Three internal reports from the Andalusian Junta warn that patients with multiple myeloma, a type of cancer that originates in plasma cells in the bone marrow, are causing delays in access to innovative CAR-T therapy in this community, reducing patients’ hope for life.
“Delays in the availability of treatment have a negative impact on your prognosis for response to treatment, and thus on your survival.” This is the definitive sentence, marked in bold, with which the head of the Hematology Service of the Virgen del Rocio Hospital – José Antonio Pérez Olmo – closes the third part of the reports, to those who have managed to reach the country. This last document, which includes 11 patients (out of a total of 23 patients), shows the most important option for their bosses to speed up the delivery of medicine to patients.
El Virgen del Rocío is one of three hospitals accredited in Andalusia – along with Reina Sofía de Córdoba and Regional de Málaga – to administer CAR-T therapies against multiple myeloma, and has the most experience in this community in their use and research.
The treatment the reports are referring to is Carvykti, a CAR-T that has shown very good results in patients with multiple myeloma who have relapsed after receiving other prior treatments. This type of cancer is still considered incurable, although therapeutic advances have brought it under control in many cases, with long remission periods lasting several years during which patients enjoy a good quality of life.
El Carvykti is the treatment that has contributed most to these improvements, according to the results obtained in clinical trials and the real world (patients treated after exiting the pharmaceutical market). Accordingly, about a proportion of people with previous treatment failure remain disease-free within three years, whereas previously the median survival rate in this group was less than one year.
The Inter-Ministerial Committee on Pharmaceutical Prices (CIPM) last month approved the integration of Carfacti into Public Health from April 1. From this point on, the autonomous communities must process the purchase of the drug with Janssen Pharmaceuticals through some sort of landmark agreement. Since these procedures last for several months, communities turn to emergency services to obtain treatments for patients who cannot wait.
Reports to those with access to these notes form part of these proceedings and illustrate the growing impatience of those responsible for clinical trials before the delay. The first document, which includes four patients, was signed by Pérez Simón only three weeks after the treatment was integrated into public health, on April 23, so it does not contain explicit references to the delay.
The document insists only on the urgency of the cases: “Emergency action is required, and is necessary due to a very serious situation involving the patient’s life.” The document highlights that the Ministry of Health has authorized the administration of the drug and that all patients adhere to the requirements set out in its public funding.
The second report closes on June 9 and includes patients aged 44 to 73 years. It is important to highlight the annoyance of doctors due to the delay in giving treatment, which appears in some cases.
In one case, it was stated that “lymphocyte apheresis was postponed on several occasions but financing procedures were not approved” for the drug between the Andalusian Board and Janssen. Apheresis, a key moment in CAR-T therapies, is the extraction of cells from the patient’s immune system so that they… Reschedule With the aim of precisely attacking cancer cells. The losses in effect occur despite the fact that Carvicti “is today the best treatment option for achieving response and is longer lasting,” according to the report.
Regarding another patient, the document highlights that he “currently presents a high tumor burden” and that, despite delayed CAR-T, he underwent “aggressive treatment” with conventional drugs. However, this treatment should be suspended due to an adverse drug reaction. The conclusion is that “delay in receiving CAR-T therapy poses a risk to the control of high-risk multiple myeloma.”
The third report is the most harsh. It was signed on August 6 – more than four months after Carfacti was listed in Public Health – including 11 patients aged between 50 and 73 years, and in any case it insists that there are delays and the danger this poses to the lives of patients. As in the first few cases, Pérez Simón highlights that the patients obtained a good visa from the Ministry of Health.
“High risk”
On five occasions, the report states, “lymphapheresis was postponed on several occasions but not approved” and the drug purchase agreement. This forced doctors to resort to “strong treatments,” which in one case meant “the expectation of remaining disease-free decreased by about 20 percent in the first few years,” and in the other four cases, these expectations decreased “from more than 40 months to about 34.”
In the sixth case, the document indicates that “the delay in the availability of treatment implies the development of organic damage resulting from myeloma.” However, delaying “assumes a very high risk of not being able to control the progression of high-risk multiple myeloma.”
It is a more difficult situation for another patient, as delay in receiving treatment “significantly hampers the possibility of controlling the disease (implying a) higher risk of a negative impact on their survival.”
Another warning that doctors issue in the reports is that if patients do not receive Carvacti in time, the disease will continue to progress until they are unable to benefit from the treatment. “Delays in making treatment available cause multiple myeloma to progress at a slower rate than treatment, which increases the risk of missing out on Carvacti due to clinical deterioration.”
The Council refused to evaluate the delays mentioned in the reports. A hospital spokesperson explains that emergency procedures have been launched to “accelerate” the purchase of treatment, explaining that as of today, 15 patients have been received and another 14 patients are awaiting authorization for treatment. On August 6, after the last report revealing the delay, there were 23 patients waiting for Carvicti.
The means of procurement by the emergency route, and consequently the delay which occurred in its administration, are known to the most responsible persons in the Andalusian Junta. The documents include signed by the director of Virgen del Rocio Hospital, Nieves Romero; Director of the Seville Regional Procurement Centre, Salud Rivero; and Salud’s vice chancellor, María Luisa del Moral, among others.
The Regional Government Council, headed by Juan Manuel Moreno Bonilla, also received the reports. The emergency route, set out in the Public Sector Contracts Act, stipulates that the procurement can be carried out without waiting for the approval of the regional executive, but it must only be informed and granted its visa much later for the entire procedure. This is what happened in three cases during the Andalusian Executive Board meetings held on June 18, August 4, and October 8.
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