Public Consultation is open at the National Commission for the Incorporation of Technology into the Unified Health System (CONITEC) to assess the incorporation of ibrutinib into the SUS.
That's a demand mapped by the ABHH LLC and Equity Committees., through its essentiality program, which identified the need for the incorporation of essential drugs into the public system and that Is in line with the World Health Organization (WHO) list of mandatory or essential drugs.
Therefore, there is a great effort to support CONITEC in the process of understanding the drug. In this way, the ABHH Committees support, in a technical manner, important decisions that impact the lives of thousands of people.
Participate by April 29th.
Public Consultation Link: https://www.gov.br/participamaisbrasil/consulta-publica-conitec-sectics-n-11-2024-ibrutinibe
➡️Why is the incorporation of Ibrutinib into the treatment of CLL RR in the SUS important?
🔹 Ibrutinib is a drug from the Bruton tyrosine kinase inhibitor (BtKi) class, a target therapy, for oral use, approved by the Health Surveillance Agency (ANVISA) in 2015.
🔹 Since 2018, the drug has been included in the ROL of drugs authorized by the National Health Agency (ANS) for patients in the private system (learn more). However, 70% of Brazilian patients are treated by the public health system.
🔹 In addition, in general, it is estimated that SUS patients are 3 times more likely to die than patients in the private system, with an average of 7 years the difference in life expectancy [1].
🔹 The incorporation of Ibrutinib in the treatment of CLL RR is, therefore, a major medical need not yet met in the SUS, as these patients do not have therapeutic alternatives available in the public system [2,3,4].
🔹 Therefore, Ibrutinib is the only medication recommended by the World Health Organization (WHO) exclusively for RR CLL [5.6] and is also recommended by all international guidelines [7,8,9].
🔹 Also, there is scientific evidence showing that patients treated with Ibrutinib have an overall survival similar to that of the general population without CLL [10].
References:
1.Pfister et al. Lower access to risk stratification tests and drugs, and worse survival of chronic lymphocytic leukaemia patients treated in public as compared to private hospitals in Brazil: A retrospective analysis of the Brazilian registry of chronic lymphocytic leukaemia. EJ Haem. 2022 Aug 6; 3 (3) :698-706.
2. Rodrigues et al. Diagnosis and treatment of chronic lymphocytic leukemia: recommendations from the Brazilian Group of Chronic Lymphocytic Leukemia. Rev Bras Hematol Hemoter. 2016 Oct; 38 (4) :346—57.
3. Burger, JA. N Engl J Med 383; 5. July 30, 2020.
4. Bulletin of the products consulted in the Electronic Bulletin provided by ANVISA: https://consultas.anvisa.gov.br/#/bulario/.
5. World Health Organization. WHO Model List of Essential Medicines — 22nd List (2021) [Internet]. 2021 [cited 2023 May 7]. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02.
6. World Health Organization. WHO Model List of Essential Medicines — 23rd list, 2023 [Internet]. 2023 [cited 2023 Aug 3]. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02.
7. Eichhorst B, Robak T, Montserrat E, Ghia P, Niemann CU, Kater AP, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2021 Jan; 32 (1) :23—33.
8. Walewska R, Parry‐Jones N, Eyre TA, Follows G, Martinez‐N Street, McCarthy H, et al. Guideline for the treatment of chronic lymphocytic leukaemia. Br J Haematol. 2022 Jun 21; 197 (5) :544—57.
9. Walewska et al. Guideline for the treatment of chronic lymphocytic leukaemia. Br J Haematol. 2022 Jun 21; 197 (5) :544—57.
10. Ghia P et al. Blood (2022) 140 (Supplement 1): 4159—4161. https://doi.org/10.1182/blood-2022-163257.
