Obstacles and lack of resources hold back the prescription of innovations against cancer
Health takes 469 days to finance them, compared to 120 days in Germany or 257 in France
The fight against cancer advance in giant steps. Practically every week scientific journals publish an innovation related to with immunotherapies, antibodies or biomarkers, which are far from being a definitive cure for a disease that causes second cause of death in Spain, but they can lengthen and improve life of thousands of patients. Spain is also one of the countries with the most clinical trials in search of medical revolutions. But, despite this leadership, bureaucratic obstacles and lack of personal and economic resources are causing a bottleneck that prevents many drugs from reaching patients on time, to sick despair and their healthcare professionals.
For example, in the 2016-2019 period they were included in the public funding only 54% of medicines authorized by the EU, compared to 88% in Germany or 75% in Italy. And attending to oncological drugs, 61% of authorized drugs are available in the last four years, the lowest figure of the surrounding countries. In Germany 100% has been financed and in France 80%. In addition, the average time has increased by 74 days from 2018 to 2021, so that the time it takes from when a medicine is authorized until it is included in public financing reaches a whopping 469 days. In Germany it is around 120 days and in France 257 and in Spain it should not exceed 180 days, according to the law.
In this context, it is paradoxical that Spain is one of the leading countries in clinical trials but the results do not always reach the recipients. In 2021, Spain closed with almost a thousand investigations underway. Of these, four out of ten were directed at some type of cancer and 5.6% at covid. These data place Spain at the head of the EU and in second position as investor destination by the pharmaceutical companiesaccording to Pharmaindustrywhich attributes the success to the “scientific level, the excellence of the hospitals, the support of the administration, the involvement of the patients and the commitment of the industry.”
The times
Check this review Thomas Paschalscientific director of solti academic group and oncologist at the Clínic who points out “that the times to start the trials and the number of procedures to be carried out are less than in other countries & rdquor ;, which together with the “great acceptance” when participating in the patients and that these are concentrated in large hospitals makes it possible for “there to be more essays than in other health systems”. However, he criticizes that this leadership does not translate into greater access to medicines or techniques resulting from this R&D.
Pascual recently published a tweet denouncing that 10 drugs that have been approved by the European Medicines Agency (EMA) are not yet funded or not for all indications by Spanish health.
Some drugs with indication approved in breast cancer by the EMA and pending or rejected in Spain.
❌Pertuzumab: adjuvant HER2+ early BC
❌Neratinib: adjuvant HER2+ early BC
❌Olaparib: gmBRCA HER2- met BC
❌Talazoparib: gmBRCA HER2- met BC
❌Tucatinib: HER2+ met BC
⬇️– Tomas Pascual (@TomasPascualMD) June 10, 2022
@AEMPSGOB @sanidadgob @_SEOM @CMMetastasic
– Tomas Pascual (@TomasPascualMD) June 10, 2022
The model
Farmaindustria blames this situation on the authorization model, which “suffers a problem of structure, human resources and procedure&rdquor ;, according to the Director of Access of the employer, Isabel Pineros. The system is not enough to evaluate, negotiate with pharmaceutical companies and set a price in the face of the boom in approved drugs in recent years, according to the industry. To this is added that in 2020 the financing was conditioned to the Therapeutic Positioning Report, a document based on scientific evidence on the assessment of a new drug (or a new indication) in comparison with existing drugs. The problem is that the administration “has no resources” to have all the reports ready on time, which “hinders & rdquor; access and generates a “bottleneck”.
In short, the model “no longer works”, according to Pineros, who also criticizes its “opacity&rdquor ;, given that the industry does not know the calendar in which its requests will be studied or the reasons if a drug or an indication is rejected.
Prices
Since PharmaScienceassociation of pharmacists in favor of scientific evidence, Roi Calpoints out another reason that delays the prescription of innovative therapies: their high price and the resistance of the laboratories to reduce them. “If between Health and the pharmaceutical company there is no entry agreement, the Ministry waits for the price to drop and be affordable […] since the resources are limited and you have to know how to manage them for the benefit of the patient and the entire system”. Cal points out that there are medicines with “crazy prices & rdquor; which, on occasions, suppose “improvements in the life expectancy of one or a few monthshaving cheaper alternatives & rdquor ;.
However, from Farmaindustria they respond that if the problem is the price, the solution is for Health to impose a system of “pay for results& rdquor ;, which is already applied in some ultra-expensive medicines and which consists in that if the formula does not obtain the expected efficacy, the laboratory is not paid.
Along the same lines, Dr. Pascual indicates that they should be “prioritize certain drugs [en base a la eficacia demostrada en los ensayos], monitor and, if the desired benefits are not obtained, rethink its financing & rdquor ;. “Now we have a system that is not transparent, does not prioritize or track. Perhaps the problem is that the industry’s pricing approach is unaffordable, but since there is opacity, we don’t know it & rdquor ;, she laments.
despair
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And, along the way, the most affected are the patients, on all those who have cancer in a more advanced stage. “The situation is dramatic because our time is limited.We can’t wait forever”, says Pilar Fernández, president of the Metastatic Breast Cancer Associationwhich has launched a campaign to demand more investment in innovative drugs and fewer bureaucratic obstacles.
Fernández denounces that there is not only a problem when it comes to financing new therapies, but “lack of equity between communities and between hospitals & rdquor ;, which causes many patients, “Desperate, go from hospital to hospital” looking for that drug that can lengthen their lives, either because it is funded in that community, or to participate in a trial or some other formula that gives them access.