High-cost medications — next-generation oncology drugs, biologics, orphan drugs for rare diseases, compassionate-use treatments, and gene therapies — are frequently subject to denials or delays by social health insurance funds (obras sociales) and private health insurers (prepagas). The grounds typically combine economic considerations, administrative requirements (audits, usage protocols), challenges to the prescription, or arguments about product coverage.
The patient's right to receive the treatment prescribed by their treating physician is grounded in the National Constitution, international human rights treaties, Supreme Court case law (cases Asociación Benghalensis, Etcheverry, Mosqueda), and the specific regulations of each insurer. The amparo with a precautionary measure is the primary tool when there is a denial or a health-endangering delay.
Immunotherapies, targeted therapies, monoclonal antibodies. Monthly costs are very high. An oncologist's specialist prescription is essential.
Used for rheumatoid arthritis, multiple sclerosis, and inflammatory diseases. Coverage typically requires prior exhaustion of conventional treatment lines.
For rare (low-prevalence) diseases. Frequently imported, requiring specific ANMAT authorization. These cases produce some of the most significant judicial precedents.
Medications without local approval but with international scientific backing. ANMAT issues authorization under the Exceptional Access Regime for Unregistered Medications (RAEM-NR). Coordination with the insurer is required to secure coverage.
Emerging treatments with high costs, often with no existing coverage. An area of innovative litigation with developing jurisprudence.
The typical sequence: a well-founded specialist prescription; a formal request to the insurer; upon denial or delay, filing an amparo with an initial precautionary measure. The injunction is usually decided within days and compels the insurer to supply the medication while the merits are adjudicated. Success depends on the strength of the prescription, the documentation of the patient's condition, and the urgency of the case.
For medications not authorized by ANMAT, the strategy includes parallel management of the RAEM-NR process, which in many cases is a prerequisite for insurer coverage. We coordinate with the family and the medical team to ensure every step is properly documented.