Cofepris takes 4.3 years to approve innovative drugs

Cofepris takes 4.3 years to approve innovative drugs

Innovative drugs are constantly being developed around the world. Everyone’s goal is to offer a solution against a specific disease or to help treat ailments. But one of the problems is that these types of options are not always immediately available to Mexican patients. To a greater extent it is all due to the bureaucracy they have to face.

To better understand this situation, the consulting firm IQVIA carried out a study that shows how long it takes for patients in Mexico to have access to pharmaceutical innovation and how those times can be improved. The processes through which the drugs must pass are analyzed: from the application for the sanitary registration, passing through the evaluation carried out by the General Health Council (CSG), its inclusion in institutional catalogs and even its availability in public sector hospitals.

During the presentation of the study, Ángeles Martínez, Director of Consulting for the North region of Latin America in IQVIA, showed the main findings, among which the following stand out:

  • Between 2015 and 2020, an innovative drug in Mexico takes an average of 4.3 years (51 months) to be available in public hospitals for patients.
  • This time is almost double what it takes to Brazil (2.4 years) and up to four times longer than what it takes to other reference countries in the study: Germany, Japan, France, USA and the United Kingdom.
  • The time to obtain the health registration before Cofepris was 57% longer in 2019-2020 than between 2017-2018.

Ángeles Martínez pointed out the difference that exists in access times between high specialty drugs and those of primary care:

  • The process of inclusion of high specialty drugs by the CSG takes 50% longer than the inclusion of drugs for primary care.
  • High specialty drugs, in general, take up to 50% longer to be available in hospitals.

He also noted the difference in access times by therapeutic area, since “although 4.3 years is the average time for the inclusion of innovation in Mexico, supplies aimed at the oncology area take an average of 5.2 years to reach the and the patients who need it ”. And since Mexico is one of the two countries in the world with the highest incidence of diabetes, and with acute myocardial infarction as the main cause of mortality, we have that supplies for diabetes and cardiometabolic areas, on average, take 3.2 years before reaching the persons.

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How and where can access times be improved?

The IQVIA study, Ángeles Martínez explained, shows two important areas of opportunity in the short term:

1.- Reduce the time it takes Cofepris to issue the health registration.
2.- The adoption of the National Compendium of Health Supplies.

Between these two actions, the wait for Mexican patients could be reduced between 1.5 years (when compared with Brazil) and 1.7 years (when compared with all the reference countries.

For his part, Cristóbal Thompson, Executive Director of the Mexican Association of Pharmaceutical Innovation Industries (AMIIF), pointed out that what this study seeks is a shared understanding, based on evidence, of the root causes of delays in access to jointly build solutions between patient associations, the health system, the pharmaceutical industry and authorities regulatory. And he celebrated that the construction of these collaborative solutions begins today with the presence of Pablo Quiroga Adame, Executive Director of Health Promotion of Cofepris, at the press conference.

After listing some of those actions, Quiroga pointed out that the cornerstone of this transformation is reliance, an international mechanism for collaboration between regulators to speed up approval times.

He also suggested a period of between six months and a year for IQVIA and AMIIF to repeat the study and to reflect the changes in the Cofepris related to the access times of innovative medicines.