Implementation of the National Cancer Law for health technology assessments of high-cost technologies for oncological diseases in a Latin American middle – income country: a descriptive analysis of regulations and assessment reports

In the complex world of modern healthcare, governments face a constant and difficult balancing act. They must ensure that people with serious illnesses, particularly cancer, can access the newest and most effective treatments, while also managing the limited funds available to pay for them. When a new drug or medical device costs a great deal of money, health officials cannot simply buy it for everyone without careful thought. They need a way to decide if the high price is worth the benefit it brings to patients. This is where a process called health technology assessment comes in. Think of it as a rigorous, evidence-based review where experts examine the safety, effectiveness, and cost of a medical tool before a country agrees to pay for it. In many places, this process is straightforward, but in countries with limited resources, the rules governing these decisions are often new and still being tested.

Peru, a middle-income nation in South America, recently took a significant step to formalize this process for cancer care. In 2022, the country approved regulations to implement its National Cancer Law, creating a specific system to evaluate high-cost oncological technologies. The goal was to use a structured, multi-factor analysis to guide decisions on which expensive treatments should be covered by the public health system. A team of researchers set out to examine how well these new rules were actually working in the real world. They looked at the written laws that established the system and compared them directly with the actual reports produced by the national network of experts who perform these evaluations. Their work reveals a story of good intentions meeting the messy reality of implementation, highlighting where the rules are clear and where they leave too much room for confusion.

The researchers began by gathering the official documents that set the rules for these assessments. They then collected every report generated by the national network between 2022 and 2025, a total of 106 evaluations. By placing the written regulations side-by-side with the actual reports, they could see if the system was functioning as the lawmakers intended. What they found was a system that was technically functional but legally imprecise. The regulations contained vague definitions and missing details that made it difficult to apply the rules consistently. For instance, the law stated that the system would assess high-cost technologies for cancer, but it never clearly defined what counted as a "high-cost" medical device, nor did it explain what types of cancer-related conditions were covered. It also restricted the scope to only drugs and devices, leaving out other potential interventions like new surgical procedures or diagnostic tests.

When the researchers looked at the actual work being done, a clear pattern emerged that reflected these gaps. Every single one of the 106 reports they analyzed focused exclusively on pharmaceutical products, or drugs. No reports were found for medical devices, likely because the rules for assessing them were never clearly defined. Furthermore, nearly all of these assessments were for treatments intended to cure or manage the disease itself, rather than for prevention or rehabilitation. The types of cancer being evaluated were also skewed; while the law was meant to cover all oncological diseases, the reports focused heavily on specific types like leukemia and breast cancer, while other major cancers received far less attention. This suggests that the system was reacting to individual requests from doctors rather than proactively addressing the nation's broadest cancer needs.

The study also uncovered significant delays in the process. The regulations promised that an assessment would be completed within 45 business days, a timeline intended to ensure patients did not wait too long for a decision. However, the reality was quite different. The median time it actually took to complete a report was 177 business days, which is nearly four times longer than the rule allowed. The researchers noted that the rules did not specify exactly when the clock started ticking, which made it hard to enforce the deadline, but the delay was substantial regardless. This gap between the promised speed and the actual pace of work highlights a common challenge in new health systems: writing a rule is easier than building the infrastructure to follow it quickly.

Another critical area of concern was the involvement of the people most affected by these decisions: the patients. The regulations stated that doctors and patient representatives should participate in the evaluation process. In practice, doctors were involved in every single report, providing their expert medical opinions. However, the participation of patients or their families was much lower. In fewer than half of the reports did a patient or family member contribute their perspective, and in many cases, patient groups were not even contacted. The rules did not clearly define how this participation should happen, leading to a system where the voices of the people living with cancer were often missing from the very process meant to decide their access to care.

The researchers also examined the final recommendations made in these reports. The system produced two types of outcomes: a recommendation to use the technology or a recommendation against it. The majority of the reports, about three-quarters of them, advised against using the expensive technology, often due to high costs or insufficient evidence of benefit. Only about one-quarter received a recommendation to proceed. While the law intended for these reports to guide funding decisions, it was not entirely clear if the recommendations were legally binding for the government. A temporary rule existed that made the advice binding for drugs, but this was a short-term measure and did not apply to other types of technology. This ambiguity leaves the final decision-making power somewhat unclear, potentially allowing political or financial factors to override the expert analysis.

Ultimately, the study suggests that while Peru has successfully built a framework for assessing high-cost cancer treatments, the framework itself needs refinement. The regulations contain definitional gaps, procedural ambiguities, and a lack of clarity on who is responsible for what. The system is currently dominated by requests from individual doctors for specific drugs, rather than a broader, strategic approach to national cancer care. The delays in processing and the limited involvement of patients indicate that the system is not yet operating at the speed or with the inclusivity that the law envisioned. The authors conclude that to make the system work better, the government needs to clarify its definitions, establish clear timelines, and create stronger mechanisms for patient participation. Without these adjustments, the gap between the written law and the reality of patient care will likely persist, leaving the promise of equitable access to high-cost treatments unfulfilled.