DAILYPHARMA | 02.17.2022 – 11:46
The appearance of innovative therapies in the therapeutic arsenal of onco-haematology has been a real challenge for the National Health System, both because of the opportunities it represents and because of the organizational changes it must face, especially in pathologies where precision medicine could be a key factor.
In order to respond to the needs of maximizing results and equitably organizing the use of precision medicine, Catalonia has launched its Precision Medicine Program in oncology, being a pioneer in all of Spain. With the aim of analyzing the keys to this program, Diariofarma has organized a Meeting of Experts in Barcelona under the name ‘Precision medicine and evaluation of results: the case of Catalonia’, whose main objective is to offer some light on the value of innovation in onco-hematology, what can be expected from precision medicine and what processes are required. This meeting, held with the support of Astellas, is the first of a cycle that will be held in different autonomous communities to delve into the management of precision medicine in each of them.
All the health professionals involved agree that the right thing to do would be to guide these changes based on a national coordination project, an exchange of information and adequate collaboration between the different stakeholders, with the main objective of identifying patients in the most appropriate way. as accurate as possible. No one is unaware that the key element for the success of this new healthcare paradigm is an agile and personalized approach, and multidisciplinary coordination.
The Ministry of Health of the Generalitat of Catalonia presented the precision medicine project at the end of 2021. This initiative, oriented on this occasion towards onco-hematology, means having a new tool in the portfolio of Health services for the treatment personalized treatment of cancer, an initiative that has been developed based on three basic objectives: coordinated organization of this strategy, that its development is carried out based on the criteria of experts, and that its results facilitate laying the foundations for future use to obtain new biomarkers or new clinical outcomes. Together with the development of the program, a scientific committee was appointed to define the relevant panels in four oncological areas (pediatrics, solid, hematological and hereditary tumors), and the reference centers were established where these tests could be carried out, and which hospitals depended on each one from them.
Assessment of the initiative
The Meeting, moderated by José María López Alemany, director of Diariofarma, began with an assessment of the project. Caridad Pontes, manager of CatSalut Medication, assured that the initiative on precision oncology supposes “putting order” in a field that has been developing for a long time in Catalonia, but based on criteria of equity and accessibility to precision diagnoses that are generated within it, at the same time as guaranteeing the homogenization of criteria and carrying out tests, also offering “the maximum guarantee in the data collection process” which, in turn, facilitates its use and the achievement of concrete fruits in life real. In this sense, and in reference to the aspect that most concerns him, which is that of medication, Pontes trusted that this project will translate into a rational use of medications and proper financing by the Health Administration.
Conxi Lázaro, head of ICO’s Molecular Diagnostic Laboratory, expressed herself in similar terms, insisting on the fact that the implementation of the program facilitates the “homogenization of the processes that are currently being developed in precision oncology”, pointing out that A first fruit of this initiative has been to regularize hereditary cancer. Likewise, Lázaro agrees with Pontes that one of the capabilities of this program has been to guarantee territorial equity.
Maria Queralt Gorgas, clinical director of the Vall d’Hebron Hospital Pharmacy Service, endorsed this wish and described the arrival of precision medicine as a “great opportunity”, especially in the field of medicine, for what it can mean to improve efficacy and safety. In similar terms, Josep Maria Ribera, head of the ICO Badalona Hematology Service, expressed himself, who described precision oncology as a true reality, predicting that it will have “an enormous diagnostic, therapeutic, prognostic and toxicity prediction impact”. In this sense, he assured that its implementation will also mean the opportunity to determine a series of genetic markers agreed by experts, which will emerge from common platforms and from all over the territory, also congratulating himself for being a public initiative.
For her part, Beatriz Bellosillo, Head of Section of the Hospital del Mar Pathology Service, insisted on the idea that this is a historic moment. “To date, markers were made precariously, on many occasions with the sole help of the pharmaceutical industry, or with research resources from the hospital itself, irregularly and without consensus between the different centers in the same territory,” he said, but With the launch of this initiative, there will be “a lot of quality and agreed information, a flow of information that will increase in the future, and that will make it possible to anticipate and develop future treatments.”
The vision of the industry was provided by Asunción Somoza, Director of Government Affairs and Market Access Director of Astellas, who wanted to point out that the initiative promoted in Catalonia responds positively to the “already urgent need to develop molecules arising from biomarkers”, and saw the need for it to be done in a coordinated manner, both in terms of the drug’s own regulatory process, and the incorporation of the biomarker into the portfolio of services.
The director of the Oncology Plan/Precision Oncology Program of Catalonia, Josep Maria Borràs, wanted to remind us that this project “is not the flower of a day, but has matured over the years”, assuming an effort both in the creation of reference centers, such as the search for financing. Similarly, he warned that the project is still taking its first steps, and that a good proof of this is that work is still being done on the creation of a common database.
Carme Balaña, president of the Catalan-Balearic Oncology Society, also expressed her satisfaction at the arrival of this project, but did not want to disguise her feeling that, despite everything, this is a project that, in her opinion, “comes late”. According to her, it possibly should have been started years before, when it was found that the centers were precariously working on the development of biomarkers without any coordination and with precarious results. In addition, Ella Balaña raised her concern regarding fairness and process.
challenges and difficulties
All these opinions regarding the appearance of the precision oncology project seem to converge on a series of common wishes, focused on the need to promote teamwork, make collegial decisions and that the effort made reaches all corners of the territory. In Ribera’s opinion, meeting these objectives will require an added effort to manage the enormous amount of information that will be generated, which will mean creating information channels for both the doctor and the patient.
The importance of the project is summarized by Pontes in an essential phrase: “precision medicine supposes an amendment to the entirety of the current health paradigm”, an affirmation that all the attendees subscribe to, due to what it supposes for the present and for the future transformation of medicine. In addition, the attendees agreed that not only will it be necessary to work on fulfilling the project’s own objectives, but also that it will have to be done without previous examples of how to do it. “We will go from directing our efforts to the large population”, specifies Pontes, “to offering personalized results, and we must do it without having previously adapted to it, without having regulatory measures, without, in short, having time to adopt the concept from the clinic”. For this reason, he insists that the change is of such magnitude that it will even involve a change in the way of approaching clinical studies and how to guide the research of new drugs.
The moderator took advantage of this reference to research to ask about the possibility of this initiative interweaving with other initiatives, such as those carried out by the Carlos III Institute with the IMPACT project. Borràs pointed out that they are different approaches, emphasizing that, while one is purely healthcare, the other focuses on research. In this sense, he stressed that one of the main objectives of precision medicine must be to find the formulas for its healthcare application.
Another aspect discussed, due to its complexity, referred to the need to strengthen ties between academia and the pharmaceutical industry, making clear reference to financing problems. Both Somoza, representing the industry, and Ribera agreed to recall that it will be necessary to review where the resources are allocated, especially when a change in models is proposed in which, possibly, very expensive drugs in their development process are destined for a very small group of patients. In this regard, references were made to the need to learn from the flexibility of the industry and the need to bring positions closer between it and a public initiative like this. The participants agreed that all the information obtained with the Precision Medicine Program would be key to help the development of new drugs. For this reason, Pontes raised the need for the public sector to benefit and obtain access to medicines under more advantageous conditions, having contributed decisively to their development.
Attendees also discussed what the role of precision medicine should be outside of oncology. Borràs recalled that “cancer is a good laboratory for all kinds of initiatives”, but defends that this is a project that should be extended to all fields of medicine. This was understood by the attendees who recalled that the definitive implementation of precision medicine will suppose a management problem that will have to be solved, and that it will require additional organization. Pontes pointed out that it will be necessary to be selective and harvest results to verify that they respond to expectations. Likewise, it was indicated that, once correctly developed, the results of precision medicine should become part of the patient’s clinical history.
One of the most interesting aspects of precision medicine is determining how data is collected and what use can be made of it.
Borrás recalls that the initial idea of the project is that the different centers collect all the information collected and release it to the central repositories, recalling that, in this field, they are still immersed in a transition phase. Pontes, for his part, warns that these data must be subjected to continuous evaluation, which determines the evolution of the objectives, and Queralt adds, in this sense, that to guarantee this evaluation it would be necessary to develop a comparison of results.
All those present agree that, once the data collection and evaluation process has been completed, molecular information must be added, as a new criterion, to the clinical studies that have already been carried out.
In short, and by way of conclusion, the attendees affirm that the project developed in Catalonia on precision medicine raises well-founded hopes, given that it is a reality, but without forgetting that there is much work to be done, that it is true that there will be time to readjust mechanisms, but that its adoption requires the implementation of a new model capable of managing all the information it generates, and that this translates into more useful and safer drugs. They also agree that this is the beginning of a change at all levels, both economic and healthcare, and that its implementation is leading to a disruptive transformation of medicine.
Text and photos: Xavier Grace
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