The Italian Medicines Agency (AIFA)'s National Observatory on the Use of Medicines (OsMed) has published a national report containing the latest available data on drug spending in 2015. Outpatient public and private expenditure increased by 8.9% year on year to EUR21.778 billion (USD23.08 billion).
Implications | OsMed concludes that public and private pharmaceutical expenditure amounted to EUR28.9 billion (USD30.5 billion) in 2015, of which 76.3% was reimbursed by the National Health Service (SSN). Public and private spending on outpatient pharmaceuticals increased by 8.9% year on year (y/y) during 2015 to reach EUR21.778 billion. Total SSN pharmaceutical expenditure – including outpatient pharmaceutical expenditure and expenditure on ‘Class A’ medicines distributed through direct channels – amounted to EUR13.398 billion, up 13.1% y/y. |
Outlook | Hepatitis C virus (HCV) and oncology therapeutic areas continue to represent the therapeutic areas that have the largest impact on expenditure and consumption of pharmaceuticals purchased by public utilities. For the first time, anti-infectives for systemic use recorded the highest overall spending by therapeutic class, at EUR4.402 billion, followed by antineoplastic and immunomodulators at EUR4.213 billion. Cardiovascular drugs also had a strong influence on spending and consumption patterns, with public and private expenditure reaching EUR4.079 billion. |
Italy’s National Observatory on the Use of Medicines (Osservatorio sull'impiego dei medicinali: OsMed), under the Italian Medicines Agency (Agenzia Italiana del Farmaco: AIFA), has published an English-language pharmaceutical expenditure review for 2015. The February 2017 report is available to view here and dovetails with previous analysis conducted by IHS Markit Life Sciences (see Italy: 23 June 2016: Italian pharmaceutical spending surges 8.6% y/y to USD32.6 bil. in 2015). OsMed concludes that Italian public and private pharmaceutical expenditure amounted to EUR28.9 billion in 2015, of which 76.3% was reimbursed by the National Health Service (SSN). Public pharmaceutical expenditure amounted to EUR13.398 billion (EUR220.4 per capita), a substantial increase of 13.1% y/y. This increase was primarily the result of a significant increase in ‘Class A’ medicine expenditure. Patient expenditure on ‘Class C’ medicines (drugs available through prescription, but not reimbursed by the SSN), and over-the-counter (OTC) treatments, increased by 2.1% y/y and 4.7% y/y respectively. Meanwhile, Italy recorded a 1.4% increase in patient co-payments during the year. Total co-payment expenditure exceeded EUR1.5 billion (equivalent to 14% of the SSN's pharmaceutical expenditure).
Expenditure (EUR bil.) | Percentage of total expenditure | Percentage difference (y/y) | |
|---|---|---|---|
Gross SSN outpatient expenditure * | 10.863 | 37.6 | -1.1 |
Class A medicines dispensed by direct distribution (reimbursed) | 4.921 | 17 | 51.4 |
Out of pocket Class A medicines | 1.487 | 5.1 | 3.1 |
Class C medicines under prescription | 2.997 | 10.4 | 2.1 |
OTC (public and private) | 2.375 | 8.2 | 4.7 |
Health public facilities (nursing homes, penitentiary etc.) | 6.282 | 21.7 | 9.4 |
Total | 28.926 | 100 | 8.6 |
Notes: * excludes expenditure for Class A medicines dispensed by direct distribution | |||
Source: OsMed (February 2017) – available here | |||
Anti-infectives for systemic use rank first in value terms overall
OsMed concludes that the anti-infectives for systemic use therapeutic area accounted for the largest share of expenditure, amounting to EUR4.4 billion, followed by oncology drugs (EUR4.2 billion), and the cardiovascular therapeutic area (EUR4.0 billion). IHS Markit Life Sciences previously reported that Sovaldi (sofosbuvir; Gilead Sciences, US) was the best-selling hospital medicine in Italy in 2015 at EUR681 million.
Class A medicines reimbursed by the SSN | Class A medicines purchased privately | Class C prescription medicines | OTC drugs | Medicines purchased by public health facilities | Total | |
|---|---|---|---|---|---|---|
A- Alimentary tract and metabolism | 2.004 (52.0%) | 0.287 (7.4%) | 0.245 (6.4%) | 0.657 (17.0%) | 0.664 (17.2%) | 3.856 |
B- Blood and blood forming organs | 0.527 (24.9%) | 0.105 (4.9%) | 0.092 (4.3%) | 0.005 (0.2%) | 1.393 (65.6) | 2.122 |
C- Cardiovascular system | 3.384 (83.0%) | 0.264 (6.5%) | 0.046 (1.1%) | 0.148 (3.6%) | 0.237 (5.8%) | 4.079 |
D- Dermatological | 0.057 (8.4%) | 0.027 (4.0%) | 0.267 (39.0%) | 0.312 (45.6%) | 0.021 (3.1%) | 0.684 |
G- Genito urinary system, sex hormones | 0.427 (32.6%) | 0.039 (3.0%) | 0.641 (48.9%) | 0.082 (6.3%) | 0.121 (9.2%) | 1.311 |
H- Systemic hormonal prep., excl. sex hormones and insulins | 0.177 (31.1%) | 0.057 (10.0%) | 0.031 (5.4%) | N/A | 0.304 (53.5%) | 0.569 |
J – Anti-infective for systemic use | 0.862 (19.6%) | 0.167 (3.8%) | 0.082 (1.9%) | N/A | 3.292 (74.8%) | 4.402 |
L- Antineoplastic and immunomodulating agents | 0.253 (6.0%) | 0.027 (0.6%) | 0.011 (0.3%) | N/A | 3.923 (93.1%) | 4.213 |
M- Musculo-skeletal system | 0.423 (33.6%) | 0.170 (13.5%) | 0.188 (15.0%) | 0.413 (32.9%) | 0.063 (5.0%) | 1.257 |
N- Nervous system | 1.375 (41.5%) | 0.173 (5.2%) | 0.987 (29.8%) | 0.269 (8.1%) | 0.508 (15.3%) | 3.313 |
P- Anti-parasitic products, insecticides and repellents | 0.012 (57.4%) | 0.004 (16.8%) | 0.002 (10.2%) | 0.002 (8.4%) | 0.002 (7.1%) | 0.022 |
S- Sensory organs | 0.228 (34.8%) | 0.020 (3.1%) | 0.196 (29.9%) | 0.087 (13.3%) | 0.124 (18.9%) | 0.656 |
V-Various | 0.065 (11.2%) | 0.005 (0.9%) | 0.036 (6.3%) | 0 (0%) | 0.473 (81.6%) | 0.580 |
Total | 10.840 (37.5%) | 1.487 (5.1%) | 2.997 (10.4%) | 2.375 (8.2%) | 11.203 (38.8%) | 28.902 |
Source: OsMed (February 2017) | ||||||
The data show that anti-infectives for systemic use rank first in terms of the incidence of spending, at EUR72.4 per capita. Furthermore, these medicines rank in ninth place in volume terms, at 37.8 daily defined doses (DDD) per 1,000 inhabitants. Cardiovascular drugs continue to account for the largest proportion in volume terms, at 534.3 DDD per 1,000 inhabitants and EUR67.1 per capita.
Class A medicines reimbursed by SSN | Class A medicines purchased privately | Class C prescription medicines | OTC drugs | Medicines purchased by public health facilities | Total | |
|---|---|---|---|---|---|---|
A- Alimentary tract and metabolism | 232.3 (66.0%) | 35.4 (10.1%) | 8.9 (2.5%) | 41.5 (11.8%) | 33.8 (9.6%) | 351.9 |
B- Blood and blood forming organs | 144.0 (53.5%) | 49.4 (18.3%) | 36.1 (13.4%) | 0.2 (0.1%) | 39.4 (14.6%) | 269.2 |
C- Cardiovascular system | 465.6 987.1%) | 41.5 (7.8%) | 1.5 (0.3%) | 9.0 (1.7%) | 16.7 (3.1%) | 534.3 |
D- Dermatological | 2.3 (4.7%) | 2.6 (5.3%) | 17.1 (35.0%) | 20.0 (41.1%) | 6.7 (13.8%) | 48.7 |
G- Genito urinary system, sex hormones | 42.6 (51.8%) | 5.7 (7.0%) | 29.3 (35.5%) | 2.8 (3.5%) | 1.9 (2.3%) | 82.4 |
H- Systemic hormonal prep., excl. sex hormones and insulins | 34.0 (64.5%) | 12.1 (22.9%) | 0.9 (1.7%) | N/A | 5.7 (10.9%) | 52.7 |
J – Anti-infective for systemic use | 22.1 (58.4%) | 6.0 (15.9%) | 2.4 (6.4%) | N/A | 7.3 (19.4%) | 37.8 |
L- Antineoplastic and | 4.8 (35.2%) | 0.4 (3.2%) | 0.1 (0.5%) | N/A | 8.4 (61.1%) | 13.8 |
immunomodulating agents | ||||||
M- Musculo-skeletal system | 39.6 (45.6%) | 21.6 (24.9%) | 4.3 (4.9%) | 17.8 (20.5%) | 3.6 (4.1%) | 86.7 |
N- Nervous system | 61.6 (37.1%) | 8.9 (5.4%) | 64.8 (39.0%) | 6.5 (3.9%) | 24.1 (14.5%) | 165.9 |
P- Anti-parasitic products, insecticides and repellents | 0.8 (75.8%) | 0.2 (16.0%) | N/A | N/A | N/A | 1.1 |
S- Sensory organs | 18.7 (37.2%) | 2.3 (4.6%) | 12.7 (25.3%) | 14.7 (29.2%) | 1.8 (3.6%) | 50.2 |
V-Various | 0.1 (3.3%) | 0.2 (4.6%) | 1.1 (32.8%) | N/A | 2.0 (59.1%) | 3.4 |
Total | 1,114.9 (62.2%) | 197.2 (11.0%) | 193.0 (10.8%) | 132.7 (7.4%) | 154.1 (8.6%) | 1,791.9 |
Source: OsMed (February 2017) | ||||||
Outlook and implications
The latest data published by OsMed are in line with figures published by IHS Markit Life Sciences in mid-2016. The 8.6% y/y growth recorded was chiefly driven by strong sales increases for anti-HCV drugs and innovative oncology drugs. The fact that OsMed registered a significant increase in pharmaceutical expenditure was a positive development for companies operating in Italy. However, the attempted renegotiation of price agreements for HCV medicines may moderate future increases somewhat (see Italy: 18 November 2016: Italian health minister hints at agreement to reduce HCV drug prices). Meanwhile, inpatient pharmaceutical expenditure is forecast to exceed budget targets for the 2016 financial year by about EUR2.5 billion (see Italy: 21 December 2016: National and regional pharmaceutical expenditure in Italy forecast to exceed budget plans by EUR2.5 bil. in 2016). Provisional data available for 2016 show that the overall pressure on regional administrations and hospitals to contain future spending growth will continue. The current growth trends may increase political pressure to deploy a strong focus on cost-containment and to rein in spending on new high-cost medicines. This would be a less positive development for innovative drug companies. OsMed is expected to publish provisional figures for 2016 by June 2017.