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Spain: Cancer Patients & Clinical Trials – Access to Drugs

by Olivia Martinez
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Delayed access to cancer medications, particularly for treatments targeting tumors affecting women, is prompting oncologists in Spain to increasingly enroll their patients in clinical trials as a means of securing access to these drugs. While the medications have been authorized by the European Commission, they are not yet covered by Spain’s national healthcare system. This practice, debated at the III Encuentro Woman Cancer Day held at the Spanish Congress of Deputies on Wednesday, raises questions about equitable access to care and the role of research in filling gaps in healthcare coverage.

Spain is a leading nation in cancer clinical trials in Europe, second only to the United States (excluding China), boasting a strong network of hospitals and research oncologists. However, Dr. Javier Cortés, a breast cancer specialist, president of the Contigo Foundation, and director of the International Breast Cancer Center (IBCC), questioned whether the high rate of patient enrollment in trials is truly in their best interest. “Are we enrolling so many patients in studies because it’s better for them, or because we sometimes lack drugs that have proven effective and are approved in the United States and Europe, but don’t reach Spain, leaving this pathway as the only way for our patients to benefit?” he asked.

Ana Oaknin: «Many times the trial is the only way for the patient to receive an effective drug»

The reality, according to Dr. Ana Oaknin, head of the Gynecological Cancer Program at the Oncology Medical Service of Puerta de Hierro Hospital in Madrid, is that “the trial supplements the lack of access to approved medications in daily practice.” Dr. Oaknin actively seeks to include her patients in trials when the most appropriate medications are not funded by the Spanish National Health System (SNS), stating that “many times the trial is the only way for the patient to receive an effective drug.” However, this creates an inequity, as “unfortunately, these trials are not available in all hospitals,” she noted.

Participants at the III Encuentro Woman Cancer Day

Both Dr. Cortés, and Dr. Oaknin emphasized that research should be a choice, not the sole route to accessing necessary medications. Dr. Cortés as well deemed it “unacceptable” not to refer patients to hospitals where trials for already-reimbursed drugs are available. “It’s a double-edged sword, but we must all work together to get these cases into clinical studies to save the system the cost of the drug – it’s the best way to reduce the budgetary burden,” he argued. This highlights the complex interplay between healthcare costs, research opportunities, and patient access to innovative treatments.

Only large hospitals can access the study of «biomarkers that are in the highest category at European level» and that are not yet in the portfolio of services of the SNS, points out Dr. José Ángel García

Access to medications and biomarkers was a central theme in discussions about the current state and future of cancer care for women. Experts also addressed the importance of multidisciplinary approaches, the value of oncology nursing, and preventative strategies for cancers like cervical and ovarian cancer, which often receive less public attention.

Similar to clinical trials, larger hospitals with significant research activity are typically able to perform molecular tumor characterization for biomarkers not yet included in the SNS’s basic service portfolio. “These are biomarkers that are at the highest level in Europe,” explained Dr. José Ángel García, an oncologist at Clínico San Carlos Hospital and a member of the Geicam research cooperative’s Executive Committee. While his hospital can perform these tests, “there are smaller hospitals that cannot, and there is a need to incorporate these biomarkers into the service portfolio.” Without accurate molecular determination, targeted therapies cannot be effectively applied, the physicians noted.

Ángeles Peñuelas defends the presence of oncology nursing in any service dedicated to cancer: «The nurse is the person who accompanies the patient throughout their oncology process»

Oncology Nursing and “Well-being”

Another crucial aspect of care for women with cancer is oncology nursing, which has evolved significantly in recent decades but still lacks standardized, certified training. Ángeles Peñuelas, president of the Spanish Society of Oncology Nursing, and a pioneer in specialized consultations, advocates for its consistent presence in all oncology services, as the nurse “is the person who accompanies the patient throughout their oncology process.” Her consultations address not only clinical issues but also emotional and even social concerns.

«The oncology of the 21st century should take a step further» to reach what Dr. Mercedes Herrero calls «the well-being» of patients

Nursing is an integral part of the team caring for these patients, which should be “multidisciplinary,” the speakers agreed. Mercedes Herrero, head of the Breast Unit at Gine4 and HM Hospitals, believes progress has been made in forming these teams during the acute phase of the disease, with tumor committees “that have changed the paradigm of care.” However, in the subsequent follow-up of patients, “we still have a long way to go.”

Herrero emphasized the importance of including gynecologists and other professionals, such as nutritionists, in this phase. She believes that oncology in the 21st century should advance towards what she calls “well-being,” focusing on quality of life and concerns related to “hope for pregnancy, maternity, cancer-induced menopause, or patients’ sexual lives.”

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