The new Clinical Protocol and Therapeutic Guidelines for Hepatitis C (PCDT) was put into effect last March. Since de Ordinance effectiveness on, the Ministry of Health must make available the new drugs introduced by the protocol to population in 180 days.
Unfortunately, the drugs newly introduced might not achieve those one in need so early. It is easy to predict that by a simple reading of the Circular Letter n° 8/2018/CGCEAF/DAF/SCTIE/MS, in which the Ministry of Health declares that “it keeps studying new strategies in order to optimize the medicine distribution, and that is “affecting the start of the Hepatitis C new drugs purchase process, resulting in an additional waiting time for them to commit with what was agreed.
The lack of medicine is quite predictable due to the State of São Paulo Health Care System situation so, since the first trimester, more than 500 patients are not receiving Hepatitis C treatment. In the context presented, the FOAESP sent an Official Letter to Gilberto Occhi, the Minister of Health, raising questions about the subject, among other points.
The document was registered at the Ministry of Health headquarters on April 26.
Check out the document below.
São Paulo, Abril 25, 2018.
The Honorable Mr.
Gilberto Magalhães Occhi
Minister of Health
Adeilson Loureiro Cavalcante
The Ministry of Health Executive Secretary
Copy to Dr. Adele Benzaken
STI, Aids and Viral Hepatitis Department
Renato Alves Teixeira Lima
Department of Pharmaceutical Services and Strategic Imputs
Brasília – DF
Ref.: Situation of the Hepatitis C antiviral medicine in Brazil
The State of São Paulo Forum on NGO/AIDS (FOAESP), collegiate body set up of more than one hundred Civil Society Organizations policy advocating for the Human Rights of people living with HIV/AIDS (PLWHA) and the valorization of the Unified Health System, hereby brings questions regarding to the Circular Letter n. 8/2018CGCEAF/DAF/SCTIE/MS and the alignment of HCV medicine allocation as prescribed by the Clinical Protocol and Therapeutic Guidelines on Hepatitis C”, for instance:
In item 3 of the Circular Letter it is emphasized that the drugs elbasvir+grazoprevir and sofosbuvir+ledispavir were incorporated to the Unified Health System on March 13, 2018, through the Ordinances SCTIE/MS n° 11 and n°13, respectively.
Item 4, however, affirms that the Ministry of Health “is studying new strategies, aiming at optimizing the purchase process, but that is obstructing the beginning of the processes of the new Hepatitis C medicine acquisition and distribution”.
Finally, the item 6 states then “patients whom have the prerogative on receiving the newly incorporated medicine must wait until there is a definition regarding the procedures and deadlines of their acquisition and distribution.
Considering the request letter for treatment supply sent by the São Paulo state manager on February 2nd, of 14.336 declastavir 30 mg pills, 5.404 declastavir 60 mg pills, 8.120 simeprevir pills and 2.520 sofosbuvir pills, as well as the request letter for treatment supply for the second trimester of 2.520 declastavir 30 mg pills, 16.800 declastavir 60 mg pills, 1.512 simerevir pills and 19.656 sofosbuvir pills, which would serve 557 patients benefited by the 2017 PCDT were not met, we ask:
- How many patients and the amount sent by the State of São Paulo in order to fulfill the request made for the first trimester and the purchase plan for the second one?
- How many HCV antiviral are there in stock in Brasilia?
- Will the medicine distribution start in 180 days deadline, as recommends the 2018 PCDT, I accordance with Art. 25 of the Decree n° 7.646, from December 2011?
- What was the resources invested to buy Hepatitis C treatment, as well as how much is still in the 2018 budget?
- What is the 2018 budget on the purchase of HIV and HCV treatment?
Expecting to have access to the information above requested well soon, we lay emphasis,
Cordially and cooperatively,