The development of innovative pharmaceutical products is crucial to ensuring the well-being of the entire population of a country. The adoption of the new therapeutic proposals by the Italian institutions is contributing greatly to improving the quality of life of patients and those close to them, as already highlighted by I-Com during the public conference entitled "The big bet of pharmaceutical innovation. New therapies, access and economic and industrial sustainability" held in Rome in September 2015. The arrival of these drugs is an important weapon that, made available to our doctors, can make a real difference in the fight against diseases previously considered incurable, such as cancer hepatitis C, as reported in the new I-Com report"Reform of pharmaceutical governance: from a siloed vision to a holistic health spending", presented on 6 July public meeting entitled “FROM SILOS TO THE CONTROL ROOM. For new pharmaceutical governance integrated into the health system”.
According to reports from the 8th Report on the Welfare Condition of Cancer Patients (2016), created by FAVO, and discussed in the new I-Com reports, "Today, 132 cancer drugs are available and 63 have been placed on the market in the last 15 years alone; of these, 14 are categorized as classic cytotoxics, 20 belong to the kinase inhibitors family and 12 are monoclonal antibodies." 27% of Italians with cancer can be defined as "already cured" while 60% of patients diagnosed with cancer have been diagnosed for over 5 years. In particular, we remember that "5-year survival improved by 18% between 2005 and 2009, from 39% in 1990-1992 to 57% in 2005-2007, with particularly positive situations for breast, prostate and colorectal cancer" (8th FAVO Report).
AIFA plays a key role in regulating the entry into the market of innovative medicines in our country, whose work also includes the definition of the degree of therapeutic innovation of each medicine, such as "important", "moderate" or "modest", combining the "gravity of the disease to be treated", with the "availability of standard treatments" and with the "entity of the therapeutic effect". The combination of scores, defined as , to, B or or, obtained from the drug in each of these sectors, allows to assess the degree of innovation, as shown in the algorithm in the figure. This algorithm also shows the possibility of attributing the so-called 'potential therapeutic innovation', including a pharmacological innovation (e.g. new mechanism of action) or technological innovation (e.g. a new active ingredient release system or a new production method). In fact, while a new drug is considered innovative when it offers the patient additional therapeutic benefits compared to treatments already on the market, it is not said that the presence of a pharmacological or technological innovation is able to give rise to additional therapeutic benefits compared to pre-existing treatments: therapeutic innovation is therefore defined as potential while waiting for the arrival of such evidence.
The effectiveness of these medicines, as we have seen, is undoubted, having reduced the mortality associated with diseases considered to be previously fatal, not only in the case of cancer, but also in the case of hepatitis C. The sofosbuvir-based drug Sovaldi is now allowing many doctors to treat the drug in the best possible way.hepatitis C adults, representing an important innovation in this area. The use of this therapy, which involves "administering a 400 mg tablet orally once a day, to be taken with food", as reported in the RCP of the drug shown in database AIFA, is at odds with the high cost of the same, as a 28-unit package has a price tag to the public of a whopping 24,756.00 euros, according to the report.class A medicines list AIFA. At present, innovative drugs are therefore medicinal, which, while mortality from diseases previously considered lethal decreases, on the other hand, because of their high costs, contribute to a situation in which the increase in survival obtained through them adds up to an increase in the average age and the costs associated with them: an elderly population, polymorbida and characterized by the presence of chronic diseases , in fact, produces an increase in costs, which is putting a strain on the sustainability of the entire system. The misguided view of pharmaceutical innovation, whose role is of fundamental importance to the well-being of all citizens, often seen as a mere entry of cost rather than development, risks breaking down the three pillars of our NHS, such as the principles of universality, fairness and equality, which have always characterized it. Rethinking a change in governance now seems necessary, but starting to think about new models, different from those used up to now, with which to define the innovation and value of today's drugs, could also be important.