Lima, Peru

 

History and Structure

Peru is considered one of the pioneer countries in the concept of essential medicines; since 1959, lists of medicines selected according to the country’s needs have been developed. The General Directorate of Medicines, Supplies and Drugs (DIGEMID, for its acronym in Spanish), created on April 18, 1990 and recognized as the National Authority of Medicines, Medical Devices and Health Products, is a technical regulatory institution of the Peruvian Ministry of Health whose main objective is to ensure that Peruvian population has access to safe, effective and quality medicines, and that they are used rationally. To this end, in 1998, DIGEMID published the first National List of Essential Medicines; for the selection of medicines, criteria of need, efficacy, safety and cost were considered, using the principles of Evidence-Based Medicine (EBM).

Over the years, the technical area specialized in health technology assessment has strengthened its competences in the selection and evaluation of the efficacy, safety and cost-effectiveness of drugs, biological products and medical devices, forming the Health Technologies Assessment and Rational Use of Medicines team (ETS-URM, for its acronym in Spanish), under the Directorate of Pharmacovigilance, Access and Use (DFAU, for its acronym in Spanish) of DIGEMID. The National Authority of Medicines, Medical Devices and Health Products, through the ETS-URM team, has established the mechanisms for the formulation and updating of National Lists of Essential Medicines and Essential Medical Devices in order to promote the rational, safe and effective use of health technologies for Peruvian people.

Mission

  • Execute and implement norms, guidelines, plans, strategies and projects related to the process of elaboration, updating and implementation of the National Unique List of Essential Medicines, Complementary Lists, the National List of Essential Medical Devices and the National Formulary of Essential Medicines, as well as carry out follow-up and evaluation actions.
  • Elaborate and develop the proposal for the selection of medicines and health technologies assessment, as a basis for decision making in the framework of health care and its budgetary impact at the national level.
  • Execute and implement the regulations for the functioning of the Pharmacotherapeutic Committees at the national, sectoral and intergovernmental levels, as well as oversee, monitor and evaluate them.

How the Agency Works

The National Health Authority, through DIGEMID, conducts the processes of elaboration and updating of the National List of Essential Medicines and Essential Medical Devices in coordination with the public health institutions; they form an Interinstitutional Technical Team in charge of evaluating the requests and deciding the inclusion or exclusion of pharmaceutical products and medical devices based on the evidence presented in the health technology assessment reports developed by the ETS-URM team.

The ETS-URM team has a group of specialized professionals (pharmacists and economists) who prepare the rapid health technology assessment reports and economic evaluation of health technology reports in response to a request issued by the Interinstitutional Technical Team and by the Pharmacotherapeutic Committees of national hospitals or other public health institutions.

Additionally, the ETS-URM team performs rapid health technology assessment reports to authorize the use of drugs not considered in the National List of Essential Drugs, as well as drugs requested for inclusion in clinical practice guidelines or technical health standards in the framework of strategic public health interventions.

Finally, the ETS-URM team updates the regulations on the selection and evaluation of health technologies, the National List of Essential Medicines and Essential Medical Devices, the Pharmacotherapeutic Committees, authorizations for the use of medicines outside the National List of Essential Medicines, and the cost-effectiveness and high-cost thresholds for pharmaceutical products.

Dissemination Activities

The rapid health technology assessment reports and economic evaluation of health technology reports are published in full text in the DIGEMID’s Institutional Repository and are grouped in the following categories:

– National Unique List of Essential Medicines (PNUME, for its acronym in Spanish).

– Lists complementary to the PNUME

– National Unique List of Essential Medical Devices (PNUDME, for its acronym in Spanish)

– Use of medicines not considered in the PNUME.

This portal is publicly accessible (https://repositorio.digemid.minsa.gob.pe/handle/DIGEMID/21).

Additionally, the ETS-URM team, on behalf of the National Authority of Medicines, Medical Devices and Health Products, constantly participates in technical meetings and academic events aimed at health professionals, university students and the general public, in order to guide and disseminate the process of evaluating the efficacy, safety and cost-effectiveness of drugs, biological products and medical devices through health technologies assessment.

Recently completed or milestone HTA reports

  • In 1998, the first National List of Essential Medicines was published, which was updated in 2002 and 2005. With the new National Drug Policy, in 2010 the first National Unique List of Essential Medicines was published for the entire public health sector, which was updated in 2012, 2015 and 2018.
  • In 2013, the first Complementary List of medicines for the treatment of neoplastic diseases was published; subsequently, in 2015, the Complementary List of medicines for the treatment of tuberculosis, STIs HIV/AIDS and malaria was drawn up. In 2016, the Complementary Lists of medicines for maternal-natal and mental health, as well as for the control of childhood anemia and parasitosis were drawn up. Finally, in 2017, the Complementary Lists of medicines for the treatment of neurological diseases, as well as for neoplastic diseases (second version) were elaborated.
  • In 2019, the first National Unique List of Essential Medical Devices for the entire public health sector was published.
  • In March 2022, the cost-effectiveness threshold for health technology assessments was published at the proposal of the professionals responsible for the economic evaluations of the ETS-URM Team
  • In October 2022, the first phase of updating the National Unique List of Essential Medicines (PNUME) was completed; this process involved the preparation of 127 rapid health technology assessment reports. They are currently in public consultation, in January 2023 the next phase in health technologies assessment will continue for the final decision.
  • In November 2022, a new version of the Complementary List of medicines for the treatment of neoplastic diseases to the PNUME was published; this process involved the preparation of 72 rapid health technology assessment reports and 15 economic evaluation of health technologies reports.
  • In November 2022, the threshold for high-cost oncology pharmaceuticals was published at the proposal of the professionals responsible for the economic evaluations of the ETS-URM Team.
  • In December 2022, the development of the Complementary List of medicines for the treatment of pre-XDR and XDR tuberculosis, as well as RR, MDR and latent tuberculosis was completed; this process involved the development of 06 rapid health technology assessment reports.

Current (selected) projects

  • In January 2023, the approval of the selection process of drugs for the treatment of lung cancer to the PNUME was completed. This process involved the preparation of 13 rapid health technology assessment reports and 10 economic evaluation of health technology reports.
  • In February 2023, the elaboration process of the Complementary Lists of medicines for the treatment of malaria and leishmaniasis will be completed, as well as the Complementary Lists of medicines for the treatment of HIV/AIDS and hepatitis C. Those process involved the preparation of 04 and 08 rapid health technology assessment reports, respectively.
  • In addition, the ETS-URM team is evaluating medicines for updating the Technical Health Standard for the treatment of Diabetes Mellitus.
  • The team is also formulating the update of the regulations for Pharmacotherapeutic Committees and the authorization of drugs not considered in the PNUME.
  • The calculation of the threshold for high-cost pharmaceutical products is under development.

Future Plans

  • Publication of the update of the National Unique List of Essential Medicines
  • Update of the National Unique List for Essential Medical Devices
  • Elaboration of decision models for economic evaluations
  • Elaboration of a manual for cost-effectiveness studies.
  • Articulation with the General Directorate of Strategic Interventions in Public Health (DGIESP, for its acronym in Spanish) for the prioritization of health technology assessment.
  • Research related to the selection processes and elaboration of National Lists of Essential Medicines and Essential Medical Devices.

 

Agency Information

Country: Peru
Description of population served: National
Population served (mil): 33
Current HTA budget (mil USD):
Permanent staff: 10
Consultants: 6
Ongoing TA projects:

Contact Information

General Director: Ana Gabriela Silva Flor
Contact person: Ivan Solis Ricra

Av. Parque de las Leyendas 240
San Miguel – Lima

Tel: +51 1 6314300 Int 6413
Internet: https://www.digemid.minsa.gob.pe
Email: eurm.digemid@minsa.gob.pe