The European Conference on Agnostic Tumor Oncology, organized by the Foundation for Excellence and Quality in Oncology (ECO), was marked by advances in the investigation of the cancer in recent years and the appearance of drugs capable of acting on therapeutic targets. What is known as personalized or precision medicine achieves the use of the most effective treatment based on the individual characteristics of each patient.
During the conference, they highlighted the advances in treatments for agnostic tumors, drugs developed to act based on a specific molecular alteration regardless of whether the primary tumor appeared in one organ or another of the body.
The director of Farmaindustria’s Access Department, Isabel Pineros, highlights that these therapies are posing a great challenge. “There are currently four treatments for agnostic tumors approved in Europe and presented for sale in Spain between 2019 and 2021 that have not yet managed to obtain financing in our country and be available to patients,” she says.RELATED
There are four treatments for agnostic tumors approved in Europe and presented for commercialization in Spain between 2019 and 2021 that have not yet managed to obtain financing
The first challenge focuses on the evaluation of the clinical trials themselves, which, as Pineros explains, have a small population of patients in which the inclusion criterion is the presence of the specific biomarker and they are usually patients who have exhausted other alternatives. Regarding the authorization, the regulatory agency did understand that it is about medicines different and that the evidence they provide is different. “For this reason, the European Medicines Agency (EMA) has granted them a conditional authorization, which meets the safety, quality and efficacy premises and therefore concludes with a favorable benefit-risk balance”.
The point where Isabel Pineros stops is in the financing phase, in which she stresses that there is a difference between countries, since some place more emphasis on clinical results and the evaluation of comparative clinical benefits, while others, such as Spain, focus more on cost-effectiveness. As a solution, the Farmaindustra expert considers it necessary to establish a specific financing model and a price for innovations that combines an evaluation methodology with clear criteria, with the management of therapeutic and economic uncertainty, and the contribution to the sustainability of the health system. with the different agreements between the Administration and the companies.
“It would also be necessary to establish an approval model for these new indications. Each new indication must go through the financing process again, including the preparation of a new Therapeutic Positioning Report (IPT) for each of the indications, and there is no clear criteria for companies to have the indications included in the pharmaceutical service”, he concludes.
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