Therapeutic innovation

Diabetes, how weekly insulin improves the quality of life of 1.3 mln patients in Italy

Our country is first in Europe after the go-ahead from Ema to make available the treatment that drastically reduces the number of injections each year from 365 to 52 with expected benefits in treatment adherence and environmental impact

by Barbara Gobbi

(AdobeStock)

4' min read

4' min read

A real turning point in the lives of 1.3 million Italians with type 2 and type 1 diabetes mellitus: from now on, they will be able to switch from 365 injections to 52 insulin injections a year. This, thanks to the fact that Italy, a pioneer country in Europe after the go-ahead came from Ema a year ago, has approved the world's first weekly basal insulin indicated for the treatment of diabetes in adults, produced by the Denmark-based multinational Novo Nordisk.

With concrete results first of all for the quality of life of at least 30% of the 4 million diabetics in Italy, but also in terms of therapeutic adherence and environmental sustainability with a reduction estimated by Altems of 865 tonnes of Co2 in five years, thanks to the collapse in the number of 'pens' used to administer the drug.

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Italy first in Europe

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"Putting the patient at the centre as prescribed by Article 32 of the Constitution, simplifying adherence to therapies, and guaranteeing sustainable innovation are fundamental priorities in the health policies of our government, to protect the right of access to medicines for all citizens and in a demographic context characterised by an ageing population and the growing incidence of chronic diseases," explained Health Undersecretary Marcello Gemmato speaking in Rome at the presentation of the new therapy. "The fact that Italy is the first country in the world to make this innovation available at the expense of the National Health Service testifies to the strength of a virtuous collaboration between institutions, politics, industry, the scientific community, and patient associations, united to improve citizens' quality of life. It is also confirmation of the solidity and excellence of the Italian pharmaceutical and regulatory system on the international scene,' he continued.

While Alfredo Galletti, Vice President and General Manager Novo Nordisk Italy, explained that 'the access process at regional level is going very fast thanks to the great attention that there is also at local level for this innovation, which is therefore already available to more than 70 per cent of Italian patients. In the shortest possible time we count on reaching 100 per cent, thanks to the full understanding of the impact of this important public health challenge,' the manager concluded.

A 'battle of civilisations'

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For Senate Vice President Giorgio Mulè, the fight against diabetes is 'a battle of civilisation'. Italy, he recalled, is proceeding along a virtuous path of combating major chronicities and 'has already had a pioneering approach in the world with Law 130 of 2023 on paediatric screening from zero to 17 years of age for type 1 diabetes and coeliac disease. The pilot project in five regions,' he then announced, 'has ended with over 5,000 cases "screened" with a very high percentage of positivity: by the end of the year, guidelines will arrive on a national basis to start at the beginning of 2026 at the latest throughout Italy'. Today, 'making the first weekly insulin reimbursable,' Mulè emphasised, 'puts Italy once again in a position of excellence with regard to health priorities in the field of chronic diseases.

What changes for patients

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But what actually changes for patients and care management with the novelty of weekly basal insulin? If until now insulin therapy involved at least one injection a day, with repercussions on the personal, social and work spheres, the change of pace is drastic. As the president of Fand - the Italian Diabetic Association, Manuela Bertaggia, explains: 'The introduction of the first weekly insulin represents a significant step: by reducing annual injections from 365 to just 52, it offers more flexible management of the disease. It is a concrete response for those living with diabetes can help improve therapeutic adherence and help reduce the mental burden associated with the chronic disease'.

It is estimated that 50 per cent of patients delay starting insulin therapy for more than two years, and this high percentage is unfortunately affected by the 'therapeutic inertia' of prescribing physicians, as the president of the Association of Diabetes Physicians (Amd) Riccardo Candido recalled. In Italy, according to data, one in three patients is still not treated with insulin, despite HbA1c values ≥9%. "We must then consider," continues the Amd president, "that weekly administration insulin represents the first major pharmacological innovation for people with diabetes after more than a century, that is, since the discovery of insulin itself, and is therefore a great opportunity that can allow a simpler and more effective course of treatment, and therefore, ultimately, more health and a better quality of life for people with diabetes.

Expectations for the innovation were high, according to a study according to which more than 90% of doctors and patients expressed the wish to be able to avoid daily injections. A non-trivial wish: delaying the start of insulin treatment also exposes one to an increased risk of serious complications such as heart attack (+67%), heart failure (+64%), stroke (+51%), nephropathy (+18%), neuropathy (+8%) and retinopathy (+7%) .

The priority: access in all regions

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'The data on the new product's safety and efficacy profile are optimal,' said Raffaella Buzzetti, president of the Italian Society of Diabetology (Sid) and president of the Federation of Italian Diabetes Societies (Fesdi), 'but the turning point is in compliance: think of a young person whose social life is conditioned by daily dosing, or of the elderly, who are perhaps struggling with taking polypharmacies. Now,' he added, 'we need to guarantee fair and fast access for the benefit of all people with diabetes, and also ensure full confidence in its use by the medical profession. Lombardy was the first,' Buzzetti further explained, 'followed by many regions, including Lazio, Tuscany, and Emilia Romagna. While others, especially in the south, have yet to get the final go-ahead, such as Sardinia, Sicily and Calabria. We must make sure that it reaches everyone soon, bridging these differences,' he said.

In phase 3 clinical trials, weekly insulin resulted in a reduction in glycaemia (measured as a change in HbA1c) compared to daily basal insulin by promoting glycaemic control in people with type 21 diabetes,4. The introduction of the first weekly insulin in Italy therefore represents a significant change in the management of diabetes.

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