Three internal reports from the Andalusian government have warned that delays in accessing innovative CAR-T therapy in the community are ending hope for life for patients with multiple myeloma, a type of cancer that originates from the plasma cells of the bone marrow.
“Delays in the availability of treatment are having a negative impact on the expected response to treatment and thus on survival,” is the decisive sentence, highlighted in bold, that José Antonio Pérez Olmo, head of the Department of Hematology at the Virgen del Rocio Hospital, concludes the third of his report to those who have accessed the country. This last document includes 11 patients (out of 23 total) and indicates that the option is more important to the supervisor in order to speed up the administration of medication to the patient.
El Virgen del Rocio is one of the three accredited hospitals, along with Andalusia’s Reina Art Hospital Sofía de Córdoba and Malaga Regional Hospital, to implement CAR-T therapy for multiple myeloma, and has the most experience in its use and research in this community.
The treatment this report references is Carvykti, a CAR-T that has shown very good results in patients with multiple myeloma who have relapsed after previously receiving other treatments. Although this type of cancer is still considered incurable, advances in treatment often allow it to be controlled, with long-term remission lasting several years and patients enjoying a good quality of life.
According to the results obtained in clinical trials and in the real world (patients treated after withdrawal from the drug market), El Carvykti is the treatment that contributed most to these improvements. Therefore, although about a fraction of those who previously failed treatment remain disease-free within 3 years, the average survival rate for this group was previously less than 1 year.
The Inter-Ministerial Committee on Pharmaceutical Prices (CIPM) last month agreed to incorporate Kalvikti into public health from April 1. From this point on, autonomous communities must arrange for drug purchases with Janssen Pharmaceutical Company through some kind of landmark agreement. These procedures last several months, so communities rely on emergency services to get treatment for patients who can’t wait.
The briefings to those with access to the diary form part of these steps and show the growing impatience of clinical trial leaders in the face of delays. The first document included four patients and was signed by Pérez Simón on April 23, just three weeks after the therapy was included in public health, so it contains no explicit mention of delays.
The document simply emphasizes the urgency of the situation, saying, “The patient’s life is in serious danger, and emergency treatment is required.” The document emphasizes that the Ministry of Health has authorized the administration of this drug and that all patients comply with the requirements envisaged for public funding.
The second report was completed on June 9 and included patients between the ages of 44 and 73. It is important to emphasize the physician’s discomfort due to delayed treatment, which is obvious in some cases.
In one case, it was stated that “lymphocyte apheresis was postponed several times, but the financing procedure for the drug was not approved between the Andalusian Congress and Janssen.” A key moment in CAR-T therapy, apheresis extracts cells from the patient’s immune system and rescheduled The aim is to precisely attack cancer cells. According to the report, the loss of apheresis occurs despite the fact that Calvicti is “currently the best treatment option for achieving response, with longer-lasting effects.”
Regarding another patient, the document highlights that he “currently exhibits a high tumor burden” and that while treatment with CAR-T has been delayed, he is receiving “intensive treatment” with conventional drugs. However, this treatment must be discontinued due to drug side effects. They found that “delays in receiving CAR-T therapy pose a risk to control of high-risk multiple myeloma.”
The third report is the most distressing. The agreement was signed on August 6, more than four months after the inclusion of Kalvikuti in the public health field, involving 11 patients aged between 50 and 73, in each case asserting the existence of delays and the risks this poses to the lives of the sick. As in the first few times, Perez Simón stressed that the patient had received a good visa from the Ministry of Health.
“High risk”
“Lymphocyte apheresis has been postponed several times but has not been approved,” the report states in five drug purchase agreements. This forced doctors to rely on “aggressive treatments,” which in one case meant “expectations of disease-free survival were reduced by about 20% in the first few years,” and in four other cases, those expectations were reduced “from more than 40 months to about 34 months.”
In the sixth lawsuit, the documents charge that “delays in the availability of treatment imply the development of organic damage from ongoing myeloma.” However, this delay “assumes a very high risk of not controlling the progression of high-risk multiple myeloma.”
The situation is more difficult for other patients, who say that delaying receiving treatment “significantly impedes their chances of controlling the disease (which means a higher risk of negative impact on survival)”.
Another warning issued by doctors in the report is that if patients do not receive Kalvikti in a timely manner, the disease will continue to progress until the treatment is no longer effective. “Delays in the availability of treatments are increasing the risk that multiple myeloma may progress more slowly than treatment and that patients may ultimately miss out on treatment (Carvykti) due to worsening clinical symptoms.”
The board declined to assess the delays described in the report. The spokesperson explained that emergency measures had been launched to “expedite” the purchase of the treatment, detailing that as of today, 15 patients have been admitted and a further 14 patients are awaiting approval for treatment. On August 6, after the last report of delays, 23 sick people were waiting for Kalvikuti.
The acquisition through the emergency route and the consequent delays in its operation are known to the most responsible people of the Andalusian Parliament. The document included is signed by Nieves Romero, the manager of Virgen del Rocio Hospital. Saldo Rivero, Director of the Provincial Purchasing Center of Seville. and, among others, Vice Consehera de Salud, María Luisa del Moral.
The Local Government Council, chaired by Juan Manuel Moreno Bonilla, also received the report. The emergency route set out in the Public Sector Contracts Act, which allows purchases to be made without waiting for approval from regional authorities, requires advance notice and visas to be issued long after the entire procedure has been completed. This is what happened in three cases at the meetings of the Andalusian Executive, held on June 18th, August 4th and October 8th.
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