The biggest commercial success in the history of the pharmaceutical industry is called Humira. This monoclonal antibody, indicated for multiple autoimmune and inflammatory processes such as rheumatoid arthritis, has provided the American company Abbvie with revenues of more than 200 billion euros since 2002. The high price of innovative medicines – more of a thousand euros per month per patient in Spain, in this case – forces health systems to be cautious when it comes to universalizing its use.
“Clinical guidelines order treatment options according to their cost-benefit balance, because it is the way to make the best use of available resources. New biological drugs such as adalimumab (the active ingredient in Humira) have such high prices that they are usually placed on the third line. This means that the patient must first take two treatments and, only if these fail, will they receive the pointer.†explains Encarna Cruz, general director of the Spanish Association of Biosimilar Medicines (BioSim). This situation changes substantially if, when patents expire, biosimilar drugs enter the scene. “By having a much lower price (up to 80%), they not only save resources for the system, but they can also help more patients receive these therapies,†he adds.
BioSim presented this Tuesday in Madrid the first complete report on the penetration of biosimilars in public healthcare. Graduated Study on the market for biosimilar medicines in the National Health System in Spain, The work has been coordinated by Jaime Espín, professor at the Andalusian School of Public Health and former advisor to the World Bank and the European Commission. The main conclusion is that there is “great heterogeneity in all aspects of the biosimilar market,” according to the author.
If you look at hospitals, for example, in medicines in which there is a biosimilar version, the market share of these drugs rises to 73% on average, while this percentage drops to 30% among those sold in pharmacy. The differences are also enormous between autonomous communities. The Basque Country has the lowest penetration of biosimilars (31%), while Castilla-La Mancha has almost double that (54%). The national average is 46%. The figures are also very different depending on the types of medications or the diseases for which they are indicated.
“Spain has a wide margin for improvement,†Espín defended in reference to the incorporation of biosimilars into the health system. According to the study, the country occupies an intermediate position in Europe, where the Nordic countries occupy the leading positions and those in the east of the continent a more lagging position. This expert has argued that the most important benefit that comes with greater penetration of biosimilars is not savings, but rather that they “improve efficiency” and cutting-edge treatments “reach more patients.” With this objective, and given the variability that exists in Spain, “policies that give a boost” to this type of drugs are necessary.
An important fact to highlight is that the differences in penetration of biosimilars (as well as generics) between communities do not mean that there are differences in patient access to treatments depending on where they live. In Spain, the reference price system means that all equivalent drugs (brand name and biosimilar) must have the same cost for the health system. Less pressure from competition from biosimilars and generics, therefore, means less pressure for prices to decrease and, therefore, improves the efficiency of the system, but it does not open the door to inequalities.
The molecules of biological drugs – hormones such as insulin, antibodies… – are usually very large, with long and complex chains of more than 20,000 atoms. Dimensions that contrast with the small and simple structures of chemically synthesized drugs (about 120 atoms maximum). This means that, unlike generic medicines, which can copy chemically synthesized drugs in detail, biosimilars have small differences with the original, without this affecting their quality, effectiveness and safety.
“Although they have differences in development and regulatory issues, biosimilars and generics agree that they promote competition in the market, achieve a price reduction in the system and improve its efficiency,†Espín highlights.
The conclusions of the study advocate the convenience of creating a Biosimilars Observatory which, like the preparation of this first edition of the work, requires greater transparency and availability of data from the National Health System. “What is not measured cannot be improved, and what is not improved is degraded,†says EspÃn.
The general director of Pharmacy of the Ministry of Health, César Hernández, expressed at the presentation of the report that the department's desire is to be “the primary source of information on biosimilar medicines” and that the data should be available to the public in the “most up-to-date possible” manner.
Hernández has also been in favor of promoting biosimilars and has pointed to the current legislation on reference prices – which equalizes that of original drugs with that of biosimilars and also generics. ©rich—as one of the barriers, since “they do not encourage competition.”
The deputy director of Biosim, Isabel del RÃo, highlighted another potential benefit of the Observatory at the event: the possibility of having information on the most relevant policies carried out in Spain by the communities to promote biosimilars.
Félix Lobo has confirmed that with 17 autonomous communities and many health centers, a certain variability is to be expected and that “it is even desirable that there be some.” In this way, according to the president of the CAPF, you can learn from best practices, as well as identify those that should be excluded. But to do so “there must be transparency since only having data and good indicators is an advance†and, on the other hand, the evaluation of technologies and services must be deepened, as well as “focus on the results in health†.
Félix Lobo, president of the Advisory Committee for Pharmaceutical Benefits (CAPF) and emeritus professor at the Carlos III University of Madrid, has stated that it is “to be expected and even desirable” that there are differences between the data of the different autonomous communities, since this allows “identifying” the best management practices and extending them to the rest.