Olga Delgado (SEFH), Ramón García Sanz (SEHH) and Enriqueta Felip (SEOM).
The scientific societies of Hematology and Hemotherapy (SEHH), Medical Oncology (SEOM) and Hospital Pharmacy (SEFH) come together to claim more transparency and clinical safety in the process of approval of new drugs to treat the cancer. Through a joint document that they have sent to the General Directorate of the Common Portfolio of the Ministry of Health and the Spanish Agency for Medicines and Health Products (Aemps), they mark the 12 points to improve in the process of incorporating drugs into the health portfolio of the SNS.
These companies, as you have learned Medical WritingThey have also requested a meeting with the portfolio led by Carolina Darias with the aim of to be able to articulate a line of work with the leaders of the Ministry of Health.
Regarding the document, it is divided into four areas that comprise the twelve points: medication registration procedure, preparation of Therapeutic Positioning Reports (IPT), evaluation nodes and price fixing and financing decision.
Public traceability in approval processes
In the first point, the three scientific societies seek “guarantee transparency and traceability” of the registration processes of a new drug or indication, since beyond the date of approval of a drug by the European Medicines Agency (EMA) the dates of subsequent procedures are unknown.
“This entails uncertainties and an indefinite period of opacity in which the situation in Spain is unknown, and there are inequities in access according to the hospital and the Autonomous Community”, detail the companies.
For this reason, they ask that dates are published in which the company presents to Aemps the National Code request and in which this body sends the Notification of Communication of the National Codel For marketing in Spain, both to the pharmaceutical industry and to the General Directorate of Basic Portfolio. “It would be desirable to publish the dates of each step, in a way that allows the traceability of the entire process and thus be able to know at all times the status of a new drug approved by the EMA and not yet financed in Spain”, they say.
The IPT, in the focus of claims
Regarding the ITherapeutic Positioning Reports (IPT)which cover half of the proposals, the first claim is to know the duration of the pilot phase of the Consolidation Plan of the IPT, the variables of evaluation of the results and the subsequent plans.
The second proposal passesr “guarantee” the participation of multidisciplinary experts in the preparation of the IPT. While in third place they propose to carry out advice from scientific societies the experts during the elaboration of these IPT. So that the scientific organizations would offer a list of specialists (with the respective declarations of conflict of interest) in breast cancer, digestive tumors, lung, genito-urinary, gynecological, melanoma, sarcoma and hematological tumors, among others.
Finally, the companies claim Greater transparency in processing timesinclude the magnitude of clinical benefit of the drug according to the ESMO scale (ESMO-MCBS) and the Periodic revision of the reports. Specifically, they suggest publishing the phases each IPT is in, identifying three stages: document approved by the network coordination group, once it has been reviewed by the corresponding evaluation node; after analyzing the allegations of the interested agents, and after incorporating the IPT once the price and reimbursement have been approved.
Three proposals for evaluation nodes
Faced with the new structure of the Drug Evaluation Network (REvalMed), in which 120 management and clinical experts from the Autonomous Communities participate, the societies understand that “it is important to guarantee the multidisciplinary contribution in each evaluation”, making public list of experts.
Also for the evaluation nodes, the three medical organizations understand that it must be “guarantee” a multidisciplinary evaluation of the IPT with the participation of oncologists, hematologists and pharmacists. Furthermore, they claim that the allegations are made public that are made to the IPT and the responses to them.
Pricing and reimbursement
The fourth point of the document covers two proposals on pricing and reimbursement. On the one hand, they ask the criteria that lead to the financing of a medicine are published or an indication. If it is not finally approved, they consider convenient a supporting report when the non-financing is resolved. “It is necessary to clarify that, on occasions, it is necessary to make decisions based on sustainability criteria, although this may entail a certain scientific sacrifice”, they claim.
On the other hand, they suggest indicating which medications or combinations are explicitly referred to when the existence of therapeutic alternatives. “In any case, it must be indicated which medications or combinations are explicitly referred to. Likewise, when there are no alternatives, it must also be emphasized,” they claim.
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