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
Year: 2026
Type: preprint
Abstract: Background In 2022, Peru approved the implementing Regulation of the National Cancer Law, establishing multicriteria health technology assessment (MC-HTA) through the national HTA network (RENETSA) to inform coverage decisions for high-cost oncological technologies. This study aimed to describe and assess the drafting quality of the regulatory provisions governing MC-HTA for high-cost oncological technologies in Peru and examine their implementation using RENETSA assessment reports published between 2022–2025 in addition to international multicriteria frameworks. Methods We conducted a descriptive study of regulatory provisions governing MC-HTA for high-cost oncology technologies in Peru. Provisions were analyzed across five dimensions (assessment requests, assessment criteria, stakeholder participation, timelines, and use of recommendations) and their drafting quality was assessed using Peruvian legislative drafting guidelines. Regulatory provisions were compared with RENETSA assessment reports and three international multicriteria frameworks (GRADE-EtD, WHO-INTEGRATE, and HTA Core Model). Report characteristics were summarized using descriptive measures. Results Six regulatory provisions and 106 MC-HTA reports were included. Drafting imprecisions were identified across all five dimensions. Ministry of Health-initiated requests represented 3.8% of assessments. The Regulation restricted eligible technologies to pharmaceutical products and medical devices, omitted other types of interventions and purposes beyond treatment, did not define “oncological disease”, and did not establish a high-cost threshold for medical devices. All reports assessed pharmaceutical products, 97.2% concerned treatment, and 91.5% addressed malignant neoplasms. The assessment criteria specified in the Regulation differed from those included in the reference multicriteria frameworks. Stakeholder participation definition was omitted; patient and physician participation was documented in 41.5% and 100% of reports, respectively. Median development time was 177 business days, compared with a regulatory limit of 45 business days for which the starting point was not specified. A transitional provision established a ‘binding opinion’ requirement only for the acquisition of pharmaceutical products. Conclusions The regulatory framework governing MC-HTA for high-cost oncology technologies in Peru contains definitional, technical, and procedural imprecisions, while its implementation shows differences between regulatory provisions and observed assessment practices. Clarifying the scope of eligible technologies, assessment criteria, stakeholder participation, timelines, and the use of recommendations could strengthen the consistency of the MC-HTA process.
Source: Research Square
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7213870397