The public money that is invested in the financing of medicines is limited. No one discusses that reality, nor that the Interministerial Commission on Medicines Price (CIPM), an organ dependent on the Ministry of Health, wields the arguments of “budgetary impact on the National Health System (SNS)” and “Rationalization of public spending” when it rejects the financing of an innovative therapy.
But there are flagrant situations that cannot be understood in a country that is a European leader in clinical trials in the field of medical oncology. The Spanish Agency for Medicines and Health Products (AEMPS) authorized 930 studies last year.
While great advances are achieved in access to innovative treatments for some pathologies, others remain forgotten, with the consequent damage to the sick who suffer from them.
This is the case of kidney cancer, a tumor not especially media, quite invisible and on which there is hardly any awareness that, in the opinion of experts in their approach, is like “the poor brother” of other neoplasms such as breast, colon or lung.
However, in Spain it has a prevalence of more than 66,000 cases and More than 9,000 new cases are detected every year, with a very high mortality, which exceeds even 25%. “In a context like the current one, in which there are early diagnostic strategies in much of the tumors, renal cancer is a ‘rare avis’, since it debuts with nonspecific symptoms, which greatly hinders its detection,” he explains Aránzazu González del Alba, Coordinator of the Genitourinary Tumor Unit of the Puerta de Hierro Hospital, of Madrid, and president of the Spanish Genitourinary Oncology Group (SOGUG).
In fact, more than 50% of cases are diagnosed casually when the patient undergoes an image test for another type of cancer. At the time in which 25% of renal cancer patients already have an advanced stage, and between 20-50% of those diagnosed in early stages that undergo surgery, they progress to a metastatic disease.
A group of patients does not respond
Most patients with metastatic intermediate or bad prognosis disease can be treated with double immunotherapy – with which today a survival of up to 30% to 9 years is achieved – but there is a Group of people with aggressive and large volume tumors (about 1,000 patients a year) that would benefit more than a combination of immunotherapy and antiangiogenic drugs (tyrosine-chew-tki inhibitors), recommended by national and international clinical guides and financed in most countries around our surroundings. Less in Spain.
The CIPM has rejected, in the last four years and for price reasons, the financing of up to three of these combined treatments approved by Europe that have shown a significant improvement in global survival and in the quality of life of this patient profile.
“All clinical guides recommend these combinations with the highest level of evidence. Therefore, We need to fund at least one of the three that are authorized by the European Medication Agency“González del Alba points out.” This is what We have been requesting four yearsespecially when, with this time that has passed, there is already five years that consolidates its results in all patients, but especially in the aforementioned group, “adds this specialist.
The reasons that the CIMP wields to deny them is that there are already funded treatments equally troops, “But this is not because in that concrete profile of patients, double immunotherapy is not equally effective because it is slower,” explains the expert.
“The patient progresses before he can have a positive response; that is, he dies. Therefore, we need to combine immunotherapy with a TKI, since we get very high response rates, delay in tumor progression and, above all, a very low progressive index (below 10% in some combinations), “he adds.
Spain, an exception in the EU
Spain is an exception in the European sphere because in all countries there are at least one of these drug combinations. To this is added the complication that, having a non -financing resolution, no patient can benefit from these combined therapies, not even exceptionally.
“We must insist that the fundamental problem is the lack of agreement between the parties involved, on the one hand the Ministry and, on the other, the pharmacists requesting the financing of the combinations in question “clarifies the oncologist.
“From Soug we must continue claiming the non -covered clinical need that metastatic renal cancer patients have, and therefore We request the financing of at least one of these combinations “stands out.
“While in neighboring countries all combinations are available, in Spain, the three authorized by EMA with an indication indication in advanced renal cancer have a negative financing resolution,” says the president of the National Federation of Associations for the fight against kidney diseases (Alcer), Juan Carlos Julián. “Having renal cancer in this country means having less possibilities of survival than in the rest of the European states in our environment. To find a case just like that of Spain you have to go to Eastern Europe,” he laments.