already have it available “, adds Laura Borgna, Head of Hospital Care Business Unit and Policy & Market access of Viatris in Italy. “This result testifies to Viatris’ commitment in this therapeutic area. A result achieved thanks to the partnership with scientific societies and patient associations to reduce the impact of exocrine pancreatic insufficiency and malnutrition in subjects suffering from pancreatic diseases”.
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