In relation to this segment of drugs, it is common for different organizations, institutions and the media to ask us about the future of biosimilar drugs in the short and medium term, about their penetration dynamics in the Spanish market and about the rate at which will reach the European market shares.
In an environment other than healthcare, the answer to these questions would be very simple. Biosimilars will very soon reach high levels of use in the healthcare system, since they are drugs that, with the same guarantees of safety, quality and efficacy as the original reference drugs, provide efficiency to the system, due to the competitiveness they generate and the consequent lower prices that originate. They are therefore an appreciable contribution to the sustainability of the National Health System (SNS).
However, the answer is not so simple due to the complexity of the Spanish health sector, subject to certain tensions between the different agents that intervene in its future, which should not be forgotten if we want to accurately approach future predictions.
As a first approximation we can say that, unlike other areas of consumption, the health sector shows peculiar aspects. Indeed, the one who buys (the health service) does not consume; the one who orders the purchase (the doctor) neither pays nor consumes, and the one who consumes (the patient) neither orders the purchase nor pays. This, which seems like a tongue twister, is a reality that is characteristic of health care and that takes on special relevance in pharmaceutical services. So we are faced with an equation of numerous unknowns whose resolution will determine the entry of drugs into the system. Its goodness in terms of cost/effectiveness or cost/benefit will not be enough for optimal market penetration.
And the proof that this is so is that, if we analyze the penetration of the sixteen molecules that currently have biosimilars, we can see how in 2018 biosimilars accounted for 38,4 percent of the total packaging of the molecule (original plus biosimilar ). But while some of these biosimilar molecules reached penetration rates of 90 percent, in the case of filgrastim, others remained at a rate of 10 percent, in the case of insulin glargine. But not only this is limited to variability. Penetration is also uneven between CCAAs. Thus, Castilla-La Mancha led the market share achieved in 2018, with 53 percent of biosimilar packaging compared to the total molecule, while the Basque Country was the CCAA with the lowest penetration, 13,4 percent. And the heterogeneity in the consumption pattern does not even stop there, because if we were to analyze a community entirely, we would see that the different hospitals, even grouped by their size and degree of complexity, present different penetration rates.
All this corroborates the need to advance in a multifactorial approach as a way of understanding the behavior of this market and being able to respond with certain criteria and knowledge of the facts to questions about the future. Let's see what are those factors that are influencing the resolution of our equation and how each of the agents involved in the process influences the final result.
First, we have the originators of biologic drugs, the pharmaceutical companies that research, develop, produce, and/or market original biologic or biotechnological drugs. On the other, there are companies dedicated to biosimilar drugs. Some companies have both originator biologics and biosimilars in their portfolio. The former exert significant active resistance to the therapeutic introduction of drugs from the latter, using different strategies, many of them legitimate and some others that are located on the border of competition laws. And this despite the fact that they have already had exclusivity in the market for the time that is considered sufficient to guarantee the return on the investment made in the development of the original drug. But it is that some of these original drugs constitute true blockbusters and the economic impact they suffer with the arrival of the biosimilar is sometimes of enormous magnitude. For their part, biosimilar companies do not always have a large budget to invest economic and human resources in the marketing and sales operations of their molecules or not enough to counteract that carried out by their adversaries. It must be understood that off-patent medicines cannot have budgets for these activities at the same level as those that have exclusivity, because, obviously, they do not have the same profit margin.
In their commercial activities, original and biosimilar companies compete for the acceptance of doctors to prescribe their products, pharmacists to dispense them, managers to buy them and patients to comply with treatments.
Secondly, there are the state health authorities, responsible for setting prices and defining supply, and the regional authorities, competent to develop pharmaceutical policies that encourage, to a greater or lesser extent, the use of these drugs, modulating demand. But let us not forget that the authorities, of any sign, seek political gains beyond the gains from efficiency in the use of the resources that citizens make available to them in a public system. And, of course, these political gains are highly conditioned by the position and demands of citizens in general and patients in particular.
Health managers, both in Primary Care and Specialized Care, are well aware that any objective of change or modification in care protocols, including the change from original medicines to biosimilars, must have the acceptance of the doctor. Let's not forget that all biological medicines, whether original or biosimilar, must be prescribed by brand and cannot be automatically substituted by the pharmacist as occurs with generic medicines. It is, therefore, about achieving consensus among managers, doctors and pharmacists, because measures that do not have the prescribing physician are doomed to failure no matter how reasonable they may be or seem, as history has repeatedly demonstrated.
The role of the hospital pharmacist is also key to establishing consensus in the hospital setting and managing purchases appropriately, and that of the community pharmacist is also key in advising patients and will be even more so in the future, when more biosimilar medicines They are dispensed by pharmacies.
For its part, the participation of patients in decisions that concern them has undergone an important transformation in recent years. Spain has gone, in a pendulum fashion, from practically ignoring its intervention in processes in which its voice should have been taken into consideration to leading an empowerment movement, induced to a large extent by agents interested in this change, which is sometimes excessive due to the level of decision that is intended to be attributed to them. The Hippocratic principle of autonomy and the Patient Autonomy Law, on the one hand, and the rights of patients, included in the General Health Law, on the other, are mandates related to the freedom that the patient must have to choose between the different therapeutic alternatives that the doctor offers, surgical, medical, etc., but which, naturally, does not affect the decisions about commercial brands to use. We cannot forget that the SNS is a public system and, therefore, based on solidarity, which could not sustain these types of demands.
And finally, we analyze the role of the doctor in this equation. The doctor is subject to the demands of all the above agents. Of the laboratories, which argue scientific, clinical and collaboration reasons with the doctor in their teaching and research activities to promote his products against those of his adversaries. Of the health authorities and managers of the public system who set objectives for a more rational use of health resources without, in many cases, providing them with healthcare support to achieve them and, in most cases, without recognition for meeting the objectives translates into a reward in their own right or from the center/service to which they belong. For their part, patients are increasingly demanding information and aspire to a greater role in the decisions that affect them, sometimes lacking a scientific basis, inspired by information or misinformation from sources that do not comply with the minimum guarantees required of patients. any therapy, whether pharmacological or not, and this is an important aspect that the doctor must manage in his or her office, not always with the necessary time to address it adequately.
It is a challenge and a responsibility for the doctor to harmonize all these demands, so that he achieves a balance between his freedom of prescription, the principle of patient autonomy and the principle of distributive justice that must preside over his actions in order to contribute to sustainability. of the health system.
In this context, in which the role of the physician as the main key to the orderly incorporation of biosimilar medicines into clinical practice in the NHS can be clearly identified, the actions of BioSim, the Spanish association that represents the legitimate interests, were designed. of pharmaceutical companies that research, develop, produce or market biosimilar medicines. For BioSim, since its creation, activities and actions aimed at doctors have been a priority. These actions include the preparation and publication of the Guide to Biosimilar Medicines for Physicians and the courses organized with the Collegiate Medical Organization, as well as with SEFAC and SEMERGEN jointly. Collaboration with the FACME and individually with different medical scientific societies that integrate it, such as SEOM, is equally key. And the training actions in hospitals promoted by BioSim. In 2018, 20 training sessions were given with an approach that analyzes, on the one hand, the scientific bases for the approval of biosimilar medicines by the regulatory authorities and, on the other, the clinical aspects of the management of these medicines, in which specialist physicians of recognized prestige and proven experience present their vision on the use of these drugs.
And for this reason, one of BioSim's main lines of action for 2019 has focused on dialogue with the health and finance authorities of the Autonomous Communities, to propose measures that allow an impact on the doctor, individually, or at the service or center care, its effort to rationalize the use of medicines that includes the use of biosimilars.
The Ministry of Health, Consumption and Social Welfare has recently published a proposal for the Action Plan to promote the use of market-regulating medicines in the SNS: generic and biosimilar medicines, the result of consensus with the Autonomous Communities in the Permanent Pharmacy Commission of the Interterritorial Council of the National Health System. Biosim has positively valued the initiative of this Ministry to finally address the promotion of biosimilar medicines in the SNS, especially when it suggests measures aimed at expediting their inclusion in the pharmaceutical provision and promoting their use. All in all, BioSim considers that the Plan's approach is excessively focused on short-term savings and this could put the biosimilars market at risk, whose contribution to improving efficiency and patient access to biological therapies is indisputable.
The Plan addresses in some points the actions of physicians in terms of their involvement in the management of biosimilars, and in this sense it is worth highlighting the training of doctors.
In recent years, the appearance of biosimilars of a large number of monoclonal antibodies, insulins, and low molecular weight heparins, among others, has transformed the therapeutic landscape. What used to be a topic that only concerned very specific specialties (Nephrology, Oncology or Pediatric Endocrinology) today concerns everyone. Physicians must become familiar with the use of biosimilars, dispelling myths, understanding the scientific and technical bases of their development and their approval by regulatory agencies, as well as essential concepts for their prescription and monitoring.
In short, the progress of biosimilars in Spain will depend on the actions of all the agents involved and, in this sense, the doctor is undoubtedly the agent that will make the greatest contribution to achieving this objective.