by Joaquim Augusto Melo de Queiroz
The criteria used by the agency to evaluate technologies need to be clear and objective
The supplementary health sector is at the center of the national stage. The increase in health plan prices resonated strongly in society. The Superior Court of Justice (STJ) judgment on the nature of the National Supplementary Health Agency’s (ANS) list also made newspaper headlines in recent weeks. It is a time of ferment, on different fronts and in different scenarios of supplementary health care.
The recent entry into force of Law 14,307/2022 is one of the developments that has stirred the segment. This is the law that changed the deadlines and procedure for updating the list of coverage mandatory for health plans. In technical jargon, the list is called the List of Health Events and Procedures, or the ANS list. The expression is sophisticated, but its purpose is simple: to list the medicines and procedures that must necessarily be covered by health plans.
The criteria used by the agency to evaluate technologies need to be clear and objective
The ANS list is the star of the moment. On June 8, the STJ resumed and concluded its judgment on the nature of the list (exhaustive or illustrative). The issue caused an uproar and mobilized a considerable part of civil society. The view that prevailed was that the list is exhaustive, allowing for exceptions provided certain requirements are met. Although it was not issued in a repetitive appeal and applies only to the parties to the case, the decision has been criticized regarding the contours of the modulation made by the STJ. The controversy is likely to continue — possibly even reaching the Federal Supreme Court (STF).
Despite the frenzy, restraint and reflection are needed. Significant changes will shape supplementary health care in the coming years. Regulation is expected to advance, but discussions on thorny issues need to be deepened. Improving the process for updating the ANS list is precisely one of them.
Law 14,307/2022 stands out in this context. It changed the deadlines and the system for updating the coverage mandatory for health plan operators. In short, it introduced a new dynamic of continuous updating of the list. At the same time, it reduced the time for review by the regulatory agency and introduced rules and stages into the updating procedure. It reduced, for example, the deadline for reviewing requests to include (oral) cancer medicines, setting a 120-day limit for the review, extendable by a further 60 days. For other types of medicines, the deadline is now 180 days, extendable by a further 90 days.
The recent rules triggered a surge in requests to include new technologies in the list for the treatment of various types of cancer. There are therapeutic and economic reasons for this. Cancer, as is well known, is an extremely aggressive disease. Days can be decisive for a favorable outcome. Patients and families are fully aware of this urgency. And this sense of urgency is one of the factors that has driven the pharmaceutical industry to regularly submit requests for the inclusion of these medicines — as has the economic appeal inherent in this expanding market.
Innovative cancer therapies require massive investment in research and development. Few of the molecules researched actually become medicines. And there is, logically, a high cost in the development process of these new medicines that needs to be recovered.
The reduction in the deadlines for ANS reviews may also have contributed to the increase in the number of new requests. This is because predictable deadlines allow better organization of the procedures required to submit requests, especially for coordinating the scientific evidence that will support the inclusion request.
There are, however, considerable challenges in the current landscape. On the one hand, maintaining technical rigor in the assessments. On the other, the pressure to meet the new deadlines. And, in addition, the need to standardize the decision parameters used by the ANS.
This review process is based, in short, on a mechanism known as Health Technology Assessment (HTA). Briefly, it is a multidisciplinary tool to support decision-making by health managers.
HTA includes the assessment of scientific evidence instruments (systematic reviews and meta-analyses), clinical studies and observational studies, as well as the review of economic studies. The economic studies mainly address the technology’s cost-effectiveness and the financial impact of its inclusion. It is precisely the review of this complex body of documents that raises questions about the ANS’s decisions.
The criteria used by the agency to evaluate technologies need to be clear and objective. There has been progress, but there are still significant reservations about the lack of consistency in decisions. In recently assessed cases, for example, the ANS was seen to interpret similar technologies differently. This type of distortion raises doubts about the system used by the agency. And it may tarnish the image of the decision-making process, especially given the actions of segments interested in possibly blocking the inclusion of new technologies.
This is a key moment. The ANS has just launched an important public consultation (CP No. 99/2022) to issue a normative resolution that will regulate essential aspects of updating the list. It is therefore essential that all stakeholders involved in the inclusion process take part in this public consultation. The model is currently in transition, and the new format will affect a significant part of the population.
Article originally published on 07.25.2022 in the Valor Econômico newspaper (in Portuguese).
