The strengthening of the Covid Green Pass and the modification of references for adoption of restrictive measures, with the abandonment of the Rt: this is the backgound of the presentation of OsMed Report 2020 published by the Italian Medicines Agency (AIFA). The opening speech of Minister Roberto Speranza is a passionate defense of the value system of Italian health service.

Interventions in Healthcare must be up to needs and expectations

“These have been the most difficult months for our health service”, recalls the Minister, underlining the emotional burden that the emergency has entailed. “The resources invested in public health are the most important tool to increase the quality of life of citizens. Thanks to the PNRR, 20 billion euros have been made available to Healthcare: the challenge is now to use these resources well and build an offer of assistance that lives up to citizens’ expectations”.

Speranza praises the value system of the national service and its universality, the extended access to assistance independent of income and social conditions.

Still, he warns: “It is not enough to have huge resources: we have to understand how to invest them. The challenge posed by digitization sees our country fully involved. I think AIFA should participate in this challenge by making it a mission: we expect a commitment to self-reform, an ability to understand and guide new drug policies and healthcare spending planning, in order to overcome the model of closed silos and spending caps, a model that denies the priority of the right to health”.

The weight of regulatory agencies

This difficult season has highlighted like never before the real weight of the regulatory agencies. It is within this dramatic experience that they have become a public subject familiar to all citizens.

“This is the time to raise the bar, to be ambitious”, resumes Minister Speranza. “A country today is in a position to restart if it has a health system that is up to the complexity of the situation”.

To the minister follows the intervention of the General Manager of AIFA, Nicola Magrini, who introduces the presentation of the OsMed Report 2020 with some reflections on the pharmaceutical market, the most regulated in the world. In his speech he conveys the agency’s commitment to guaranteeing transparency in access to clinical data, as a tool to improve access to medicines.

OsMed Report 2020: the numbers of the pharmaceutical market

The global pharmaceutical market has a total value of $ 1,250 billion, mainly concentrated in the United States. Second is Europe, third place is China and India, to which 12% of the value refers (IQVIA data).

In this scenario, the regulatory framework stands out, with lights and shadows, both on local and global scene.

It is true that AIFA and EMA are much more centered in their institutional contexts. But there is no lack of gray aspects, of knots to be solved.

Procurement contracts

The joint procurement of vaccines is a useful mechanism, which will be proposed again, but which did not shine in terms of transparency since the contracts have been partly secreted. Its procedures will also need to be improved.

As regards the Market-entry agreements (Pay-for-Performance), these are very onerous agreements, some effective and others to rethink, on which Germany also has recently expressed many doubts.

Wide differences in European pharmaceutical expenditure

The European drug market was worth 190 billion in 2018. Numbers, those pitted by Guillaume Daudet, Policy Analyst and Health Economist of OECD (Organization for Economic Co-operation and Development), which do not include hospital drugs.

These numbers also show wide differences in spending between different countries. They are due to:

  • different types of drugs available;
  • different prices and consumption;
  • specific role of hospitals in the dispensing of drugs;
  • different market penetration of the generics.

Pharmaceuticals are following a slower growth trend than that of other items of health expenditure. This is an effect of the introduction of containment factors, such as the promotion of the use of generics and biosimilars. It should also be noted that the increase in pharmaceutical expenditure has been supported in recent years by the introduction of high-cost innovative drugs.

Generic and bioequivalent drugs

There is also a large gap in the use of bioequivalent medicines. In the United Kingdom they represent 75% of total drugs, in a ranking that sees Italy, Switzerland and Luxembourg at the bottom 3 places. These data reflect the effectiveness of the policies used in these countries to promote the use of generics.

In our country, as pointed out by Agnese Cangini, the use of generics is stable. While equivalent medicines account for 31% of the total by consumption and 25% by expenditure, biosimilars account for 47.6% of expenditure and 67% of consumption (both increasing).

Italy is very well positioned for the use of biosimilars, at the second place for expenditure in Europe after the UK and at the first place for consumption.

The loss of patent coverage by drugs such as trastuzumab, bevacizumab and rituximab, with their significant price drop, certainly contributed to the overall reduction in spending. Anna Maria Marata (Territorial Assistance Service, General Directorate for Health and Social Policies of the Emilia-Romagna Region) frames this aspect in detail, adding that generication positively impacts the regional budgets.

Drugs consumption: present and future

The consumption of drugs is the mirror of society: for example, the use of antihypertensives increased by 70% from 2010 to 2017, while in the same period the use of antidiabetic drugs doubled.

For the future, the common trend seems to be to improve the transparency of the pharmaceutical market. There are also other goals to achieve:

  • monitoring access to medicines in EU countries;
  • increased transparency in the allocation of pharmaceutical industry resources to R&D;
  • the exploitation of competition in the market for patented drugs;
  • improving the collection of data on hospital drug use.

OsMed Report 2020: composition of the expenditure

The OsMed Report 2020 shows a total expenditure of 30.5 billion euros. This is an important share of resources, even if down by 0.9% compared to the period observed previously.

The numbers are articulated, generally and in detail for the individual categories, by Francesco Trotta, AIFA Pharmaceutical Expense Monitoring Office Manager.

The total expense reimbursed by the NHS was 76.5%.

In one year, each Italian citizen has absorbed resources for € 512 (per capita expenditure), of which almost € 400 were covered by the NHS, and assumed in average 1.5 doses every day. With a confirmation of previous data: expenditure and consumption increase in the older age groups.

Public expenditure is in decline and, overall, under control. Hospital spending has doubled compared to 2011, while the expenditure borne by citizens has increased.

The differences in consumption and expenditure at interregional level express the need for planning interventions oriented towards the prevention and control of lifestyles, especially in the center-south of Italy. The territory needs more scrupulous monitoring, also in terms of promoting the appropriateness of use.

Important informations on regional differences also emerge from the speech by Simona Zito, in which the role of the assessment of variability is emphasized for the orientation of future policies.

The most used drugs

Among the drugs whose expense items are increasing most significantly there are anticoagulants (including heparins, which have had an important use for the treatment of SARS-CoV-2 infection), immunosuppressants, antidepressants and anxiolytics.

Lowers the consumption of anti-osteoporosis drugs (also thanks to the effectiveness of the regulatory measures), drugs for HCV (providing a one-shot treatment that legitimizes the stabilization of the consumption curve on a plateau) and antibiotics (down by more than 20%, also due to the containment of the contagion of other infections during lockdown).

The data show also an improvement in therapeutic adherence for some categories of drugs, such as antiplatelet and anticoagulants.

COVID-19: which drugs, which impact?

The case of azithromycin is paradigmatic, with very high consumption peaks perfectly coinciding with the waves of the pandemic. A cost of inappropriateness, judging by the results from the latest studies, which have shown that this antibiotic does not differ in effectiveness from placebo.

The consumption of oxygen, general anesthetics, hypnotics and curaries (reflecting the pressure on hospitals and intensive care), of heparins (+ 6.2%), of tocilizumab, remdesivir, dexamethasone is strongly increasing.

The PNRR and the geographical evolution of services

Alongside the non-innovative but only expansive services envisaged by the PNRR, there are two disruptive interventions. The first is the idea that the community house would pivot the management of chronic conditions. On the other hand, the second is the introduction of a Territorial Operations Center (Centrale Operativa Territoriale, COT).

In parallel to the identification of community houses and COTs as the two vectors of care, the decision was taken not to increase the number of places in the nursing homes. A decision that lends itself to some doubts about the real feasibility of the overall intervention, explains Francesco Longo (CERGAS Bocconi).

First of all, the one regarding the gap in terms of staff shortages. If the new hires do not seem to be able to meet the need, it will be necessary to proceed with a reduction of the number of visits per patient and a drastic decrease in the number of patients taken in care.

Consequently, the adoption of this new welfare model puts at the center the issue of priorities.

Big data: who does what

Thanks to the extension of digitalisation, citizens will have access to much more information. It may prove itself strategic for the purpose of improving compliance with prevention and treatment schemes.

In the new model, the personalization aspect will also affect this specific area.

If big data are collected predominantly at the local level, their analysis will require more adequate conceptual and analytical tools at the central level. Who, ultimately, will analyze them? It is an open question. Just like the questions about the role of AIFA in this change of paradigm.

Increased survival and quality of life: the social role of innovative drugs

A relatively low pharmaceutical expenditure is the result of a clear resource problem.

“But we all observed”, emphasizes Carlo Riccini, bringing the position of Farmindustria, “the contribution in terms of increased survival and quality of life that innovative drugs have been able to guarantee to the population: in 5 years about 500,000 more patients have survived thanks to them “.

A concept that doesn’t fit well with the gap in Italian per capita spending, equal to 290 euros and 25% lower than in other EU countries.