Since the Spanish Association of Biosimilar Medicines (biosim) was born in November 2015, has made a significant effort to make the different agents of the health sector aware of the contribution of biosimilar medicines to the therapeutic arsenal, emphasizing transfer the guarantees of effectiveness and safety granted by drug regulatory agencies and its contribution to the efficiency in the use of health resources and, therefore, to the sustainability of the National Health System (Social Media).
Regina Muzquiz, CEO of BioSim, highlights that the activity carried out in 2019 to train clinicians, through agreements and conventions, was quite intense. 'The main obstacle that we have encountered to advance in the proposals that we consider to be key to improving the penetration of biosimilars in the SNS has been fundamentally in what required a consolidated legislative power or a Ministry of Health also with consolidation and capacity to take initiatives in the medium and long term', he admits. He recalls that last year both general and regional elections were held. Therefore, there wassome instability' For dialogue with the Administrations, both central and regional. That has slowed them down to some extent some of the projects they had. In the rest, they arereasonably satisfied' of the things they have done.
Despite all this, from BioSim they believe that one of the achievements was having an important dialogue with the Ministry of Health, and with the Autonomous Communities. Although it was not a completely direct cause, they consider that this has contributed to the fact that the Ministry prepares a Plan for Generics and Biosimilars. 'We think that, in a country as decentralized as Spain, a Strategic Plan is necessary. It has to be coordinated by the central government, in this case by the Ministry of Health, and establish some minimums so that all the CCAAs go in the same direction and join forces', it states. Of course, without diminishing the health management capacities of each autonomous community.
Regarding the draft of the Plan for the promotion of generic and biosimilar medicines that the Ministry published in October, Múzquiz points out that Health 'has great merit in having managed to get the Permanent Pharmacy Commission of the Interterritorial Council to reach an agreement with the Autonomous Communities'. In his opinion, this fact evidences 'the leadership of the General Directorate of Basic Portfolio of Services of the National Health and Pharmacy System in the SNS'.
For BioSim, several of the proposals are very suitable. For example, training and information for healthcare professionals and patients. Also, it seems very good fast-track or streamlining the entry of biosimilars, having an agile system for inclusion in the nomenclature and price concession.
They do not agree with other proposals. Some even call them 'unassumable'. Múzquiz cites at this point the reference price system for the name of TC4. In other words, groups can be made not by active principle but by therapeutic groups. 'Some measures seem to us to be short-sighted, with immediate savings', the Mint. He is in favor of the comments of the Advisory Committee for the financing of the SNS Pharmaceutical Benefit, chaired by Felix Wolf. As explained by the general director of BioSim, the Advisory Committee urges not to refer in the title of the Plan to market-regulating medicines, because 'biosimilars are more than market regulating medicines'. It warns, in the same way, that the similar ones and the generic ones are not the same, so they should be separated into two plans or, at least, that they be included in a Plan 'with two well-differentiated sections'. Otherwise, 'some issues could lead to misunderstanding'.
Two very important points
He mentions two points to which the draft Plan does not refer and which are very important for BioSim. On the one hand, 'encouraging prescribing doctors, centers or services to which they belong for a more rational use of biological and biosimilar medicines'. He alleges that it is very necessary because the doctor is being asked to make efforts to rationalize the benefit. It indicates that this could be articulated through the program contracts signed by the heads of Service or hospital managers and, to avoid suspicion, it could be done not as an incentive to the doctor but as an incentive to the care service. It nuances that they could be used to improve service conditions, in human and material resources, the resources that have been released by the use of biosimilars.
'This is an issue that should be addressed. Not for the Ministry to say how it should be done, since each autonomous community must have its own incentive system, but to make a call', he argues.
On the other hand, it alludes to the point of acquisition. 'For us, it is key that the framework agreement is preferably used as a form of acquisition', he declares. Said framework agreement must have a series of conditions; such as the one that all the companies that present themselves with a lower price than the tender are approved or included in it, that the price is not the only criterion and that there are no second rounds.
Sentence that 'the Plan should take economic criteria into account, but not be economistic'. Defines that economist is that which puts the economy above any other consideration.
The news that Faustino Blanco will continue as Secretary General of Health and will be the right hand of the minister Salvador Illa, and Patricia Lacruz will remain in charge of the General Directorate of Pharmacy, which suggests that there will be a certain policy of continuity in the Ministry. What 'Illa is a very political minister', Múzquiz understands that he will leave a lot 'free letter' to the general secretary and the director in the most technical questions.
Lastly, he criticizes that 'the Plan practically does not speak of interchangeability'. 'It only says that it will have to be studied. I believe that the position of the Advisory Committee for the financing of the SNS Pharmaceutical Benefit is really very good. I have talked a lot about hospitals, but because 85% of our molecules are in hospitals. In the pharmacy it is clear that it is a substitution, because the connection link between the doctor and the pharmacy is usually the patient with his prescription. But in hospitals the system is different. It is not the same to talk about pure substitution in the Pharmacy Office than about the interchangeability that the doctor makes in the hospital with the consensus of the Management, the Pharmacy Service and the different specialties.', he muses. They are different due to the very nature of the care setting in which they occur.