“One in four of the medicines authorised by the European Medicines Agency in recent years has an indication in oncology and in Spain only 57% are available, with an average waiting time for patients to access them of up to 20 months”. This was pointed out by the director of Farmaindustria’s Access Department, Isabel Pineros, at a conference of the Spanish Society of Medical Oncology (SEOM) held on Wednesday in Madrid to analyse the challenges of medical oncology in private medicine.
These delays and lack of availability affect patients in both public and private healthcare, said Pineros, as the availability of an oncology drug in private medicine is conditioned by funding in the public system. “Pharmaceutical companies do not market a new innovation in our country until they have the resolution of the funding process by the Ministry of Health,” he said.
The data provided by Pineros at the conference are contained in the annual report Indicators of access to innovative therapies in Europe 2022 (W.A.I.T. Indicator), prepared by the consultancy firm Iqvia for the European Federation of the Pharmaceutical Industry (Efpia), which analyses the state of public funding on 1 January 2023 for medicines authorised between 2018 and 2021. It is the largest European study on the availability of innovative medicines and patient access time with data from 37 countries (27 EU and 10 non-EU), providing an understanding of the status of access to new EMA-approved treatments across the region.
The director of Farmaindustria’s Access department underlined that, in the case of oncology medicines, both availability and waiting times have worsened in the last year, compared to the previous report. “Availability has gone from 61% to 57% in the last year, while patient waiting time has increased to 611 days on average, compared to 469 days in the previous study.
“The fact that in Spain this availability is lower than in France and Germany, with indicators of 72% and 98% respectively, is a huge disadvantage for Spanish patients, who cannot access the most effective treatments or do so with a long delay. To this we have to add that one out of every two drugs indicated for oncology are available with restricted funding, selecting subpopulations of patients,” Pineros explained. The absence of an agile and efficient procedure encourages the use of alternative routes that were not designed for this purpose, such as medicines in special situations, which results in more uncertainty and, on occasions, more inequity, including territorial inequity, he added.
Therefore, in order to try to shorten these times and equalise opportunities for Spanish patients with those of their European neighbours, Farmaindustria has been proposing a series of improvements to the procedure for evaluating and setting prices and public funding of medicines in our country, with the aim of establishing an agile, predictable and efficient model, in order to help solve the current problem.
Pineros also highlighted the importance of clinical research in Spain in the area of oncology, as evidenced by the fact that one third of the more than 900 clinical trials launched last year in Spain (36%) were for oncological therapies. “Of these trials, 72% were in phases I and II, the most complex at a scientific level, but also the ones that allow access to treatment earlier for patients who need it”. These clinical trials are not only carried out in the public health sector, but private hospitals are increasingly participating in them.
He also highlighted the importance of personalised medicine and genetic diagnosis in the treatment of cancer patients. In fact, he recalled, most of the new cancer drugs approved by Europe – 40 in the last three years – already belong to personalised medicine, which achieves the use of the most effective treatment according to the individual characteristics of each patient, while improving their safety profile.
In this precision medicine, diagnosis, as well as medical and drug treatment, is tailored to the individual characteristics of each patient or patient profile. “In these cases, it is just as important to have the medicine available as it is for the patient to have access to the biomarker linked to it,” said Pineros, who called for the incorporation of biomarkers into healthcare services “through a transparent, agile, evidence-based procedure with the participation of scientific societies and patient associations. “We need a map in our country that defines and simplifies the circuit that a patient has to follow to access the biomarker and the medicine. For all these reasons, we must ensure that Spain is at the forefront not only in clinical research, but also in access to medicines, in order to achieve the best health results in the treatment of cancer,” he concluded.