Good news for healthcare spending, the consumption of expired patent medicines continues to grow

Il Sole 24ORE – Cristina Da Rold – 16 September 2019

Also for 2018 the growing trend in the consumption of expired patent drugs is confirmed, which make up 65.9% of expenditure and 82.7% of consumption under the agreed assistance regime. The use of generic drugs is also growing slowly, i.e. medicines produced from scratch starting from the active ingredients of medicines with expired patents, which instead accounted for 19.0% of the expenditure and 29.4% of total consumption.

Just seven years earlier, in 2011, off-patent drugs accounted for 37% of Class A drug spending (free for citizens because they are reimbursed), or half compared to 2018. In the last year alone, their weight on the total has grown by 6%. A similar gap is also observed in the use of generic medicines, which in 2011 represented only 9% of expenditure in territorial assistance, against 19% today.

In other words, today the 17% of the drugs used in agreed care is still covered by a patent, with the 34% affecting the total territorial pharmaceutical expenditure. This is highlighted by the latest OSMED annual report by AIFA “The use of medicines in Italy. National Report 2018”.

A terminological clarification. We often hear - erroneously - referred to as a "generic" medicine. Initially, in 1996, this term was introduced as a synonym for "equivalent" with respect to an "originator" with an expired patent, but since the term "generic" could induce the idea in the population that these were less effective specialties or with non-specific action, in 2005 it was decided to officially replace it with the formula "equivalent medicine".

The first region with the highest incidence of expenditure for expired patent drugs on regional subsidized pharmaceutical expenditure is Emilia Romagna with 70.7%, followed by Umbria (69.6%) and the Public Administration of Trento (69.2%). Lombardy (60.7%), Valle d'Aosta (64.4%) and Sardinia (64.5%) are instead the regions with the lowest spending level.

Another good news is that there are no particularly significant regional differences: both in the north and in the center and in the south, the percentage of expenditure represented by class A drugs with expired patents is around 65%. However, the same cannot be said of the use of generic medicines, the expenditure of which represents 18% of the total in Calabria, 19% in Basilicata and Campania, and 20% in Sicily, but rises to 41% in Lombardy and 43% in the Autonomous Province of Trent. The further you go from north to south, the less equivalent drugs are used, compared to the former originators, i.e. drugs for which the patent has only expired.

Most of the patent-expired drugs used concern the cardiovascular and antimicrobial fields, with percentages respectively around 84%.

The top three active ingredients with expired patents at the highest expense in 2018 are pantoprazole and colecalciferol (both class A). The first used against gastric ulcer and gastroesophageal reflux diseases, represents 272 million euros of expenditure, while the second a steroid known as Vitamin D, 268 million euros: the 17% of expenditure more than in 2017. The third an expired patent medicine is atorvastatin (class C drug, therefore at the expense of the citizen), used to lower cholesterol, which produced an expenditure of 248 million euros in 2018 alone, a change of 6% on the previous year . Among the antimicrobials, in first place we find Amoxicillin, an antibiotic used among other things against Streptococci and influenza and in general against bacterial infections of the upper airways and respiratory tract. Also among the class C drugs we find bisoprolol, a beta blocker against heart failure, arrhythmias and hypertension, in the first places in terms of expenditure, with 138 million in annual expenditure, 6.8% more than in 2017.

Related news: AIFA. Transparency lists